(170 days)
FemSpec, LLC, FemECC™ Endocervical Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis.
FemSpec, LLC, FemECC™ Endocervical Curette is a sterile, disposable curette.
This looks like a 510(k) clearance letter from the FDA for a medical device called the "FemECC™ Endocervical Curette." This type of document is a regulatory approval, not a clinical study report. Therefore, it does not contain the specific information requested about acceptance criteria, study design, or performance metrics.
The letter explicitly states:
"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... "
This means the device was cleared based on its substantial equivalence to an already approved predicate device, not on a new clinical study demonstrating performance against specific acceptance criteria. The 510(k) process often relies on non-clinical testing (e.g., biocompatibility, sterilization validation, mechanical testing) and comparison to a predicate device's design and indications for use.
Therefore, I cannot provide the requested information based on this document.
To provide an answer to your prompt, a document detailing a clinical trial or performance study would be required.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB - 1 2013
FemSpec. LLC c/o Carl Youngmann, Ph.D., RAC Director, Regulatory and Quality Affairs The Presidio, HQ, Building 220. Suite 120 P.O. Box 29450 SAN FRANCISCO CA 94129-0450
Re: K060320
Trade/Device Name: FemSpec, LLC, FemECC™ Endocervical Curette Regulation Number: 21 CFR 884.1050 Regulation Name: Endocervical aspirator Regulatory Class: II Product Code: PCF Dated: June 23, 2006 Received: June 26, 2006
Dear Dr. Youngmann:
This letter corrects our substantially equivalent letter of July 28, 2006.
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 (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 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
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Page 2 - Carl Youngmann, Ph.D., RAC
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section IV-Indications for Use Statement
510(k) Number: K060320
Device Name: FemSpec, LLC, FemECC™ Endocervical Curette
Indications for Use:
FemSpec, LLC, FemECC™ Endocervical Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
V. barry C. Ferguson
(Division Sign-Off)
Division of Reproductive, Ab and Radiological Devices 510(k) Number
Prescription Use _ × (Per 21 CFR §801 subpart D) OR
Over-The-Counter Use_ (Per 21 CFR §801 subpart C)
§ 884.1050 Endocervical aspirator.
(a)
Identification. An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.(b)
Classification. Class II (performance standards).