(77 days)
The Cervical Cytology C-Brush is intended for the collection of cervical cells for Pap smear analysis and /or for sexually transmitted disease (STD) testing. The Cervical Cytology C-Brush is not intended for use in pregnant women.
Indication for use are the endocervical collection of specimens used in Pap smear, chlamydia and HPV testing.
The Cervical Cytology C-Brush has a truncated cone-shaped brush head composed of nylon bristles joined to a wire shaft. The brush head on the wire shaft is bonded to a plastic handle. To collect cervical cells, the brush end of the Cervical Cytology C-Brush is inserted 1.0 to 1.5 cm into the cervical os until the longest outer bristles of the brush touch the ectocervix. The brush is rotated two full turns in counter - clockwise direction and withdrawn. The brush is then used to spread the specimen onto a glass slide for a Pap smear.
The provided text is a 510(k) summary for the Canadian Medical Brush Inc. Cervical Cytology C-Brush. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Based on the provided text, there is no information about a study that describes acceptance criteria for device performance, nor any reported device performance metrics tied to such criteria.
The document primarily focuses on establishing "substantial equivalence" of the Cervical Cytology C-Brush to a predicate device (Team Technologies, Inc. - Cytology Brush, K971849) in terms of:
- Design
- Materials
- Manufacturing processes
- Physical properties
- Intended use
- Principles of operation
The FDA's finding of substantial equivalence means that the device is considered as safe and effective as the predicate device, and thus does not require a new premarket approval (PMA) pathway which would typically involve extensive clinical trials with specific performance metrics and acceptance criteria.
Therefore, I cannot provide the requested information, as it is not present in the provided 510(k) summary. The document does not describe any specific performance acceptance criteria or a study designed to demonstrate the device meets such criteria through quantitative performance metrics.
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic 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 (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(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 § 884.9.