Lapas attēli
PDF
ePub

concerning records, and $820.198, with tion procedures in subpart E of part 807 respect to complaint files.

of this chapter. $880.6250 Patient examination glove.

[45 FR 69682-69737, Oct. 21, 1980, as amended

at 61 FR 1123, Jan. 16, 1996) (a) Identification. A patient examination glove is a disposable device in- 8880.6350 Battery-powered medical tended for medical purposes that is

examination light. worn on the examiner's hand or finger (a) Identification. A battery-powered to prevent contamination between pa- medical examination light is a batterytient and examiner.

powered device intended for medical (b) Classification. Class I (general con- purposes that is used to illuminate trols).

body surfaces and cavities during a (45 FR 69682-69737, Oct. 21, 1980, as amended

medical examination. at 53 FR 1604, Jan. 13, 1989]

(b) Classification. Class I (general con

trols). The device is exempt from pre8880.6265 Examination gown.

market notification procedures in sub(a) Identification. An examination

part E of part 807. The device also is ex

empt from the good manufacturing gown is a device intended for medical purposes that is made of cloth, paper,

practice regulation in part 820, with

the exception of $820.180, with respect or other material that is draped over or

to general requirements concerning worn by a patient as a body covering during a medical examination.

records, and $ 820.198, with respect to

complaint files. (b) Classification. Class I (general controls). The device is exempt from the

$880.6375 Patient lubricant. premarket notification procedures in subpart E of part 807. If the device is

(a) Identification. A patient lubricant not labeled or otherwise represented as

is a device intended for medical pursterile, it also is exempt from the good

poses that is used to lubricate a body manufacturing practice regulation in

orifice to facilitate entry of a diagpart 820, with the exception of 8820.180,

nostic or therapeutic device. with respect to general requirements

(b) Classification. Class I (general conconcerning records, and $ 820.198, with

trols). respect to complaint files.

8880.6430 Liquid medication dis$ 880.6280 Medical insole.

penser.

(a) Identification. A Liquid medica(a) Identification. A medical insole is a device intended for medical purposes

tion dispenser is a device intended for

medical purposes that is used to issue a that is placed inside a shoe to relieve

measured amount of liquid medication. the symptoms of athlete's foot infection by absorbing moisture.

(b) Classification. Class I (general con

trols). The device is exempt from the (b) Classification. Class I. The device

premarket notification procedures in is exempt from the premarket notifica

subpart E of part 807. The device also is tion procedures in subpart E of part 807 of this chapter.

exempt from the good manufacturing

practice regulation in part 820, with (45 FR 69682-69737, Oct. 21, 1980, as amended the exception of $ 820.180, with respect at 54 FR 25050, June 12, 1989)

to general requirements concerning

records, and $820.198, with respect to $ 880.6320 AC-powered medical exam- complaint files.

ination light. (a) Identification. An AC-powered

$880.6450 Skin pressure protectors. medical examination light is an AC- (a) Identification. A skin pressure propowered device intended for medical tector is a device intended for medical purposes that is used to illuminate

purposes that is used to reduce presbody surfaces and cavities during a sure on the skin over a bony promimedical examination.

nence to reduce the likelihood of the (b) Classification. Class I. The device patient's developing decubitus ulcers is exempt from the premarket notifica- (bedsores).

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the good manufacturing practice regulation in part 820, with the exception of $ 820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files.

tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $880.9. [45 FR 69682-69737, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]

$880.6500 Medical ultraviolet air puri.

fier. (a) Identification. A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.

(b) Classification. Class II (performance standards).

$ 880.6760 Protective restraint.

(a) Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.

(b) Classification. Class I (general controls). [61 FR 8439, Mar. 4, 1996)

8880.6710 Medical ultraviolet water

purifier. (a) Identification. A medical ultraviolet water purifier is a device intended for medical purposes that is used to destroy bacteria in water by exposure to ultraviolet radiation.

(b) Classification. Class II (performance standards).

8 880.6730 Body waste receptacle.

(a) Identification. A body waste receptacle is a device intended for medical purposes tht is not attached to the body and that is used to collect the body wastes of a bed patient.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the good manufacturing practice regulation in part 820, with the exception of $ 820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files.

