VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL

K970602 · Hollister, Inc. · KPI · Apr 15, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970602
• Device Name: VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL
• Applicant: Hollister, Inc.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Apr 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vaginal Stimulation/EMG Probe - Small 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 designed for pelvic floor therapy; provides electromyographic (EMG) feedback or electrical stimulation to pelvic musculature. Used as an accessory to Pelvic Floor Therapy Systems. Input: pelvic muscle electrical activity (EMG) or electrical stimulation signals. Output: EMG signals for biofeedback or stimulation for muscle rehabilitation. Used in clinical or home settings under physician/caregiver guidance. Smaller diameter (0.750 inch) compared to standard probe to accommodate patients with smaller vaginal anatomy. Connects via 3.5 mm stereo phono plug. Benefits patients by enabling therapy for those unable to use standard-sized probes.

Clinical Evidence

No clinical data. Biocompatibility assessed via in vitro/in vivo laboratory evaluations based on ISO 10993, FDA G95-1, and USP guidelines.

Technological Characteristics

2-electrode vaginal probe; body material: Acrylonitrile-Butadiene-Styrene (ABS); electrode material: stainless steel; diameter: 0.750 inch; length: 4.8 inches; connectivity: 3.5 mm stereo phono plug; usage: reusable, single-patient; contact duration: <1 hour/session.

Indications for Use

Indicated for patients with urinary incontinence requiring pelvic floor muscle rehabilitation or neuromuscular control restoration via electrical stimulation or EMG biofeedback. Suitable for patients with smaller vaginal anatomy.

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)

Submission Summary (Full Text)

{0}

Hollister
APR 15 1997
Hollister Incorporated
2000 Hollister Drive
Libertyville, Illinois 60048-3781
K970602
P193

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

### 510(k) Summary

1. Submitter's name, Address and Contact Person

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

Date Summary Prepared - February 13, 1997

2. Name of Device:
Vaginal Stimulation/EMG Probe - Small

3. Name of Predicate Device(s)
Vaginal Stimulation/EMG Probe, K891773

4. Description of Device
Hollister Incorporated through it’s InCare Division currently markets a vaginal 2-electrode stimulation/EMG probe (K891773) as an accessory to it’s Pelvic Floor Therapy System product line. Requests and comments from physicians and caregivers has indicated the need for a smaller diameter vaginal probe that would be used by patients that have a smaller vaginal anatomy and who cannot use the currently marketed vaginal probe. In response to these comments, Hollister has developed the vaginal 2-electrode stimulation/EMG probe - small. This probe uses the same identical raw material components and manufacturing process as the currently marketed device. The only difference is that the proposed probe has a smaller diameter to accommodate smaller vaginal anatomies.

5. Statement of Intended Use
The Vaginal Stimulation/EMG Probe - Small 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.

6. Statement of Technological Characteristics of the Device
The proposed device is substantially equivalent to the predicate device. The following is a chart comparing the two devices.

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K970602
p2073

# Hollister

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

Comparison of the Vaginal Stimulation/EMG Probe-Small and Predicate device

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

## 7. Biocompatibility

The biocompatibility of the Vaginal Stimulation Probe, 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

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K970602
P393

# Hollister

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

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 Probe - Small 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 - Small is safe and effective for its intended use and is substantially equivalent to the predicate device.

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