Who is the manufacturer of DETECT CYTOLOGY BRUSH II?

Cook Urological, Inc. filed the 510(k) submission for DETECT CYTOLOGY BRUSH II (K960469).

What is the FDA product code for DETECT CYTOLOGY BRUSH II?

HHT. It is classified under 21 CFR 884.4530 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for DETECT CYTOLOGY BRUSH II?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DETECT CYTOLOGY BRUSH II?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DETECT CYTOLOGY BRUSH II

K960469 · Cook Urological, Inc. · HHT · Mar 14, 1996 · Obstetrics/Gynecology

Device Facts

Record ID	K960469
Device Name	DETECT CYTOLOGY BRUSH II
Applicant	Cook Urological, Inc.
Product Code	HHT · Obstetrics/Gynecology
Decision Date	Mar 14, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.4530
Device Class	Class 2

Intended Use

The Detect™ Cytology Brush II is a one-time use device for collecting vaginal and cervical cell samples for cytological evaluation and infection diagnosis. The device is not indicated for endometrial cell sampling or for use on pregnant patients.

Device Story

Disposable manual instrument; used for collecting vaginal and cervical cell samples; intended for cytological evaluation and infection diagnosis. Operated by clinicians in gynecological settings. Device design and function equivalent to existing cell collector brushes. Biocompatibility and performance testing confirm integrity and safety.

Clinical Evidence

Bench testing only; biocompatibility testing performed; performance and integrity testing conducted with results comparable to predicate devices.

Technological Characteristics

Manual gynecologic instrument; disposable; biocompatible materials; non-powered.

Indications for Use

Indicated for collection of vaginal and cervical cell samples for cytological evaluation and infection diagnosis. Contraindicated for endometrial cell sampling and use on pregnant patients.

Regulatory Classification

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.

Special Controls

*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.

Related Devices

K971849 — CYTOLOGY BRUSH · Team Technologies, Inc. · Jul 24, 1997
K141057 — DISPOSABLE CERVICAL BRUSH · Ningbo Hls Medical Products Co., Ltd. · May 14, 2015
K991595 — ORIBRUSH - WITH PROTECTIVE TIP - B001 · Orifice Medical AB · Jun 29, 1999
K991593 — ORIBRUSH - STANDARD - B002 · Orifice Medical AB · Jun 29, 1999
K983428 — SAFETEX CERVICAL SCRAPER (PLASTIC) · Andwin Scientific · Nov 16, 1998

Submission Summary (Full Text)

{0} 9 510(k) Premarket Notification Detect Cytology Brush II Cook OB/GYN MAR 14 1996 K 960 469 # J. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ## Submitted By: Tammy Bacon Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-6500 January 31, 1996 ## Device Trade Name: Detect™ Cytology Brush II Common/Usual Name: Biopsy Brush, Cell Collector Proposed Classification Name: Obstetrical-Gynecologic Specialized Manual Instrument ## Predicate Devices: The Detect™ Cytology Brush II is a disposable gynecologic manual instrument for collecting vaginal and cervical cell samples similar to predicate cell collector brushes in terms of indications for use and technology. ## Device Description: The Detect™ Cytology Brush II is a one-time use device for collecting vaginal and cervical cell samples for cytological evaluation and infection diagnosis. The device is not indicated for endometrial cell sampling or for use on pregnant patients. The materials of construction have undergone biocompatibility testing and met the requirements of the tests. Testing was also conducted to characterize the performance and integrity of the device. Results were comparable to those obtained when similarly testing a predicate device. ## Substantial Equivalence: The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing procedures similar to devices currently marketed and distributed by Cook OB/GYN. This device is similar with respect to indications for use and design to predicate devices in terms of section 510(k) substantial equivalency.