21 C.F.R. PART 870—CARDIOVASCULAR DEVICES
Title 21 - Food and Drugs
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
Source: 45 FR 7907-7971, Feb. 5, 1980, unless otherwise noted.
(a) This part sets forth the classification of cardiovascular devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by §807.87. (c) To avoid duplicative listings, a cardiovascular device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart. (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. (e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/cdrh/guidance.php. [52 FR 17735, May 11, 1987, as amended at 68 FR 61344, Oct. 28, 2003] A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. (a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device. (b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. [52 FR 17735, May 11, 1987] The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or (c) The device is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in §812.3(k) of this chapter; and (9) For near patient testing (point of care). [65 FR 2314, Jan. 14, 2000] (a) Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs. (b) Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See §870.1 for the availability of this guidance document. [68 FR 61344, Oct. 28, 2003] (a) Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and emits an alarm when the blood pressure falls outside a pre-set upper or lower limit. (b) Classification. Class II (performance standards). (a) Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal. (b) Classification. Class II (performance standards). (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure. (b) Classification. Class II (performance standards). (a) Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body. (b) Classification. Class II (performance standards). (a) Identification. A venous blood pressure manometer is a device attached to a venous catheter to indicate manometrically the central or peripheral venous pressure. (b) Classification. Class II (performance standards). (a) Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others. (b) Classification. Class II (performance standards). (a) Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping. (b) Classification. Class II (performance standards). (a) Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations. (b) Classification. Class II (performance standards). (a) Identification. A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter. (b) Classification. Class II (performance standards). (a) Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position. (b) Classification. Class II (performance standards). (a) Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire. (b) Classification. Class II (performance standards). (a) Identification. An intracavitary phonocatheter system is a system that includes a catheter with an acoustic transducer and the associated device that processes the signal from the transducer; this device records bioacoustic phenomena from a transducer placed within the heart, blood vessels, or body cavities. (b) Classification. Class II (performance standards). (a) Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit. (b) Classification. Class II (performance standards). (a) Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter. (b) Classification. Class II (performance standards). (a) Identification. A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector. (b) Classification. Class II (performance standards). (a) Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire. (b) Classification. Class II (performance standards). (a) Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. (b) Classification. Class II (performance standards). (a) Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery. (b) Classification. Class II (performance standards). (a) Identification. A catheter balloon repair kit is a device used to repair or replace the balloon of a balloon catheter. The kit contains the materials, such as glue and balloons, necessary to effect the repair or replacement. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any catheter balloon repair kit that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a catheter balloon repair kit that was in commercial distribution before May 28, 1976. Any other catheter balloon repair kit shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 61 FR 50706, Sept. 27, 1996] (a) Identification. A trace microsphere is a radioactively tagged nonbiodegradable particle that is intended to be injected into an artery or vein and trapped in the capillary bed for the purpose of studying blood flow within or to an organ. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any trace microsphere that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a trace microsphere that was in commercial distribution before May 28, 1976. Any other trace microsphere shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 61 FR 50706, Sept. 27, 1996] (a) Identification. A catheter tip occluder is a device that is inserted into certain catheters to prevent flow through one or more orifices. (b) Classification. Class II (performance standards). (a) Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff. (b) Classification. Class II (performance standards). (a) Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula. (b) Classification. Class II (performance standards). (a) Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs. (b) Classification. Class II (performance standards). (a) Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices. (b) Classification. Class II (performance standards). (a) Identification. A densitometer is a device used to measure the transmission of light through an indicator in a sample of blood. (b) Classification. Class II (performance standards). (a) Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography. (b) Classification. Class II (performance standards). (a) Identification. An indicator injector is an electrically or gas-powered device designed to inject accurately an indicator solution into the blood stream. This device may be used in conjuction with a densitometer or thermodilution device to determine cardiac output. (b) Classification. Class