PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM

K023906 · The Prometheus Group · KPI · Feb 19, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K023906
• Device Name: PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM
• Applicant: The Prometheus Group
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Feb 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Urinary Incontinence; Stress, Urge and Mixed Incontinence Neuromuscular Reeducation Fecal Incontinence; EMG USE ONLY

Device Story

Pathway CTS2000 provides electromyographic (EMG) or pressure biofeedback and electrical stimulation for pelvic floor muscle rehabilitation. System uses single-user vaginal or rectal sensors to monitor muscle activity during contraction/relaxation; provides electrical stimulation to assist muscle contraction. Operated by clinicians in clinical settings. Output displayed to provider to monitor progress; helps improve pelvic floor muscle strength and neuromuscular control. Device modification adds 100 Hz and 200 Hz electrical stimulation frequencies to existing system.

Clinical Evidence

Bench testing only. No clinical data provided. Testing verified electrical output parameters and biocompatibility of sensors.

Technological Characteristics

Non-implanted electrical continence device. Uses vaginal/anal EMG/pressure sensors. Stimulation: 0-100 mA, asymmetrical balanced pulsed current, 12.5-200 Hz. EMG bandwidth: 20-500 Hz. Signal processing: Root Mean Square (RMS). Connectivity: Standalone system. Materials: Biocompatibility tested.

Indications for Use

Indicated for patients with urinary incontinence (stress, urge, mixed) or fecal incontinence requiring neuromuscular reeducation. For use by clinicians under prescription.

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

• Pathway CTS2000 Pelvic Floor Training System (K001515)
• Hollister InCare PRS Pelvic Floor Therapy System (K974048)

Submission Summary (Full Text)

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K023906

Image /page/0/Picture/1 description: The image shows the word "Pathway" in a stylized font, with the letters in bold black. To the left of the word is a graphic design of dots and lines. Below the word "Pathway" is the phrase "Restoring function with innovative technology" in a smaller font. The letters "TM" are in superscript to the right of the word "Pathway".

FEB 1 9 2003

# PREMARKET NOTIFICATION [510(k)] SUMMARY

## SAFETY AND EFFECTIVENESS SUMMARY

Date Prepared: November 4, 2002

Applicant: Address:

The Prometheus Group 1 Washington St Suite 303 Dover NH 03820

Contact: Heather Magoon Electronics Engineer Tel.: [phone] Fax: [phone]

The Prometheus Group

Image /page/0/Picture/10 description: The image shows a black and white graphic design. The design features a triangle in the center, with the top portion of the triangle being white and the bottom portion being striped. There are several black circles scattered throughout the design, some inside the triangle and some outside. The background is a mix of black and white areas, creating a contrast with the central triangle.

One Washington Street, Ste. 303, Dover NH, 03820-3827 in the US and Canada: 1 - 800 - 442 - 2325 603 - 749 - 0733 - FAX: 603 - 749 - 0511 Web Site: www.theprogrp.com E-Mail:[e-mail]

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Image /page/1/Picture/0 description: The image shows the word "Pathway" in a bold, sans-serif font. To the left of the word is a graphic of black dots and lines. Below the word is the phrase "Restoring function with innovative technology" in a smaller font.

| Device Name: | |
|----------------------|----------------------------------------------------------|
| Trade Name: | Pathway CTS2000 Pelvic Floor Training System |
| Common Name: | Non-implanted Electrical Continence Device |
| Classification Name: | CLASS II, 78KPI (876.5320) |
| Predicate Device(s): | |
| Trade Name: | Pathway CTS2000 Pelvic Floor Training System K001515 |
| Manufacturer: | The Prometheus Group |
| Trade Name: | Hollister InCare PRS Pelvic Floor Therapy System K97404- |
| Manufacturer: | Hollister, Inc. |

#### Description of Device:

The Pathway CTS2000 Pelvic Floor Training System provides electromyographic or pressure biofeedback from pelvic musculature as well as provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.

The Pathway CTS 2000 uses Pathway Perineometer Sensors which are single-user sensors, and inserts the sensor into the vagina or rectum while using the Pathway CTS 2000 Pelvic Floor Training System to monitor the muscle activity during contraction and relaxation of the pelvic floor muscles. The patient can also use the Pathway CTS 2000 Pelvic Floor Training System to electrically stimulate the pelvic floor muscles to assist the contraction. The aim is to improve the strength and control of the pelvic floor muscles.

