(86 days)
Bioteque's vaginal pessaries are indicated as removable devices placed in the vaginal cavity to provide a non-surgical alternative for the treatment of organ prolapse and to relieve the symptoms of pelvic relaxation with and without urinary incontinence.
Not Found
I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance. The text is a 510(k) clearance letter from the FDA for a Bioteque Vaginal Pessary, indicating that the device is substantially equivalent to a legally marketed predicate device.
The letter discusses regulatory aspects, such as compliance with the Federal Food, Drug, and Cosmetic Act, and general controls provisions. It also includes the specific indications for use of the Bioteque Vaginal Pessary. However, it does not detail any specific acceptance criteria for performance, nor does it describe a study that was conducted to demonstrate the device meets such criteria. Therefore, I cannot accurately fill in the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, or types of ground truth.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 7 2001
Mr. Dennis Dorsey Bioteque America, Inc. 340 East Maple Avenue Suite 204C LANGHORNE PA 19047 Re: K013289
Trade/Device Name: Bioteque Vaginal Pessary Regulation Number: 21 CFR 884.3575 Regulation Name: Vaginal Pessary Regulatory Class: II Product Code: 85 HHW Dated: September 28, 2001 Received: October 2, 2001
Dear Mr. Dorsey:
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 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 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 If you desire spooline act one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on by received to promained the Act may be obtained from the Division of Small Manufacturers, your responsibilities and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
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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K 613289/A
Page L ol_
510(k) Number (if known): K013289
Device Name: Bioteque Vaginal Posserias
Indications For Use:
Bioteque's vaginal pessaries
are indicated as removable devices
placed in the vaginal cavity to
provide a non-surgical alternative
for the treatment of organ prolapse
and to relieve the symptoms of
pelvic relaxation with and without
urinary incontinence.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancyc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013289
Prescription Use
(Per 21 CFR 801.109)
OR
Over The Counter Use
(Optional format 1-2
§ 884.3575 Vaginal pessary.
(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).