INCARE PELVIC FLOOR THERAPY SYSTEM

K013612 · Hollister, Inc. · HIR · Mar 19, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K013612
• Device Name: INCARE PELVIC FLOOR THERAPY SYSTEM
• Applicant: Hollister, Inc.
• Product Code: HIR · Obstetrics/Gynecology
• Decision Date: Mar 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1425
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The electrical stimulation component of the InCare Pelvic Floor Therapy System provides stimulation capabilities that are intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence. The biofeedback components of the InCare Pelvic Floor Therapy System are intended to provide electromyography or pressure biofeedback from the pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.

Device Story

Office-based system for pelvic floor rehabilitation; used by physicians, nurses, and physiotherapists in clinics or hospitals. Inputs: electromyography (EMG) or pressure signals from pelvic musculature. System comprises an instrumentation unit linked to a personal computer. Instrumentation unit performs patient therapy (electrical stimulation); PC handles data manipulation and presentation. Output: visual biofeedback and electrical stimulation therapy. Clinicians use output to monitor muscle activity and guide therapy, aiming to restore neuromuscular control and treat urinary incontinence.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Office-based instrument consisting of an instrumentation unit and a personal computer. Provides electrical stimulation and EMG/pressure biofeedback. Connectivity via communication pathway between instrumentation unit and PC. Software-based data manipulation and presentation.

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 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 Pelvic Floor Therapy Systems (K930530/c, K961872, K974048)
• Elpha 2000 Conti Device (K964738)

Submission Summary (Full Text)

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MAR 1 9 2002

Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048-3781 Telephone: [phone] Facsimile: 847.918.3860

K013612
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Hollister Incorporated InCare Pelvic Floor Therapy System

# Safety and Effectiveness 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 Ph : [phone] Fax: [phone]

Date Summary Prepared - November 2, 2001

### 2. Name of Device:

InCare Pelvic Floor Therapy System.

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

- 1. InCare Pelvic Floor Therapy Systems K930530/c, K961872, and K974048
- 2. Elpha 2000 Conti Device, K964738

### 4. Description of Device

The InCare Pelvic Floor Therapy System is an office based instrument that is intended to be used by physicians, nurses, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital for the purpose of providing electromyography or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and the restoration of neuromuscular control for the treatment of urinary incontinence.

The InCare Pelvic Floor Therapy System also provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

# 5. Statement of Intended Use

The electrical stimulation component of the InCare Pelvic Floor Therapy System provides r it e clource. band it is that are intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

The biofeedback components of the InCare Pelvic Floor Therapy System are intended to provide electromyography or pressure biofeedback from the pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.

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# Hollister

Hollister Incorporated InCare Pelvic Floor Therapy System

# 6. Statement of Technological Characteristics of the Device

The proposed InCare Pelvic Floor Therapy System is an office based instrument that is intended to be used by physicians, nurses, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital for the purpose of providing electromyography or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and the restoration of neuromuscular control for the treatment of urinary incontinence. The InCare Pelvic Floor Therapy System also provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

The proposed InCare Pelvic Floor Therapy System is comprised of a combination of an instrumentation unit and a personal computer. Other peripheral devices such as monitors and printers can be added for convenience or ease of use. The personal computer and instrumentation unit are physically separate devices "linked" to each other by a communication pathway. Features or functions that are "data manipulation and presentation" activities are properly associated with the personal computer. Features or functions that are" patient therapy" actions are controlled by the instrumentation unit.

## 7. Conclusion

Based upon the information presented within this pre-market notification it is concluded that the proposed InCare Pelvic Floor Therapy System with expanded stimulation parameter of 10 Hz and updated clinician application software is substantially equivalent to the predicate devices.

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MAR 1 9 2002

Mr. Joseph S. Tokarz Manager Regulatory Affairs Hollister Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048-3781 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K013612 Trade/Device Name: InCare PRS9500 Pelvic Floor Therapy System Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted electrical continence device Product Code: 78 KPI Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Product Code: 85 HIR Regulatory Class: II Dated: February 13, 2002 Received: February 27, 2002

Dear Mr. 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 I mis letter will anow you to begin nationing , "
notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Drice 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 II you desire specific advice for your de rest on 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 Additionally, for questions on and please note the regulation entitled, "Misbranding Other of Compilance at (2017 22ation" (21 CFR Part 807.97). Other general information on by responsibilities under the Act may be obtained from the Division of Small Manufacturers, your responsibilition and Consumer 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

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

Enclosure

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Hollister Incorporated InCare Pelvic Floor Therapy System

# Statement of Intended Use

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

013612

InCare Pelvic Floor Therapy Stimulation/Biofeedback Device

### Indications For Use:

The electrical stimulation component of the InCare Pelvic Floor Therapy System provides stimulation capabilities that are intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

The biofeedback components of the InCare Pelvic Floor Therapy System are intended to provide electromyography or pressure biofeedback from the pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:flex; align-items:center;"> <span style="text-decoration: overline;"></span> <span style="margin-left: 5px;">OR</span> </div> | Over-the-Counter-Use | <span style="text-decoration: overline;"></span> |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|--------------------------------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) | |


| (Division Sign-Off) | |
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| Division of Reproductive, Abdominal, | Page 6 |

and Radiological Devices 510(k) Number