INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER

K961872 · Hollister, Inc. · KPI · Aug 9, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961872
• Device Name: INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
• Applicant: Hollister, Inc.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Aug 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Office-based system for pelvic floor rehabilitation; utilizes instrumentation unit linked to desktop computer. Inputs: electromyographic (EMG) signals or pressure measurements from pelvic musculature. Transformation: instrumentation unit manages patient treatment (electrical stimulation/biofeedback); desktop computer handles data manipulation and presentation. Outputs: visual biofeedback and electrical stimulation (square, symmetrical, balanced, biphasic waveforms). Used in physician offices, clinics, or hospitals by physicians, nurses, or physiotherapists. Healthcare providers use output to monitor muscle activity and guide therapy sessions; electrical stimulation aids muscle rehabilitation. Benefits: restoration of neuromuscular control and treatment of female urinary incontinence.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and bench testing comparisons to the predicate device.

Technological Characteristics

System consists of an instrumentation unit and a desktop computer. Stimulation: 0-30 VDC, square/symmetrical/balanced/biphasic waveforms, 12.5-100 Hz frequency. Biofeedback: 2-channel EMG (100-500 Hz bandwidth, RMS processing) or pressure sensing. Connectivity: communication pathway between instrumentation unit and desktop PC. Compliance: IEC 601-1, IEC 601-1-1, IEC 601-2-10, EN 60601-1-2, CISPR 11, IEC 801-2/3/4/5.

Indications for Use

Indicated for female patients with weak pelvic floor muscles requiring rehabilitation 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

• Hollister PRS9300 Pelvic Floor Therapy System (K930530/C)

Submission Summary (Full Text)

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K961872

AUG - 9 1996

# InCare Pelvic Floor Therapy System with Desktop Computer

## Safety and Effectiveness Summary

### 1. Submitter's name, Address and Contact Person

| Submitter | Contact Person |
| --- | --- |
| Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60048
Ph | Joseph S. Tokarz
Manager, Regulatory Affairs
[phone]
Fax [phone] |
| Date Summary Prepared - May 13, 1996 | |

### 2. Name of Device:

InCare Pelvic Floor Therapy System with Desktop Computer

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

Hollister PRS9300 Pelvic Floor Therapy System, K930530/C

### 4. Description of Device

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

The "nucleus" of the system is the combination of an instrumentation unit and a desktop computer. Other peripheral devices such as monitors and printers can be added for convenience or ease of use. There is a clear separation of functional control between the two elements of the system. Features or functions that are "data manipulation and presentation" activities are properly associated with the personal computer. Features and functions that are "patient treatment" actions are controlled by the Instrumentation Unit.

The desktop computer and Instrumentation Unit are physically separate devices "linked" to each other by a communication pathway.

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# InCare Pelvic Floor Therapy System with Desktop Computer

## 5. Statement of Intended Use

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

The electrical stimulation component of the InCare Pelvic Floor Therapy System with Desktop Computer provides stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of female urinary incontinence.

## 6. Statement of Technological Characteristics of the Device

- The InCare Pelvic Floor Therapy System with Desktop Computer and the InCare PRS9300 (K930530\C) are substantially equivalent based upon the following:

1. Intended Use of the two devices are identical.
2. The InCare Pelvic Floor Therapy System with Desktop Computer utilizes the exact same instrumentation unit as the predicate device (InCare PRS9300). The Instrumentation Unit controls features and functions that are patient treatment actions.
3. The InCare Pelvic Floor Therapy System with Desktop Computer utilizes the same software that is used in the predicate device (InCare PRS9300) for the data manipulation and presentation activities associated with the personal computer and the patient therapy actions associated with the Instrumentation Unit.
4. The InCare Pelvic Floor Therapy System with Desktop Computer differs from the predicate device (InCare PRS9300) in one aspect only. The proposed device utilizes a desktop personal computer whereas the predicate device utilizes a laptop personal computer. Because of this difference the communication pathway between the respective computers and the Instrumentation Unit is different.

