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884.3200 Cervical drain. 884.3575 Vaginal pessary. 884.3650 Fallopian tube prosthesis. 884.3900 Vaginal stent.

Subpart B-Obstetrical and Gynecological

Diagnostic Devices 884.1040 Viscometer for cervical mucus. 884.1050 Endocervical aspirator. 884.1060 Endometrial aspirator. 884.1100 Endometrial brush. 884.1175 Endometrial suction curette and

accessories. 884.1185 Endometrial washer. 884.1300 Uterotubal carbon dioxide

insufflator and accessories. 884.1425 Perineometer. 884.1550 Amniotic fluid sampler

(amniocentesis tray). 884.1560 Fetal blood sampler. 884.1600 Transabdominal amnioscope

(fetoscope) and accessories. 884.1630 Colposcope. 884.1640 Culdoscope and accessories. 884.1660 Transcervical

endoscope (amnioscope) and accessories. 884.1690 Hysteroscope and accessories. 884.1700 Hysteroscopic insufflator. 884.1720 Gynecologic laparoscope and acces

sories. 884.1730 Laparoscopic insufflator. Subpart C–Obstetrical and Gynecological

Monitoring Devices

Subpart E-Obstetrical and Gynecological

Surgical Devices 884.4100 Endoscopic electrocautery and ac

cessories. 884.4120 Gynecologic electrocautery and ac

cessories. 884.4150 Bipolar endoscopic coagulator-cut

ter and accessories. 884.4160 Unipolar endoscopic coagulator

cutter and accessories. 884.4250 Expandable cervical dilator. 884.4260 Hygroscopic Laminaria cervical di

lator. 884.4270 Vibratory cervical dilators. 884.4340 Fetal vacuum extractor. 884.4400 Obstetric forceps. 884.4500 Obstetric fetal destructive instru

ment. 884.4520 Obstetric-gynecologic general man

ual instrument. 884.4530 Obstetric-gynecologic specialized

manual instrument. 884.4550 Gynecologic surgical laser. 884.4900 Obstetric table and accessories. Subpart F-Obstetrical and Gynecological

Therapeutic Devices 884.5050 Metreurynter-balloon abortion sys

tem. 884.5070 Vacuum abortion system. 884.5100 Obstetric anesthesia set. 884.5150 Nonpowered breast pump. 884.5160 Powered breast pump. 884.5225 Abdominal decompression chamber. 884.5250 Cervical cap. 884.5300 Condom. 884.5310 Condom with spermicidal lubricant. 884.5320 Glans sheath. 884.5330 Female condom. 884.5350 Contraceptive diaphragm and acces

sories. 884.5360 Contraceptive intrauterine device

(IUD) and introducer. 884.5380 Contraceptive tubal occlusion de

vice (TOD) and introducer.

884.2050 Obstetric data analyzer. 884.2225 Obstetric-gynecologic ultrasonic

imager. 884.2600 Fetal cardiac monitor. 884.2620 Fetal electroencephalographic mon

itor. 884.2640 Fetal phonocardiographic monitor

and accessories. 884.2660 Fetal ultrasonic monitor and acces

sories. 884.2675 Fetal scalp circular (spiral) elec

trode and applicator. 884.2685 Fetal scalp clip electrode and appli

cator. 884.2700 Intrauterine pressure monitor and

accessories. 884.2720 External uterine contraction mon

itor and accessories.

884.5390 Perineal heater. 884.5400 Menstrual cup. 884.5425 Scented or scented deodorized men

strual pad. 884.5435 Unscented menstrual pad. 884.5460 Scented or scented deodorized men

strual tampon. 884.5470 Unscented menstrual tampon. 884.5900 Therapeutic vaginal douche appa

ratus. 884.5920 Vaginal insufflator. 884.5940 Powered vaginal muscle stimulator

for therapeutic use. 884.5960 Genital vibrator for therapeutic

use. 884.5970 Clitoral engorgement device.

(e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart.

(d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

(e) Guidance documents referenced in this part are available on the Internet at (52 FR 17740, May 11, 1987, as amended at 68 FR 44415, Aug. 27, 2003]

Subpart G-Assisted Reproduction Devices

884.6100 Assisted reproduction needles. 884.6110 Assisted reproduction catheters. 884.6120 Assisted reproduction accessories. 884.6130 Assisted reproduction microtools. 884.6140 Assisted reproduction micropipette

fabrication instruments. 884.6150 Assisted reproduction micro

manipulators and microinjectors. 884.6160 Assisted reproduction labware. 884.6170 Assisted reproduction water and

water purification systems. 884.6180 Reproductive media and supple

ments. 884.6190 Assisted reproductive microscopes

and microscope accessories. 884.6200 Assisted reproduction laser system.

AUTHORITY: 21 U.S.C. 351, 360, 3600, 360e, 360j, 371.

SOURCE: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

Subpart A-General Provisions $ 884.1 Scope.

(a) This part sets forth the classification of obstetrical and gynecological devices intended for human use that are in commercial distribution.

(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by $ 807.87.

(c) To avoid duplicative listings, an obstetrical and gynecological device that has two or more types of uses

$884.3 Effective dates of requirement

for premarket approval. A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device.

(a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device.

