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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the "Pathway CTS2000 Pelvic Floor Training System." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria for device performance. Therefore, many of the requested elements (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or extractable from this type of regulatory submission.

The submission primarily compares the technical characteristics of the new device with existing predicate devices to show it is as safe and effective.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

There are no explicit "acceptance criteria" for device performance in the traditional sense (e.g., clinical trial endpoints with predefined thresholds). Instead, the device is deemed acceptable if its technical characteristics are substantially equivalent to the predicate devices. The "reported device performance" is a comparison of these technical characteristics.

Characteristic	Acceptance Criteria (Predicate Device K001515)	Proposed Device Performance (Pathway CTS2000)
Intended Use	Treatment of Urinary Incontinence	Treatment of Urinary Incontinence
Stimulator Output	0-100 mA	0-100 mA
Waveform	Asymmetrical Balanced Pulsed Current	Asymmetrical Balanced Pulsed Current
Charge/pulse at 500 ohms	28uC	28uC
Frequency	12.5, 50 Hz	12.5, 50, 100, 200 Hz (This is the primary change seeking approval)
Peak pulse intensity	100 mA	100 mA
Pulse width	.3 ms fixed	.3 ms fixed
Ramps	2 sec on ramp, one sec off ramp	2 sec on ramp, one sec off ramp
Duty Cycle	On (sec): 1-80, Off (sec): 0-80	On (sec): 1-80, Off (sec): 0-80
Session Duration (min)	0-30	0-30
Programmable features	None by Patient; Frequency, Duty cycle, Session Length by physician	None by Patient; Frequency, Duty cycle, Session Length by physician
Vaginal EMG/Stim Probe Used	Pathway Vaginal EMG/Stimulation Sensor K993976	Pathway Vaginal EMG/Stimulation Sensor K993976
Anal EMG/Stim Probe Used	Pathway Anal EMG/Stimulation Sensor K993976	Pathway Anal EMG/Stimulation Sensor K993976
Vaginal EMG/Stim probe electrode surface area	2.31 cm²	2.31 cm²
Anal EMG/Stim probe Electrode surface area	2.12 cm²	2.12 cm²
Current Density (full output)	Pathway Vaginal EMG/Stim Sensor: .043 A/cm²Pathway Anal EMG/Stim Sensor: .047 A/cm² (Max. Instantaneous)	Pathway Vaginal EMG/Stim Sensor: .043 A/cm²Pathway Anal EMG/Stim Sensor: .047 A/cm² (Max. Instantaneous)
Power Density (full output @ 500 ohms)	Pathway Vaginal EMG/Stim Sensor: .487 mW/cm²Pathway Anal EMG/Stim Sensor: .531 mW/cm² (.3mS pulse, 50Hz)	Pathway Vaginal EMG/Stim Sensor: 7.79 mW/cm²Pathway Anal EMG/Stim Sensor: 8.49 mW/cm² (.3mS pulse, 200Hz)
EMG Ranges	0-5, 0-30, 0-100, 0-1000 uV Ranges	0-5, 0-30, 0-100, 0-1000 uV Ranges
EMG Bandwidth	20-500Hz	20-500Hz
EMG Signal Processing	Root Mean Square (RMS)	Root Mean Square (RMS)
EMG Detection	Bipolar	Bipolar
Vaginal Pressure Probe Used	Pathway Vaginal Pressure Sensor manufactured by DesChutes Medical K934552	Pathway Vaginal Pressure Sensor manufactured by DesChutes Medical K934552
Anal Pressure Probe Used	Pathway Anal Pressure Sensor manufactured by DesChutes Medical K934552	Pathway Anal Pressure Sensor manufactured by DesChutes Medical K934552
Work Period (sec)	1-80 seconds	1-80 seconds
Rest Period (sec)	0-80 seconds	0-80 seconds

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This submission relies on technical comparisons and bench testing rather than a clinical human test set.
Data Provenance: The data is from laboratory (bench) tests conducted by The Prometheus Group, likely within the United States. It is retrospective in the sense that it evaluates the modified device against existing and approved predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No human experts were used to establish ground truth for a test set in this 510(k) submission. Equivalency is based on objective technical specifications and bench testing.