The purpose of this premarket notification submission is to include additional electrical stimulation treatment frequencies of 100 and 200 Hz to the existing Pathway CTS2000 Pelvic Floor Therapy System, K001515.

Intended Use:

Indications for Use: Urinary Incontinence; Stress, Urge and Mixed Incontinence Neuromuscular Reeducation Fecal Incontinence; EMG USE ONLY

The Prometheus Group

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Image /page/2/Picture/0 description: The image shows the word "Pathway" in a stylized font, with the letters in bold black. To the left of the word is a graphic design of black squares and circles. Below the word is the phrase "Restoring function with innovative technology" in a smaller font. The letters "TM" are to the right of the word "Pathway".

## Technical Characteristics Comparison:

| | PROPOSED DEVICE | Pathway CTS2000<br>K001515 | InCare PRS K974048 |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Intended Use | Treatment of Urinary<br>Incontinence | Treatment of Urinary<br>Incontinence | Treatment of Urinary<br>Incontinence |
| Stimulator Output | 0-100 mA | 0-100 mA | 0-30 V |
| Waveform | Asymmetrical Balanced<br>Pulsed Current | Asymmetrical Balanced<br>Pulsed Current | Square, Symmetrical, Balanced, Biphasic |
| Charge/pulse at 500 ohms | 28uC | 28uC | 60uC |
| Frequency | 12.5, 50, 100, 200 Hz | 12.5, 50 Hz | 12.5, 20, 50, 100, 200 Hz |
| Peak pulse intensity | 100 mA | 100 mA | 30V |
| Pulse width | .3 ms fixed | .3 ms fixed | .3 ms, 1 ms |
| Ramps | 2 sec on ramp, one sec off<br>ramp | 2 sec on ramp, one sec off<br>ramp | On ramp: 20%, 40%, 60%,<br>80%, 100% of "On" time, no<br>off ramp |
| Duty Cycle | On (sec): 1-80<br>Off (sec): 0-80 | On (sec): 1-80<br>Off (sec): 0-80 | On (sec): 1-80<br>Off (sec): 0-80 |
| Session Duration (min) | 0-30 | 0-30 | 0-30 |
| Programmable features | None by Patient; Frequency,<br>Duty cycle, Session Length<br>by physician | None by Patient; Frequency,<br>Duty cycle, Session Length<br>by physician | None by patient; Pulse width,<br>Frequency, Duty cycle,<br>Session Length by physician |
| Vaginal EMG/Stim Probe<br>Used | Pathway Vaginal<br>EMG/Stimulation Sensor<br>K993976 | Pathway Vaginal<br>EMG/Stimulation Sensor<br>K993976 | InCare Vaginal EMG/Stim<br>Probe<br>K891773 |
| Anal EMG/Stim Probe Used | Pathway Anal<br>EMG/Stimulation Sensor<br>K993976 | Pathway Anal<br>EMG/Stimulation Sensor<br>K993976 | InCare Anal EMG/Stim<br>Probe<br>K930530 |
| Vaginal EMG/Stim probe<br>electrode surface area: | 2.31 cm² | 2.31 cm² | 7.98 cm² |
| Anal EMG/Stim probe<br>Electrode surface area: | 2.12 cm² | 2.12 cm² | 1.99 cm² |
| Current Density<br>(full output) | Pathway Vaginal EMG/Stim<br>Sensor: .043 A/cm²<br>Pathway Anal EMG/Stim<br>Sensor: .047 A/cm²<br>(Max. Instantaneous) | Pathway Vaginal EMG/Stim<br>Sensor: .043 A/cm²<br>Pathway Anal EMG/Stim<br>Sensor: .047 A/cm²<br>(Max. Instantaneous) | Probe 9595 - .003 A/cm²<br>Probe 9596 - .018A/cm²<br>(1ms pulse, 100Hz, 500ohm ) |
| Power Density<br>(full output @ 500 ohms) | Pathway Vaginal EMG/Stim<br>Sensor: 7.79 mW/cm²<br>Pathway Anal EMG/Stim<br>Sensor: 8.49 mW/cm²<br>(.3mS pulse, 200Hz) | Pathway Vaginal EMG/Stim<br>Sensor: .487 mW/cm²<br>Pathway Anal EMG/Stim<br>Sensor: .531 mW/cm²<br>(.3mS pulse, 50Hz) | Probe 9595 - .047 W/cm²<br>Probe 9596 - .239 W/cm²<br>(1ms pulse, 100Hz) |
| EMG Ranges | 0-5, 0-30, 0-100, 0-1000 uV<br>Ranges | 0-5, 0-30, 0-100, 0-1000 uV<br>Ranges | 0-5, 0-10, 0-25, 0-100, 0-250,<br>0-500 uV Ranges |
| EMG Bandwidth | 20-500Hz | 20-500Hz | 100-500 Hz |
| EMG Signal Processing | Root Mean Square (RMS) | Root Mean Square (RMS) | Root Mean Square (RMS) |
| EMG Detection | Bipolar | Bipolar | Bipolar |
| Vaginal Pressure Probe Used | Pathway Vaginal Pressure<br>Sensor manufactured by<br>DesChutes Medical K934552. | Pathway Vaginal Pressure<br>Sensor manufactured by<br>DesChutes Medical K934552 | InCare Vaginal Pressure<br>Probe<br>K891774 |
| Anal Pressure Probe Used | Pathway Anal Pressure<br>Sensor manufactured by<br>DesChutes Medical K934552. | Pathway Anal Pressure<br>Sensor manufactured by<br>DesChutes Medical K934552 | InCare Anal Pressure Probe<br>K891774 |
| Work Period (sec) | 1-80 seconds | 1-80 seconds | 1-80 seconds |
| Rest Period (sec) | 0-80 seconds | 0-80 seconds | 0-80 seconds |

