ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP

K990456 · Hollister, Inc. · KPI · Mar 25, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990456
• Device Name: ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP
• Applicant: Hollister, Inc.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Mar 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anal Stimulation/EMG Probe - w/Stop, 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

Anal Stimulation/EMG Probe - w/Stop is a reusable, single-patient-use accessory for pelvic floor therapy systems. It features two stainless steel electrodes for electromyographic (EMG) sensing or electrical stimulation of pelvic musculature. The device is inserted anally; it provides feedback or stimulation to assist in muscle rehabilitation and neuromuscular control restoration for urinary incontinence treatment. It connects to a therapy system via a 3.5 mm stereo phono plug. The probe is constructed from ABS copolymer. It is intended for intermittent mucosal contact, limited to under 30 minutes per stimulation session or under 1 hour per EMG session, not exceeding 1 hour total combined use. The device is operated by healthcare professionals in a clinical setting.

Clinical Evidence

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

Technological Characteristics

Materials: Acrylonitrile-Butadiene-Styrene (ABS) copolymer body, stainless steel electrodes. Sensing/Actuation: 2-electrode circular configuration for EMG sensing and electrical stimulation. Connectivity: Attached cord with 3.5 mm stereo phono plug. Form factor: Anal probe with integrated stop. Usage: Reusable, single-patient use. Biocompatibility: Compliant with ISO 10993 and USP.

Indications for Use

Indicated for patients requiring rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control 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

• Anal Stimulation/EMG Probe (K891773)
• Anal Stimulation/EMG Probe (K930530)

Submission Summary (Full Text)

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3/25/99

riomster Incorporated 2000 Hollister Drive Libertyville, illinois 60048-3781 Telephone, 847,680,1000 Facsmile: 347.918 3860

Hollister Incorporated Anal Stimulation/EMG Probe - w/Stop

# K990456

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### 510(k) Summary

### 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 [phone] Ph [phone] Fax

Date Summary Prepared - February 9, 1999

### 2. Name of Device:

Anal Stimulation/EMG Probe - w/Stop

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

Anal Stimulation/EMG Probe, K891773 and K930530

### 4. Description of Device

Hollister Incorporated through it's InCare Division currently markets an Anal 2-electrode Stimulation/EMG Probe (K891773 and K930530) as an accessories to it's Pelvic Floor Therapy System product line. The proposed probe uses the same identical raw material components and manufacturing process as the currently marketed predicate devices.

#### 5. Statement of Intended Use

The Anal Stimulation/EMG Probe - w/Stop, 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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### Hollister Incorporated Anal Stimulation/EMG Probe - w/Stop

Image /page/1/Picture/3 description: The image shows the Hollister company logo. The logo consists of a geometric symbol to the left of the word "Hollister". The geometric symbol is a square shape made up of intersecting lines, with a smaller square shape in the center.

## 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 Characteristics | Anal Stimulation/EMG<br>Probe - w/Stop | Anal Stimulation/EMG<br>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-<br>Styrene Copolymer (ABS) | Acrylonitrile-Butadiene-<br>Styrene Copolymer (ABS) |
| Probe Length | 2.349 inches nominal | 3.45 inches nominal |
| Probe Diameter (between<br>electrode) | 0.453 inch nominal | 0.394 inch nominal |
| Electrode Material | Stainless Steel | Stainless Steel |
| Electrode Placement | Anal | Anal |
| Device Connector | Attached cord with 3.5 mm<br>stereo phono plug | Attached cord with 3.5 mm<br>stereo phono plug |
| Contact Duration | Intermittent mucosal contact<br><30 min/session - Stim<br><1 hour/session - EMG<br>not exceeding 1 hr combined<br>Stim/EMG | Intermittent mucosal contact<br><30 min/session - Stim<br><1 hour/session - EMG<br>not exceeding 1 hr combined<br>Stim/EMG |
| Indications for Use | Electrical stimulation of the<br>pelvic floor muscles for the<br>teatment 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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### Hollister Incorporated Anal Stimulation/EMG Probe - w/Stop

Image /page/2/Picture/3 description: The image contains the word "Hollister" in a serif font, with a geometric symbol to the left of the word. The symbol is a stylized cross or asterisk shape, composed of intersecting lines. The text and symbol are both in black, contrasting with the white background.

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### 7. Biocompatibility

The biocompatibility of the Anal Stimulation/EMG Probe - w/Stop, 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 States 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 evlautions have been contracted either by Hollister or the suppliers of the materials.

Based upon the results of this assessment, the materials used to fabricate Anal Stimulation/EMG Probe - w/Stop, is safe and effective for its intended use and is substantially equivalent to the predicate device.

#### 8. Conclusion

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

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Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

MAR 2 5 1999

Mr. Joseph S. Tokarz Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048-3781 Re: K990456

Anal Stimulation/EMG Probe with Stop Dated: February 9, 1999 Received: February 12, 1999 Regulatory Class: II 21 CFR 876.5320/Procode: 78 KPI 21 CFR 884.1425/Procode: 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 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, 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 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/dsma/dsmamain.html".

Sincerely yours,

Dan Setiz

APT Daniel G. Schultz, M.D. Acting 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 Anal Stimulation/EMG Probe - w/Stop

a.

### Statement of Intended Use

510(k) Number (if known):

1990456

Device Name:

Anal Stimulation/EMG Probe - w/Stop

#### Intended Use:

The Anal Stimulation/EMG Probe - w/Stop, 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 V (Per 21 CFR 801.109)

OR

Over-the-Counter-Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Vinich Vr. Algnam

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

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