TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER

K082066 · Cook Urological, Inc. · HFE · Nov 7, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K082066
• Device Name: TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
• Applicant: Cook Urological, Inc.
• Product Code: HFE · Obstetrics/Gynecology
• Decision Date: Nov 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1100
• Device Class: Class 2

Intended Use

Used to obtain endometrial cytological and histological samples.

Device Story

The Tao Brush™ I.U.M.C. Endometrial Sampler is a manual medical instrument designed for endometrial sampling. It consists of a brush assembly housed within a shaft, featuring a coaxial sheath for sample protection and positioning marks on the shaft end. The device is operated by a clinician to procure representative endometrial samples; the brush head collects the tissue while the tip is designed to protect the patient from abrasion. The device is provided sterile for single-use. It is used in a clinical setting to assist in diagnostic procedures by providing samples for cytological and histological analysis.

Clinical Evidence

Bench testing only. Biocompatibility, sterility, and performance testing were performed in accordance with FDA guidance and recognized international standards.

Technological Characteristics

Manual endometrial sampling brush assembly with coaxial sheath. Materials and design are identical to the predicate K941298. Provided sterile for single-use.

Indications for Use

Indicated for obtaining endometrial cytological and histological samples in patients requiring endometrial sampling.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Tao Brush™ I.U.M.C. Endometrial Sampler (version 1, K941298)
• Pipelle™ by CooperSurgical (K881456)

Submission Summary (Full Text)

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K082066

Tao Brush™ I.U.M.C. Endometrial Sampler STED 510(k) submission Cook Urological, Incorporated July 31, 2008

NOV - 7 2008

#### 510(k) SUMMARY

| Submitted by: | Cindy Foote<br>Regulatory Affairs Specialist<br>Cook Urological, Incorporated<br>1100 West Morgan Street<br>Spencer, IN 47460<br>July 31, 2008 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Device: | |
| Trade Name: | Tao Brush™ I.U.M.C. Endometrial Sampler |
| Proposed Classification Name: | Brush, Endometrial<br>21 CFR Part 884.1100<br>Class II, HFE |

#### Predicate Devices:

The Tao Brush™ I.U.M.C. Endometrial Sampler is identical to the Tao Brush™ I.U.M.C. Endometrial Sampler (version 1, K941298) in design, materials of construction, and cytological sampling. The Tao Brush™ I.U.M.C. Endometrial Sampler is similar to the Pipelle™ by CooperSurgical (K881456), in regards to histological sampling.

### Device Description:

The Tao Brush™ I.U.M.C. Endometrial Sampler is a brush assembly fitted inside a shaft. A coaxial sheath promotes sample protection and there are positioning marks on the end of the shaft. The brush head procures and adequate representative sample of the endometrial and the tip protects the patient from abrasion. The devices are provided sterile and are intended for one time use.

### Substantial Equivalence:

The Cook® Cervical Ripening Balloon is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.

### Test Data:

Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards. Testing data and information is included in this submission.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three branches instead of the usual one.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2008

Ms. Cindy Footc Regulatory Affairs Specialist COOK® Urological 1100 W. Morgan Street SPENCER IN 47460

Re: K082066

> Trade/Device Name: Tao Brush I.U.M.C. Endometrial Sampler Regulation Number: 21 CFR §884.1100 Regulation Name: Endometrial brush Regulatory Class: II Product Code: HFE Dated: September 30, 2008 Received: October 1, 2008

Dear Ms. Foote:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jorgu Mzhang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Tao Brush™ I.U.M.C. Endometrial Sampler STED 510(k) submission Cook Urological, Incorporated July 31, 2008

# Indications for Use

510(k) Number (if known):_ KO82066 __

Name of Device:

Tao Brush™ I.U.M.C. Endometrial Sampler

Indications for Use:

Used to obtain endometrial cytological and histological samples.

Prescription Use?____ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hels Remer

Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number

Company Confidential Cook Urological