UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES

K070331 · Laborie Medical Technologies · KPI · May 4, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070331
• Device Name: UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES
• Applicant: Laborie Medical Technologies
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: May 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

UROSTYM™ is a non-implanted electrical stimulation and biofeedback system for treating urinary incontinence. Device utilizes probes and patches applied to pelvic floor musculature; provides electrical stimulation for muscle re-education. Operated in clinical settings (office/hospital) by physicians or licensed healthcare professionals. System monitors physiological signals via biofeedback to assist patient in pelvic floor muscle control. Output used by clinicians to guide therapy sessions; intended to improve patient continence through muscle strengthening and awareness.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Non-implanted electrical stimulation device. Components include probes and patches for pelvic floor application. Probes/patches are non-sterile, single-patient use/disposable. Operates as a biofeedback and stimulation system for perineal re-education.

Indications for Use

Indicated for patients requiring treatment for urinary incontinence via perineal re-education. Used for pelvic floor muscle therapy. Contraindications not specified.

Regulatory Classification

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).

Submission Summary (Full 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 [phone] or [phone] 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