DIGENE CERVICAL BRUSH

K971586 · Digene Corp. · HHT · Sep 19, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K971586
• Device Name: DIGENE CERVICAL BRUSH
• Applicant: Digene Corp.
• Product Code: HHT · Obstetrics/Gynecology
• Decision Date: Sep 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Indications for Use

The Digene Cervical Brush is intended for the collection of cervical cells for Pap smear analysis and/or for sexually transmitted disease (STD) testing. The Digene Cervical Brush is not intended for use in pregnant women.

Device Story

Digene Cervical Brush is a manual specimen collection tool; features truncated cone-shaped brush head with bristles on wire shaft bonded to plastic handle. Used by clinicians to collect cervical cells; inserted 1.0 to 1.5 cm into cervical os; rotated three full turns counter-clockwise; withdrawn. Collected specimen is spread on glass slide for Pap smear or placed in transport tube for STD testing. Device facilitates diagnostic sampling; benefits patient by enabling screening for cervical abnormalities and STDs.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material comparison to predicate.

Technological Characteristics

Truncated cone-shaped brush head; bristles attached to wire shaft; plastic handle; distal wire end embedded in solidified glue. Manual operation; non-powered.

Indications for Use

Indicated for collection of cervical cells for Pap smear analysis and/or STD testing in non-pregnant women.

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.

Predicate Devices

• Medscand Cytobrush (K832986)

Submission Summary (Full Text)

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K 971586

fi92

#### 510(k) SUMMARY

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

SEP 1 9 1997

Submitter Digene Corporation 9000 Virginia Manor Road Beltsville, MD 20705 [phone] Phone: Facsimile: [phone]

Contact Person Constance A. Finch, Dr.P.H. Director, Regulatory Affairs Digene Corporation [phone] Phone: [phone] Facsimile:

Date Prepared: June 30, 1997

### Name of Device and Name/Address of Sponsor

Name of Device Digene Cervical Brush

Sponsor Digene Corporation 9000 Virginia Manor Road Beltsville, MD 20705

#### Common or Usual Name

Specimen (cervical) collection brush

## Classification Name

Spatula, cervical, cytological

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K971586
p2072

### Predicate Device

Medscand Cytobrush (K832986)

### Device Description

The Digene Cervical Brush has a truncated cone-shaped brush head composed of bristles joined to a wire shaft; the brush head on the wire shaft is bonded to a plastic handle. The distal end of the wire shaft is embedded in solidified glue. To collect cervical cells, the brush end of the Digene Cervical 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 three full turns in a counter-clockwise direction and withdrawn. The brush is then used to spread the specimen onto a glass slide for a Pap smear or is inserted into a transport tube for use in STD testing.

#### Intended Use

The Digene Cervical Brush is intended for the collection of cervical cells for Pap smear analysis and/or for sexually transmitted disease (STD) testing. The Digene Cervical Brush is not intended for use in pregnant women.

#### Technological Characteristics and Substantial Equivalence

The Digene Cervical Brush is substantially equivalent in terms of intended use, design, materials, manufacturing processes, physical properties, and principles of operation to the Medscand Cytobrush.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the top half of the circle. In the center of the logo is an abstract symbol that resembles a stylized caduceus or a person with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 1 9 1997

Constance A. Finch, Dr.P.H. Director, Regulatory and Clinical Affairs Digene Corporation 9000 Virginia Manor Road, Suite 206 Beltsville, Maryland 20705

Dear Dr. Finch:

Re: K971586

Digene Cervical Brush Dated: July 1, 1997 Received: July 1, 1997 Regulatory class: II 21 CFR §884.4530/Product code: 85 HHT

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the intentions for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject

to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

h.J.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

510(k) Number (if known): ¥971586

Device Name:

Digene Cervical Brush

Indications for Use:

The Digene Cervical Brush is intended for the collection of cervical cells for Pap smear analysis and/or for sexually transmitted disease (STD) testing.

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

Robert R Ratliff

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 71586 510(k) Number