OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM

K093600 · Accelerated Care Plus · KPI · Dec 4, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K093600
• Device Name: OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM
• Applicant: Accelerated Care Plus
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Dec 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

A non-implanted electrical stimulator for urinary incontinence is intended to retrain the urinary continence mechanisms by way of electrical stimulation applied to the pelvic floor musculature and surrounding structures. Typically, these devices are indicated for use in females for treatment of stress incontinence, urge incontinence, or mixed incontinence (a combination of stress and urge incontinence). Intended for use in acute and ongoing treatment of urinary incontinence in cases where the following results may improve urinary control: Improvement of urethral sphincter closure, strengthening of pelvic floor muscles, Inhibition of the detrusor muscle through reflexive mechanisms.

Device Story

Omnistim® Continence+ Pelvic Floor Stimulation System is a non-implanted electrical stimulator; delivers electrical stimulation to pelvic floor musculature and surrounding structures; intended to retrain urinary continence mechanisms; used for acute and ongoing treatment of female urinary incontinence; improves urethral sphincter closure, strengthens pelvic floor muscles, and inhibits detrusor muscle via reflexive mechanisms; operated by healthcare professionals in clinical settings.

Clinical Evidence

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

Technological Characteristics

Non-implanted electrical stimulator; delivers electrical stimulation to pelvic floor musculature; intended for treatment of urinary incontinence; classified under 21 CFR 876.5320 (Product Code KPI).

Indications for Use

Indicated for females with stress, urge, or mixed urinary incontinence to improve urethral sphincter closure, strengthen pelvic floor muscles, and inhibit detrusor muscle activity.

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 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Accelerated Care Plus % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 E. Aurora Road, Unit B7 TWINSBURG OH 44087

Re: K093600

Trade/Device Name: Omnistim® Continence+ Pelvic Floor Stimulation System Regulation Number: 21 CFR 876.5320 Regulation Name: Non-implanted electrical continence device Regulatory Class: II Product Code: KPI Dated: November 19, 2009 Received: November 20, 2009

DEC - 4 2009

Dear Mr. Lehtonen:

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 (PMA), it may be subject to 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.

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); medical device reporting of medical

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device-related adverse events} (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Pre-market (510K) Notification Submission

Revision 4 02/12/09

## Section 4 - Indications for use

510(k) Number (if known):

Classification Name/Code:

Also, irrigated [T

KO93600

Device Name:

Non-Implanted Electrical Continence Device

Omnistim® Continence+ Pelvic Floor Stimulation System

Model Numbers:

300100A

## Indications for Use:

A non-implanted electrical stimulator for urinary incontinence is intended to retrain the urinary continence mechanisms by way of electrical stimulation applied to the pelvic floor musculature and surrounding structures. Typically, these devices are indicated for use in females for treatment of stress incontinence, urge incontinence, or mixed incontinence (a combination of stress and urge incontinence).

Intended for use in acute and ongoing treatment of urinary incontinence in cases where the following results may improve urinary control: Improvement of urethral sphincter closure, strengthening of pelvic floor muscles, Inhibition of the detrusor muscle through reflexive mechanisms.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number

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