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.

AI/ML Overview

The provided text describes a 510(k) summary for the Pathway STM-10 Pelvic Floor Stimulator. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the safety and effectiveness of a novel device through extensive clinical trials with acceptance criteria.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not applicable (N/A) in this context as they pertain to clinical or algorithm-specific performance studies that were not part of this 510(k) submission.

Here's the information that can be extracted from the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define "acceptance criteria" in the way it would for a clinical trial (e.g., a specific sensitivity or specificity target). Instead, the "acceptance" for this 510(k) summary is demonstrating substantial equivalence to a predicate device (Pathway CTS 2000). The "device performance" is reported through a comparison of technical characteristics and bench test results.

Parameter (Acceptance Criteria)	Pathway STM-10 (Reported Device Performance)	Predicate Device: Pathway CTS 2000 (Performance for comparison)
Intended Use (Substantially equivalent)	Treatment of Urinary Incontinence; Neuromuscular Reeducation	Treatment of Urinary Incontinence; Neuromuscular Reeducation
Stimulator Output (Comparison)	0-60 mA	0-100 mA
Waveform (Substantially equivalent)	Asymmetrical Balanced Pulsed Current	Asymmetrical Balanced Pulsed Current
Charge/pulse at 500 ohms (Comparison)	17uC	28uC
Frequency (Substantially equivalent)	12.5, 50, 100, 200 Hz	12.5, 50, 100, 200 Hz
Peak pulse intensity (Comparison)	60 mA	100 mA
Pulse width (Substantially equivalent)	.3 ms fixed	.3 ms fixed
Ramps (Substantially equivalent)	2 sec on ramp, one sec off ramp	2 sec on ramp, one sec off ramp
Duty Cycle (Comparison)	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) (Comparison)	5, 10, 15, 20, 25, or 30.	0-60
Programmable features (Substantially equivalent)	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 (Substantially equivalent)	Pathway Vaginal EMG/Stimulation Sensor K993976	Pathway Vaginal EMG/Stimulation Sensor K993976
Anal EMG/Stim Probe Used (Substantially equivalent)	Pathway Anal EMG/Stimulation Sensor K993976	Pathway Anal EMG/Stimulation Sensor K993976
Vaginal EMG/Stim probe electrode surface area (Equivalent)	2.31 cm²	2.31 cm²
Anal EMG/Stim probe electrode surface area (Equivalent)	2.12 cm²	2.12 cm²
Current Density (full output @ 500 ohms) (Comparison)	Pathway Vaginal: 26.0 mA/cm²; Pathway Anal: 28.3 mA/cm² (Max. Instantaneous)	Pathway Vaginal: 43.3 mA/cm²; Pathway Anal: 47.2 mA/cm² (Max. Instantaneous)
Power Density (full output @ 500 ohms) (Comparison)	Pathway Vaginal: 5.6 mW/cm²; Pathway Anal: 6.1 mW/cm² (maximum intensity, .3ms pulse width 200Hz)	Pathway Vaginal: 15.6 mW/cm²; Pathway Anal: 17.0 mW/cm² (maximum intensity, .3ms pulse width 200Hz)
Bench Test Results (Accurate application of stimulation)	The Pathway STM-10 was used to apply programmed stimulation outputs and the resulting waveforms were measured and compared to the intended signals. The tests show the device accurately applies muscle stimulation.	N/A (Comparison is implicit against intended signals and substantial equivalence to predicate which also accurately applies stimulation)
Biocompatibility Testing (Safety of materials)	Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor were laboratory tested and found safe under required standards.	N/A (The sensors are the same as used by the predicate and were previously tested)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: N/A (No clinical test set described in this 510(k) for performance evaluation. The "bench tests" refer to testing the device's electrical outputs, not patient performance.)
Data Provenance: N/A

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: N/A
Qualifications of Experts: N/A

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: N/A

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

MRMC Study: No. This is not an AI-assisted diagnostic device, but a therapeutic electrical stimulator.
Effect Size: N/A

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

Standalone Performance: Not applicable. This is not an algorithm, but a medical device for direct patient application. The "standalone" evaluation involved bench testing the electrical output of the device itself. The document states: "A series of bench tests were performed using the Pathway STM-10 to show the device accurately applies stimulation..."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: For the "bench tests," the ground truth was the intended programmed stimulation outputs/signals. The measured waveforms were compared against these intended signals. For biocompatibility, the ground truth was established by laboratory testing standards for material safety.

8. The sample size for the training set

Sample Size for Training Set: N/A (No training set described as this is not an AI/machine learning device.)

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

How Ground Truth for Training Set Established: N/A

Summary

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	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

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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 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

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K'030039
Page 394

SUMMARY OF TECHNICAL CHARACTERISTIC COMPARISON TO PREDICATE DEVICE

Parameter	Pathway STM-10	Pathway CTS 2000
Intended Use	Treatment of UrinaryIncontinence; NeuromuscularReeducation	Treatment of UrinaryIncontinence; NeuromuscularReeducation
Stimulator Output	0-60 mA	0-100 mA
Waveform	Asymmetrical Balanced PulsedCurrent	Asymmetrical Balanced PulsedCurrent
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, 5seconds off (5/5), 5/10, 10/10,10/20.	Work Time: 1 - 60 SecondsRest Time: 0 - 60 Seconds
Session Duration (min)	5, 10, 15, 20, 25, or 30.	0-60
Programmable features	None by Patient; Frequency, Dutycycle, Session length by physician	None by Patient; Frequency, Dutycycle, Session length by physician
Vaginal EMG/Stim Probe Used	Pathway VaginalEMG/Stimulation SensorK993976	Pathway VaginalEMG/Stimulation SensorK993976
Anal EMG/Stim Probe Used	Pathway Anal EMG/StimulationSensor K993976	Pathway Anal EMG/StimulationSensor K993976
Vaginal EMG/Stim probeelectrode surface area:	2.31 cm2	2.31 cm2
Anal EMG/Stim probe electrodesurface area:	2.12 cm2	2.12 cm2
Current Density(full output @ 500 ohms)	Pathway Vaginal EMG/StimSensor: 26.0 mA/cm2Pathway Anal EMG/Stim Sensor:28.3 mA/cm2(Max. Instantaneous)	Pathway Vaginal EMG/StimSensor: 43.3 mA/cm2Pathway Anal EMG/Stim Sensor:47.2 mA/cm2(Max. Instantaneous)
Power Density(full output @ 500 ohms)	Pathway Vaginal EMG/StimSensor: 5.6 mW/cm2Pathway Anal EMG/Stim Sensor:6.1 mW/cm2(maximum intensity, .3ms pulsewidth 200Hz)	Pathway Vaginal EMG/StimSensor: 15.6 mW/cm2Pathway Anal EMG/Stim Sensor:17.0 mW/cm2(maximum intensity, .3ms pulsewidth 200Hz)

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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

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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.

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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.

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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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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
---------------	---------

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).