← Product Code [KPI](/productcode/KPI) · K030039 # PATHWAY STM-10 PELVIC FLOOR STIMULATOR (K030039) _The Prometheus Group · KPI · May 23, 2003 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K030039 ## Device Facts - **Applicant:** The Prometheus Group - **Product Code:** [KPI](/productcode/KPI.md) - **Decision Date:** May 23, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5320 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use Urinary Incontinence : Stress, Urge and Mixed Incontinence * Neuromuscular Reeducation ## Device Story Pathway STM-10 is a non-implanted electrical continence device used to treat urinary incontinence and provide neuromuscular reeducation. The device connects to single-user vaginal or anal EMG/stim perineometer sensors. The patient inserts the sensor, and the device delivers electrical stimulation to the pelvic floor muscles to assist contraction, aiming to improve muscle strength and control. The device is operated by a physician or clinician who programs parameters such as frequency, duty cycle, and session length; patients do not program the device. Output is delivered via an asymmetrical balanced pulsed current. The device assists in muscle contraction, potentially benefiting patients by improving pelvic floor function. ## Clinical Evidence Bench testing only. Testing confirmed the device accurately applies programmed stimulation outputs and produces waveforms consistent with intended signals. Biocompatibility testing was performed on the vaginal and anal sensors, confirming safety. ## Technological Characteristics Non-implanted electrical stimulator; asymmetrical balanced pulsed current; 0-60 mA output; 12.5, 50, 100, 200 Hz frequencies; 0.3 ms fixed pulse width; 2s on/off ramps. Uses single-user vaginal/anal sensors (2.31 cm2 and 2.12 cm2 electrode surface areas). Physician-programmable frequency, duty cycle, and session duration. ## Regulatory 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 CTS 2000 ([K023906](/device/K023906.md)) ## Reference Devices - Pathway Vaginal EMG/Stimulation Sensor ([K993976](/device/K993976.md)) - Pathway Anal EMG/Stimulation Sensor ([K993976](/device/K993976.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ | | K030039 | |--|-------------| | | Page 1 of 4 | **The Prometheus Group** One Washington Street, #303 Dover, NH 03801 Phone: 603-749-0733 Fax: 603-749-0511 MAY 2 3 2003 # 510(k) SUMMARY Safety and Effectiveness Summary # Pathway STM-10 Pelvic Floor Stimulator ### Submitted by: Peter A Sullivan One Washington Street Suite 303 Dover, NH 03820 Phone: 603-749-0733 Fax: 603-749-0511 ### Contact Person: Peter Sullivan 781-582-2328 Date Submitted: April 7, 2002 {1}------------------------------------------------ K030039 Page 2 of 4 ### NAME OF DEVICE Pathway STM-10 Pelvic Floor Stimulator Trade name: Common name: Non-implanted Electrical Continence Device Classification name: 78 KPI, ClassII, (876.5320) #### IDENTIFICATION OF PREDICATE DEVICE The device to which we claim substantial equivalence is the Pathway CTS 2000 K023906 manufactured by The Prometheus Group. ### DESCRIPTION OF DEVICE The Pathway STM-10 is used to stimulate the pelvic floor muscles for the treatment of incontinence. The Pathway Vaginal or Anal EMG/Stim perineometer sensor is connected to the Pathway STM-10 device to provide stimulation to the patient. This assists the patient with muscle contractions. The Pathway STM-10 uses Pathway EMG/Stim Perineometer Sensors which are single-user sensors. The patient inserts the sensor into the vagina or rectum and uses the Pathway STM-10 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. ### INTENDED USE Indications For Use: - * Urinary Incontinence : Stress, Urge and Mixed Incontinence - * Neuromuscular Reeducation {2}------------------------------------------------ K'030039 Page 394 ### SUMMARY OF TECHNICAL CHARACTERISTIC COMPARISON TO PREDICATE DEVICE | Parameter | Pathway STM-10 | Pathway CTS 2000 | |---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Treatment of Urinary
Incontinence; Neuromuscular
Reeducation | Treatment of Urinary
Incontinence; Neuromuscular
Reeducation | | Stimulator Output | 0-60 mA | 0-100 mA | | Waveform | Asymmetrical Balanced Pulsed
Current | Asymmetrical Balanced Pulsed
Current | | Charge/pulse at 500 ohms | 17uC | 28uC | | Frequency | 12.5, 50 100, 200Hz | 12.5, 50, 100, 200 Hz | | Peak pulse intensity | 60 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 | Work/Rest of 5 seconds on, 5
seconds off (5/5), 5/10, 10/10,
10/20. | Work Time: 1 - 60 Seconds
Rest Time: 0 - 60 Seconds | | Session Duration (min) | 5, 10, 15, 20, 25, or 30. | 0-60 | | 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 @ 500 ohms) | Pathway Vaginal EMG/Stim
Sensor: 26.0 mA/cm2
Pathway Anal EMG/Stim Sensor:
28.3 mA/cm2
(Max. Instantaneous) | Pathway Vaginal EMG/Stim
Sensor: 43.3 mA/cm2
Pathway Anal EMG/Stim Sensor:
47.2 mA/cm2
(Max. Instantaneous) | | Power Density
(full output @ 500 ohms) | Pathway Vaginal EMG/Stim
Sensor: 5.6 mW/cm2
Pathway Anal EMG/Stim Sensor:
6.1 mW/cm2
(maximum intensity, .3ms pulse
width 200Hz) | Pathway Vaginal EMG/Stim
Sensor: 15.6 mW/cm2
Pathway Anal EMG/Stim Sensor:
17.0 mW/cm2
(maximum intensity, .3ms pulse
width 200Hz) | {3}------------------------------------------------ KO30039 Page 4 of 4 #### BENCH TEST DATA A series of bench tests were performed using the Pathway STM-10 to show the device accurately applies stimulation and is substantially equivalent to the predicate device. The Pathway STM-10 was used to apply programmed stimulation outputs and the resulting waveforms were measured and compared to the intended signals. The bench tests show the Pathway STM-10 accurately applies muscle stimulation. ### BIOCOMPATIBILITY TESTING The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation 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 STM-10 is safe and effective for its intended use. The Pathway STM-10 is substantially equivalent to the predicate device. # END OF 510(k) SUMMARY {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing right, with flowing lines representing movement or connection. { "markdown": "" } Food and Drug Administration 9200 Corporate Boulevald Rockville MD 20850 Mr. Peter A. Sullivan Engineer The Prometheus Group 2 Mallards Cove DUXBURY MA 02332 Re: K030039 MAY 2 3 2003 Trade/Device Name: Pathway STM-10 Pelvic Floor Stimulator Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: 78 KPI Dated: April 7, 2003 Received: April 9, 2003 . Dear Mr. Sullivan: 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. {5}------------------------------------------------ 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}------------------------------------------------ KO30039 ### SECTION 2 - STATEMENT OF INDICATIONS FOR USE ### 2.1 STATEMENT OF INDICATIONS FOR USE 510(k) Number:_K030039 Device Name:__Pathway STM-10 pelvic floor stimulator ### Indications for Use: Indications For Use - * Urinary Incontinence : Stress, Urge and Mixed Incontinence - * Neuromuscular Reeducation Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use:
(Per 21 CFR 801.109) | X | OR | Over-the-Counter Use: | | |-------------------------------------------|---|----|-----------------------|--| |-------------------------------------------|---|----|-----------------------|--| (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices | 510(k) Number | X030039 | |---------------|---------| |---------------|---------| --- **Source:** [https://fda-staging.innolitics.com/device/K030039](https://fda-staging.innolitics.com/device/K030039) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com