Image /page/2/Picture/3 description: The image shows the logo and contact information for The Prometheus Group. The logo includes the company name in bold font, followed by the trademark symbol. Below the logo is the company's address, phone number (1-800-442-2325), fax number (603-749-0511), and website address (www.theprogrn.com).

One Washington Street, Ste. 303, Dover NH, 03820-3827

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Image /page/3/Picture/0 description: The image shows the logo for Pathway. The logo features the word "Pathway" in a bold, serif font, with a stylized graphic to the left of the word. The graphic consists of a grid-like pattern with circles and lines. Below the word "Pathway" is the tagline "Restoring function with innovative technology" in a smaller, italicized font.

#### Non-Clinical Performance Data:

The bench tests conducted provide sufficient data to establish substantial equivalency to the original device Pathway CTS2000 Pelvic Floor Training System K001515 and substantial equivalency to the predicate device InCare PRS Pelvic Floor Training System K974048.

#### Biocompatibility:

The Pathway Vaginal EMG/Stimulation Perineometer Sensor, the Pathway Anal EMG/Stimulation Perineometer Sensor, The Pathway Vaginal Pressure Perineometer Sensor, and the Pathway Anal Pressure Perineometer Sensor have been laboratory tested for the safety of the materials. The Pathway Perineometer Sensors were found to be safe under the standards required for each test.

#### Conclusion:

The Pathway CTS 2000 Pelvic Floor Training System is safe and effective for its intended use. The Pathway CTS 2000 Pelvic Floor Training System is substantially equivalent to the predicate device and to the existing Pathway CTS2000 Pelvic Floor Training System K001515.

## END OF 510(k) SUMMARY

Image /page/3/Picture/8 description: The image is a black and white graphic with a triangle in the center. The triangle is filled with horizontal lines and has a smaller triangle at the top. There are several black dots scattered around the triangle. The left side of the image has the text "1M, 7, 5, 1, 0" vertically aligned.

One Washington Street, Ste. 303, Dover NH, 03820-3827 In the US and Canada: 1 - 800 - 442 - 2325 603 - 749 - 0733 - FAX: 603 - 749 - 0511 Web Site: www.theprogrp.com E-Mail:[e-mail]

The Prometheus Group

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2003

Ms. Heather Magoon Electrical Engineer The Prometheus Group 1 Washington Street, Suite 303 DOVER NH 03820

Re: K023906

Trade/Device Name: Pathway CTS2000 Pelvic Floor Training System Regulation Number: 21 CFR §876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: 78 KPI Dated: November 15, 2002 Received: November 22, 2002

Dear Ms. Magoon:

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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Page 2

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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

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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## SECTION 2 - STATEMENT OF INDICATIONS FOR USE

## 2.1 PATHWAY CTS2000 STATEMENT OF INDICATIONS FOR USE

K023906 510(k) Number (if known): Pathway CTS 2000 Pelvic Floor Training System Device Name: ________________

## Indications for Use:

Indications For Use

- Urinary Incontinence: Stress, Urge and Mixed Incontinence ●
- Neuromuscular Reeducation .
- Fecal Incontinence: EMG USE ONLY ●

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:___________ X

Over-the-Counter Use: ________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

Daniel A. Syzem

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

OR