SMALL VAGINAL/RECTAL ELECTRODE

K983206 · Empi · KPI · Nov 3, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K983206
• Device Name: SMALL VAGINAL/RECTAL ELECTRODE
• Applicant: Empi
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Nov 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The electrode is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and monitors and allows assessment of EMG activity of the pelvic floor muscles. The electrode can be used either vaginally and rectally; it should not be interchanged between the two positions. The electrode is reusable between patients if reuse instructions are followed.

Device Story

Small Vaginal and Rectal Stimulation Electrode; reusable device for pelvic floor muscle stimulation and EMG activity assessment. Input: electrical signals for stimulation or EMG signals for monitoring. Output: electrical stimulation to pelvic floor muscles or EMG data for assessment. Used in clinical or home settings; operated by patients or clinicians. Device design identical to predicate rectal electrode; no design changes required for vaginal use. Benefits patients by providing a dual-purpose tool for incontinence treatment and muscle activity monitoring.

Clinical Evidence

Clinical study performed to establish equivalence between the electrode used vaginally and currently marketed stimulation electrodes. Study confirmed suitability of performance.

Technological Characteristics

Reusable electrode for vaginal or rectal placement. Designed for pelvic floor stimulation and EMG sensing. Identical design to predicate rectal electrode.

Indications for Use

Indicated for patients requiring pelvic floor stimulation for the treatment of urinary incontinence and for the monitoring/assessment 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

• Empi, Inc. Innova Rectal or Small Vaginal EMG Sensing Electrode (K952688)
• Empi, Inc. Innova Rectal Stimulation Electrode (K954272)
• Innova® ComfortPulse™ Vaginal Electrodes (Small and Std.) (K964577)
• Innova® Vaginal Electrode (K940091)

Submission Summary (Full Text)

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1983206

Cost Effective Health Care Solutions

# SUMMARY OF SAFETY AND EFFECTIVENESS Innova Small Vaginal and Rectal Stimulation Electrode

Date of Summary: September 11, 1998 Page 1 of 1

Empi. Inc. 599 Cardigan Road St. Paul, Minnesota 55126-4099 USA

612-415-9000 FAX [phone]

| General Provisions | FAX |
|----------------------|--------------------------------------------------------------------|
| Submitter's Name: | Empi, Inc. |
| Submitter's Address: | 599 Cardigan Road<br>St. Paul, Minnesota 55126-3965 |
| Contact Person: | Carolyn M. Steele Husten<br>Regulatory Affairs Manager |
| Classification Name: | Non-Implanted Electrical Continence Device<br>21 CFR Part 876.5320 |
| Proprietary Name: | Innova® Small Vaginal and Rectal Stimulation<br>Electrode |
| Common Name: | Pelvic Floor Stimulation Device |

#### B. Name of Predicate Devices

| • | Empi, Inc. Innova Rectal or Small Vaginal EMG Sensing Electrode | K952688 |
|---|-----------------------------------------------------------------|---------|
| • | Empi, Inc. Innova Rectal Stimulation Electrode | K954272 |
| • | Innova® ComfortPulse™ Vaginal Electrodes (Small and Std.) | K964577 |
| • | Innova® Vaginal Electrode | K940091 |

### C. Device Description

The Small Vaginal and Rectal Stimulation Electrode is identical in design to the predicate rectal electrode device except for the addition of vaginal use for stimulation. There were no design changes required or made to allow for this change.

### D. Intended Use

The electrode is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and monitors and allows assessment of EMG activity of the pelvic floor muscles. The electrode can be used either vaginally and rectally; it should not be interchanged between the two positions. The electrode is reusable between patients if reuse instructions are followed.

### E. Non-Clinical and Clinical Test Summary

A Clinical study was performed to establish equivalence between this electrode used vaginally and the currently marketed stimulation electrodes. This study confirmed the suitability of performance of this electrode.

3 1998 NOV

A.

NOV 3

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1998 NOVI

Ms. Carolyn M. Steele Husten Regulatory Affairs Manager Empi, Incorporated 599 Cardigan Road St. Paul, Minnesota 55126-4099 Re: K983206 Empi Small Vaginal and Rectal Stimulation Electrode Dated: September 11, 1998 Received: September 14, 1998 Regulatory Class: II 21 CFR §876.5320/Product Code: 78 KPI

Dear Ms. Steele Husten:

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 (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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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/cdr/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Empi, Inc. 510(k) Submission Small Vaginal/Rectal Stimulation Electrode Page 3

## 510(k) Number: (if known): Unknown at time of submission Device Name: Small Vaginal and Rectal Electrode Indications for Use:

The electrode is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and monitors and allows assessment of EMG activity of the pelvic floor muscles. The electrode can be used either vaginally and rectally; it should not be interchanged between the two positions. The electrode is reusable between patients if reuse instructions are followed.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vinid G. Logom

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

OR

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

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