The Pathway Vaginal/Rectal Perineometer Probe is an EMG perineometer probe used to monitor the pelvic floor muscles for the treatment of incontinence. This probe is connected to a surface EMG device to provide Bio-feedback to the patient. This allows the patient to monitor their pelvic muscle activity which is otherwise difficult due to the anatomical location of the pelvic floor muscles.
The Pathway Vaginal/Rectal Perineometer Probe is a single-user plastic probe with three metal electrode contacts. The patient inserts the probe into the vagina or rectum and uses a surface EMG instrument to monitor the muscle activity during contraction and relaxation of the pelvic floor muscles. The aim is to improve the strength and control of the pelvic floor muscles.

AI/ML Overview

The provided document describes a device called the Pathway Vaginal/Rectal Perineometer Probe and its substantial equivalence to a predicate device. The information requested pertains to the acceptance criteria and the study that proves the device meets those criteria.

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

The document does not explicitly state "acceptance criteria" in a tabular format with defined thresholds. Instead, it presents performance data used to demonstrate substantial equivalence to a predicate device. The implied acceptance criterion is that the Pathway probe performs "similarly" to the predicate device and accurately measures EMG signals.

Acceptance Criterion (Implied)	Reported Device Performance (Pathway Probe)
Accurately measures EMG signals (Non-clinical)	Accurately measures EMG signals. Readings generally within 5% of predicate device.
Performs similarly to predicate device (Non-clinical)	Performs similarly to the predicate device. Readings generally within 5% of predicate device.
Accurately monitors pelvic floor muscles (Clinical)	Accurately monitors the pelvic floor muscles.
Performs similarly to predicate device (Clinical)	Performs similarly to the predicate device. Pathway probe had an overall ratio between EMG contraction and relaxation of 5.4:1.
Biocompatibility: Skin Sensitization	0% Sensitization; Weak allergenic potential.
Biocompatibility: Systemic Injection	Negative: No significant biological reaction.
Biocompatibility: L929 MEM Elution	Non-cytotoxic.
Biocompatibility: Pyrogen Testing	Non-pyrogenic.
Biocompatibility: Primary Vaginal Test - Repeated Exposure	Minimal irritant.
Biocompatibility: Rectal Irritation Test - Repeated Exposure	Non-irritant.

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

Non-clinical (Bench Tests): The document states "A series of bench tests were performed" and "A matrix of different frequencies and amplitudes was measured." It does not specify a numerical sample size for these tests (e.g., number of measurements or repetitions).
Clinical Tests: The document states "A number of Male and Female subjects were instructed to perform a series of contractions and relaxations." It does not specify the exact number of subjects or the sample size of the clinical test set.
Data Provenance: The document does not explicitly state the country of origin. The submission is from a US company (The Prometheus Group, Portsmouth, NH) to the FDA, suggesting the studies were likely conducted in the US. The studies are prospective in nature, as they involve performing tests and gathering data specifically for the device submission.

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

The document describes tests to measure EMG signals and compare the Pathway probe's performance to a predicate device. These tests involved instrumental measurements (non-clinical) and subject-performed contractions/relaxations (clinical). The "ground truth" here is the physical EMG signal itself and the performance relative to a known predicate device. There is no mention of human experts establishing ground truth in the context of interpretation or diagnosis for the test set. The ground truth for the non-clinical tests was the input signals, and for clinical tests, it was the recorded muscle activity during contractions/relaxations, compared against the predicate device.

4. Adjudication method for the test set

Not applicable. The tests measured physical properties (EMG signals, biocompatibility) or compared performance to a predicate device. There was no diagnostic interpretation or subjective assessment that would require an adjudication method.

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 device is an EMG perineometer probe, not an AI-powered diagnostic tool requiring human readers or interpretation of complex cases. Therefore, no MRMC study or AI assistance effect size is relevant or reported.

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

Not applicable. This is a medical device for monitoring physiological signals, not an algorithm. Its performance is inherent to its physical design and sensor capabilities.

