INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205)

K964577 · Empi · KPI · Jan 24, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964577
• Device Name: INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205)
• Applicant: Empi
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Jan 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Innova® ComfortPulse® Vaginal Electrodes are a component of the Innova Pelvic Floor Stimulation (PFS) System which is indicated for use in the treatment of urinary incontinence. These electrodes are also a component of the Innova® Clinical EMG System which is indicated for monitoring and evaluating EMG activity of the pelvic floor muscles.

Device Story

Innova® ComfortPulse® Vaginal Electrodes (standard and small sizes) function as accessories for pelvic floor stimulation and EMG sensing systems. Devices feature three conductive elements separated by non-conductive thermoplastic; standard size has hourglass shape, small size has flared cylindrical shape. Electrodes connect to stimulation systems via integrated 40-inch leadwire (adapter required for EMG systems). Used in home or clinic settings for repeated intermittent use by single user for up to one year. Electrodes deliver electrical stimulation to induce pelvic muscle contractions or sense voluntary muscle activity. Healthcare providers use output to monitor pelvic floor function or treat incontinence; patient benefits from improved muscle control and incontinence management. Device requires manual cleaning with soap and water between uses.

Clinical Evidence

Acute clinical testing compared subject electrodes to predicate Innova Vaginal Electrodes. Primary endpoints included pelvic floor muscle contraction (measured via urethral pressure) and EMG sensing capability. Results demonstrated that subject electrodes produced contractions equivalent to predicates and successfully discriminated between volitional contraction and rest.

Technological Characteristics

Materials: Biocompatible thermoplastic. Configuration: Three conductive elements separated by non-conductive elements. Dimensions: Small (2.3" length, 0.8" max diameter), Standard (2.8" length, 1.025" max diameter). Connectivity: Hardwired 40-inch leadwire. Sterilization: None (single-user, reusable).

Indications for Use

Indicated for patients requiring treatment for urinary incontinence or monitoring/evaluation of pelvic floor muscle EMG 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).

Predicate Devices

• Innova® Vaginal Stimulation Electrode (K910081)
• Innova® Vaginal EMG Sensing Electrode (K940091)
• Innova® Rectal or Small Vaginal EMG Sensing Electrode (K952688)
• Innova® Rectal Stimulation Electrode (K954272)

Submission Summary (Full Text)

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JAN 24 1997
K964577
P173
Empi.

Cost Effective Health Care Solutions

SUMMARY OF SAFETY AND EFFECTIVENESS
Empi, Inc. Innova® ComfortPulse® Vaginal Electrode and Innova® ComfortPulse® Small Vaginal Electrode

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

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 Electrodes (Stimulation Electrodes) 21 CFR Part 876.5320 and Perineometers (EMG Sensing Electrodes) 21 CFR Part 884.1425

Common or Usual Name: Vaginal EMG Sensing and Stimulating Electrodes

Proprietary Name: Innova® ComfortPulse® Vaginal Electrode and Innova® ComfortPulse® Small Vaginal Electrode

B. Name of Predicate Devices

♦ Empi, Inc. Innova® Vaginal Stimulation Electrode K910081
♦ Empi, Inc. Innova® Vaginal EMG Sensing Electrode K940091
♦ Empi, Inc. Innova® Rectal or Small Vaginal EMG Sensing Electrode K952688
♦ Empi, Inc. Innova® Rectal Stimulation Electrode K954272

C. Device Description

The Innova® ComfortPulse® Vaginal Electrodes, small and standard sizes, have three conductive elements separated by non-conductive elements of thermoplastic material. The small size electrode has a flared cylindrical shape and the standard size electrode has an hourglass shape. The electrodes are designed for repeated intermittent use in the home or clinic for up to one year by a single user. Because it is designed for use by a single user, it does not require sterilization. It does, however, require washing with soap and water and drying between uses. Both small and standard size electrodes have a permanently attached, insulated 40 inch leadwire cable that connects directly to the Stimulation System, but requires an adapter to connect to the EMG System.

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# SUMMARY OF SAFETY AND EFFECTIVENESS
## Empi, Inc. Innova® ComfortPulse® Vaginal Electrode and Innova® ComfortPulse® Small Vaginal Electrode
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The small size electrode is approximately 2.3 inches in length from tip to end, with a maximum diameter of 0.8 inches. The standard size electrode is approximately 2.8 inches in length from tip to end, with a maximum diameter of 1.025 inches.

## D. Intended Use

The Innova® ComfortPulse® Vaginal Electrodes are a component of the Innova Pelvic Floor Stimulation (PFS) System which is indicated for use in the treatment of urinary incontinence. These electrodes are also a component of the Innova® Clinical EMG System which is indicated for monitoring and evaluating EMG activity of the pelvic floor muscles.

## E. Summary of Technological Characteristics

The Innova® ComfortPulse® Vaginal Electrodes use common biocompatible materials which are identical to those of the Empi, Inc. Innova® Rectal or Small Vaginal EMG Sensing Electrode. The electrodes are configured similar to currently marketed Innova® Vaginal and Rectal Electrodes used for the treatment of urinary incontinence. The design allows the electrodes to be used with the currently marketed Innova® Pelvic Floor Stimulation System and Empi’s Clinical EMG Sensing Systems.

## F. Non-Clinical and Clinical Test Summary

The electrodes have been verified as meeting specifications for internal wire location and integrity, initial impedance, surface inspection, material integrity (mechanical shock) and dimensions. Test results from Innova® Rectal Electrode for material stability and biocompatibility were applied to this device and not repeated because they are comprised of identical material. The results of functional testing were analyzed against product specifications and currently marketed devices. The test results demonstrate that the product meets requirements, is acceptable for its intended use and is equivalent to currently marketed devices.

An acute clinical test was performed to verify that the Innova® ComfortPulse® Vaginal Electrodes produce a pelvic floor muscle contraction equivalent to that produced by the current Innova® Vaginal Electrode as demonstrated by the generation of increased urethral pressure. In addition, both Innova® ComfortPulse® Vaginal Electrodes were assessed for their ability to sense voluntary pelvic muscle contraction by an EMG System.

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K964577
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# SUMMARY OF SAFETY AND EFFECTIVENESS

Empi, Inc. Innova® ComfortPulse® Vaginal Electrode and Innova® ComfortPulse® Small Vaginal Electrode

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The electrically stimulated pelvic muscle contractions induced by both new Innova® ComfortPulse® Vaginal Electrodes and the currently marketed Innova® Vaginal Electrodes were clinically observable, palpable and measurable. When stimulation induced pelvic muscle contractions were compared, the new Innova® ComfortPulse® Vaginal Electrodes, both small and standard sizes, produced contractions substantially equivalent to those of the currently marketed Innova® Vaginal Electrodes. All of the electrodes discriminated between volitional contraction and rest, demonstrating that the Innova® ComfortPulse® Vaginal Electrodes, both small and standard sizes, are substantially equivalent to the currently marketed Innova® Vaginal Electrodes in sensing volitional contraction and rest.