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(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 vibratory cervical dilator 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 vibratory cervical dilator that was in commercial distribution before May 28, 1976. Any other vibratory cervical dilator 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 50708, Sept. 27, 1996)

8884.4340 Fetal vacuum extractor.

(a) Identification. A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.

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

8884.4520 Obstetric-gynecologic

general manual instrument. (a) Identification. An obstetricgynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

(1) An episiotomy scissors is a cutting instrument, with two opposed shearing blades, used for surgical incision of the vulvar orifice for obstetrical purposes.

(2) A fiberoptic metal vaginal speculum is a metal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.

(3) A metal vaginal speculum is a metal instrument used to expose the interior of the vagina.

(4) An umbilical scissors is a cutting instrument, with two opposed shearing blades, used to cut the umbilical cord.

(5) A uterine clamp is an instrument used to hold the uterus by compression.

(6) A uterine packer is an instrument used to introduce dressing into the uterus or vagina.

(7) A vaginal applicator is an instrument used to insert medication into the vagina.

(8) A vaginal retractor is an instrument used to maintain vaginal exposure by separating the edges of the vagina and holding back the tissue.

(9) A gynecological fibroid hook is an instrument used to exert traction upon a fibroid.

(10) A pelvimeter (external) is an instrument used to measure the external diameters of the pelvis.

(b) Classification. Class I (general controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 8884.9. (45 FR 12684-12720, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 1989; 66 FR 38809, July 25, 2001)

$ 884.4400 Obstetric forceps.

(a) Identification. An obstetric forceps is a device consisting of two blades, with handles, designed to grasp and apply traction to the fetal head in the birth passage and facilitate delivery.

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

8884.4500 Obstetric fetal destructive

instrument. (a) Identification. An obstetric fetal destructive instrument is a device designed to crush or pull the fetal body to facilitate the delivery of a dead or anomalous (abnormal) fetus. This generic type of device includes the cleidoclast, cranioclast,craniotribe, and destructive hook.

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

8 884.4530 Obstetric-gynecologic

spe cialized manual instrument. (a) Identification. An obstetricgynecologic specialized manual instrument is one of a group of devices used

during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

(1) An amniotome is an instrument used to rupture the fetal membranes.

(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.

(3) An umbilical clamp is an instrument used to compress the umbilical cord.

(4) A uterine curette is an instrument used to scrape and remove material from the uterus.

(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.

(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.

(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.

(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.

(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.

(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.

(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.

(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.

(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.

(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.

(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.

(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.

(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.

(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.

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

(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 8884.9. [45 FR 12684-12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, 2001]

$ 884.4550 Gynecologic surgical laser.

(a) Identification. A gynecologic surgical laser is a continuous wave carbon dioxide laser designed to destroy tissue thermally or to remove tissue by radiant light energy. The device is used only in conjunction with a colposcope as part of a gynecological surgical system. A colposcope is a magnifying lens system used to examine the vagina and cervix.

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

$ 884.4900 Obstetric table and acces

sories. (a) Identification. An obstetric table is a device with adjustable sections designed to support a patient in the various positions required during obstetric and gynecologic procedures. This generic type of device may include the following accessories: patient equipment, support attachments, and cabinets for warming instruments and disposing of wastes.

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

Subpart F-Obstetrical and Gyne

cological Therapeutic Devices

for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.

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

$ 884.5050 Metreurynter-balloon abor

tion system. (a) Identification. A metreurynter-balloon abortion system is a device used to induce abortion. The device is inserted into the uterine cavity, inflated, and slowly extracted. The extraction of the balloon from the uterus causes dilation of the cervical os. This generic type of device may include pressure sources and pressure controls.

(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 metreurynter-balloon abortion system 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 metreurynter-balloon abortion system that was in commercial distribution before May 28, 1976. Any other metreurynter-balloon abortion system shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

8884.5150 Nonpowered breast pump.

(a) Identification. A nonpowered breast pump is a manual suction device used to express milk from the breast.

(b) 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 $884.9, if the device is using either a bulb or telescoping mechanism which does not develop more than 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce cytotoxicity, irritation, or sensitization effects. (45 FR 12684–12720, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, 2001)

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).

[45 FR 12684–12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 FR 50709, Sept. 27, 1996)

$ 884.5070 Vacuum abortion system.

(a) Identification. A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.

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

$ 884.5225 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 preg. nancy 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 for 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

$ 884.5100 Obstetric anesthesia set.

(a) Identification. An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended

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)

8884.5250 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).

(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 September 12, 2002, for any glans sheath that was in commercial distribution before May 28, 1976, or that has, on or before September 12, 2002, been found to be substantially equivalent to a glans sheath that was in commercial distribution before May 28, 1976. Any other glans sheath shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. [59 FR 67187, Dec. 29, 1994, as amended at 67 FR 40849, June 14, 2002]

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

(b) Classification. Class II (performance standards). $884.5310 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).

$ 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 initiation of coitus. It is indicated for contraceptive and prophylactic (preventing the transmission of sexually transmitted diseases) purposes.

(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 for the devices described in paragraph (b) of this section. See 8884.3 for effective dates of requirement for premarket approval.

[65 FR 31455, May 18, 2000]

(47 FR 49022, Oct. 29, 1982]

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.

8 884.5350 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).

tion 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)

$ 884.5360 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 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)

$ 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).

$ 884.5400 Menstrual cup.

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

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

8 884.5380 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 Administra

8 884.5425 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

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