II (performance standards). (a) Identification. A syringe actuator for an injector is an electrical device that controls the timing of an injection by an angiographic or indicator injector and synchronizes the injection with the electrocardiograph signal. (b) Classification. Class II (performance standards). (a) Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies. (b) Classification. Class II (performance standards). (a) Identification. A withdrawal-infusion pump is a device designed to inject accurately drugs into the bloodstream and to withdraw blood samples for use in determining cardiac output. (b) Classification. Class II (performance standards). (a) Manual stethoscope—(1) Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. (2) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §870.9. (b) Electronic stethoscope—(1) Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs. (2) Classification. Class II (performance standards). [45 FR 7907-7971, Feb. 5, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38796, July 25, 2001] (a) Identification. A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes. (b) Classification. Class II (performance standards). (a) Identification. A biopotential amplifier and signal conditioner is a device used to amplify or condition an electrical signal of biologic origin. (b) Classification. Class II (performance standards). (a) Identification. A transducer signal amplifier and conditioner is a device used to provide the excitation energy for the transducer and to amplify or condition the signal emitted by the transducer. (b) Classification. Class II (performance standards). (a) Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal. (b) Classification. Class II (performance standards). (a) Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel. (b) Classification. Class II (performance standards). (a) Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits. (b) Classification. Class II (performance standards). (a) Identification. An apex cardiograph (vibrocardiograph) is a device used to amplify or condition the signal from an apex cardiographic transducer and to produce a visual display of the motion of the heart; this device also provides any excitation energy required by the transducer. (b) Classification. Class II (performance standards). (a) Identification. A ballistocardiograph is a device, including a supporting structure on which the patient is placed, that moves in response to blood ejection from the heart. The device often provides a visual display. (b) Classification. Class II (performance standards). (a) Identification. An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners. (b) Classification. Class II (performance standards). (a) Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart. (b) Classification. Class II (performance standards). (a) Identification. An electrocardiograph lead switching adaptor is a passive switching device to which electrocardiograph limb and chest leads may be attached. This device is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations such as leads I, II, and III. (b) Classification. Class II (performance standards). (a) Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. (b) Classification. Class II (performance standards). (a) Identification. An electrocardiograph surface electrode tester is a device used to test the function and application of electrocardiograph electrodes. (b) Classification. Class II (performance standards). (a) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound transducer. This device furnishes the excitation energy for the transducer and provides a visual or audible display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §870.9. [45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] (a) Identification. A vectorcardiograph is a device used to process the electrical signal transmitted through electrocardiograph electrodes and to produce a visual display of the magnitude and direction of the electrical signal produced by the heart. (b) Classification. Class II (performance standards). (a) Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal. (b) Classification. Class II (performance standards). (a) Identification. A signal isolation system is a device that electrically isolates the patient from equipment connected to the commercial power supply received from a utility company. This isolation may be accomplished, for example, by transformer coupling, acoustic coupling, or optical coupling. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §870.9. [45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] (a) Identification. A line isolation monitor is a device used to monitor the electrical leakage current from a power supply electrically isolated from the commercial power supply received from a utility company. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §870.9. [45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] (a) Identification. A portable leakage current alarm is a device used to measure the electrical leakage current between any two points of an electrical system and to sound an alarm if the current exceeds a certain threshold. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §870.9. [45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] (a) Identification. An oscillometer is a device used to measure physiological oscillations of any kind, e.g., changes in the volume of arteries. (b) Classification. Class II (performance standards). (a) Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter. (b) Classification. Class II (performance standards). (a) Identification. An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation. (b) Classification. Class II (performance standards). (a) Identification. An impedance phlebograph is a device used to provide a visual display of the venous pulse or drainage by measuring electrical impedance changes in a region of the body. (b) Classification. Class II (performance standards). (a) Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. (b) Classification. Class II (performance standards). (a) Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques. (b) Classification. Class II (performance standards). (a) Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers. (b) Classification. Class II (performance standards). (a) Identification. A paper chart recorder is a device used to print on paper, and create a permanent record of the signal from, for example, a physiological amplifier, signal conditioner, or computer. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §870.9. [45 FR 7907–7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] (a) Identification. An apex cardiographic transducer is a device used to detect motion of the heart (acceleration, velocity, or displacement) by changes in the mechanical or electrical properties of the device. (b) Classification. Class II (performance standards). (a) Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer. (b) Classification. Class II (performance standards). (a) Identification. Implantable intra-aneurysm pressure measurement system is a device used to measure the intra-sac pressure in a vascular aneurysm. The device consists of a pressure transducer that is implanted into the aneurysm and a monitor that reads the pressure from the transducer. (b) Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System.” See §870.1 (e) for the availability of this guidance document. [71 FR 7871, Feb. 15, 2006] (a) Identification. A heart sound transducer is an external transducer that exhibits a change in mechanical or electrical properties in relation to sounds produced by the heart. This device may be used in conjunction with a phonocardiograph to record heart sounds. (b) Classification. Class II (performance standards). (a) Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing. (b) Classification. Class II (performance standards). (a) Identification. An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers. (b) Classification. Class II (performance standards). (a) Identification. A vessel occlusion transducer is a device used to provide an electrical signal corresponding to sounds produced in a partially occluded vessel. This device includes motion, sound, and ultrasonic transducers. (b) Classification. Class II (performance standards). (a) Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers. (b) Classification. Class II (performance standards). (a) Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed. (b) Classification. Class II (performance standards). (a) Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals. (b) Classification. Class II (performance standards). (a) Identification. A vascular clip is an implanted extravascular device designed to occlude, by compression, blood flow in small blood vessels other than intracranial vessels. (b) Classification. Class II (performance standards). (a) Identification. A vena cava clip is an implanted extravascular device designed to occlude partially the vena cava for the purpose of inhibiting the flow of thromboemboli through that vessel. (b) Classification. Class II (performance standards). (a) Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see §882.5950 of this chapter. (b) Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see §870.1(e). [69 FR 77899, Dec. 29, 2004] (a) Identification. A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation. (b) Classification. Class II. The special controls for this device are: (1) “Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ ” and (2) FDA's: (i) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90–1)” and (ii) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.” [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 65 FR 17144, Mar. 31, 2000] (a) Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.” [66 FR 18542, Apr. 10, 2001] (a) Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures. (b) Classification. Class II (performance standards). (a) Identification. A intra-aortic balloon and control system is a device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §870.3. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987] (a) Identification. A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §870.3. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987] (a) Identification. An external pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing sytem until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §870.3. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987] (a) Identification. An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device includes triggered, inhibited, and asynchronous devices implanted in the human body. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §870.3. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987] (a) Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.” [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 66 FR 18542, Apr. 10, 2001] (a) Identification. A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold. (b) Classification. Class II (performance standards). (a) Identification. An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or pacemaker battery function by periodically monitoring an implanted pacemaker's pulse rate and pulse width. The device is noninvasive, and it detects pacemaker pulse rate and width via external electrodes in contact with the patient's skin. (b) Classification. Class II (performance standards). (a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a pacemaker pulse generator. The bag is designed to create a stable implant environment for the pulse generator. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §870.9. [45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] (a) Identification. A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable pacemaker. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §870.9. [45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] (a) Temporary pacemaker electrode—(1) Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. (2) Classification. Class II (performance standards). (b) Permanent pacemaker electrode—(1) Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. (2) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See §870.3. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987] (a) Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type of pacemaker pulse generator and cause an inhibited or triggered generator to revert to asynchronous operation. