21 C.F.R. Subpart D—Cardiovascular Prosthetic Devices
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart D—Cardiovascular Prosthetic Devices
§ 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.
