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(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 61 FR 1123, Jan. 16, 1996)

tion procedures in subpart E of part 807 of this chapter. (45 FR 69682-69737, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994]

$880.5570 Hypodermic single lumen

needle. (a) Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

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

$ 880.5640 Lamb feeding nipple.

(a) Identification. A lamb feeding nipple is a device intended for use as a feeding nipple for infants with oral or facial abnormalities.

(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 also is exempt from the good manufacturing practice regulation in part 820, with the exception of 8 820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files.

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$880.5580 Acupuncture needle.

(a) Identification. An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.

(b) Classification. Class II (special controls). Acupuncture needles must comply with the following special controls:

(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,

(2) Device material biocompatibility, and

(3) Device sterility.

$ 880.5680 Pediatric position holder.

(a) Identification. A pediatric position holder is a device used to hold an infant or a child in a desired position for therapeutic or diagnostic purposes, e.g., in a crib under a radiant warmer, or to restrain child while intravascular injection is administered.

(b) Classification. Class I (general controls). The device 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.

(61 FR 64617, Dec. 6, 1996)

$880.5700 Neonatal phototherapy unit.

(a) Identification. A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.

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

8 880.5630 Nipple shield.

(a) Identification. A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk.

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

8880.5725 Infusion pump.

(a) Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

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

$ 880.5740 Suction snakebite kit.

(a) Identification. A suction snakebite kit is a device consisting of a knife, suction device, and tourniquet used for first-aid treatment of snakebites by removing venom from the wound.

(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 59 FR 63011, Dec. 7, 1994]

8 880.5780 Medical support stocking.

(a) Medical support stocking to prevent the pooling of blood in the legs—(1) Identification. A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg.

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

(b) Medical support stocking for general medical purposes—(1) Identification. A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.

(2) 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)

$ 880.5760 Chemical cold pack snake

bite kit. (a) Identification. A chemical cold pack snakebit kit is a device consisting of a chemical cold pack and tourniquet used for first-aid treatment of snakebites.

(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 chemical cold pack snakebite kit 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 chemical cold pack snakebite kit that was in commercial distribution before May 28, 1976. Any other chemical cold pack snakebite kit shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. (45 FR 69682-69737, Oct. 21, 1980, as amended at 52 FR 17739, May 11, 1987; 61 FR 50708, Sept. 27, 1996)

8880.5820 Therapeutic scrotal support.

(a) Identification. A therapeutic scrotal support is a device intended for medical purposes that consist of a pouch attached to an elastic waistband and that is used to support the scrotum (the sac that contains the testicles).

(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.

$ 880.5860 Piston syringe.

(a) Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

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

(b) Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports," FDA October 1990.

[65 FR 37043, June 13, 2000)

$880.5950 Umbilical occlusion device.

(a) Identification. An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant.

(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 59 FR 63011, Dec. 7, 1994)

$ 880.5970 Percutaneous, implanted,

long-term intravascular catheter. (a) Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

(b) Classification. Class II (special controls) Guidance Document: “Guidance

Premarket Notification (510(k)] Submission for Short-Term and Long-Term Intravascular Catheters." [65 FR 37043, June 13, 2000)

8 880.5960 Lice removal kit.

(a) Identification. The lice removal kit is a comb or comb-like device intended to remove and/or kill lice and nits from head and body hair. It may or may not be battery operated.

(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 $ 880.9.

on

(63 FR 59718, Nov. 5, 1998]

Subpart G-General Hospital and

Personal Use Miscellaneous
Devices

a

$ 880.5965 Subcutaneous, implanted,

intravascular infusion port and

catheter. (a) Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to

long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.

$ 880.6025 Absorbent tipped appli

cator. (a) Identification. An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification pro lures in subpart E of part 807. If the device is not labeled or otherwise represented 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.

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

$880.6050 Ice bag.

(a) Identification. An ice bag is a device intended for medical purposes that is in the form of a container intended to be filled with ice that is used to apply dry cold therapy to an area of the ody. The device may include a holder that keeps the bag in place against an external area of the patient.

(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 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. 8880.6060 Medical disposable bedding.

(a) Identification. Medical disposable bedding is a device intended for medical purposes to be used by one patient for a period of time and then discarded. This generic type of device may include disposable bedsheets, bedpads, pillows and pillowcases, blankets, emergency rescue blankets, or waterproof sheets.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of 8820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files.

$ 880.6080 Cardiopulmonary resuscita

tion board. (a) Identification. A cardiopulmonary resuscitation board is a device consisting of a rigid board which is placed under a patient to act as a support during cardiopulmonary resuscitation.

(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.

$ 880.6085 Hot/cold water bottle.

(a) Identification. A hot/cold water bottle is a device intended for medical purposes that is in the form of a container intended to be filled with hot or cold water to apply heat or cold to an area of the body.

(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.

(45 FR 69682-69737, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994]

8880.6070 Bed board.

(a) Identification. A bed board is a device intended for medical purposes that consists of a stiff board used to increase the firmness of a bed.

(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

$ 880.6100 Ethylene oxide gas aerator

cabinet. (a) Identification. An ethyene oxide gas aerator cabinet is a device that is intended for use by a health care provider and consists of a cabinet with a ventilation system designed to circulate and exchange the air in the cabinet to shorten the time required to remove residual ethylene oxide (ETO) from wrapped medical devices that have undergone ETO sterilization. The device may include a heater to warm the circulating air.

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

cerning records, and $ 820.198, with respect to complaint files.

$ 880.6140 Medical chair and table.

(a) Identification. A medical chair or table is a device intended for medical purposes that consists of a chair or table without wheels and not electrically powered which, by reason of special shape or attachments, such as food trays or headrests, or special features such as a built-in raising and lowering mechanism or removable arms, is intended for use of blood donors, geriatric patients, or patients undergoing treatment or examination.

(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.

8880.6190 Mattress cover for medical

purposes. (a) Identification. A mattress cover for medical purposes is a device intended for medical purposes that is used to protect a mattress. It may be electrically conductive or contain a germicide.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is exempt from the 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)

$ 880.6150 Ultrasonic cleaner for med

ical instruments. (a) Identification. An ultrasonic cleaner for medical instruments is a device intended for cleaning medical instruments by the emission of high frequency soundwaves.

(b) Classification. Class I. The device, including any solutions intended for use with the device for cleaning and sanitizing the instruments, 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; 59 FR 63011, Dec. 7, 1994]

8880.6200 Ring cutter.

(a) Identification. A ring cutter is a device intended for medical purposes that is used to cut a ring on a patient's finger so that the ring can be removed. The device incorporates a guard to prevent injury to the patient's finger.

(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.

$880.6175 (Reserved]

$ 880.6185 Cast cover.

(a) Identification. A cast cover is a device intended for medical purposes that is made of waterproof material and placed over a cast to protect it from getting wet during a shower or a bath.

(b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart 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 g 820.180, with respect to general requirements con

8 880.6230 Tongue depressor.

(a) Identification. A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

(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 also is exempt from the good manufacturing practice regulation in part 820, with the exception of $ 820.180, with respect to general requirements

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