Lapas attēli
PDF
ePub

(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 8870.3. (45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987)

8 870.4360 Nonroller-type

cardiopulmonary bypass blood

pump. (a) Identification. Anonroller-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)

$ 870.4310 Cardiopulmonary bypass

coronary pressure gauge. (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). 8870.4320 Cardiopulmonary bypass

pulsatile flow generator. (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 8870.3. (45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987) $ 870.4330 Cardiopulmonary bypass

on-line blood gas monitor. (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). 8870.4340 Cardiopulmonary bypass

level sensing monitor and/or con

trol. (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). 8870.4350 Cardiopulmonary bypass

oxygenator. (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.

8870.4370 Roller-type

cardiopulmonary bypass blood

pump. (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).

8870.4380 Cardiopulmonary bypass

pump speed control. (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). 8870.4390 Cardiopulmonary bypass

pump tubing. (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

[blocks in formation]

or

com

or

blood vessels from one site in the vas- tricles of the heart or to terminate cular tree to another.

other cardiac arrhythmias. This ge(b) Classification. Class II (perform- neric type of device includes low enance standards).

ergy defibrillators with a maximum

electrical output of less than 360 joules $ 870.5175 Septostomy catheter.

of energy that are used in pediatric (a) Identification. A septostomy cath- defibrillation or in cardiac surgery. eter is a special balloon catheter that

The device may either synchronize the is used to create or enlarge the atrial

shock with the proper phase of the septal defect found in the heart of cer

electrocardiogram may operate tain infants.

asynchronously. The device delivers (b) Classification. Class II (perform

the electrical shock through paddles ance standards).

placed either directly across the heart 8870.5200 External cardiac

or on the surface of the body. pressor.

(2) Classification. Class II (perform(a) Identification. An external cardiac

ance standards). compressor is an external device that (b) High-energy DC-defibrillator-(1) is electrically, pneumatically, Identification. A high-energy DCmanually powered and is used to com- defibrillator is a device that delivers press the chest periodically in the re- into a 50 ohm test load an electrical gion of the heart to provide blood flow shock of greater than 360 joules of enduring cardiac arrest.

ergy used for defibrillating the atria or (b) Classification. Class III (premarket ventricles of the heart or to terminate approval).

other cardiac arrhythmias. The device (c) Date PMA or notice of completion of may either synchronize the shock with a PDP is required. No effective date has the proper phase of the electrocardiobeen established of the requirement for gram or may operate asynchronously. premarket approval. See $ 870.3.

The device delivers the electrical shock (45 FR 7907-7971, Feb. 5, 1980, as amended at through paddles placed either directly 52 FR 17737, May 11, 1987)

across the heart or on the surface of

the body. 8870.5225 External counter-pulsating (2) Classification. Class III (premarket device.

approval). (a) Identification. An external

(c) Date PMA or notice of completion of counter-pulsating device is a

a PDP is required. A PMA or a notice of noninvasive device used to assist the

completion of a PDP is required to be heart by applying positive or negative

filed with the Food and Drug Adminispressure to one or more of the body's

tration on or before December 26, 1996 limbs in synchrony with the heart

for any DC-defibrillator (including padcycle.

dles) described in paragraph (b)(1) of (b) Classification. Class III (premarket

this section that was in commercial approval). (c) Date PMA or notice of completion of

distribution before May 28, 1976, or that

has, on or before December 26, 1996 a PDP is required. No effective date has been established of the requirement for

been found to be substantially equivapremarket approval. See $870.3.

lent to a DC-defibrillator (including

paddles) described in paragraph (b)(1) [45 FR 7907-7971, Feb. 5, 1980, as amended at

of this section that was in commercial 52 FR 17737, May 11, 1987)

distribution before May 28, 1976. Any $ 870.5300 DC-defribrillator (including

other DC-defibrillator (including padpaddles).

dles) described in paragraph (b)(1) of

this section shall have an approved (a) Low-energy DC-defibrillator—(1) Identification. А low-energy

DC

PMA or declared completed PDP in efdefibrillator is a device that delivers

fect before being placed in commercial into a 50 ohm test load an electrical

distribution. shock of a maximum of 360 joules of en- (45 FR 7907–7971, Feb. 5, 1980, as amended at ergy used for defibrillating (restoring 52 FR 17737, May 11, 1987; 61 FR 50706, Sept. normal heart rhythm) the atria or ven- 27, 1996)

8870.5325 Defibrillator tester.

(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).

$ 870.5925 Automatic rotating tour.

niquet. (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).

PART 872-DENTAL DEVICES

Subpart A-General Provisions

Sec. 872.1 Scope. 872.3 Effective dates of requirement for pre

market approval. 872.9 Limitations of exemptions from sec

tion 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

$ 870.5550 External transcutaneous

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."

Subpart B-Diagnostic Devices

872.1500 Gingival fluid measurer. 872.1720 Pulp tester. 872.1730 Electrode gel for pulp testers. 872.1740 Caries detection device. 872.1745 Laser fluorescence caries detection

device. 872.1800 Extraoral source x-ray system. 872.1810 Intraoral source x-ray system. 872.1820 Dental X-ray exposure alignment

device. 872.1830 Cephalometer. 872.1840 Dental x-ray position indicating de

vice. 872.1850 Lead-lined position indicator. 872.1870 Sulfide detection device. 872.1905 Dental x-ray film holder.

[ocr errors]

[45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 65 FR 17144, Mar. 31, 2000]

Subpart C [Reserved)

$ 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 (performance standards).