A chart showing the differences and similarities of the InCare Pelvic Floor Therapy System with Desktop Computer and the predicate device follows on the next page:

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# InCare Pelvic Floor Therapy System with Desktop Computer

Comparison of the Technological Characteristics of the InCare Pelvic Floor Therapy System with Desktop Computer and the Predicate Device InCare PRS9300 (K930530/c)

| Stimulation Characteristics | Predicate device PRS9300 - K930530/C | Proposed device InCare Pelvic Floor Therapy System w/ Desktop Computer |
| --- | --- | --- |
| Intended Use | Treatment of Urinary Incontinence | Treatment of Urinary Incontinence |
| Computer Type (see Exhibit I, Section VI, page 29) | Laptop Computer | Desktop Computer |
| Output (nominal) | 0-30 VDC | 0-30 VDC |
| Waveform | Square, Symmetrical, Balanced, Biphasic | Square, Symmetrical, Balanced, Biphasic |
| charge/pulse at 500Ω | 60 μC/phase; net charge/pulse = 0 | 60 μC/phase; net charge/pulse = 0 |
| Frequency | 12.5, 20, 50, 100 Hz | 12.5, 20, 50, 100 Hz |
| Peak Pulse Intensity | 30 VDC | 30 VDC |
| Pulse width | 0.3, 1 ms | 0.3, 1 ms |
| Ramps | 20%, 40%, 60%, 80%, 100% of “ON” time (no down ramping) | 20%, 40%, 60%, 80%, 100% of “ON” time (no down ramping) |
| Duty Cycle | On (sec): 1-80 in 1 sec increments
Off (sec): 0 - 80 in 1 sec increments | On (sec): 1-80 in 1 sec increments
Off (sec): 0 - 80 in 1 sec increments |
| Session Duration (min) | 0-30, 1 minute increments | 0-30, 1 minute increments |
| Programmable Features | NONE BY PATIENT | NONE BY PATIENT |
| | By Physician:
Pulse width, Frequency, Duty Cycle, Session length | By Physician:
Pulse width, Frequency, Duty Cycle, Session length |
| Current Density Conditions: Full output setting, 100Hz, 1ms pulse width at 500 ohms (nominal) | Probe 9595 - 0.003 amperes/cm²
Probe 9596 - 0.018 amperes/cm² | Probe 9595 - 0.003 amperes/cm²
Probe 9596 - 0.018 amperes/cm² |
| Power Density Conditions: Full output setting, 100Hz, 1ms pulse width at 500 ohms (nominal) | Probe 9595 - 0.047 watts/cm²
Probe 9596 - 0.239 watts/cm² | Probe 9595 - 0.047 watts/cm²
Probe 9596 - 0.239 watts/cm² |
| EMI | Engineering models of PRS9300 have been tested and shown to comply with EN 55011 and IEC 801-3 emissions and immunity, respectively. | **See note on following page |

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# InCare Pelvic Floor Therapy System with Desktop Computer

| Biofeedback Characteristics | Predicate device PRS9300 - K930530/C | Proposed device InCare Pelvic Floor Therapy System w/ Desktop Computer |
| --- | --- | --- |
| Intended Use | Treatment of Urinary Incontinence | Treatment of Urinary Incontinence |
| Measurement Channels | Adjustable, 2 channels EMG, 2 channels pressure, or combination EMG and pressure | Adjustable, 2 channels EMG, 2 channels pressure, or combination EMG and pressure |
| EMG Sensitivity (microvolts) | 0-5, 0-10, 0-25, 0-50, 0-100, 0-250, 0-500 | 0-5, 0-10, 0-25, 0-50, 0-100, 0-250, 0-500 |
| EMG Bandwidth | 100-500 Hz | 100-500 Hz |
| EMG Signal Processing | Root Mean Squared (RMS) | Root Mean Squared (RMS) |
| EMG Detection | Bipolar | Bipolar |
| Pressure Sensitivity (cm-H2O) | 0-10, 0-25, 0-50, 0-100 | 0-10, 0-25, 0-50, 0-100 |
| Work Period (seconds) | 1-80 in 1 second increments | 1-80 in 1 second increments |
| Rest Period (seconds) | 0-80 in 1 second increments | 0-80 in 1 second increments |
| Session Duration (minutes) | 1-60 in 1 minute increments | 1-60 in 1 minute increments |

**NOTE** IEC 601-1 (except Amendment 2:1995, new subclause 56.3c)
IEC 601-1-1
IEC 601-2-10 (except Paragraph 36)
EN 60601-1-2/IEC 601-1-2
EN 55011/CISPR 11
EN60801-2/IEC 801-2, 3kv contact, 8kv air
IEC 801-3, 3v/m, 1 khz
IEC 801-4, 1kv
IEC 801-5, 1kv

## 7. Conclusion

Based upon the information presented above it is concluded that the proposed InCare Pelvic Floor Therapy System with Desktop Computer is safe and effective for its intended use and is substantially equivalent to the predicate device.

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