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Title 21 Part 880 → Subpart F

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart F

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart F

e-CFR data is current as of November 19, 2019

Title 21Chapter ISubchapter HPart 880 → Subpart F


Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES


Subpart F—General Hospital and Personal Use Therapeutic Devices


Contents
§880.5025   I.V. container.
§880.5045   Medical recirculating air cleaner.
§880.5075   Elastic bandage.
§880.5090   Liquid bandage.
§880.5100   AC-powered adjustable hospital bed.
§880.5110   Hydraulic adjustable hospital bed.
§880.5120   Manual adjustable hospital bed.
§880.5130   Infant radiant warmer.
§880.5140   Pediatric medical crib.
§880.5145   Medical bassinet.
§880.5150   Nonpowered flotation therapy mattress.
§880.5160   Therapeutic medical binder.
§880.5180   Burn sheet.
§880.5200   Intravascular catheter.
§880.5210   Intravascular catheter securement device.
§880.5240   Medical adhesive tape and adhesive bandage.
§880.5270   Neonatal eye pad.
§880.5300   Medical absorbent fiber.
§880.5400   Neonatal incubator.
§880.5410   Neonatal transport incubator.
§880.5420   Pressure infusor for an I.V. bag.
§880.5430   Nonelectrically powered fluid injector.
§880.5440   Intravascular administration set.
§880.5445   Intravascular administration set, automated air removal system.
§880.5450   Patient care reverse isolation chamber.
§880.5475   Jet lavage.
§880.5500   AC-powered patient lift.
§880.5510   Non-AC-powered patient lift.
§880.5550   Alternating pressure air flotation mattress.
§880.5560   Temperature regulated water mattress.
§880.5570   Hypodermic single lumen needle.
§880.5580   Acupuncture needle.
§880.5630   Nipple shield.
§880.5640   Lamb feeding nipple.
§880.5680   Pediatric position holder.
§880.5700   Neonatal phototherapy unit.
§880.5725   Infusion pump.
§880.5740   Suction snakebite kit.
§880.5760   Chemical cold pack snakebite kit.
§880.5780   Medical support stocking.
§880.5820   Therapeutic scrotal support.
§880.5860   Piston syringe.
§880.5950   Umbilical occlusion device.
§880.5960   Lice removal kit.
§880.5965   Subcutaneous, implanted, intravascular infusion port and catheter.
§880.5970   Percutaneous, implanted, long-term intravascular catheter.

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§880.5025   I.V. container.

(a) Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.

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

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§880.5045   Medical recirculating air cleaner.

(a) Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.

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

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§880.5075   Elastic bandage.

(a) Identification. An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.

(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. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation 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, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]

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§880.5090   Liquid bandage.

(a) Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

(b) Classification. Class I (general controls). When used only as a skin protectant, 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, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000]

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§880.5100   AC-powered adjustable hospital bed.

(a) Identification. An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

(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, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]

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§880.5110   Hydraulic adjustable hospital bed.

(a) Identification. A hydraulic adjustable hospital bed is a device intended for medical purposes that consists of a bed with a hydraulic mechanism operated by an attendant to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

(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.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]

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§880.5120   Manual adjustable hospital bed.

(a) Identification. A manual adjustable hospital bed is a device intended for medical purposes that consists of a bed with a manual mechanism operated by an attendant to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

(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. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation 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, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 66 FR 38804, July 25, 2001]

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§880.5130   Infant radiant warmer.

(a) Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.

(b) Classification. Class II (Special Controls):

(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;

(2) A prescription statement in accordance with §801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and

(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.

[62 FR 33350, June 19, 1997]

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§880.5140   Pediatric medical crib.

(a) Identification. A pediatric medical crib is a prescription device intended for medical purposes for use with a pediatric patient that consists of an open crib, fixed end rails, movable and latchable side rail components, and possibly an accompanying mattress. The contour of the crib surface may be adjustable.

(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. The special controls for this device are:

(1) Crib design and performance testing shall demonstrate the mechanical and structural stability of the crib under expected conditions of use, including the security of latches and other locking mechanisms when engaged;

(2) Materials used shall be appropriate for the conditions of use, allow for proper sanitation, and be free from surface defects that could result in injuries;

(3) The height of the rail and end panel as measured from the top of the rail or panel in its highest position to the top of the mattress support in its lowest position shall be at least 26 inches (66 centimeters). Any mattress used in this crib must not exceed a thickness of 6 inches;

(4) Hardware and fasteners shall be designed and constructed to eliminate mechanical hazards to the patient;

