FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1

K051294 · Femspec LLC · HHK · Dec 21, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K051294
• Device Name: FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
• Applicant: Femspec LLC
• Product Code: HHK · Obstetrics/Gynecology
• Decision Date: Dec 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1175
• Device Class: Class 2

Intended Use

FemSpec, LLC, FemTest™ Endometrial Suction Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples for histological analysis of the uterine mucosal lining from the endocervical canal and is indicated for: Cancer screening; Endometrial dating; Determining response to estrogen replacement therapy; Bacterial culturing; Detection of pathology resulting in infertility; Monitoring patients receiving Tamoxifen therapy; Evaluating secondary amenorrhea.

Device Story

FemTest™ Endometrial Suction Curette is a sterile, disposable manual instrument used by clinicians to obtain endometrial tissue samples for histological analysis. The device functions via suction to collect mucosal lining samples from the uterine cavity/endocervical canal. It is intended for use in clinical settings for diagnostic procedures including cancer screening, fertility evaluation, and monitoring hormonal therapies. The clinician performs the procedure, and the collected tissue is sent to a laboratory for analysis to assist in clinical decision-making regarding patient pathology and treatment response.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile, disposable manual suction curette. Form factor designed for endocervical/uterine access. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring endometrial tissue sampling for histological analysis, including cancer screening, endometrial dating, monitoring estrogen replacement or Tamoxifen therapy, bacterial culturing, infertility pathology detection, and evaluation of secondary amenorrhea.

Regulatory Classification

Identification

An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2005

Carl Youngmann, Ph.D., RAC Director, Regulatory and Quality Affairs FemSpec™ The Presidio, HQ, Bldg 220, Suite 120, P.O. Box 29450 SAN FRANCISCO CA 94129-0450

Re: K051294 Trade/Device Name: FemTest™ Endometrial Suction Curette Regulation Number: 21 CFR 884.1175 Regulation Name: Endometrial suction curette and accessories Regulatory Class: II Product Code: HHK Dated: October 31, 2005 Received: November 2, 2005

Dear Dr. Youngmann:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter with anow you to oghi maning of substantial equivalence of your device to a legally prematication. "The PDF 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 If you desire specific active for your er of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation entires) formation on your responsibilities under the Act from the 807.97). Tou may outlik onter general meeting and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrlvindustry/support/index.html.

Sincerely yours,

Nancy C. Brigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

## 510(k) Number: K051294

FemSpec, LLC, FemTest™ Endometrial Suction Curette Device Name:

Indications for Use:

FemSpec, LLC, FemTest™ Endometrial Suction Curette is a sterile, Fellispec, LLC, Felfrest - Endoniedle patient use in obtaining tissue
disposable curette indicated for single patient use in obtaining the could disposable curette indicated vois from the endocervical canal and samples for nistological analysis of the uterine mucosal lining is indicated for:

- Cancer screening .
- Endometrial dating .
- Determining response to estrogen replacement therapy .
- Bacterial culturing ●
- Detection of pathology resulting in infertility .
- Monitoring patients receiving Tamoxifen therapy .
- Evaluating secondary amenorrhea .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONTINUE - CONTINUE - CONTINUE - CONTI (I LERSEDO NOT THE Office of Device Evaluation (ODE)

| Prescription Use | X | OR | Over-The-Counter Use |
|-----------------------------|---|----|-----------------------------|
| (Per 21 CFR §801 subpart D) | | | (Per 21 CFR §801 subpart C) |

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

| 510(k) Number | K051294 |
|---------------|---------|
|---------------|---------|