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8884.5160 Powered breast pump.

(a) Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.

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

ease). The device may also be used to collect semen to aid in the diagnosis of infertility.

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

8884.5310 Condom with spermicidal

lubricant. (a) Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).

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

[47 FR 49022, Oct. 29, 1982]

8884.5225 Abdominal decompression

chamber. (a) Identification. An abdominal decompression chamber is a hoodlike device used to reduce pressure on the pregnant patient's abdomen for the relief of abdominal pain during pregnancy or labor.

(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

any abdominal decompression chamber 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 an abdominal decompression chamber that was in commercial distribution before May 28, 1976. Any other abdominal decompression chamber shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. (45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 FR 50709, Sept. 27, 1996)

for

8884.5320 Glans sheath.

(a) Identification. A glans sheath device is a sheath which covers only the glans penis or part thereof and may also cover the area in the immediate proximity thereof, the corona and frenulum, but not the entire shaft of the penis. It is indicated only for the prevention of pregnancy and not for the prevention of sexually-transmitted diseases.

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

(c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. No effective date has been established of the requirement for premarket approval. See $884.3.

(59 FR 67187, Dec. 29, 1994)

$ 884.5250 Cervical cap.

(a) Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.

(b) Classification. Class II (performance standards). 8 884.5300 Condom.

(a) Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of venereal dis

8 884.5330 Female condom.

(a) Identification. A female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. It is indicated for contraceptive and prophylactic (preventing the transmission of sexually transmitted diseases) purposes.

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

introducer shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. [45 FR 12684–12720, Feb. 26, 1980, as amended at 51 FR 16649, May 5, 1986)

(c) Date premarket approval application (PMA) of notice of completion of a product development protocol (PDP) is required. No effective date has been established of the requirement for premarket approval for the devices described in paragraph (b) of this section. See $ 884.3 for effective dates of requirement for premarket approval. [65 FR 31455, May 18, 2000) 8884.5350 Contraceptive diaphragm

and accessories. (a) Identification. A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posterior vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of device may include an introducer.

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

$ 884.5380 Contraceptive tubal occlu

sion device (TOD) and introducer. (a) Identification. A contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a fallopian tube with a mechanical structure, e.g., a band or clip on the outside of the fallopian tube or a plug or valve on the inside. The devices are used to prevent pregnancy.

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

(c) Date premarket approval application (PMA) or notice of completion of a product development protocol (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 30, 1987, for any TOD and introducer that was in commercial distribution before May 28, 1976, or that has on or before December 30, 1987, been found to be substantially equivalent to a TOD and introducer that was in commercial distribution before May 28, 1976. Any other TOD and introducer shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

(45 FR 12684–12720, Feb. 26, 1980, as amended at 52 FR 36883, Oct. 1, 1987)

8884.5360 Contraceptive intrauterine

device (IUD) and introducer. (a) Identification. A contraceptive intrauterine device (IUD) is a device used to prevent pregnancy. The device is placed high in the uterine fundus with a string extending from the device through the cervical os into the vagina. This generic type of device includes the introducer, but does not include contraceptive IUD's that function by drug activity, which are subject to the new drug provisions of the Federal Food, Drug, and Cosmetic Act (see $310.502).

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

(c) Labeling. Labeling requirements for contraceptive IUD's are set forth in $ 801.427.

(d) Date premarket approval application (PMA) or notice of completion of a product development protocol (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 August 4, 1986, for any IUD and introducer that was in commercial distribution before May 28, 1976, or that has on or before August 4, 1986, been found to be substantially equivalent to an IUD and introducer that was in commercial distribution before May 28, 1976. Any other IUD and

$ 884.5390 Perineal heater.

(a) Identification. A perineal heater is a device designed to apply heat directly by contact, or indirectly from a radiant source, to the surface of the perineum (the area between the vulva and the anus) and is used to soothe or to help heal the perineum after an episiotomy (incision of the vulvar orifice for obstetrical purposes).