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §870.9. [45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] (a) Identification. A pacemaker programmer is a device used to change noninvasively one or more of the electrical operating characteristics of a pacemaker. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §870.3. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987] (a) Identification. A pacemaker repair or replacement material is an adhesive, a sealant, a screw, a crimp, or any other material used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker pulse generator. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §870.3. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987] (a) Identification. A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential. (b) Classification. Class II (performance standards). (a) Identification. Pacemaker service tools are devices such as screwdrivers and Allen wrenches, used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker generator. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §870.9. [45 FR 7907–7971, Feb. 5, 1980, as amended at 54 FR 25049, June 12, 1989; 66 FR 38797, July 25, 2001] (a) Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.” [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 66 FR 18542, Apr. 10, 2001] (a) Identification. A carotid sinus nerve stimulator is an implantable device used to decrease arterial pressure by stimulating Hering's nerve at the carotid sinus. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any carotid sinus nerve stimulator that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a carotid sinus nerve stimulator that was in commercial distribution before May 28, 1976. Any other carotid sinus nerve stimulator shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 61 FR 50706, Sept. 27, 1996] (a) Identification. A replacement heart valve is a device intended to perform the function of any of the heart's natural valves. This device includes valves constructed of prosthetic materials, biologic valves (e.g., porcine valves), or valves constructed of a combination of prosthetic and biologic materials. (b) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 9, 1987 for any replacement heart valve that was in commercial distribution before May 28, 1976, or that has on or before December 9, 1987 been found to be substantially equivalent to a replacement heart valve that was in commercial distribution before May 28, 1976. Any other replacement heart valve shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 18163, May 13, 1987; 52 FR 23137, June 17, 1987] (a) Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996] (a) Identification. A prosthetic heart valve sizer is a device used to measure the size of the natural valve opening to determine the size of the appropriate replacement heart valve. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §870.9. [45 FR 7907-7971, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38797, July 25, 2001] (a) Identification. An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart. (b) Classification. Class II (performance standards). (a) Identification. Cardiopulmonary bypass accessory equipment is a device that has no contact with blood and that is used in the cardiopulmonary bypass circuit to support, adjoin, or connect components, or to aid in the setup of the extracorporeal line, e.g., an oxygenator mounting bracket or system-priming equipment. (b) Classification. (1) Class I. The device is classified as class I if it does not involve an electrical connection to the patient. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §870.9. (2) Class II (special controls). The device is classified as class II if it involves an electrical connection to the patient. The special controls are as follows: (i) The performance standard under part 898 of this chapter, and (ii) The guidance document entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §870.9. [65 FR 19319, Apr. 11, 2000] (a) Identification. A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.” [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 66 FR 18542, Apr. 10, 2001] (a) Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.” [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 66 FR 18542, Apr. 10, 2001] (a) Identification. A cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary prebypass filter is a device used during priming of the oxygenator circuit to remove particulates or other debris from the circuit prior to initiating bypass. The device is not used to filter blood. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary bypass coronary pressure gauge is a device used in cardiopulmonary bypass surgery to measure the pressure of the blood perfusing the coronary arteries. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary bypass pulsatile flow generator is an electrically and pneumatically operated device used to create pulsatile blood flow. The device is placed in a cardiopulmonary bypass circuit downstream from the oxygenator. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976. Any other cardiopulmonary bypass pulsatile flow generator shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 69 FR 34920, June 23, 2004] (a) Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood in the blood reservoir and to sound an alarm when the level falls below a predetermined value. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.” [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 66 FR 18542, Apr. 10, 2001] (a) Identification. A nonroller-type cardiopulmonary bypass blood pump is a device that uses a method other than revolving rollers to pump the blood through the cardiopulmonary bypass circuit during bypass surgery. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §870.3. