(217 days)
FemSpec, LLC, FemTest™ Endometrial Suction Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples from the endocervical canal and for histological analysis of the uterine mucosal lining. It 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
FemSpec, LLC, FemTest™ Endometrial Suction Curette is a sterile, disposable curette.
The provided text describes the 510(k) clearance for the FemTest™ Endometrial Suction Curette. This document is a regulatory approval, not a scientific study describing performance criteria and results of a device.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because the provided text does not contain such details. It is a regulatory letter confirming substantial equivalence to a legally marketed predicate device, not a performance study.
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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 (800) 638-2041 or (301) 443-6597 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 |
|---|---|
| --------------- | --------- |
§ 884.1175 Endometrial suction curette and accessories.
(a)
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.(b)
Classification. Class II (performance standards).