INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE

K013653 · Hollister, Inc. · HIR · Mar 5, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K013653
• Device Name: INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
• Applicant: Hollister, Inc.
• Product Code: HIR · Obstetrics/Gynecology
• Decision Date: Mar 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1425
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InCare Biofeedback Vaginal Pressure Probes and Anal Pressure Probes are intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.

Device Story

InCare Pressure Biofeedback Vaginal and Anal Pressure Probes consist of a silicone bladder covering a probe body connected to a pressure transducer. Device inserted into anus or vagina; bladder filled with air. Measures pelvic floor muscle strength by providing resistance to voluntary muscle contractions. Used as an accessory with InCare Pelvic Floor Therapy devices. Provides pressure biofeedback to assist in rehabilitation of weak pelvic floor muscles for urinary incontinence treatment.

Clinical Evidence

Bench testing only; no clinical data presented. Biocompatibility assessment conducted per ISO 10993-1 and USP guidelines.

Technological Characteristics

Silicone bladder; air-filled; connects to external pressure transducer. Accessory to InCare Pelvic Floor Therapy devices. Biocompatible per ISO 10993-1.

Indications for Use

Indicated for patients requiring rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

Regulatory Classification

Identification

A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.

Predicate Devices

• InCare Pressure Biofeedback Vaginal Pressure Probe (K891774)
• InCare Pressure Biofeedback Anal Pressure Probe (K891774)

Submission Summary (Full Text)

{0}------------------------------------------------

Hollister Incorporated 2000 Hollister Drive Libertyville, Illino s 60048-3781

MAR 5 2002

# Hollister

## Hollister Incorporated InCare Pressure Biofeedback Vaginal and Anal Pressure Probes

## 510(k) Summary

## 1. Sponsor's name. Address and Contact Person

Sponsor Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048

Contact Person Cindy Roberts Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 [phone] Ph: Fax: [phone]

Date Summary Prepared -- November 5, 2001

## 2. Name of Device:

InCare Pressure Biofeedback Vaginal Pressure Probe InCare Pressure Biofeedback Anal Pressure Probe

## 3. Name of Predicate Device(s)

InCare Pressure Biofeedback Vaginal Pressure Probe -- 510(k) #K891774 InCare Pressure Biofeedback Anal Pressure Probe - 510(k) #K891774

## 4. Description of Device

The InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe are designed with a silicone bladder or sack that covers the probe body and tubing that connects the probe to a pressure transducer. Once the probe is inserted into the anus or vagina the bladder is filled with air. The probes measure the strength of the pelvic floor muscles by offering resistance to a patient's voluntary contractions of these muscles.

## 5. Statement of Intended Use

The InCare Biofeedback Vaginal Pressure Probe and Anal Pressure Probe are intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.

## 6. Statement of Technological Characteristics of the Device

The InCare Biofeedback Vaginal Pressure Probe and Anal Pressure Probe are used as an accessory with the InCare Pelvic Floor Therapy devices to provide pressure biofeedback from pelvic floor musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence. To meet the changing needs of

{1}------------------------------------------------

#### page 20f2 X D13653

## Hollister

## Hollister Incorporated InCare Pressure Biofeedback Vaginal and Anal Pressure Probes

Hollister's customers the InCare Biofeedback Vaginal Pressure Probe and Anal Pressure Probe has been constructed with a silicone bladder.

The InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (with silicone bladder) and the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (K891774 - 8/23/89) are equivalent in intended use, manufacturing processes and labeling as a biofeedback therapy device for the treatment of urinary incontinence. Furthermore, product performance test results demonstrate the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (with silicone bladder) and the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (K891774) are equivalent in product performance.

Biocompatibility assessment of the silicone bladder has been conducted based on the principles and guidelines established by various governmental regulatory agencies and standard setting organizations. Among these are the following: United States Pharmacopoeia, General program memorandum #G95-1, United States Food and Drug Administration Office of Device Evaluation and The International Standards Organization ISO 10993-1 Biological Evaluation of Medical Devices. Based upon the results of this assessment, the silicone bladder material is considered biocompatible and appropriate for its intended use.

#### 7. Conclusion

Based on information presented above and in the body of this premarket notification the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe with silicone bladder are substantially equivalent to devices currently in commercial distribution.

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 5 2002

Ms. Cindy Roberts Global Regulatory Affairs Analyst Hollister Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048-3781

Re: K013653

Trade/Device Name: InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe Non-Latex probe bladder Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: 85 HIR Dated: February 14, 2002 Received: February 19, 2002

Dear Ms. Roberts:

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.

{3}------------------------------------------------

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 nredicate 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 yours,

Nancy C. Brogdon

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

Enclosure

{4}------------------------------------------------

## Hollister Incorporated InCare Pressure Biofeedback Vaginal and Anal Pressure Probes

b. Statement of Intended Use

KOI 3653 510(k) Number (if Known): InCare Pressure Biofeedback Vaginal and Anal Pressure Probes Device Name:

#### Intended Use:

The InCare Biofeedback Vaginal Pressure Probes and Anal Pressure Probes are intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.

David A. Segerson

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 11.0136 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V OR Prescription Use (Per 21 CFR 801.109)

Over-the-Counter-Use (Optional Format 1-2-96)