(5) The distance between components of the side rail (i.e., slats, spindles, and corner posts) shall not be greater than 238 inches (6 centimeters) apart at any point;

(6) The mattress must fit tightly around all four sides of the crib base, such that entrapment or impingement of occupant is prevented;

(7) The mattress for the crib shall meet the Consumer Product Safety Commission (CPSC) Standard for the flammability of mattresses and mattress pads (FF 4-72, amended) and Standard for the flammability (open flame) of mattress sets, 16 CFR parts 1632 and 1633, respectively; and

(8) Each device must have the following label(s) affixed:

(i) Adequate instructions for users to care for, maintain, and clean the crib; and

(ii) A warning label on at least two sides of the medical crib with the following language in text of at least 9 millimeters in height:

WARNING: Never leave a child unsupervised when the moveable side is open or not secured.

[81 FR 91737, Dec. 19, 2016]

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§880.5145   Medical bassinet.

(a) Identification. A medical bassinet is a prescription device that is a small bed intended for use with pediatric patients, generally from birth to approximately 5 months of age. It is intended for medical purposes for use in a nursery, labor and delivery unit, or patient room, but may also be used outside of traditional health care settings. A medical bassinet is a non-powered device that consists of two components: The plastic basket or bed component and a durable frame with wheels, which holds the basket or bed component. The basket or bed component is a box-like structure, generally made of a clear, high impact-resistant plastic material, with an open top and four stationary walls to hold the pediatric patient. The frame can include drawers, shelving, or cabinetry that provides space to hold infant care items. The wheels or casters allow the bassinet to transport the infant throughout the care setting.

(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. The special controls for this device are:

(1) The manufacturer must conduct performance testing to determine material compatibility with cleansing products labeled to clean the device. Testing must demonstrate that the cleaning instructions provided by the manufacturer do not cause crazing, cracking, or deterioration of the device;

(2) Manufacturers shall conduct performance testing to ensure the mechanical and structural stability of the bassinet under expected conditions of use, including transport of patients in the bassinet. Testing must demonstrate that failures such as wheel or caster breakage do not occur and that the device does not present a tipping hazard due to any mechanical failures under expected conditions of use; and

(3) Each device must have the following label(s) affixed:

(i) Adequate instructions for users to care for, maintain, and clean the bassinet; and

(ii) A warning label on at least two sides of the plastic basket or bed component with the following language in text of at least 9 millimeters in height:

WARNING: To avoid tipping hazards of this device, make sure that the basket or bed component sits firmly in the base and that all doors, drawers, and casters are secure.

[81 FR 91737, Dec. 19, 2016]

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§880.5150   Nonpowered flotation therapy mattress.

(a) Identification. A nonpowered flotation therapy mattress is a mattress intended for medical purposes which contains air, fluid, or other materials that have the functionally equivalent effect of supporting a patient and avoiding excess pressure on local body areas. The device is intended to treat or prevent decubitus ulcers (bed sores).

(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. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation 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, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]

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§880.5160   Therapeutic medical binder.

(a) Identification. A therapeutic medical binder is a device, usually made of cloth, that is intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place. This generic type of device includes the abdominal binder, breast binder, and perineal binder.

(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. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation 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, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]

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§880.5180   Burn sheet.

(a) Identification. A burn sheet is a device made of a porous material that is wrapped aroung a burn victim to retain body heat, to absorb wound exudate, and to serve as a barrier against contaminants.

(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.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38804, July 25, 2001]

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§880.5200   Intravascular catheter.

(a) Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

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

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§880.5210   Intravascular catheter securement device.

(a) Identification. An intravascular catheter securement device is a device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or the catheter flat and securely anchored to the skin.

(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.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38804, July 25, 2001]

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§880.5240   Medical adhesive tape and adhesive bandage.

(a) Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.

(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.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38804, July 25, 2001]

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§880.5270   Neonatal eye pad.

(a) Identification. A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.

(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 §880.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180 of this chapter, with respect to general requirements concerning records, and §820.198 of this chapter, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000]

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§880.5300   Medical absorbent fiber.

(a) Identification. A medical absorbent fiber is a device intended for medical purposes that is made from cotton or synthetic fiber in the shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category.

(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. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation 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, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]

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§880.5400   Neonatal incubator.

(a) Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

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

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§880.5410   Neonatal transport incubator.

(a) Identification. A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.

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

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§880.5420   Pressure infusor for an I.V. bag.

(a) Identification. A pressure infusor for an I.V. bag is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of the fluid.

(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 §880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000]

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§880.5430   Nonelectrically powered fluid injector.