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987] (a) Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation. (b) Classification. Class II (performance standards), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. (a) Identification. A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary bypass cardiotomy return sucker is a device that consists of tubing, a connector, and a probe or tip that is used to remove blood from the chest or heart during cardiopulmonary bypass surgery. (b) Classification. Class II (performance standards). (a) Identification. A cardiopulmonary bypass intracardiac suction control is a device which provides the vacuum and control for a cardiotomy return sucker. (b) Classification. Class II (performance standards). (a) Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily. (b) Classification. Class II (performance standards). (a) Identification. A surgical vessel dilator is a device used to enlarge or calibrate a vessel. (b) Classification. Class II (performance standards). (a) Identification. Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §870.9. [45 FR 7907–7971, Feb. 5, 1980, as amended at 54 FR 25049, June 12, 1989; 66 FR 38797, July 25, 2001] (a) Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.) (b) Classification. Class II (performance standards). (a) Identification. An external vein stripper is an extravascular device used to remove a section of a vein. (b) Classification. Class II (performance standards). (a) Identification. A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery. (b) Classification. Class II (performance standards). (a) Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another. (b) Classification. Class II (performance standards). (a) Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants. (b) Classification. Class II (performance standards). (a) Identification. An external cardiac compressor is an external device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §870.3. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987] (a) Identification. An external counter-pulsating device is a noninvasive device used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §870.3. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987] (a) Low-energy DC-defibrillator—(1) Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body. (2) Classification. Class II (performance standards). (b) High-energy DC-defibrillator—(1) Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body. (2) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 61 FR 50706, Sept. 27, 1996] (a) Identification. An automated external defibrillator (AED) is a low-energy device with a rhythm recognition detection system that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart. An AED analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia. (b) Classification. Class III (premarket approval) (c) Date PMA or notice of PDP is required. No effective date has been established of the requirement for premarket approval. See §870.3. [68 FR 61344, Oct. 28, 2003; 69 FR 10615, Mar. 8, 2004] (a) Identification. A defibrillator tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. Some testers also provide waveform information. (b) Classification. Class II (performance standards). (a) Identification. An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles. (b) Classification. Class II. The special controls for this device are: (1) “American National Standards Institute/American Association for Medical Instrumentation's DF–21 ‘Cardiac Defibrillator Devices’ ” 2d ed., 1996, and (2) “The maximum pulse amplitude should not exceed 200 milliamperes. The maximum pulse duration should not exceed 50 milliseconds.” [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 65 FR 17144, Mar. 31, 2000] (a) Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. (b) Classification. Class II (performance standards). (a) Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature. (b) Classification. Class II (performance standards). (a) Identification. An automatic rotating tourniquet is a device that prevents blood flow in one limb at a time, which temporarily reduces the total blood volume, thereby reducing the normal workload of the heart. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Section Contents
§ 870.1 Scope.
§ 870.3 Effective dates of requirement for premarket approval.
§ 870.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
§ 870.1100 Blood pressure alarm.
§ 870.1110 Blood pressure computer.
§ 870.1120 Blood pressure cuff.
§ 870.1130 Noninvasive blood pressure measurement system.
§ 870.1140 Venous blood pressure manometer.
§ 870.1200 Diagnostic intravascular catheter.
§ 870.1210 Continuous flush catheter.
§ 870.1220 Electrode recording catheter or electrode recording probe.
§ 870.1230 Fiberoptic oximeter catheter.
§ 870.1240 Flow-directed catheter.
§ 870.1250 Percutaneous catheter.
§ 870.1270 Intracavitary phonocatheter system.
§ 870.1280 Steerable catheter.
§ 870.1290 Steerable catheter control system.
§ 870.1300 Catheter cannula.
§ 870.1310 Vessel dilator for percutaneous catheterization.
§ 870.1330 Catheter guide wire.
§ 870.1340 Catheter introducer.
§ 870.1350 Catheter balloon repair kit.
§ 870.1360 Trace microsphere.
§ 870.1370 Catheter tip occluder.
§ 870.1380 Catheter stylet.
§ 870.1390 Trocar.
§ 870.1425 Programmable diagnostic computer.
§ 870.1435 Single-function, preprogrammed diagnostic computer.
§ 870.1450 Densitometer.
§ 870.1650 Angiographic injector and syringe.
§ 870.1660 Indicator injector.
§ 870.1670 Syringe actuator for an injector.
§ 870.1750 External programmable pacemaker pulse generator.
§ 870.1800 Withdrawal-infusion pump.
§ 870.1875 Stethoscope.
§ 870.1915 Thermodilution probe.
§ 870.2050 Biopotential amplifier and signal conditioner.
§ 870.2060 Transducer signal amplifier and conditioner.
§ 870.2100 Cardiovascular blood flowmeter.
§ 870.2120 Extravascular blood flow probe.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
§ 870.2310 Apex cardiograph (vibrocardiograph).
§ 870.2320 Ballistocardiograph.
§ 870.2330 Echocardiograph.
§ 870.2340 Electrocardiograph.
§ 870.2350 Electrocardiograph lead switching adaptor.
§ 870.2360 Electrocardiograph electrode.
§ 870.2370 Electrocardiograph surface electrode tester.
§ 870.2390 Phonocardiograph.
§ 870.2400 Vectorcardiograph.
§ 870.2450 Medical cathode-ray tube display.
§ 870.2600 Signal isolation system.
§ 870.2620 Line isolation monitor.
§ 870.2640 Portable leakage current alarm.
