INNOVA RECTAL STIMULATON ELECTRODE

K954272 · Empi · KPI · Apr 15, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K954272
• Device Name: INNOVA RECTAL STIMULATON ELECTRODE
• Applicant: Empi
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Apr 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Innova Rectal Stimulation Electrode is designed for use with the Innova PFS System which has market clearance for the treatment of urinary incontinence.

Device Story

Innova Rectal Stimulation Electrode is a reusable, single-patient-use accessory for the Innova PFS System. Device consists of a lightweight, watertight cylinder with two conductive rings; shaped with a waist and handle for positioning and removal. Used in home or clinic settings by a single user for up to one year. Device delivers electrical stimulation to pelvic floor muscles to treat urinary incontinence. Healthcare providers use the system to induce pelvic muscle contractions; the electrode's design allows for higher comfortable current intensity and contraction-induced pressures compared to predicate devices, while maintaining lower current density. Cleaning requires washing with soap and water between uses.

Clinical Evidence

Acute clinical study comparing Innova Rectal Stimulation Electrode to InCare Rectal Electrode. Sample size not specified. Primary endpoints: pelvic muscle contraction amplitude, maximum comfortable current intensity, and induced pressure. Results: Innova electrode produced pelvic contractions of sufficient amplitude; maximum comfortable current intensity was significantly higher (p < 0.05); contraction-induced pressures were significantly higher (p < 0.01); maximum current density was significantly lower (p < 0.01). No adverse effects reported.

Technological Characteristics

Cylinder form factor with two conductive rings. Materials: Medical-Grade Santoprene body, carbon-loaded Santoprene electrodes. Dimensions: 2.4 in. nominal length, 0.8 in. nominal diameter. Connectivity: Attached cord with custom 2.5mm 2-pin plug. Biocompatibility: Meets ISO 10993 and USP Class VI. Non-sterile; reusable, single-patient use. Electrical: 0.43 in. electrode spacing, 0.9 in²/band active surface area.

Indications for Use

Indicated for electrical stimulation of the pelvic floor muscles for the treatment of urinary incontinence in patients requiring such 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).

Predicate Devices

• Innova Vaginal Stimulation Electrode (K910081, K940091)
• InCare Rectal Electrode (K891773)

Submission Summary (Full Text)

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# SUMMARY OF 510(k) SAFETY AND EFFECTIVENESS INFORMATION

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K954272

Applicant name: Empi, Inc.
Applicant address: 5255 East River Rd.
Fridley, MN 55421
Contact person: Stacy Mattson, Regulatory Affairs Manager
Phone: [phone]
FAX: [phone]
Date Prepared: August 8, 1995

## Identification:

Classification Name: Nonimplanted Electrical Continence Device
Common/Usual Name: Rectal Stimulation Electrode
Trade/Proprietary Name: Innova Rectal Stimulation Electrode

## Equivalent Devices:

Innova Vaginal Stimulation Electrode (K910081,K940091)
InCare Rectal Electrode (K891773)

## Product Description:

The Innova Rectal Stimulation Electrode assembly is a light-weight cylinder consisting of two conductive rings that are paired and isolated, physically and electrically. The cylinder is shaped with a waist and a handle for comfort, positioning and ease in removing. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use in the home or clinic for up to one year by a single user. It does not require sterilization, but does require washing with soap and water and drying between uses.

## Intended Use:

The Innova Rectal Stimulation Electrode is designed for use with the Innova PFS System which has market clearance for the treatment of urinary incontinence.

## Product Verification and Validation:

The following parameters were tested: leadwire placement and integrity; impedance; tensile strength; connection strength; flexion; label durability; surface integrity; material integrity (mechanical shock); material stability; dimensions; and material biocompatibility. The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use.

## Clinical Testing:

An acute clinical test was performed to verify that the Innova Rectal Stimulation Electrode could produce a pelvic floor contraction equal to or greater than the InCare Rectal Electrode. The results showed that:

1. All subjects had pelvic muscle contractions using both electrodes that were of sufficient amplitude to produce an observable and measurable response at maximum comfortable intensity.
2. The maximum comfortable current intensity achieved with the Innova rectal electrode was significantly higher than with the InCare rectal electrode ($p &lt; 0.05$).
3. The contraction induced pressures achieved with the Innova rectal electrode were significantly higher than the pressures achieved with the InCare rectal electrode ($p &lt; 0.01$).
4. The maximum current density attained with the Innova rectal electrode was significantly lower than with the InCare rectal electrode ($p &lt; 0.01$).

No adverse effects were noted by the investigator in any of the subjects tested.

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# Conclusion from Non-Clinical and Clinical Testing

The data obtained from the non-clinical and clinical tests demonstrate that this electrode is as safe, as effective and performs as well or better than the InCare Rectal Electrode.

# Comparison of Product Specifications

See the following chart for details on the similarities and differences of the predicate devices and the Innova Rectal Stimulation Electrode.

## COMPARISON OF INNOVA RECTAL ELECTRODE SPECIFICATIONS TO PREDICATE DEVICES

| Electrode Characteristics | InCare Rectal Electrode | Innova Rectal Electrode | Innova Vaginal Electrode |
| --- | --- | --- | --- |
| Premarket Notification | Stimulation - K891773
EMG Sensing - K891774 | Current Submission | Stimulation - K910081
EMG Sensing - K940091 |
| Number Of Electrodes | 2 - Stimulation | 2 - Stimulation | 3 - Sensing
4 - Stimulation |
| Biocompatibility | Unknown | Meets ISO 10993 and USP class VI | Meets the Tripartite Guidance and USP class VI |
| Usage Conditions | Reusable single patient use | Reusable single patient use | Reusable single patient use |
| Electrode Orientation | Circular | Circular | Circular |
| Body Material | plastic | Medical-Grade Santoprene | Medical-Grade silicone rubber |
| Insertable Length | 2.3 in. nominal | 2.4 in. nominal | 3 in. nominal |
| Diameter (Max.) | 0.6 in. nominal | 0.8 in. nominal | 1 in. nominal |
| Electrode Material | Metal | Carbon loaded Santoprene | Carbon loaded silicone rubber |
| Electrode Spacing | 0.32 in. nominal | 0.43 in. nominal | 1.7 in. nominal |
| Active Surface Area (nominal) | 0.3 in²/band | 0.9 in²/band | 1.9 in.²/band |
| Electrode Placement | Rectum | Rectum | Vagina |
| Device Connection | Attached cord with 3.5mm phone plug. | Attached cord with custom 2.5mm 2 pin plug* | Attached cord with custom 2.5mm 2 pin plug* |
| Max. Power Density | 81 mW/cm² | 51 mW/cm² | 24.45 mW/cm² |
| Max. Current Density | 6.5 mA/cm² | 3.0 mA/cm² | 1.41 mA/cm² |
| Contact Duration | Unknown | Intermittent mucosal contact < 30 days but > 24 hours | Intermittent mucosal contact < 30 days but > 24 hours |
| Indications For Use | Electrical stimulation of the pelvic floor muscles for the treatment of incontinence; EMG sensing of the pelvic floor muscles. | Electrical stimulation of the pelvic floor muscles for the treatment of incontinence | Electrical stimulation of the pelvic floor muscles for the treatment of incontinence; EMG sensing of the pelvic floor muscles. |

Note: The italics indicate parameters which are the same or equivalent.
*Meets the proposed performance standard, described in FR Volume 60, No. 119, in that the pins are set too closely together to allow insertion into a wall socket or power cord such that conductive contact would occur without damaging the connector.

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