VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON

K971541 · Hollister, Inc. · KPI · Jun 25, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971541
• Device Name: VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON
• Applicant: Hollister, Inc.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Jun 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vaginal Stimulation/EMG Probe - Tampon, is intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Device Story

Vaginal 2-electrode probe for pelvic floor therapy; provides electromyographic (EMG) feedback or electrical stimulation to pelvic musculature. Input: physiological signals (EMG) or electrical stimulation delivery. Output: EMG data for clinician/patient feedback or muscle stimulation for rehabilitation. Designed for use in clinical or home settings; operated by patients or caregivers. Shorter length (2.3 inches) compared to standard probes allows for retention during patient movement (standing, bending, squatting). Connects to Pelvic Floor Therapy System via 3.5 mm stereo phono plug. Benefits: enables active therapy during normal physical activities, improving patient compliance and neuromuscular control restoration.

Clinical Evidence

No clinical data. Biocompatibility assessment performed per ISO 10993, FDA G95-1, and USP guidelines using in vitro/in vivo laboratory evaluations.

Technological Characteristics

ABS copolymer body; stainless steel electrodes; 2-electrode configuration; 2.3-inch nominal length; 0.841-inch nominal diameter; 3.5 mm stereo phono plug connector. Reusable, single-patient use. Intermittent mucosal contact (<30 min stimulation, <1 hour EMG).

Indications for Use

Indicated for patients requiring pelvic floor muscle rehabilitation or neuromuscular control restoration for the treatment of urinary incontinence.

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

• Vaginal Stimulation/EMG Probe (K891773)
• Vaginal Stimulation/EMG Probe (K930530)
• Vaginal Stimulation/EMG Probe - Small (K970602)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the Hollister logo. The logo consists of a geometric symbol to the left of the word "Hollister". The geometric symbol is a stylized cross or asterisk shape, formed by intersecting bars. The word "Hollister" is written in a bold, sans-serif font.

Hollister Incorporated 2000 Ho!lister Drive Libertyville, Illinois 60048-3781

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### Hollister Incorporated Vaginal Stimulation/EMG Probe - Tampon

## 510(k) Summary

JUN 2 5 1997

### 1. Submitter's name, Address and Contact Person

Submitter Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048

Contact Person Joseph S. Tokarz Manager, Regulatory Affairs Ph [phone] [phone] Fax -

Date Summary Prepared - April 24, 1997

## 2. Name of Device:

Vaginal Stimulation/EMG Probe - Tampon

### 3. Name of Predicate Device(s)

Vaginal Stimulation/EMG Probe, K891773 and K930530 Vaginal Stimulation/EMG Probe - Small K970602

#### 4. Description of Device

Hollister Incorporated through it's InCare Division currently markets a vaginal 2-electrode Stimulation/EMG probe (K891773 and K930530) and a Small Vaginal Stimulation/EMG probe (K970602) as accessories to it's Pelvic Floor Therapy System product line. Therapy with these currently marketed probes, is normally performed with the patient in the supine position. Requests and comments from physicians and caregivers has indicated the need for a probe that will remain in place and allow the patient to perform normal activities, such as standing or bending during therapy. In response to these comments, Hollister has developed the vaginal 2-electrode stimulation/EMG probe - Tampon. The proposed probe uses the same identical raw material components and manufacturing process as the currently marketed devices. The proposed probe has a shorter overall length to help it remain in place while a patient is standing, bending, stooping or squatting during therapy.

#### 5. Statement of Intended Use

The Vaginal Stimulation/EMG Probe - Tampon, is intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

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Image /page/1/Picture/1 description: The image shows the Hollister logo. On the left is a black geometric shape that resembles a plus sign with additional arms. To the right of the shape is the word "Hollister" in a serif font.

# Hollister Incorporated Vaginal Stimulation/EMG Probe - Tampon

# 6. Statement of Technological Characteristics of the Device

The proposed device is substantially equivalent to the predicate devices. The following is a chart comparing the devices.