7. The type of ground truth used

Non-clinical (Bench Tests): The ground truth was the known input signals (specific frequencies and amplitudes) generated for the test setup, against which the probe's readings were compared.
Clinical Tests: The ground truth was the EMG activity generated by subjects' pelvic floor muscle contractions and relaxations, measured by both the Pathway probe and the predicate device. The performance of the predicate device (Perrymeter probe, K911190/A) served as a comparative ground truth for "similar" performance.
Biocompatibility Tests: The ground truth was established by standardized laboratory test protocols for biocompatibility, using accepted criteria for safety (e.g., 0% sensitization, negative reactions, non-cytotoxic, non-pyrogenic).

8. The sample size for the training set

Not applicable. This device is not an algorithm that requires a training set.

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

Not applicable. As this device is not an algorithm, there is no training set or associated ground truth establishment process.

Summary

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	KY14036
	page 1 of 6

The Prometheus Group

80 Bow Street	Portsmouth, NH 03801
Phone: 603-431-5121	Fax: 603-431-0650

DEC 2 2 1997

510(k) SUMMARY Safety and Effectiveness Summary

Pathway Vaginal/Rectal Perineometer Probe

Submitted by:

Peter A Sullivan 80 Bow Street Portsmouth, NH 03801 Phone: 603-431-5121 Fax: 603-431-0650

Contact Person:

Peter A Sullivan

Date Submitted:

October 23, 1997

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NAME OF DEVICE

Trade name: Pathway Vaginal/Rectal Perineometer Probe Common name: Perineometer Probe Classification name: Perineometer (per 21 CFR section 884.1425)

IDENTIFICATION OF PREDICATE DEVICE

The device to which we claim substantial equivalence is the Perrymeter Vaginal Perineometer Probe and Perrymeter Anal Perincometer Probe 510(k) number K911190/A. The Perrymeter probes are also single-user plastic probes with three metal electrode contacts.

DESCRIPTION OF DEVICE

The Pathway Vaginal/Rectal Perineometer Probe is a single-user plastic probe with three metal electrode contacts. The patient inserts the probe into the vagina or rectum and uses a surface EMG instrument to monitor the muscle activity during contraction and relaxation of the pelvic floor muscles. The aim is to improve the strength and control of the pelvic floor muscles.

Pathway Vaginal/Rectal Perineometer Probe

Image /page/1/Picture/9 description: The image shows a thermometer. The thermometer is white and has a digital display. The thermometer is lying on a dark surface. The thermometer is used to measure temperature.

INTENDED USE

Indications For Use:

- Urinary Incontinence : Stress, Urge and Mixed Incontinence
- Fecal Incontinence
- Neuromuscular Reeducation

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SUMMARY OF TECHNICAL CHARACTERISTIC COMPARISON TO PREDICATE DEVICE

	Pathway Probe	Perrymeter Probe
Single-User Perineometer Probe	Yes	Yes
Plastic Probe with Metal Contacts	Yes	Yes
Three Electrode Contacts	Yes	Yes
Two Active, One Ground Contact	Yes	Yes
Shielded Cable	Yes	Yes
1/8" Stereo Plug Connector	Yes	Yes
Proper Orientation for Best Use	Yes	Yes
Urinary or Fecal Incontinence	Yes	Yes
Vaginal Use	Yes	Yes (Perry Vaginal)
Rectal Use	Yes	Yes (Perry Anal)
Clinic, Hospital & Home Use	Yes	Yes
Bulb at Tip of Probe to AssistRetention of Probe During Use	No	Yes
Light Weight to Assist Retentionof Probe During Use	Yes	No
Bulb at Base of Probefor Insertion/Removaland Control Insertion Depth	No	Yes
Tab at Base of Probefor Insertion/Removaland Control Insertion Depth	Yes	No
Arrow on Bottom of Probefor Orientation	No	Yes
Tab at Base of Probefor Orientation	Yes	No

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1714056 page 4 of 6

NON-CLINICAL PERFORMANCE DATA

A series of bench tests were performed using the Pathway Vaginal/Rectal Perineometer Probe to show the probe accurately measured EMG signals and was substantially equivalent to the predicate device. The Pathway Vaginal/Rectal Perineometer Probe was used to measure signals spanning the input range of the EMG device. A matrix of different frequencies and amplitudes was measured by the probe and the resulting readings compared to the input signals. The same bench tests were performed on the predicate device.

