MICROGYN PLUS STIMULATION DEVICE

K963222 · Hollister, Inc. · KPI · Oct 23, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K963222
• Device Name: MICROGYN PLUS STIMULATION DEVICE
• Applicant: Hollister, Inc.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Oct 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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; rehabilitates weak pelvic floor muscles. Caregiver selects frequency (20, 50, 100 Hz); device delivers current-controlled, balanced biphasic pulses (0-60 mA) via anatomically shaped vaginal or anal probe. Muscle contraction occurs in response to stimulation. Used in clinical or home settings under caregiver guidance to treat urinary incontinence; improves muscle strength.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Battery-powered; current-controlled stimulator. Output: 0-60 mA; frequencies: 20, 50, 100 Hz. Waveform: balanced biphasic pulse (net charge zero). Interface: anatomically shaped vaginal/anal probe.

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 II Stimulation Device (K891773)
• InCare PRS9300 Pelvic Floor Therapy System (K930530C)
• Empi Innova Stimulation device (K910081/A)

Submission Summary (Full Text)

{0}

OCT 23 1996
K963222
p1012
Hollister
Hollister Incorporated
2000 Hollister Drive
Libertyville, Illinois 60048-3781

Hollister Incorporated
Microgyn Plus Stimulation Device, K963222
Additional Information

# 510(k) 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 - August 14, 1996

## 2. Name of Device:

Hollister Microgyn Plus Stimulation Device

## 3. Name of Predicate Device(s)

- InCare Microgyn II Stimulation Device, K891773
- InCare PRS9300 Pelvic Floor Therapy System, K930530C
- Empi Innova Stimulation device, K910081/A

## 4. Description of Device

The 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 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 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

TEL [phone] FAX [phone]

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# Hollister

## Hollister Incorporated
### Microgyn Plus Stimulation Device

anatomically shaped probe to the device and then inserting the probe into the patient's vagina or anus. The Microgyn Plus provides a balanced biphasic stimulation pulse. The pulse has a positive and negative phase such that the net charge applied to the patient is zero.

The 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 (20, 50, 100 Hz) depending on the frequency selected by the caregiver and the individual needs of the patient.

## 7. Conclusion

Based upon the information presented above 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.