UROSTYM

K962009 · Laborie Medical Technologies, Ltd. · KPI · May 20, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K962009
• Device Name: UROSTYM
• Applicant: Laborie Medical Technologies, Ltd.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: May 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Laborie UROSTYM™ is intended to be used in treating urinary incontinence (stress incontinence (hypermobility) and bladder instability) by way of perineal reeducation. Using the available accessories, the system can be used for performing biofeedback and electro-stimulation therapy as treatment modalities for urinary incontinence.

Device Story

UROSTYM™ is a biofeedback and electro-stimulation system for treating urinary incontinence. Device utilizes perineal sensors/electrodes to monitor muscle activity and deliver electrical stimulation. Operated by clinicians in a clinical setting to facilitate perineal reeducation. Biofeedback provides visual/auditory cues to patients regarding pelvic floor muscle contraction; electro-stimulation assists in muscle conditioning. Output allows clinicians to monitor progress and adjust therapy parameters. Benefits include improved muscle control and reduction of incontinence symptoms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes biofeedback and electro-stimulation modules. Operates via perineal sensors/electrodes. Intended for clinical use. Connectivity and specific material standards not detailed in provided documentation.

Indications for Use

Indicated for patients with urinary incontinence, specifically stress incontinence (hypermobility) and bladder instability, requiring perineal reeducation via biofeedback or electro-stimulation therapy.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

# MAY 20 1997

Mr. Thomas G. Hirte
Regulatory Affairs Manager
Laborie Medical Technologies Corporation
6 Hurricane Lane
Williston, Vermont 05495

Re: K962009
UROSTYM™ Biofeedback and Stimulation Device
Dated: March 24, 1997
Received: March 27, 1997
Regulatory class: II
21 CFR §876.5320/Product code: 78 KPI
21 CFR §884.1425/Product code: 85 HIR

Dear Mr. Hirte:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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), please 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/dsmamain.html".

Sincerely yours,


Enclosure

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510(k) Number (if known): K962009

Device Name: UROSTYM™ Biofeedback and Stimulation Device

Indications For Use:

The Laborie UROSTYM™ is intended to be used in treating urinary incontinence (stress incontinence (hypermobility) and bladder instability) by way of perineal reeducation. Using the available accessories, the system can be used for performing biofeedback and electro-stimulation therapy as treatment modalities for urinary incontinence.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Sillig
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K962009

Prescription Use ☑ OR Over-The-Counter Use ☐
(Per 21 CFR 801.109)

(Optional Format 1-2-96)