CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010

K980356 · Canadian Medical Brush, Inc. · HHT · Apr 16, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K980356
• Device Name: CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010
• Applicant: Canadian Medical Brush, Inc.
• Product Code: HHT · Obstetrics/Gynecology
• Decision Date: Apr 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

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.

Device Story

Cervical Cytology C-Brush is a manual specimen collection tool; features truncated cone-shaped nylon brush head on wire shaft bonded to plastic handle. Clinician inserts brush 1.0-1.5 cm into cervical os; rotates two full turns counter-clockwise; withdraws. Collected cells are transferred to glass slide for Pap smear or STD testing. Device facilitates diagnostic sampling; aids in detection of cervical abnormalities or infections. Used in clinical settings by healthcare providers.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarity to predicate.

Technological Characteristics

Truncated cone-shaped nylon bristles; wire shaft; plastic handle. Manual operation. Non-sterile or sterile (implied by medical device classification).

Indications for Use

Indicated for endocervical specimen collection for Pap smear, chlamydia, and HPV testing. Contraindicated for use in 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

• Team Technologies, Inc. - Cytology Brush (K971849)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a black and white drawing of a caduceus. The caduceus is a symbol often associated with medicine and healthcare. It features a staff with two snakes coiled around it, and a pair of wings at the top.

Canadian Medical Brush Inc. Mississauga, Ontario L5S 1A3 Canada 2299 Drew Road, unit # 6

APR 1 6 1998

# 510(k) SUMMARY

K980356 PI 72

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

| Submitter: | Canadian Medical Brush Inc. |
|------------|------------------------------|
| | 2299 Drew road, Unit #6 |
| | Mississauga, Ontario L5S 1A3 |
| | Canada |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

Contact Person: Stephen Jemuovic, Director, Regulatory Affairs Canadian Medical Brush Inc Phone: [phone] (905) 405- 1108 Fax:

# Name of Device and Name / Address of Sponsor

Name of Device: Cervical Cytology C-Brush

Sponsor: Canadian Medical Brush Inc. 2299 Drew Road, Unit #6 Mississauga, Ontario L5S 1A3 Canada

Common or Usual Name:

Specimen (cervical) collection brush

Classification Name:

C ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

DACE

Spatula, cervical, cytological

Phone: [phone] Fax: [phone] E-mail: [e-mail]

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Image /page/1/Picture/0 description: The image shows a caduceus symbol, which is often associated with medicine and healthcare. The symbol features a staff with two snakes coiled around it, and a pair of wings at the top. The staff is vertical and the snakes are intertwined, creating a symmetrical design. The wings are spread out, adding to the overall visual balance of the symbol.

Canadian Medical Brush Inc. 2299 Drew Road, unit # 6 Canada

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1980356 02012

# 510(K) SUMMARY - PAGE 2

Predicate Device:

Team Technologies, Inc. - Cytology Brush (K971849)

#### Device Description:

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.

# Intended Use:

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.

### Technological Characteristics and Substantial Equivalence

The Cervical Cytology C-Brush is substantially equivalent in terms of design, materials, manufacturing processes, physical Intended use, properties, and principles of operation to the Team Technologies, Inc. Cytology Brush.

E-mail: [e-mail] Phone: [phone] Fax: [phone]) 11

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APR 1 6 1998

Re: K980356

Cytology Cervical C-Brush

Received: March 31, 1998

21 CFR 884.4530/Procode: 85 HHT

Dated: March 23, 1998

Regulatory Class: II

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stephen Jemuovic Director Canadian Medical Brush, Inc. 2299 Drew Road, unit # 6 Mississauga, Ontario L5S 1A3 CANADA

Dear Mr. Jemuovic:

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 indications 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 III (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 equivalience compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510%) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 on the promotion 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/odrh/dsmaldsmamain.html".

Sincerely yours.

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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510(k) Number (if known):

Cervical Cytology C-Brush Device Name:

Indications For Use:

Indication for use are the endocervical collection of specimens used in Pap smear, chlamydia and HPV testing.

K980356

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Roder R. Rathbun

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 11 980356 510(k) Number _

Prescription Use > (Per 21 CFR 801.109)

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Over-The-Counter Use

(Optional Format 1-2-96)