The bench tests show the Pathway Vaginal/Rectal Perineometer Probe accurately measures EMG signals. The bench tests also show that the Pathway Vaginal/Rectal Perineometer Probe performs similarly to the predicate device. The readings obtained using the Pathway Vaginal/Rectal Perineometer Probe were generally within 5% of the readings obtained using the predicate device.

CLINICAL PERFORMANCE DATA

)

The Pathway Vaginal/Rectal Perineometer Probe was used in a series of simple clinical tests to show the probe accurately measured EMG signals and was equivalent to the predicate device. A number of Male and Female subjects were instructed to perform a series of contractions and relaxations using the Pathway Vaginal/Rectal Perineometer Probe and also using the predicate device. These sessions were recorded using a personal computer.

The clinical tests show the Pathway Vaginal/Rectal Perineometer Probe accurately monitors the pelvic floor muscles. The clinical tests also show the Pathway Vaginal/Rectal Perineometer Probe performs similarly to the predicate device. The Pathway Vaginal/Rectal Perineometer Probe had an overall ratio between EMG contraction levels and EMG relaxation levels of 5.4:1 and the predicate device had an overall ratio between EMG contraction levels and EMG relaxation levels of 5.1:1.

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K974036 page 5 € f 6

BIOCOMPATIBILITY TESTING

The Pathway Vaginal/Rectal Perineometer Probe has been laboratory tested for the safety of the materials. The Pathway Vaginal/Rectal Perineometer Probes were found to be safe under the standards required for each test. A listing of each performed test and the result:

Test	Result
SKIN SENSITIZATION KLIGMAN MAXIMIZATION TESTDate of Test: 9/25/97	0% Sensitization;Weak allergenic potential
SYSTEMIC INJECTION TESTDate of Test: 9/9/97	Negative:No significant biologicalreaction
L929 MEM ELUTION TESTDate of Test: 8/21/97	Non-cytotoxic
PYROGEN TEST (Material Mediated)Date of Test: 9/3/97	Non-pyrogenic
PRIMARY VAGINAL TEST - REPEATED EXPOSUREDate of Test: 10/14/97	Minimal irritant
RECTAL IRRITATION TEST - REPEATED EXPOSUREDate of Test: 9/26/97	Non-irritant

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CONCLUSION

The Pathway Vaginal/Rectal Perineometer Probe is safe and effective for its intended use. The Pathway Vaginal/Rectal Perineometer Probe is substantially equivalent to the predicate device.

END OF 510(k) SUMMARY

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 1997

Mr. Richard Horton Vice President of Engineering The Prometheus Group 2 Mallards Cove Duxbury, Massachusetts 02332

Re: K974036

Pathway Vaginal/Rectal Perineometer Probe Dated: October 23, 1997 Received: October 24, 1997 Regulatory class: II 21 CFR §884.1425/Product code: 85 HIR

Dear Mr. Horton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that through periodic OS inspections the Food and Drue Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

William Yu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, 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

510(k) Number (if known): Pathway Vaginal/Rectal Perineometer Probe Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

ﻪ‌ﺳﺮ

Indications For Use

- Urinary Incontinence : Stress, Urge and Mixed Incontinence
- Fecal Incontinence
- Neuromuscular Reeducation

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Sather /

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K974036 510(k) Number

Prescription Use:_ X (Per 21 CFR 801.109)

Over-the-Counter Use: _________________

Regulation Number and Section

§ 884.1425 Perineometer.

(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).