MICROGYN PLUS STIMULATION DEVICE

K013141 · Hollister, Inc. · KPI · Dec 19, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K013141
• Device Name: MICROGYN PLUS STIMULATION DEVICE
• Applicant: Hollister, Inc.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Dec 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence in women.

Device Story

Battery-powered electrical stimulation device; delivers regulated stimulus to pelvic floor nerves/muscles via anatomically shaped probe inserted vaginally or anally. Device provides balanced biphasic stimulation; current adjustable 0-60 mA; selectable frequencies (10, 50, 100 Hz). Caregiver selects frequency based on patient needs. Muscle contraction induced by stimulation aids rehabilitation. Used in clinical or home settings under caregiver guidance. Benefits patient by strengthening pelvic floor muscles to treat urinary incontinence.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and electrical performance comparison to predicate device.

Technological Characteristics

Battery-powered; current-controlled electrical stimulator. Output: 0-60 mA, balanced biphasic pulse. Selectable frequencies: 10, 50, 100 Hz. Interface: anatomically shaped probe for vaginal/anal insertion. Non-implanted electrical continence device (21 CFR 876.5320).

Indications for Use

Indicated for women with urinary incontinence requiring pelvic floor muscle rehabilitation.

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

• InCare Microgyn Plus Device (K963222)
• Elpha 2000 Conti Device (K964738)

Submission Summary (Full Text)

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# DEC 1 9 2001

## Hollister Incorporated Microgyn Plus (w/10Hz) Stimulation Device

## Safety and Effectiveness Summary

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

| Submitter | Contact Person |
|------------------------|-----------------------------|
| Hollister Incorporated | Joseph S. Tokarz |
| 2000 Hollister Drive | Manager, Regulatory Affairs |
| Libertyville, IL 60048 | Ph: [phone] |
| | Fax: [phone] |

Date Summary Prepared - December 18, 2001

#### 2. Name of Device:

Hollister Microgyn Plus Stimulation Device

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

InCare Microgyn Plus Device, K963222 Elpha 2000 Conti Device, K964738

#### 4. Description of Device

The proposed Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence in women.

The proposed Microgyn Plus is a battery-powered device that delivers a regulated stimulus to the nerves and muscles of the pelvic floor. The stimulus is administered by attaching an anatomically shaped probe to the device and then inserting the probe into the patient's vagina or anus. When stimulation is delivered the body responds by contracting the muscles of the pelvic floor.

#### 5. Statement of Intended Use

The proposed Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence in women.

#### 6. Statement of Technological Characteristics of the Device

The proposed Microgyn Plus is a battery-powered device that delivers a regulated stimulus to the nerves and muscles of the pelvic floor. The stimulus is administered by attaching an anatomically shaped probe to the device and then inserting the probe into the patient's vagina or anus. The Microgyn Plus provides balanced biphasic stimulation

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## Hollister Incorporated Microgyn Plus ( w/10Hz) Stimulation Device

pulse. The pulse has a positive and negative phase such that the net charge applied to the patient is zero.

The proposed Microgyn Plus is a current controlled device that provides an output that is adjustable from 0-60 milliamperes. The device also has the ability to select between three frequencies (10, 50, 100 Hz) depending on the frequency selected by the caregiver and the individual needs of the patient.

The proposed Microgyn Plus is identical to the predicate device (K963222) in electrical characteristics except that 10 Hz has been substituted for 20Hz.

#### 7. Conclusion

Based upon the information presented within this pre-market notification it is concluded that the proposed Microgyn Plus Stimulation Device is safe and effective for its intended use and is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing strokes, symbolizing service to the nation. 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

DEC 1 9 2001

Mr. Joseph S. Tokarz Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048-3781 Re: K013141 Trade/Device Name: Microgyn Plus Stimulation Device (10 Hz) Regulation Number: 21 CFR §876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: Class II Product Code: 78 KPI Dated: September 19, 2001 Received: September 20, 2001

Mr. Joseph S. Tokarz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Nancy Croyden

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Hollister Incorporated Microgyn Plus (w/10Hz) Stimulation Device

# Statement of Intended Use

KO13141

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

Microgyn Plus Stimulation Device

Indications For Use:

The Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the The Microgyn Plus Sumulation Device is included to provide to the treatment of urinary incontinence in women.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | | OR | Over-the-Counter-Use |
|----------------------|--|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number: K013141