Subpart D-Prosthetic Devices

$ 870.5900 Thermal regulating system.

(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).

872.3050 Amalgam alloy. 872.3060 Gold based alloys and precious

metal alloys for clinical use. 872.3080 Mercury and alloy dispenser. 872.3100 Dental amalgamator. 872.3110 Dental amalgam capsule. 872.3130 Preformed anchor. 872.3140 Resin applicator. 872.3150 Articulator. 872.3165 Precision attachment. 872.3200 Resin tooth bonding agent. 872.3220 Facebow. 872.3240 Dental bur. 872.3250 Calcium hydroxide cavity liner. 872.3260 Cavity varnish. 872.3275 Dental cement. 872.3285 Preformed clasp.

872.3950 Glenoid fossa prosthesis. 872.3960 Mandibular condyle prosthesis. 872.3970 Interarticular disc prosthesis

(interpositional implant). 872.3980 Endosseous dental implant acces

sories.

Subpart E-Surgical Devices 872.4120 Bone cutting instrument and acces

sories. 872.4130 Intraoral dental drill. 872.4200 Dental handpiece and accessories. 872.4465 Gas-powered jet injector. 872.4475 Spring-powered jet injector. 872.4535 Dental diamond instrument. 872.4565 Dental hand instrument. 872.4600 Intraoral ligature and wire lock. 872.4620 Fiber optic dental light. 872.4630 Dental operating light. 872.4730 Dental injecting needle. 872.4760 Bone plate. 872.4840 Rotary scaler. 872.4850 Ultrasonic scaler. 872.4880 Intraosseous fixation screw or wire. 872.4920 Dental electrosurgical unit and ac

cessories.

Subpart F-Therapeutic Devices

872.3300 Hydrophilic resin coating for den

tures. 872.3310 Coating material for resin fillings. 872.3330 Preformed crown. 872.3350 Gold or stainless steel cusp. 872.3360 Preformed cusp. 872.3400 Karaya and sodium borate with or

without acacia denture adhesive. 872.3410 Ethylene oxide homopolymer and/or

carboxymethylcellulose sodium denture

adhesive. 872.3420 Carboxymethylcellulose sodium

and cationic polyacrylamide polymer

denture adhesive. 872.3450 Ethylene oxide homopolymer and/or

karaya denture adhesive. 872.3480 Polyacrylamide polymer (modified

cationic) denture adhesive. 872.3490 Carboxymethylcellulose sodium

and/or polyvinylmethylether maleic acid calcium-sodium double salt denture ad

hesive. 872.3500 Polyvinylmethylether maleic anhy

dride (PVM-MA), acid copolymer, and carboxymethylcellulose

sodium (NACMC) denture adhesive. 872.3520 OTC denture cleanser. 872.3530 Mechanical denture cleaner. 872.3540 OTC denture cushion or pad. 872.3560 OTC denture reliner. 872.3570 OTC denture repair kit. 872.3580 Preformed gold denture tooth. 872.3590 Preformed plastic denture tooth. 872.3600 Partially fabricated denture kit. 872.3640 Endosseous implant. 872.3645 Subperiosteal implant material. 872.3660 Impression material. 872.3670 Resin impression tray material. 872.3680 Polytetrafluoroethylene (PTFE)

vitreous carbon materials. 872.3690 Tooth shade resin material. 872.3700 Dental mercury. 872.3710 Base metal alloy. 872.3730 Pantograph. 872.3740 Retentive and splinting pin. 872.3750 Bracket adhesive resin and tooth

conditioner. 872.3760 Denture relining, repairing, or re

basing resin. 872.3765 Pit and fissure sealant and condi

tioner. 872.3770 Temporary crown and bridge resin. 872.3810 Root canal post. 872.3820 Root canal filling resin. 872.3830 Endodontic paper point. 872.3840 Endodontic silver point. 872.3850 Gutta percha. 872.3890 Endodontic stabilizing splint. 872.3900 Posterior artificial tooth with a

metal insert. 872.3910 Backing and facing for an artificial

872.5410 Orthodontic appliance and acces

sories. 872.5470 Orthodontic plastic bracket. 872.5500 Extraoral orthodontic headgear. 872.5525 Preformed tooth positioner. 872.5550 Teething ring.

Subpart G-Miscellaneous Devices

tooth. 872.3920 Porcelain tooth. 872.3930 Tricalcium phosphate granules for

dental bone repair. 872.3940 Total temporomandibular joint

prosthesis.

872.6010 Abrasive device and accessories. 872.6030 Oral cavity abrasive polishing

agent. 872.6050 Saliva absorber. 872.6070 Ultraviolet activator for polym

erization. 872.6080 Airbrush. 872.6100 Anesthetic warmer. 872.6140 Articulation paper. 872.6200 Base plate shellac. 872.6250 Dental chair and accessories. 872.6290 Prophylaxis cup. 872.6300 Rubber dam and accessories. 872.6350 Ultraviolet detector. 872.6390 Dental floss. 872.6475 Heat source for bleaching teeth. 872.6510 Oral irrigation unit. 872.6570 Impression tube. 872.6640 Dental operative unit and acces

sories. 872.6650 Massaging pick or tip for oral hy

giene. 872.6660 Procelain powder for clinical use. 872.6670 Silicate protector. 872.6710 Boiling water sterilizer. 872.6730 Endodontic dry heat sterilizer. 872.6770 Cartridge syringe. 872.6855 Manual toothbrush. 872.6865 Powered toothbrush.

« iepriekšējāTurpināt »