UROSTYM BIOFEEDBACK AND STIMULATION PROBES

K990041 · Laborie Medical Tech Corp. · KPI · Aug 5, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990041
• Device Name: UROSTYM BIOFEEDBACK AND STIMULATION PROBES
• Applicant: Laborie Medical Tech Corp.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Aug 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UROSTYM™ Biofeedback and Stimulation Probes are indicated for treating urinary incontinence by way of pelvic floor muscle re-education and stimulation. The UROSTYM™ provides non-implanted electrical stimulation applied to the pelvic floor musculature and surrounding pelvic structures for therapy in the treatment of urinary incontinence. The probes are provided for single patient use/disposable. These non-sterile probes are for office use under the direction of a physician or licensed health care professional.

Device Story

UROSTYM™ Biofeedback and Stimulation Probes (Models 3AT2B and TP2B) are vaginal probes used for pelvic floor muscle re-education and electrical stimulation; intended for treatment of urinary incontinence. Device delivers non-implanted electrical stimulation to pelvic floor musculature and surrounding structures. Probes are single-patient use, disposable, and non-sterile; intended for office use under physician or licensed healthcare professional supervision. Output facilitates muscle contraction/relaxation training; aids in clinical management of incontinence.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Vaginal probes (Models 3AT2B and TP2B) for electrical stimulation and biofeedback. Single-patient use, disposable, non-sterile. Operates via electrical stimulation of pelvic floor musculature.

Indications for Use

Indicated for patients with urinary incontinence requiring pelvic floor muscle re-education and electrical stimulation therapy. For use under the direction of a physician or licensed healthcare professional.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 1999

Mr. Dale Coleman, MS, CQE, RAC Regulatory Affairs Manager Laborie Medical Technologies Corp. 310 Hurricane Lane #2 Williston. VT 05495-2070

Re: K990041

UROSTYM™ Biofeedback and Stimulation Device - Vaginal Probe Models 3AT2B and TP2B Dated: June 17, 1999 Received: June 18, 1999 Regulatory Class: II 21 CFR §876.5320/Procode: 78 KPI

Dear Mr. Coleman:

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 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, 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 (QS) 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 531 through 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), piease contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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NUMBER (IF KNOWN) : K 9900 4 | 510 (k) NAME: UROSTYM™ Dioteed back and INDICATIONS FOR USE:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use
(Per 21 CFR 801.109)

Over - The - Counter - Use (Optional Format 1-2-96

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Division of Reproductive, Abdominal, ENT,

Division of Reproductive, Abdominal, EN and Radiological Device, 510(k) Number