$880.6775 Powered patient transfer

device. (a) Identification. A powered patient transfer device is a device consisting of a wheeled stretcher and a powered mechanism that has a broad, flexible band stretched over long rollers that can advance itself under a patient and transfer the patient with minimal disturbance in a horizontal position to the stretcher.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $880.9. (45 FR 69682-69737, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]

$880.6740 Vacuum-powered body fluid

suction apparatus. (a) Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction

8 880.6785 Manual patient transfer de

vice. (a) Identification. A manual patient transfer device is a device consisting of a wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance in a horizontal position to the stretcher.

(b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807. The divice also is exempt from the good manufacturing vider that uses ethylene oxide (ETO) to sterilize medical products.

(b) Classification. Class II (performance standards).

8 880.6870 Dry-heat sterilizer.

(a) Identification. A dry-heat sterilizer is a device that is intended for use by a health care provider to sterilize medical products by means of dry heat.

(b) Classification. Class II (performance standards).

practice regulation in part 820, with the exception of $ 820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files. $880.6800 Washers for body waste re

ceptacles. (a) Identification. A washer for body waste receptacles is a device intended for medical purposes that is used to clean and sanitize a body waste receptacle, such as a bedpan. The device consists of a wall-mounted plumbing fixture with a door through which a body waste receptacle is inserted. When the door is closed the body waste receptacle is cleaned by hot water, steam, or germicide.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the good manufacturing practice regulation in part 820 with the exception of $ 820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files.

$ 880.6880 Steam sterilizer.

(a) Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.

(b) Classification. Class II (performance standards).

8 880.6820 Medical disposable scissors.

(a) Identification. Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This generic type of device does not include surgical scissors.

(b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807. 8880.6850 Sterilization wrap.

(a) Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

(b) Classification. Class II (performance standards).

8 880.6885 Liquid chemical sterilants/

high level disinfectants. (a) Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.

(b) Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training. [65 FR 36325, June 8, 2000)

8 880.6890 General purpose disinfect

ants. (a) Identification. A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in

$880.6860 Ethylene oxide gas steri.

lizer. (a) Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care pro

subpart E of part 807 of this chapter subject to the limitations in 8 880.9. [65 FR 36326, June 8, 2000)

rigate, withdraw fluid from, or instill fluid into, a body cavity or wound.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. If the device is not labeled or otherwise repr ated as sterile, it also is exempt from the good manufacturing practice regulation in part 820, with the exception of $820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files.

$ 880.6900 Hand-carried stretcher.

(a) Identification. A hand-carried stretcher is a device consisting of a lightweight frame, or of two poles with a cloth or metal platform, on which a patient can be carried.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. The device is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files. (45 FR 69682-69737, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994)

$ 880.6970 Liquid crystal vein locator.

(a) Identification. A liquid crystal vein locator is a device used to indicate the location of a vein by revealing variations in the surface temperature of the skin by displaying the color changes of heat sensitive liquid crystals (cholesteric esters).

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989)

8 880.6910 Wheeled stretcher.

(a) Identification. A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps. The frame may be fixed or collapsible for use in an ambulance.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 8 880.9. (45 FR 69682-69737, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]

$ 880.6980 Vein stabilizer.

(a) Identification. A vein stabilizer is a device consisting of a flat piece of plastic with two noninvasive prongs. The device is placed on the skin so that the prongs are on either side of a vein and hold it stable while a hypodermic needle is inserted into the vein.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. If the device is not labeled or otherwise represented as sterile, it is also exempt from the good manufacturing practice regulation in part 820, with the exception of $820.180,

requirements concerning records, and $ 820.198, with respect to complaint files.

general

$880.6920 Syringe needle introducer.

(a) Identification. A syringe needle introducer is a device that uses a springloaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.

(b) Classification. Class II (performance standards).

$ 880.6960 Irrigating syringe.

(a) Identification. An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to ir

8 880.6990 Infusion stand.

(a) Identification. The infusion stand is a stationary or movable stand intended to hold infusion liquids, infusion accessories, and other medical devices.