§ 870.2675 Oscillometer.
§ 870.2700 Oximeter.
§ 870.2710 Ear oximeter.
§ 870.2750 Impedance phlebograph.
§ 870.2770 Impedance plethysmograph.
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
§ 870.2800 Medical magnetic tape recorder.
§ 870.2810 Paper chart recorder.
§ 870.2840 Apex cardiographic transducer.
§ 870.2850 Extravascular blood pressure transducer.
§ 870.2855 Implantable Intra-aneurysm Pressure Measurement System.
§ 870.2860 Heart sound transducer.
§ 870.2870 Catheter tip pressure transducer.
§ 870.2880 Ultrasonic transducer.
§ 870.2890 Vessel occlusion transducer.
§ 870.2900 Patient transducer and electrode cable (including connector).
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
§ 870.3250 Vascular clip.
§ 870.3260 Vena cava clip.
§ 870.3300 Vascular embolization device.
§ 870.3375 Cardiovascular intravascular filter.
§ 870.3450 Vascular graft prosthesis.
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
§ 870.3535 Intra-aortic balloon and control system
§ 870.3545 Ventricular bypass (assist) device.
§ 870.3600 External pacemaker pulse generator.
§ 870.3610 Implantable pacemaker pulse generator.
§ 870.3620 Pacemaker lead adaptor.
§ 870.3630 Pacemaker generator function analyzer.
§ 870.3640 Indirect pacemaker generator function analyzer.
§ 870.3650 Pacemaker polymeric mesh bag.
§ 870.3670 Pacemaker charger.
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
§ 870.3690 Pacemaker test magnet.
§ 870.3700 Pacemaker programmers.
§ 870.3710 Pacemaker repair or replacement material.
§ 870.3720 Pacemaker electrode function tester.
§ 870.3730 Pacemaker service tools.
§ 870.3800 Annuloplasty ring.
§ 870.3850 Carotid sinus nerve stimulator.
§ 870.3925 Replacement heart valve.
§ 870.3935 Prosthetic heart valve holder.
§ 870.3945 Prosthetic heart valve sizer.
§ 870.4075 Endomyocardial biopsy device.
§ 870.4200 Cardiopulmonary bypass accessory equipment.
§ 870.4205 Cardiopulmonary bypass bubble detector.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
§ 870.4230 Cardiopulmonary bypass defoamer.
§ 870.4240 Cardiopulmonary bypass heat exchanger.
§ 870.4250 Cardiopulmonary bypass temperature controller.
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
§ 870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.
§ 870.4280 Cardiopulmonary prebypass filter.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
§ 870.4300 Cardiopulmonary bypass gas control unit.
§ 870.4310 Cardiopulmonary bypass coronary pressure gauge.
§ 870.4320 Cardiopulmonary bypass pulsatile flow generator.
§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.
§ 870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
§ 870.4350 Cardiopulmonary bypass oxygenator.
§ 870.4360 Nonroller-type cardiopulmonary bypass blood pump.
§ 870.4370 Roller-type cardiopulmonary bypass blood pump.
§ 870.4380 Cardiopulmonary bypass pump speed control.
§ 870.4390 Cardiopulmonary bypass pump tubing.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
§ 870.4410 Cardiopulmonary bypass in-line blood gas sensor.
§ 870.4420 Cardiopulmonary bypass cardiotomy return sucker.
§ 870.4430 Cardiopulmonary bypass intracardiac suction control.
§ 870.4450 Vascular clamp.
§ 870.4475 Surgical vessel dilator.
§ 870.4500 Cardiovascular surgical instruments.
§ 870.4875 Intraluminal artery stripper.
§ 870.4885 External vein stripper.
§ 870.5050 Patient care suction apparatus.
§ 870.5150 Embolectomy catheter.
§ 870.5175 Septostomy catheter.
§ 870.5200 External cardiac compressor.
§ 870.5225 External counter-pulsating device.
§ 870.5300 DC-defribrillator (including paddles).
§ 870.5310 Automated external defibrillator.
§ 870.5325 Defibrillator tester.
§ 870.5550 External transcutaneous cardiac pacemaker (noninvasive).
