(89 days)
K001515, K97404-
Not Found
No
The description focuses on biofeedback and electrical stimulation for muscle rehabilitation, with no mention of AI or ML algorithms for data analysis, diagnosis, or treatment planning. The submission is for adding electrical stimulation frequencies, not new computational capabilities.
Yes
The device provides electromyographic or pressure biofeedback and electrical stimulation for the rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence. This directly indicates a therapeutic purpose.
No
The device provides biofeedback from pelvic musculature and electrical stimulation for rehabilitation, which are therapeutic functions, not diagnostic.
No
The device description explicitly mentions hardware components like "Pathway Perineometer Sensors" and "electrical stimulation capabilities," indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pathway CTS2000 Pelvic Floor Training System works by:
- Biofeedback: Monitoring muscle activity (EMG or pressure) directly from the pelvic floor muscles using sensors inserted into the body. This is a direct measurement of physiological activity, not an analysis of a specimen.
- Electrical Stimulation: Applying electrical currents to the pelvic floor muscles to aid in strengthening and control. This is a therapeutic intervention, not a diagnostic test.
- Intended Use: The intended use is for "Neuromuscular Reeducation" and treatment of "Urinary Incontinence" and "Fecal Incontinence" through biofeedback and electrical stimulation. These are therapeutic and rehabilitative purposes, not diagnostic ones based on analyzing specimens.
The device interacts directly with the patient's body to provide feedback and therapy, rather than analyzing a sample taken from the body.
N/A
Intended Use / Indications for Use
Indications for Use: Urinary Incontinence; Stress, Urge and Mixed Incontinence Neuromuscular Reeducation Fecal Incontinence; EMG USE ONLY
Indications For Use
- Urinary Incontinence: Stress, Urge and Mixed Incontinence
- Neuromuscular Reeducation .
- Fecal Incontinence: EMG USE ONLY
Product codes (comma separated list FDA assigned to the subject device)
78 KPI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic musculature, vagina, rectum, pelvic floor muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Pathway CTS2000 Pelvic Floor Training System K001515, InCare PRS Pelvic Floor Therapy System K97404-
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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:
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
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 CTS2000
K001515 | InCare PRS K974048 |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Intended Use | Treatment of Urinary
Incontinence | Treatment of Urinary
Incontinence | Treatment of Urinary
Incontinence |
| Stimulator Output | 0-100 mA | 0-100 mA | 0-30 V |
| Waveform | Asymmetrical Balanced
Pulsed Current | Asymmetrical Balanced
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
ramp | 2 sec on ramp, one sec off
ramp | On ramp: 20%, 40%, 60%,
80%, 100% of "On" time, no
off ramp |
| Duty Cycle | On (sec): 1-80
Off (sec): 0-80 | On (sec): 1-80
Off (sec): 0-80 | On (sec): 1-80
Off (sec): 0-80 |
| Session Duration (min) | 0-30 | 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 | None by patient; Pulse width,
Frequency, Duty cycle,
Session Length by physician |
| Vaginal EMG/Stim Probe
Used | Pathway Vaginal
EMG/Stimulation Sensor
K993976 | Pathway Vaginal
EMG/Stimulation Sensor
K993976 | InCare Vaginal EMG/Stim
Probe
K891773 |
| Anal EMG/Stim Probe Used | Pathway Anal
EMG/Stimulation Sensor
K993976 | Pathway Anal
EMG/Stimulation Sensor
K993976 | InCare Anal EMG/Stim
Probe
K930530 |
| Vaginal EMG/Stim probe
electrode surface area: | 2.31 cm² | 2.31 cm² | 7.98 cm² |
| Anal EMG/Stim probe
Electrode surface area: | 2.12 cm² | 2.12 cm² | 1.99 cm² |
| Current Density
(full output) | Pathway Vaginal EMG/Stim
Sensor: .043 A/cm²
Pathway Anal EMG/Stim
Sensor: .047 A/cm²
(Max. Instantaneous) | Pathway Vaginal EMG/Stim
Sensor: .043 A/cm²
Pathway Anal EMG/Stim
Sensor: .047 A/cm²
(Max. Instantaneous) | Probe 9595 - .003 A/cm²
Probe 9596 - .018A/cm²
(1ms pulse, 100Hz, 500ohm ) |
| Power Density
(full output @ 500 ohms) | Pathway Vaginal EMG/Stim
Sensor: 7.79 mW/cm²
Pathway Anal EMG/Stim
Sensor: 8.49 mW/cm²
(.3mS pulse, 200Hz) | Pathway Vaginal EMG/Stim
Sensor: .487 mW/cm²
Pathway Anal EMG/Stim
Sensor: .531 mW/cm²
(.3mS pulse, 50Hz) | Probe 9595 - .047 W/cm²
Probe 9596 - .239 W/cm²
(1ms pulse, 100Hz) |
| EMG Ranges | 0-5, 0-30, 0-100, 0-1000 uV
Ranges | 0-5, 0-30, 0-100, 0-1000 uV
Ranges | 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 Pressure
Sensor manufactured by
DesChutes Medical K934552. | Pathway Vaginal Pressure
Sensor manufactured by
DesChutes Medical K934552 | InCare Vaginal Pressure
Probe
K891774 |
| Anal Pressure Probe Used | Pathway Anal Pressure
Sensor manufactured by
DesChutes Medical K934552. | Pathway Anal Pressure
Sensor manufactured by
DesChutes Medical K934552 | InCare Anal Pressure Probe
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
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
6
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