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Subpart C-Obstetrical and Gynecological

Monitoring Devices 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. 884.2730 Home uterine activity monitor. 884.2740 Perinatal monitoring system and

accessories. 884.2900 Fetal stethoscope. 884.2960 Obstetric ultrasonic transducer and

accessories. 884.2980 Telethermographic system. 884.2982 Liquid crystal thermographic sys

tem.

Subpart -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. 884.5390 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.

Subpart D-Obstetrical and Gynecological

Prosthetic Devices

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

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

SOURCE: 45 FR 12684-12720, Feb. 26, 1980, unless otherwise noted.

Subpart A-General Provisions 8884.1 Scope.

(a) This part sets forth the classification of obstetrical and gynecological

a

devices intended for human use that after the regulation that classifies the are in commercial distribution.

device into class III is effective, which(b) The identification of a device in a ever is later. See section 501(f)(2)(B) of regulation in this part is not a precise the act. Accordingly, unless an effecdescription of every device that is, or tive date of the requirement for prewill be, subject to the regulation. A market approval is shown in the regumanufacturer who submits pre- lation for a device classified into class market notification submission for a III in this part, the device may be comdevice under part 807 may not show mercially distributed without FDA's merely that the device is accurately issuance of an order approving a PMA described by the section title and iden- or declaring completed a PDP for the tification provisions of a regulation in device. If FDA promulgates a regulathis part, but shall state why the de- tion under section 515(b) of the act revice is substantially equivalent to quiring premarket approval for a deother devices, as required by $ 807.87. vice, section 501(f)(1)(A) of the act ap

(c) To avoid duplicative listings, a plies to the device. obstetrical and gynecological device (b) Any new, not substantially equivthat has two or more types of uses alent, device introduced into commer(e.g., used both as a diagnostic device cial distribution on or after May 28, and as a therapeutic device) is listed 1976, including a device formerly maronly in one subpart.

keted that has been substantially al(d) References in this part to regu- tered, is classified by statute (section latory sections of the Code of Federal 513(f) of the act) into class III without Regulations are to chapter I of title 21, any grace period and FDA must have unless otherwise noted.

issued an order approving a PMA or de

claring completed a PDP for the device (52 FR 17740, May 11, 1987)

before the device is commercially dis8884.3 Effective dates of requirement

tributed unless it is reclassified. If for premarket approval.

FDA knows that a device being comA device included in this part that is

mercially distributed may be a "new"

device as defined in this section beclassified into class III (premarket approval) shall not be commercially dis

cause of any new intended use or other tributed after the date shown in the

reasons, FDA may codify the statutory regulation classifying the device unless

classification of the device into class the manufacturer has an approval

III for such new use. Accordingly, the under section 515 of the act (unless an

regulation for such a class III device exemption has been granted under sec

states that as of the enactment date of tion 520(g)(2) of the act). An approval

the amendments, May 28, 1976, the deunder section 515 of the act consists of

vice must have an approval under secFDA's issuance of an order approving

tion 515 of the act before commercial an application for premarket approval

distribution. (PMA) for the device or declaring com- [52 FR 17740, May 11, 1987) pleted a product development protocol (PDP) for the device.

$ 884.9 Limitations of exemptions from (a) Before FDA requires that a device

section 510(k) of the Federal Food, commercially distributed before the

Drug, and Cosmetic Act (the act). enactment date of the amendments, or The exemption from the requirement a device that has been found substan- of premarket notification (section tially equivalent to such a device, has 510(k) of the act) for a generic type of an approval under section 515 of the act class I or II device is only to the extent FDA must promulgate a regulation that the devi has existing or reasonunder section 515(b) of the act requir- ably foreseeable characteristics

of ing such approval, except as provided commercially distributed devices within paragraph (b) of this section. Such a in that generic type or, in the case of regulation under section 515(b) of the in vitro diagnostic devices, only to the act shall not be effective during the extent that misdiagnosis as a result of grace period ending on the 90th day using the device would not be associafter its promulgation or on the last ated with high morbidity or mortality. day of the 30th full calendar month Accordingly, manufacturers of any

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)

Subpart B-Obstetrical and Gyne

cological Diagnostic Devices

a

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 legally 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 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 dis

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

eases

8884.1040 Viscometer for cervical

mucus. (a) Identification. A viscometer for cervical mucus is a device that is intended to measure the relative viscoelasticity of cervical mucus collected from a female patient. Measurements of relative viscoelasticity are intended for use as an adjunct in the clinical evaluation of a female with chronic infertility, to determine the time of ovulation and the penetrability of cervical mucus to motile sperm.

(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 884.9. [47 FR 14706, Apr. 6, 1982, as amended at 65 FR 2320, Jan. 14, 2000) $ 884.1050 Endocervical aspirator.

(a) Identification. An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a sy. ringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.

(b) Classification. Class II (performance standards). $ 884.1060 Endometrial aspirator.

(a) Identification. An endometrial aspirator is a device designed to remove materials from the endometrium (the mucosal lining of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to study endometrial cytology (cells).

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

(1) FDA's:

(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of (b) Classification. Class II (performance standards).

Medical Devices-Part I: Evaluation and Testing,'” and

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

(2) Labeling:

(i) Indication: Only to evaluate the endometrium, and

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

(3) The sampling component is covered within vagina. [45 FR 12684–12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000)

8884.1100 Endometrial brush.

(a) Identification. An endometrial brush is a device designed to remove samples of the endometrium (the mucosal lining of the uterus) by brushing its surface. This device is used to study endometrial cytology (cells).

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

(1) FDA's:

(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,' " and

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

(2) Labeling:

(i) Indication: Only to evaluate the endometrium, and

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

(3) Design and testing:

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

(ii) For adherence of the bristles and brush head. (45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000)

$884.1185 Endometrial washer.

(a) Identification. An endometrial washer is a device used to remove materials from the endometrium (the mucosal lining of the uterus) by washing with water or saline solution and then aspirating with negative pressure. This device is used to study endometrial cytology (cells).

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

(1) FDA's:

(i) “Use of International Organization for Standardization's ISO 10993 'Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,' " and

(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)

$ 884.1300 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).

$ 884.1175 Endometrial suction curette

and accessories. (a) Identification. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.

$ 884.1425 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).

(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 January 29, 1987 for any transabdominal amnioscope (fetoscope) and accessories that was in commercial distribution before May 28, 1976, or that has on or before January 29, 1987 been found to be substantially equivalent to

transabdominal amnioscope (fetoscope) and accessories that was in commercial distribution before May 28, 1976. Any other transabdominal amnioscope (fetoscope) and accessories shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

8884.1550 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. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [61 FR 1123, Jan. 16, 1996)

a

(45 FR 12684—12720, Feb. 26, 1980, as amended at 51 FR 39845, Oct. 31, 1986)

$884.1560 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).

8884.1630 Colposcope.

(a) Identification. A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.

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

8884.1600 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 through a separate cannula associated with the amnioscope, light source and cables, and component parts.

8884.1640 Culdoscope and accessories.

(a) Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.

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

(2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do

or

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