§ 870.5800 Compressible limb sleeve.
§ 870.5900 Thermal regulating system.
§ 870.5925 Automatic rotating tourniquet.
Subpart A—General Provisions
top
§ 870.1 Scope.
top
§ 870.3 Effective dates of requirement for premarket approval.
top
§ 870.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
top
Subpart B—Cardiovascular Diagnostic Devices
top
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
top
§ 870.1100 Blood pressure alarm.
top
§ 870.1110 Blood pressure computer.
top
§ 870.1120 Blood pressure cuff.
top
§ 870.1130 Noninvasive blood pressure measurement system.
top
§ 870.1140 Venous blood pressure manometer.
top
§ 870.1200 Diagnostic intravascular catheter.
top
§ 870.1210 Continuous flush catheter.
top
§ 870.1220 Electrode recording catheter or electrode recording probe.
top
§ 870.1230 Fiberoptic oximeter catheter.
top
§ 870.1240 Flow-directed catheter.
top
§ 870.1250 Percutaneous catheter.
top
§ 870.1270 Intracavitary phonocatheter system.
top
§ 870.1280 Steerable catheter.
top
§ 870.1290 Steerable catheter control system.
top
§ 870.1300 Catheter cannula.
top
§ 870.1310 Vessel dilator for percutaneous catheterization.
top
§ 870.1330 Catheter guide wire.
top
§ 870.1340 Catheter introducer.
top
§ 870.1350 Catheter balloon repair kit.
top
§ 870.1360 Trace microsphere.
top
§ 870.1370 Catheter tip occluder.
top
§ 870.1380 Catheter stylet.
top
§ 870.1390 Trocar.
top
§ 870.1425 Programmable diagnostic computer.
top
§ 870.1435 Single-function, preprogrammed diagnostic computer.
top
§ 870.1450 Densitometer.
top
§ 870.1650 Angiographic injector and syringe.
top
§ 870.1660 Indicator injector.
top
§ 870.1670 Syringe actuator for an injector.
top
§ 870.1750 External programmable pacemaker pulse generator.
top
§ 870.1800 Withdrawal-infusion pump.
top
§ 870.1875 Stethoscope.
top
§ 870.1915 Thermodilution probe.
top
Subpart C—Cardiovascular Monitoring Devices
top
§ 870.2050 Biopotential amplifier and signal conditioner.
top
§ 870.2060 Transducer signal amplifier and conditioner.
top
§ 870.2100 Cardiovascular blood flowmeter.
top
§ 870.2120 Extravascular blood flow probe.
top
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
top
§ 870.2310 Apex cardiograph (vibrocardiograph).
top
§ 870.2320 Ballistocardiograph.
top
§ 870.2330 Echocardiograph.
top
§ 870.2340 Electrocardiograph.
top
§ 870.2350 Electrocardiograph lead switching adaptor.
top
§ 870.2360 Electrocardiograph electrode.
top
§ 870.2370 Electrocardiograph surface electrode tester.
top
§ 870.2390 Phonocardiograph.
top
§ 870.2400 Vectorcardiograph.
top
§ 870.2450 Medical cathode-ray tube display.
top
§ 870.2600 Signal isolation system.
top
§ 870.2620 Line isolation monitor.
top
§ 870.2640 Portable leakage current alarm.
top
§ 870.2675 Oscillometer.
top
§ 870.2700 Oximeter.
top
§ 870.2710 Ear oximeter.
top
§ 870.2750 Impedance phlebograph.
top
§ 870.2770 Impedance plethysmograph.
top
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
top
§ 870.2800 Medical magnetic tape recorder.
top
§ 870.2810 Paper chart recorder.
top
§ 870.2840 Apex cardiographic transducer.
top
§ 870.2850 Extravascular blood pressure transducer.
top
§ 870.2855 Implantable Intra-aneurysm Pressure Measurement System.
top
§ 870.2860 Heart sound transducer.
top
§ 870.2870 Catheter tip pressure transducer.
top
§ 870.2880 Ultrasonic transducer.
top
§ 870.2890 Vessel occlusion transducer.
top
§ 870.2900 Patient transducer and electrode cable (including connector).