(a) Identification. A nonelectrically powered fluid injector is a nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body. It may be used for mass inoculations.

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

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§880.5440   Intravascular administration set.

(a) Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

(b) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in §880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 15798, Mar. 21, 2001]

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§880.5445   Intravascular administration set, automated air removal system.

(a) Identification. An intravascular administration set, automated air removal system, is a prescription device used to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the intravascular fluid. The device may include an air identification mechanism, software, an air removal mechanism, tubing, apparatus to collect removed air, and safety control mechanisms to address hazardous situations.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Provide an argument demonstrating that all reasonably foreseeable hazards have been adequately addressed with respect to the persons for whose use the device is represented or intended and the conditions of use for the device, which includes the following:

(i) Description of the device indications for use, design, and technology, use environments, and users in sufficient detail to determine that the device complies with all special controls.

(ii) Demonstrate that controls are implemented to address device system hazards and their causes.

(iii) Include a justification supporting the acceptability criteria for each hazard control.

(iv) A traceability analysis demonstrating that all credible hazards have at least one corresponding control and that all controls have been verified and validated in the final device design.

(2) Appropriate software verification, validation, and hazard analysis must be performed.

(3) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible.

(4) Performance data must demonstrate the sterility of fluid path contacting components and the shelf life of these components.

(5) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC).

(6) Nonclinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Device system and component reliability testing must be conducted.

(ii) Fluid ingress protection testing must be conducted.

(iii) Testing of safety controls must be performed to demonstrate adequate mitigation of hazardous situations, including sensor failure, flow control failure, improper device position, device malfunction, infusion delivery error, and release of air to the patient.

(7) A human factors validation study must demonstrate that use hazards are adequately addressed.

(8) The labeling must include the following:

(i) The device's air identification and removal response time.

(ii) The device's minimum air volume identification sensitivity.

(iii) The minimum and maximum flow rates at which the device is capable of reliably detecting and removing air.

(iv) Quantification of any fluid loss during device air removal operations as a function of flow rate.

[79 FR 28406, May 16, 2014]

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§880.5450   Patient care reverse isolation chamber.

(a) Identification. A patient care reverse isolation chamber is a device consisting of a roomlike enclosure designed to prevent the entry of harmful airborne material. This device protects a patient who is undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or congenital abnormality. The device includes fans and air filters which maintain an atmosphere of clean air at a pressure greater than the air pressure outside the enclosure.

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

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§880.5475   Jet lavage.

(a) Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.

(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, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]

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§880.5500   AC-powered patient lift.

(a) Identification. An AC-powered lift is an electrically powered device either fixed or mobile, used to lift and transport patients in the horizontal or other required position from one place to another, as from a bed to a bath. The device includes straps and slings to support the patient.

(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, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]

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§880.5510   Non-AC-powered patient lift.

(a) Identification. A non-AC-powered patient lift is a hydraulic, battery, or mechanically powered device, either fixed or mobile, used to lift and transport a patient in the horizontal or other required position from one place to another, as from a bed to a bath. The device includes straps and a sling to support the patient.

(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.

[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 66 FR 38804, July 25, 2001]

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§880.5550   Alternating pressure air flotation mattress.

(a) Identification. An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).

(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, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]

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§880.5560   Temperature regulated water mattress.

(a) Identification. A temperature regulated water mattress is a device intended for medical purposes that consists of a mattress of suitable size, filled with water which can be heated or in some cases cooled. The device includes electrical heating and water circulating components, and an optional cooling component. The temperature control may be manual or automatic.

(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.

[45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38804, July 25, 2001]

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§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).

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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.

[61 FR 64617, Dec. 6, 1996]

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§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 (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.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 33804, July 25, 2001]

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§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 of this chapter, subject to the limitations in §880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation 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, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001]

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§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 a child while an intravascular injection is administered.

(b) Classification. Class I (general controls). The device is exempt from the good manufacturing practice regulation 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, Oct. 21, 1980, as amended at 66 FR 46952, Sept. 10, 2001]

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§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).

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§880.5725   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).

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§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 (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.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001]

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§880.5760   Chemical cold pack snakebite 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, Oct. 21, 1980, as amended at 52 FR 17739, May 11, 1987; 61 FR 50708, Sept. 27, 1996]

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§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, subject to the limitations in §880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation 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, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001]

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§880.5820   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 of this chapter, subject to the limitations in §880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation 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, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001]

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§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).

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§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 (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.

[45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001]

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§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.

[63 FR 59718, Nov. 5, 1998]

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§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 a 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.

(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]

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§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 on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

[65 FR 37043, June 13, 2000]

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