4. Adjudication method for the test set

Not applicable. There was no test set requiring human adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-enabled device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-only device. The assessment is of the physical and electrical characteristics of the device. Bench tests were performed on the device itself.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence is based on:

Technical Specifications: Direct comparison of electrical and physical parameters (e.g., output current, frequency, pulse width, electrode surface area) against predicate devices.
Bench Test Results: Laboratory testing for electrical safety and performance (e.g., current density, power density) and biocompatibility of sensor materials, all aligned with recognized standards.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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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.: 603.749.0733 Fax: 603.749.0511

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:info@theprogrp.com

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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:

Intended Use:

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

The Prometheus Group

Image /page/1/Picture/9 description: The image shows a geometric design with a combination of shapes and patterns. A triangle is prominently featured in the center, with one half filled with horizontal lines and the other half left blank. The background consists of a dark, solid color on one side and a lighter shade on the other, with several black circles scattered throughout the image, adding a sense of depth and dimension to the overall composition.

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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 CTS2000K001515	InCare PRS K974048
Intended Use	Treatment of UrinaryIncontinence	Treatment of UrinaryIncontinence	Treatment of UrinaryIncontinence
Stimulator Output	0-100 mA	0-100 mA	0-30 V
Waveform	Asymmetrical BalancedPulsed Current	Asymmetrical BalancedPulsed 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 offramp	2 sec on ramp, one sec offramp	On ramp: 20%, 40%, 60%,80%, 100% of "On" time, nooff ramp
Duty Cycle	On (sec): 1-80Off (sec): 0-80	On (sec): 1-80Off (sec): 0-80	On (sec): 1-80Off (sec): 0-80
Session Duration (min)	0-30	0-30	0-30
Programmable features	None by Patient; Frequency,Duty cycle, Session Lengthby physician	None by Patient; Frequency,Duty cycle, Session Lengthby physician	None by patient; Pulse width,Frequency, Duty cycle,Session Length by physician
Vaginal EMG/Stim ProbeUsed	Pathway VaginalEMG/Stimulation SensorK993976	Pathway VaginalEMG/Stimulation SensorK993976	InCare Vaginal EMG/StimProbeK891773
Anal EMG/Stim Probe Used	Pathway AnalEMG/Stimulation SensorK993976	Pathway AnalEMG/Stimulation SensorK993976	InCare Anal EMG/StimProbeK930530
Vaginal EMG/Stim probeelectrode surface area:	2.31 cm²	2.31 cm²	7.98 cm²
Anal EMG/Stim probeElectrode surface area:	2.12 cm²	2.12 cm²	1.99 cm²
Current Density(full output)	Pathway Vaginal EMG/StimSensor: .043 A/cm²Pathway Anal EMG/StimSensor: .047 A/cm²(Max. Instantaneous)	Pathway Vaginal EMG/StimSensor: .043 A/cm²Pathway Anal EMG/StimSensor: .047 A/cm²(Max. Instantaneous)	Probe 9595 - .003 A/cm²Probe 9596 - .018A/cm²(1ms pulse, 100Hz, 500ohm )
Power Density(full output @ 500 ohms)	Pathway Vaginal EMG/StimSensor: 7.79 mW/cm²Pathway Anal EMG/StimSensor: 8.49 mW/cm²(.3mS pulse, 200Hz)	Pathway Vaginal EMG/StimSensor: .487 mW/cm²Pathway Anal EMG/StimSensor: .531 mW/cm²(.3mS pulse, 50Hz)	Probe 9595 - .047 W/cm²Probe 9596 - .239 W/cm²(1ms pulse, 100Hz)
EMG Ranges	0-5, 0-30, 0-100, 0-1000 uVRanges	0-5, 0-30, 0-100, 0-1000 uVRanges	0-5, 0-10, 0-25, 0-100, 0-250,0-500 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 PressureSensor manufactured byDesChutes Medical K934552.	Pathway Vaginal PressureSensor manufactured byDesChutes Medical K934552	InCare Vaginal PressureProbeK891774
Anal Pressure Probe Used	Pathway Anal PressureSensor manufactured byDesChutes Medical K934552.	Pathway Anal PressureSensor manufactured byDesChutes Medical K934552	InCare Anal Pressure ProbeK891774
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

Image /page/2/Picture/5 description: The image contains the text 'A-3' in a simple, sans-serif font. The text is black against a white background. The letter 'A' is followed by a hyphen and the number '3'.

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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:info@theprogrp.com

The Prometheus Group

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem featuring a stylized bird with outstretched wings, symbolizing health and well-being.

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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 876.5320 Nonimplanted electrical continence device.

(a)
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).(b)
Classification. Class II (performance standards).