(b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. (52 FR 17740, May 11, 1987)

gally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency Syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism directly from clinical material;

(7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in 8812.3(k) of this chapter; and

(9) For near patient testing (point of care). [65 FR 2319, Jan. 14, 2000]

$884.9 Limitations of exemptions from

section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reason ably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

(a) The device is intended for a use different from the intended use of a le

Subpart B-Obstetrical and Gyne (ii) Contraindications: Pregnancy, cological Diagnostic Devices history of uterine perforation, or a re

cent cesarean section, and 8884.1040 Viscometer for cervical (3) The sampling component is covmucus.

ered within vagina. (a) Identification. A viscometer for [45 FR 12684-12720, Feb. 26, 1980, as amended cervical mucus is a device that is in- at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. tended to measure the relative 31, 2000] viscoelasticity of cervical mucus collected from a female patient. Measure

8884.1100 Endometrial brush. ments of relative viscoelasticity are in- (a) Identification. An endometrial tended for use as an adjunct in the brush is a device designed to remove clinical evaluation of a female with samples of the endometrium (the chronic infertility, to determine the mucosal lining of the uterus) by brushtime of ovulation and the penetrability ing its surface. This device is used to of cervical mucus to motile sperm.

study endometrial cytology (cells). (b) Classification. Class I (general con- (b) Classification. Class II. The special trols). The device is exempt from the controls for this device are: premarket notification procedures in (1) FDA's: subpart E of part 807 of this chapter (i) “Use of International Standard subject to $884.9.

ISO 10993 “Biological Evaluation of

Medical Devices-Part I: Evaluation [47 FR 14706, Apr. 6, 1982, as amended at 65

and Testing,' " and FR 2320, Jan. 14, 2000)

(ii) 6510(k) Sterility Review Guidance $ 884.1050 Endocervical aspirator.

of 2/12/90 (K90-1),"

(2) Labeling: (a) Identification. An endocervical as- (i) Indication: Only to evaluate the pirator is a device designed to remove endometrium, and tissue from the endocervix (mucous

(ii) Contraindications: Pregnancy, membrane lining the canal of the cer- history of uterine perforation, or a revix of the uterus) by suction with a sy

cent cesarean section, and ringe, bulb and pipette, or catheter.

(3) Design and testing: This device is used to evaluate

(i) The sampling component is covocervical tissue to detect mang- ered within the vagina, and nant and premalignant lesions.

(ii) For adherence of the bristles and (b) Classification. Class II (perform- brush head. ance standards).

(45 FR 12684-12720, Feb. 26, 1980, as amended $ 884.1060 Endometrial aspirator.

at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar.

31, 2000) (a) Identification. An endometrial aspirator is a device designed to remove $884.1175 Endometrial suction curette materials from the endometrium (the and accessories. mucosal lining of the uterus) by suc (a) Identification. An endometrial suction with a syringe, bulb and pipette,

tion curette is a device used to remove or catheter. This device is used to

material from the uterus and from the study endometrial cytology (cells).

mucosal lining of the uterus by scrap(b) Classification. Class II. The special ing and vacuum suction. This device is controls for this device are:

used to obtain tissue for biopsy or for (1) FDA's:

menstrual extraction. This generic (i) “Use of International Standard type of device may include catheters, ISO 10993 “Biological Evaluation of syringes, and tissue filters or traps. Medical Devices-Part I: Evaluation (b) Classification. Class II (performand Testing,'” and

ance standards). (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),";

$ 884.1185 Endometrial washer. (2) Labeling:

(a) Identification. An endometrial (i) Indication: Only to evaluate the washer is a device used to remove maendometrium, and

terials from the endometrium (the

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(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),"

(2) Labeling:

(i) Indication: Only to evaluate the endometrium,

(ii) Contraindications: Pregnancy, history of uterine perforation, or a recent cesarean section, and

(iii) Warning: Do not attach to a wall or any external suction, and

(3) Design and Testing:

(i) The sampling component is covered within the vagina, and

(ii) Intrauterine pressure should not exceed 50 millimeters of mercury. (45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000)

$884.1550 Amniotic fluid sampler

(amniocentesis tray). (a) Identification. The amniotic fluid sampler (amniocentesis tray) is a collection of devices used to aspirate amniotic fluid from the amniotic sac via a transabdominal approach. Components of the amniocentesis tray include a disposable 3 inch 20 gauge needle with stylet and a 30 cc. syringe, as well as the various sample collection accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16–18 weeks gestation for antepartum diagnosis of certain congenital abnormalities or anytime after 24 weeks gestation when used to assess fetal maturity.

(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 $ 884.9. [61 FR 1123, Jan. 16, 1996, as amended at 66 FR 33808, July 25, 2001]

$884.1300 Uterotubal carbon dioxide

insufflator and accessories. (a) Identification. A uterotubal carbon dioxide insufflator and accessories is a device used to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and fallopian tubes and filling them with carbon dioxide gas.

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

8884.1560 Fetal blood sampler.

(a) Identification. A fetal blood sampler is a device used to obtain fetal blood transcervically through an endoscope by puncturing the fetal skin with a short blade and drawing blood into a heparinized tube. The fetal blood pH is determined and used in the diagnosis of fetal distress and fetal hypoxia.

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

8884.1425 Perineometer.

(a) Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.

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

$884.1600 Transabdominal amnioscope

(fetoscope) and accessories. (a) Identification. A transabdominal amnioscope is a device designed to permit direct visual examination of the fetus by a telescopic system via abdominal entry. The device is used to ascertain fetal abnormalities, to obtain fetal blood samples, or to obtain fetal tissue. This generic type of device may include the following accessories: trocar and cannula, instruments used through an operating channel or through a separate cannula associated with the amnioscope, light source and cables, and component parts.

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

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