(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 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 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 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 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]

§ 870.4370 Roller-type cardiopulmonary

pump.

bypass blood

(a) Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through

or

(a) Identification. An external cardiac compressor is an external device that is electrically, pneumatically, 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]

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]

$870.5300 DC-defribrillator (including paddles).

(a) Low-energy DC-defibrillator—(1) Identification. A low-energy DCdefibrillator 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

Identification.

DC-defibrillator—(1)

A high-energy DCdefibrillator 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]

cardiac pacemaker (noninvasive). (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]

EFFECTIVE DATE NOTE: At 65 FR 17144, Mar. 31, 2000, $870.5550 was amended by revising paragraph (b) and by removing paragraph (c), effective May 1, 2000. For the convenience of the user, the superseded text follows.

$870.5550 External transcutaneous cardiac pacemaker (noninvasive).

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of c 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.

$870.5800 Compressible limb sleeve. (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 (perform ance standards).