top
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
top
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
top
Subpart D—Cardiovascular Prosthetic Devices
top
§ 870.3250 Vascular clip.
top
§ 870.3260 Vena cava clip.
top
§ 870.3300 Vascular embolization device.
top
§ 870.3375 Cardiovascular intravascular filter.
top
§ 870.3450 Vascular graft prosthesis.
top
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
top
§ 870.3535 Intra-aortic balloon and control system
top
§ 870.3545 Ventricular bypass (assist) device.
top
§ 870.3600 External pacemaker pulse generator.
top
§ 870.3610 Implantable pacemaker pulse generator.
top
§ 870.3620 Pacemaker lead adaptor.
top
§ 870.3630 Pacemaker generator function analyzer.
top
§ 870.3640 Indirect pacemaker generator function analyzer.
top
§ 870.3650 Pacemaker polymeric mesh bag.
top
§ 870.3670 Pacemaker charger.
top
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
top
§ 870.3690 Pacemaker test magnet.
top
§ 870.3700 Pacemaker programmers.
top
§ 870.3710 Pacemaker repair or replacement material.
top
§ 870.3720 Pacemaker electrode function tester.
top
§ 870.3730 Pacemaker service tools.
top
§ 870.3800 Annuloplasty ring.
top
§ 870.3850 Carotid sinus nerve stimulator.
top
§ 870.3925 Replacement heart valve.
top
§ 870.3935 Prosthetic heart valve holder.
top
§ 870.3945 Prosthetic heart valve sizer.
top
Subpart E—Cardiovascular Surgical Devices
top
§ 870.4075 Endomyocardial biopsy device.
top
§ 870.4200 Cardiopulmonary bypass accessory equipment.
top
§ 870.4205 Cardiopulmonary bypass bubble detector.
top
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
top
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
top
§ 870.4230 Cardiopulmonary bypass defoamer.
top
§ 870.4240 Cardiopulmonary bypass heat exchanger.
top
§ 870.4250 Cardiopulmonary bypass temperature controller.
top
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
top
§ 870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.
top
§ 870.4280 Cardiopulmonary prebypass filter.
top
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
top
§ 870.4300 Cardiopulmonary bypass gas control unit.
top
§ 870.4310 Cardiopulmonary bypass coronary pressure gauge.
top
§ 870.4320 Cardiopulmonary bypass pulsatile flow generator.
top
§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.
top
§ 870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
top
§ 870.4350 Cardiopulmonary bypass oxygenator.
top
§ 870.4360 Nonroller-type cardiopulmonary bypass blood pump.
top
§ 870.4370 Roller-type cardiopulmonary bypass blood pump.
top
§ 870.4380 Cardiopulmonary bypass pump speed control.
top
§ 870.4390 Cardiopulmonary bypass pump tubing.
top
§ 870.4400 Cardiopulmonary bypass blood reservoir.
top
§ 870.4410 Cardiopulmonary bypass in-line blood gas sensor.
top
§ 870.4420 Cardiopulmonary bypass cardiotomy return sucker.
top
§ 870.4430 Cardiopulmonary bypass intracardiac suction control.
top
§ 870.4450 Vascular clamp.
top
§ 870.4475 Surgical vessel dilator.
top
§ 870.4500 Cardiovascular surgical instruments.
top
§ 870.4875 Intraluminal artery stripper.
top
§ 870.4885 External vein stripper.
top
Subpart F—Cardiovascular Therapeutic Devices
top
§ 870.5050 Patient care suction apparatus.
top
§ 870.5150 Embolectomy catheter.
top
§ 870.5175 Septostomy catheter.
top
§ 870.5200 External cardiac compressor.
top
§ 870.5225 External counter-pulsating device.
top
§ 870.5300 DC-defribrillator (including paddles).
top
§ 870.5310 Automated external defibrillator.
top
§ 870.5325 Defibrillator tester.
top
§ 870.5550 External transcutaneous cardiac pacemaker (noninvasive).
top
§ 870.5800 Compressible limb sleeve.
top
§ 870.5900 Thermal regulating system.
top
§ 870.5925 Automatic rotating tourniquet.
top
