21 C.F.R. Subpart E—Cardiovascular Surgical Devices
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart E—Cardiovascular Surgical Devices
§ 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.