| Electrode<br>Characteristics | Vaginal Stimulation/<br>EMG Probe - Tampon | Vaginal Stimulation/<br>EMG Probe-Small | Vaginal Stimulation/<br>EMG Probe - Standard |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Number of Electrode | 2-Stimulation/EMG | 2-Stimulation/EMG | 2-Stimulation/EMG |
| Usage Conditions | Reusable - single patient<br>use | Reusable - single patient<br>use | Reusable - single patient<br>use |
| Electrode<br>Orientation | Circular | Circular | Circular |
| Body Material | Acrylonitrile-Butadiene-<br>Styrene copolymer<br>(ABS) | Acrylonitrile-Butadiene-<br>Styrene copolymer<br>(ABS) | Acrylonitrile-Butadiene-<br>Styrene copolymer<br>(ABS) |
| Probe Length | 2.3 inches nominal | 4.8 inches nominal | 4.8 inches nominal |
| Probe Diameter | 0.841 inch nominal | 0.750 inch nominal | 1.0 inch nominal |
| Electrode Material | Stainless steel | Stainless steel | Stainless steel |
| Electrode Placement | Vaginal | Vaginal | Vaginal |
| Device Connector | Attached cord with 3.5<br>mm stereo phono plug | Attached cord with 3.5<br>mm stereo phono plug | Attached cord with 3.5<br>mm stereo phono plug |
| Contact Duration | Intermittent mucosal<br>contact<br><30 min/session - Stim<br><1 hour/session - EMG<br>not exceeding 1 hr<br>combined Stim/EMG | Intermittent mucosal<br>contact<br><30 min/session - Stim<br><1 hour/session - EMG<br>not exceeding 1 hr<br>combined Stim/EMG | Intermittent mucosal<br>contact<br><30 min/session - Stim<br><1 hour/session - EMG<br>not exceeding 1 hr<br>combined Stim/EMG |
| Indications for Use | Electrical stimulation of the<br>pelvic floor muscles for the<br>treatment of urinary<br>incontinence. EMG sensing<br>of the pelvic floor muscles | Electrical stimulation of the<br>pelvic floor muscles for the<br>treatment of urinary<br>incontinence. EMG sensing<br>of the pelvic floor muscles | Electrical stimulation of the<br>pelvic floor muscles for the<br>treatment of urinary<br>incontinence. EMG sensing<br>of the pelvic floor muscles |

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Image /page/2/Picture/0 description: The image shows the Hollister logo. On the left is a black geometric design that resembles a stylized snowflake or cross. To the right of the design is the word "Hollister" in a serif font.

## Hollister Incorporated Vaginal Stimulation/EMG Probe - Tampon

### 7. Biocompatibility

The biocompatibility of the Vaginal Stimulation/EMG Probe - Tampon, in nonsterilized configurations was assessed based on principles and guidelines established by various governmental and standard setting organizations, such as:

- -- ISO 10993, International Standards Organization (ISO) Standard
- -- General Program Memorandum #G95-1, United States FDA Office of Device Evaluation
- -- United Stated Pharmacopeia (USP)

Material biocompatibility issues have been addressed based upon biomaterial history or in separate in vitro or in vivo laboratory evaluations using licensed commercial reference laboratories. Specific test methodology has been chosen, where appropriate, from test protocols established or recommended by the aforementioned agencies or organizations. Product use conditions have been mimicked in testing procedures where possible. These evaluations have been contracted either by Hollister or the suppliers of the materials.

Based upon the results of this assessment, the materials used to fabricate Vaginal Stimulation/EMG Probe - Tampon, are considered biocompatible and appropriate for their intended use.

#### 8. Conclusion

Based upon the information presented above it is concluded that the proposed Vaginal Stimulation/EMG Probe - Tampon, is safe and effective for its intended use and is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

UN 2 5 997

Mr. Joseph S. Tokarz Manager. Regulatory Affairs Hollister, Inc. . . . . . . . . . . . . . . . 2000 Hollister Drive Libertyville, Illinois 60048

Re: K971541 Vaginal Stimulation/EMG Probe - Tampon Dated: April 24, 4997 ....... - - -Received: April 28, 1997 Regulatory class: II 21 CFR §876.5320/Product code: 78 KPI 21 CFR §884.1425/Product code: 85 HIR

Dear Mr. Tokarz:

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 (Special Controls) or 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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/cdrh/dsmamain.html".

Sincerely yours,

Kiliai Yi

Lillian Xia, Ph.D.

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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# Hollister Incorporated Vaginal Stimulation/EMG Probe - Tampon

# Statement of Intended Use

510(k) Number (if Known): Device Name:

K971541 Vaginal Stimulation/EMG Probe - Tampon_

#### Intended Use:

a.

The Vaginal Stimulation/EMG Probe - Tampon, is intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use *_*_

(Optional Format 1-2-96)

\n

. and Radiological Devices
510(k) Number K971541

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