MINNOVA PELVIC FLOOR STIMULATION SYSTEM

K970307 · Empi · KPI · Apr 22, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970307
• Device Name: MINNOVA PELVIC FLOOR STIMULATION SYSTEM
• Applicant: Empi
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Apr 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Minnova Pelvic Floor Stimulation System is indicated for 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 reflective mechanisms.

Device Story

Minnova Pelvic Floor Stimulation System; battery-powered external electrical stimulator; used with vaginal or rectal electrodes to stimulate pelvic floor muscles; treats urinary incontinence; improves urethral sphincter closure; strengthens pelvic floor; inhibits detrusor muscle; non-programmable; no biofeedback; clinician-prescribed; patient-operated; provides intermittent or continuous stimulation; peak pulse intensity 0-100mA; frequency 12.5Hz or 50Hz; pulse width 300μs; duty cycle 5:10.

Clinical Evidence

Bench testing only. Verification of device specifications, software verification and validation, EMI testing, and FMECA performed to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Battery-powered electrical stimulator; output 0-100mA; frequency 12.5Hz or 50Hz; pulse width 300μs; duty cycle 5:10; ramp time 2s. Electrodes feature touchproof connectors. Non-programmable; no biofeedback.

Indications for Use

Indicated for patients with urinary incontinence requiring improved urethral sphincter closure, pelvic floor muscle strengthening, or detrusor muscle inhibition.

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).

Predicate Devices

• Empi, Inc. Innova Pelvic Floor Stimulation System (K9411911/B)
• Hollister Mycrogym II Stimulation Device (K891773)
• Utah Medical Liberty System (K960496)

Reference Devices

• Innova ComfortPulse Vaginal electrodes (K964577)
• Innova Vaginal Electrode (K910081)
• Innova Rectal Stimulation Electrode (K954272)

Submission Summary (Full Text)

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APR 22 1997
Empi.

Cost Effective Health Care Solutions

SUMMARY OF SAFETY AND EFFECTIVENESS
Minnova Pelvic Floor Stimulation System
Date of Summary January 24, 1997
Page 1 of 2
K970307

A. General Provisions
Submitter's Name: Empi, Inc.
Submitter's Address: 599 Cardigan Road
St. Paul, Minnesota 55126-3965
Contact Person: Carolyn M. Steele Husten
Regulatory Affairs Manager

Classification Name: Non-Implanted Electrical Continence Device
21 CFR Part 876.5320

Proprietary Name: Minnova Pelvic Floor Stimulation System
Common Name: Pelvic Floor Stimulation Device

B. Name of Predicate Devices
- Empi, Inc. Innova Pelvic Floor Stimulation System, K9411911/B
- Hollister Mycrogym II Stimulation Device, K891773
- Utah Medical Liberty System, K960496

C. Device Description
List of Components
The Minnova Pelvic Floor Stimulation System is comprised of a external stimulator and an electrode. The device when used with the Innova® ComfortPulse® Vaginal electrodes (ComfortPulse Electrodes) (K964577 - currently under review at the FDA), Innova Vaginal Electrode (K910081), and Innova® Rectal Stimulation Electrode (Innova Rectal Electrode) (K954272), stimulates the muscles of the pelvic floor to achieve and maintain urinary continence. The electrodes are identical to those previously submitted except for the addition of touchproof connectors to comply with “Medical Devices; Performance Standards for Electrode Lead Wires and Banning of Unprotected Electrode Lead Wires; Proposed Rule.” There is no adapter required to connect the electrodes to the device. The components of the system are placed in a soft-sided carrying case.

Empi, Inc.
599 Cardigan Road
St. Paul, Minnesota
55126-3965 USA
612-415-9000
FAX [phone]

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SUMMARY OF SAFETY AND EFFECTIVENESS
Minnova Pelvic Floor Stimulation System
Date of Summary January 24, 1997
Page 2 of 2

## Electrical Characterization

### External Stimulator

The Minnova is a battery powered electrical stimulator which provides stimulus output to the electrode and can be adjusted to deliver intermittent or continuous stimulation at an peak pulse intensity range of 0 to 100mA. The ramp up/down time is 2 seconds. The stimulator is capable of providing electrical impulses at frequencies of either 12.5Hz or 50 Hz. The pulse width is 300μs. The work to rest ratio (duty cycle) is 5:10 (5 seconds on/10 seconds off). The ComfortPulse Electrodes and Innova Rectal Electrode are fully compatible with the stimulator with the touchproof connector. The device is not programmable by the patient or the clinician and there are not any biofeedback components.

## D. Intended Use

The Minnova Pelvic Floor Stimulation System is indicated for 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 reflective mechanisms.

## E. Non-Clinical and Clinical Test Summary

Non-clinical tests were performed to establish that the device when used with the ComfortPulse, Innova Vaginal and Innova Rectal electrodes meet specifications, thus providing evidence that the device when used with the electrodes are substantially equivalent to predicate devices and do not introduce new safety or effectiveness issues. Non-Clinical Tests consisted of verification of the specifications listed in the Table of Similarities and Differences, software verification and validation testing described in Section II, Part D, EMI Testing described in Section II, Part B and an FMECA test.