(178 days)
The PelvX Ring Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse.
The PelvX Ring with Support Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse combined with mild cystocele.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the PelvX Ring Vaginal Pessary and PelvX Ring with Support Vaginal Pessary, indicating that the device has been found substantially equivalent to predicate devices. It outlines the regulatory classification, indications for use, and general responsibilities but does not detail performance criteria or associated studies.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 27 1998
Mr. Matthew Hoskins Vice President of Research and Development DesChutes Medical Products, Inc. 1011 SW Emkay Drive, #104 Bend, OR 97702
Re: K974115
PelvX Ring Vaginal Pessary and PelvX Ring with Support Vaginal Pessary Dated: January 29, 1998 Received: February 5, 1998 Regulatory Class: II 21 CFR 8884.3575/Procode: 85 HHW
Dear Mr. Hoskins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours.
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat 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 (if known): KS 74115
Device name: PelvX Ring Vaginal Pessary and PelvX Ring with Support Vaginal Pessary
Indications for Use:
The PelvX Ring Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse.
The PelvX Ring with Support Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse combined with mild cystocele.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Rathbun
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974115
Prescription Use
OR
Over-The-Counter Use
§ 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).