(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 8 880.9. [63 FR 59718, Nov. 5, 1998]

882.1900 Evoked response auditory stimu

lator. 882.1925 Ultrasonic scanner calibration test

block. 882.1950 Tremor transducer.

PART 882-NEUROLOGICAL

DEVICES

Subparts C-D (Reserved) Subpart E-Neurological Surgical Devices

Subpart A-General Provisions

Sec. 882.1 Scope. 882.3 Effective dates of requirement for pre

market approval. 882.9 Limitations of exemptions from sec

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

Subpart B-Neurological Diagnostic

Devices

882.1020 Rigidity analyzer. 882.1030 Ataxiagraph. 882.1200 Two-point discriminator. 882.1240 Echoencephalograph. 882.1275 Electroconductive media. 882.1310 Cortical electrode. 882.1320 Cutaneous electrode. 882.1330 Depth electrode. 882.1340 Nasopharyngeal electrode. 882.1350 Needle electrode. 882.1400 Electroencephalograph. 882.1410 Electroencephalograph electrode/

lead tester. 882.1420 Electroencephalogram (EEG) signal

spectrum analyzer. 882.1430 Electroencephalograph test signal

generator. 882.1460 Nystagmograph. 882.1480 Neurological endoscope. 882.1500 Esthesiometer. 882.1525 Tuning fork. 882.1540 Galvanic skin response measure

ment device. 882.1550 Nerve conduction velocity measure

ment device. 882.1560 Skin potential measurement de

vice. 882.1570 Powered direct-contact tempera

ture measurement device. 882.1610 Alpha monitor. 882.1620 Intracranial pressure monitoring

device. 882.1700 Percussor. 882.1750 Pinwheel. 882.1790 Ocular plethysmograph. 882.1825 Rheoencephalograph. 882.1835 Physiological signal amplifier. 882.1845 Physiological signal conditioner. 882.1855 Electroencephalogram (EEG) te

lemetry system. 882.1870 Evoked response electrical stimu

lator. 882.1880 Evoked response mechanical stimu

lator. 882.1890 Evoked response photic stimulator.

882.4030 Skull plate anvil. 882.4060 Ventricular cannula. 882.4100 Ventricular catheter. 882.4125 Neurosurgical chair. 882.4150 Scalp clip. 882.4175 Aneurysm clip applier. 882.4190 Clip forming/cutting instrument. 882.4200 Clip removal instrument. 882.4215 Clip rack. 882.4250 Cryogenic surgical device. 882.4275 Dowel cutting instrument. 882.4300 Manual cranial drills, burrs,

trephines, and their accessories, 882.4305 Powered compound cranial drills,

burrs, trephines, and their accessories. 882.4310 Powered simple cranial drills,

burrs, trephines, and their accessories. 882.4325 Cranial drill handpiece (brace). 882.4360 Electric cranial drill motor. 882.4370 Pneumatic cranial drill motor. 882.4400 Radiofrequency lesion generator. 882.4440 Neurosurgical headrests. 882.4460 Neurosurgical head holder (skull

clamp). 882.4500 Cranioplasty material forming in

strument. 882.4525 Microsurgical instrument. 882.4535 Nonpowered neurosurgical instru

ment. 882.4545 Shunt system implantation instru

ment. 882.4560 Stereotaxic instrument. 882.4600 Leukotome. 882.4650 Neurosurgical suture needle. 882.4700 Cottonoid paddie. 882.4725 Radiofrequency lesion probe. 882.4750 Skull punch. 882.4800 Self-retaining retractor for neuro

surgery 882.4840 Manual rongeur. 882.4845 Powered rongeur. 882.4900 Skullplate screwdriver.

Subpart F-Neurological Therapeutic

Devices

882.5030 Methyl methacrylate for

aneurysmorrhaphy. 882.5050 Biofeedback device. 882.5070 Bite block. 882.5150 Intravascular occluding catheter, 882.5175 Carotid artery clamp. 882.5200 Aneurysm clip. 882.5225 Implanted malleable clip. 882.5235 Aversive conditioning device. 882.5250 Burr hole cover. 882.5275 Nerve cuff.

« iepriekšējāTurpināt »