(88 days)
The UROSTYM ™ Biofeedback and Stimulation Device is used for treating urinary incontinence by way of perineal re-education.. The Urostym probes are non-implanted electrical devices applied to the pelvic floor musculature and surrounding structures for therapy in the treatment of urinary incontinence. The probes and patches are provided nonsterile for single (individual) patient use / disposable. The probes are for office or hospital use under the direction of a physician or other licensed healthcare professional.
UROSTYM™ Biofeedback and Stimulation Device and Accessories
The provided document is a 510(k) summary for a medical device (UROSTYM™ Biofeedback and Stimulation Device and Accessories) and does not contain information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, or ground truth establishment. This document is a regulatory letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and is cleared for market.
Therefore, an answer fulfilling the request cannot be generated from the given text.
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Ms. Barbara Mornet Regulatory Affairs Deputy and Official Correspondent Laborie Medical Technologies 400 Avenue D, Suite 10 WILLISTON VT 05495-7828
Re: K070331
Trade/Device Name: UROSTYM™ Biofeedback and Stimulation Device and Accessories Regulation Number: 21 CFR §876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: March 20, 2007 Received: March 29, 2007
Dear Ms. Mornet:
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.
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Promoting and Promoting Public Health
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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.
This letter will allow you to begin marketing your device as described in your Section 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 contact the Office of Compliance at one 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 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy 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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510 (k) Number (1F KNOWN) : K070331 Page 1 of 1
DEVICE NAME: UROSTYM™ Biofeedback and Stimulation Device and Accessories
INDICATIONS FOR USE:
The UROSTYM ™ Biofeedback and Stimulation Device is used for treating urinary incontinence by way of perineal re-education.. The Urostym probes are non-implanted electrical devices applied to the pelvic floor musculature and surrounding structures for therapy in the treatment of urinary incontinence. The probes and patches are provided nonsterile for single (individual) patient use / disposable. The probes are for office or hospital use under the direction of a physician or other licensed healthcare professional.
Prescription Use X
Carolyn 4 Neuland for N. Brogdan
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070331
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).