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

8884.5400 Menstrual cup.

(a) Identification. A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.

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

labial pads and reusable menstrual pads.

(45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 67714, Dec. 24, 1996; 65 FR 2320, Jan. 14, 2000]

8 884.5460 Scented or scented deodor

ized menstrual tampon. (a) Identification. A scented or scented deodorized menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.

(b) Classification. Class II (performance standards). [45 FR 12684-12720, Feb. 26, 1980, as amended at 45 FR 51186, Aug. 1, 1980)

$ 884.5425 Scented or scented deodor

ized menstrual pad. (a) Identification. A scented or scented deodorized menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual pad) or for deodorizing purposes (scented deodorized menstrual pad). This generic type of device includes sterile scented menstrual pads used for medically indicated conditions, but does not include menstrual pads treated with added antimicrobial agents or other drugs.

(b) Classification. (1) Class I (general controls) for menstrual pads made of common cellulosic and synthetic material with an established safety profile. The devices subject to this paragraph (b)(1) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter. This exemption does not include the intralabial pads and reusable menstrual pads.

(2) Class II (special controls) for scented or scented deodorized menstrual pads made of materials not described in paragraph (b)(1). [45 FR 12684–12720, Feb. 26, 1980, as amended at 45 FR 51185, Aug. 1, 1980; 61 FR 67714, Dec. 24, 1996) $ 884.5435 Unscented menstrual pad.

(a) Identification. An unscented menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. This generic type of device includes sterile unscented menstrual pads used for medically indicated conditions, but does not include menstrual pads treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter only when the device is made of common cellulosic and synthetic material with an established safety profile. This exemption does not include the inter

8884.5470 Unscented menstrual tam

pon. (a) Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.

(b) Classification. Class II (performance standards). $884.5900 Therapeutic vaginal douche

apparatus. (a) Identification. A therapeutic vaginal douche apparatus is a device that is a bag or bottle with tubing and a nozzle. The apparatus does not include douche solutions. The apparatus is intended and labeled for use in the treatment of medical conditions except it is not for contraceptive use. After filling the therapeutic vaginal douche apparatus with a solution, the patient uses the device to direct a stream of solution into the vaginal cavity.

(b) Classification. (1) Class II (performance standards).

(2) Class I if the device is operated by gravity feed. Devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996)

$ 884.5960 Genital vibrator for thera.

peutic use. (a) Identification. A genital vibrator for therapeutic use is an electrically operated device intended and labeled for therapeutic use in the treatment of sexual dysfunction or as an adjunct to Kegel's exercise (tightening of the muscles of the pelvic floor to increase muscle tone).

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

8884.5920 Vaginal insufflator.

(a) Identification. A vaginal insufflator is a device used to treat vaginitis by introducing medicated powder from a hand-held bulb into the vagina through an open speculum.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (45 FR 12684_12720, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 1989)

$ 884.5970 Clitoral

engorgement de vice. (a) Identification. A clitoral engorgement device is designed to apply a vacuum to the clitoris. It is intended for use in the treatment of female sexual arousal disorder.

(b) Classification. Class II (special controls). The special control is a guidance document entitled: "Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for Clitoral Engorgement Devices."

[65 FR 47306, Aug. 2, 2000)

Subpart G-Assisted Reproduction

Devices

SOURCE: 63 FR 48436, Sept. 10, 1998, unless otherwise noted.

8 884.5940 Powered vaginal muscle

stimulator for therapeutic use. (a) Identification. A powered vaginal muscle stimulator is an electrically powered device designed to stimulate directly the muscles of the vagina with pulsating electrical current. This device is intended and labeled for therapeutic use in increasing muscular tone and strength in the treatment of sexual dysfunction. This generic type of device does not include devices used to treat urinary incontinence.

