INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE

K972054 · Empi · KPI · Aug 14, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972054
• Device Name: INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE
• Applicant: Empi
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Aug 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indication for Use - Stimulation: The electrode is indicated for use in the treatment of urinary incontinence. The electrode is reusable if reuse instructions are followed. Indication for Use - Sensing: The electrode monitors and allows assessment of the EMG activity of the pelvic floor muscles. The electrode is reusable if reuse instructions are followed.

Device Story

Reusable vaginal and rectal electrodes designed for pelvic floor stimulation and EMG sensing. Device functions as an interface between a pelvic floor stimulation system and the patient; electrodes deliver electrical stimulation to treat urinary incontinence or sense EMG signals for muscle assessment. Intended for clinical or home use following specific reuse and sterilization instructions. No design changes from predicate devices; modification limited to labeling for multi-patient reuse.

Clinical Evidence

Bench testing only. Testing focused on validation of the sterilization process and reuse instructions.

Technological Characteristics

Reusable vaginal and rectal electrodes for electrical stimulation and EMG sensing. No design changes from predicate devices. Sterilization process validated for multi-patient reuse.

Indications for Use

Indicated for patients requiring treatment for urinary incontinence or 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. Minnova Pelvic Floor Stimulation System (K970307)
• Empi, Inc. ComfortPulse Regular and Small Electrode (K964577)
• Empi, Inc. Innova Rectal or Small Vaginal EMG Sensing Electrode (K952688)
• Empi, Inc. Innova Rectal Stimulation Electrode (K954272)

Submission Summary (Full Text)

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K9172054

# SUMMARY OF SAFETY AND EFFECTIVENESS Reusable Vaginal and Rectal Electrodes Date of Summary May 30, 1997

AUG 1 4 1997

Page 1 of 1

#### General Provisions A.

| 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® ComfortPulse Vaginal Electrodes (Small<br>and Standard)<br>Innova® Rectal Electrode |
| Common Name: | Pelvic Floor Stimulation Device |

#### Name of Predicate Devices B.

| • Empi, Inc. Minnova Pelvic Floor Stimulation System | K970307 |
|-------------------------------------------------------------------|---------|
| • Empi, Inc. ComfortPulse Regular and Small Electrode | K964577 |
| • Empi, Inc. Innova Rectal or Small Vaginal EMG Sensing Electrode | K952688 |
| • Empi, Inc. Innova Rectal Stimulation Electrode | K954272 |

#### C. Device Description

The Reusable Vaginal and Rectal Electrodes are identical to the predicate devices except for the addition of "multi-patient use" and reuse instructions. There were no design changes required or made to allow for this change.

#### Intended Use D.

Indication for Use - Stimulation:

The electrode is indicated for use in the treatment of urinary incontinence. The electrode is reusable if reuse instructions are followed.

### Indication for Use - Sensing:

The electrode monitors and allows assessment of the EMG activity of the pelvic floor muscles. The electrode is reusable if reuse instructions are followed.

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

Non-clinical tests were performed to validate the sterilization process and instructions.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a symbol that resembles a human figure in profile, with three parallel lines extending from the head, representing the department's focus on health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 4 1997

Ms. Carolyn M. Steele Husten Regulatory Affairs Manager EMPI, Inc. 599 Cardigan Road … St.Paul, Minnesota 55126-3965 Re : K972054

Innova® ComfortPulse Vaginal Electrodes (Small and Standard) Innova® Rectal Electrode ` Dated: May 30, 1997 Received: June 2, 1997 Requlatory Class: II 21 CFR §876.5320/Product Code: 78 KPI

Dear Ms. 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 inclosure) 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, 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 III (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 requirement, as set forth in the Quality System Regulation (QS) 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 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 question 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/cdrh/dsmamain.html".

Sincerely yours.

h. William Lyr

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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K972054--

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

Indication for Use - Stimulation:

The electrode is indicated for use in the treatment of urinary incontinence. The electrode is reusable if reuse instructions are followed. .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Indication for Use - Sensing:

The electrode monitors and allows assessment of the EMG activity of the pelvic floor muscles. The electrode is reusable 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)

Daniel H.P.

(Division Sign-Off) (Division Sigil-Krif)
Division of Reproductive, Abdominai, ENT, and Radiological Devices 510(k) Number .

OR

P Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use ________