(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 for a device is required to be filed with the Food and Drug Administration on or before July 12, 2000, for any powered vaginal muscle stimulator for therapeutic use that was in commercial distribution before May 28, 1976, or that has, on or before July 12, 2000, been found to be substantially equivalent to a powered vaginal muscle stimulator that was in commercial distribution before May 28, 1976. Any other powered vaginal muscle stimulator for therapeutic use shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. [45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 19834, Apr. 13, 2000)

8884.6100 Assisted reproduction nee

dles. (a) Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.

(b) Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

$884.6110 Assisted reproduction cath- 8884.6130 Assisted reproduction eters.

microtools. (a) Identification. Assisted reproduc- (a) Identification. Assisted reproduction catheters are devices used in in tion microtools are pipettes or other vitro fertilization (IVF), gamete

devices used in the laboratory to intrafallopian transfer (GIFT), or other

denude, micromanipulate, hold, or assisted reproduction procedures to in

transfer human gametes or embryos for troduce or remove gametes, zygote(s),

assisted hatching, intracytoplasmic preembryo(s), and/or embryo(s) into or

sperm injection (ICSI), or other asfrom the body. This generic type of de

sisted reproduction methods. vice may include catheters, cannulae,

(b) Classification. Class II (special

controls) (mouse embryo assay inforintroducers, dilators, sheaths, stylets,

mation, endotoxin testing, sterilization and component parts.

validation, design specifications, label(b) Classification. Class II (special

ing requirements, and clinical testing). controls) (mouse embryo assay information, endotoxin testing, sterilization $ 884.6140 Assisted reproduction validation, design specifications, label

micropipette fabrication instruing requirements, biocompatibility

ments. testing, and clinical testing).

(a) Identification. Assisted reproduc

tion micropipette fabrication devices $ 884.6120 Assisted reproduction acces- are instruments intended to pull, bevel, sories.

or forge a micropipette or needle for (a) Identification. Assisted reproduc- intracytoplasmic sperm injection tion accessories are a group of devices (ICSI), in vitro fertilization (IVF) or used during assisted reproduction pro

other similar assisted reproduction cedures, in conjunction with assisted

procedures. reproduction needles and/or assisted re

(b) Classification. Class II (special production catheters, to aspirate, incu

controls) (design specifications, label

ing requirements, and clinical testing). bate, infuse, and/or maintain temperature. This generic type of device may 8884.6150 Assisted reproduction include:

micromanipulators

and (1) Powered aspiration pumps used to

microinjectors. provide low flow, intermittent vacuum (a) Identification. Assisted reproducfor the aspiration of eggs (ova).

tion micromanipulators are devices in(2) Syringe pumps (powered or man- tended to control the position of an asual) used to activate a syringe to in- sisted reproduction microtool. Assisted fuse or aspirate small volumes of fluid reproduction microinjectors are any during assisted reproduction proce- device intended to control aspiration dures.

or expulsion of the contents of an as(3) Collection tube warmers, used to

sisted reproduction microtool. maintain the temperature of egg (00

(b) Classification. Class II (special cyte) collection tubes at or near body

controls) (design specifications, labeltemperature. A dish/plate/microscope

ing requirements, and clinical testing). stage warmer is a device used to main

8884.6160 Assisted reproduction tain the temperature of the egg (00- labware. cyte) during manipulation.

(a) Identification. Assisted reproduc(4) Embryo incubators, used to store

tion labware consists of laboratory and preserve gametes and/or embryos

equipment or supplies intended to preat or near body temperature.

pare, store, manipulate, or transfer (5) Cryopreservation instrumentation

human gametes or embryos for in vitro and devices, used to contain, freeze,

fertilization (IVF), gamete and maintain gametes and/or embryos intrafallopian transfer (GIFT), or other at an appropriate freezing temperature. assisted reproduction procedures.

(b) Classification. Class II (special These include syringes, IVF tissue culcontrols) (design specifications, label- ture dishes, IVF tissue culture plates, ing requirements, and clinical testing). pipette tips, dishes, plates, and other

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