PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR

• K Number: K993976
• Device Name: PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR
• Manufacturer: THE PROMETHEUS GROUP
• Date Cleared: 2000-02-22 ( 90 days)
• Product Code: KPI
• Regulation Number: 876.5320

Intended Use

Indications For Use: - * Urinary Incontinence : Stress, Urge and Mixed Incontinence - * Neuromuscular Reeducation - * Fecal Incontinence (EMG use only)

Device Description

The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are EMG OR Stimulation perineometer sensors used to monitor OR stimulate the pelvic floor muscles for the treatment of incontinence. This sensor 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. This sensor is connected to a stimulator device to provide stimulation to the patient. This assists the patient with muscle contractions. The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are single-user plastic sensors with stainless steel electrode contacts. The patient inserts the sensor 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 patient can instead use a stimulator 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.

Predicate Devices

K974036, K891773, K930530

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on basic EMG monitoring and electrical stimulation, with no mention of AI or ML algorithms for data analysis, interpretation, or treatment personalization.

Therapeutic

Yes
The device is described as being used for "treatment of incontinence" and "to provide stimulation to the patient" to assist with muscle contractions, which are therapeutic actions.

Diagnostic

Yes
The device is described as an "EMG OR Stimulation perineometer sensor used to monitor OR stimulate the pelvic floor muscles." It is explicitly stated that the sensor is "connected to a surface EMG device to provide Bio-feedback to the patient," allowing the patient to "monitor their pelvic muscle activity." Monitoring and providing bio-feedback are diagnostic functions, as they involve assessing and providing information about a physiological state.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical hardware components (sensors, electrodes) that are inserted into the body and connected to other hardware (surface EMG device, stimulator). This is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

• IVDs analyze samples taken from the human body. The device description clearly states that the sensors are inserted into the vagina or rectum to monitor or stimulate pelvic floor muscles in situ. They are not used to analyze samples like blood, urine, or tissue outside of the body.
• The intended use is for treatment and monitoring of muscle activity. The indications for use and device description focus on treating incontinence through neuromuscular reeducation and providing biofeedback or stimulation to the pelvic floor muscles. This is a therapeutic and monitoring function, not a diagnostic analysis of a biological sample.

Therefore, this device falls under the category of a medical device used for monitoring and treatment, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

No

The provided FDA clearance letter does not contain any language, terms, or sections indicating that this device is authorized under a Predetermined Change Control Plan (PCCP). PCCPs are explicitly stated in clearance letters and typically involve a framework for managing future modifications to AI/ML-driven devices. This letter describes a traditional medical device without any AI/ML components or a PCCP framework.

Overview

Intended Use / Indications for Use

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, 85 HIR

Device Description

The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are EMG OR Stimulation perineometer sensors used to monitor OR stimulate the pelvic floor muscles for the treatment of incontinence. This sensor 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. This sensor is connected to a stimulator device to provide stimulation to the patient. This assists the patient with muscle contractions.

The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are single-user plastic sensors with stainless steel electrode contacts. The patient inserts the sensor 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 patient can instead use a stimulator 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Pelvic floor muscles, vagina, rectum

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinic, Hospital & Home Use

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)

Non-Clinical Performance Data: A series of bench tests were performed to show the sensor accurately measures EMG signals and is substantially equivalent to the predicate device. The sensors were used to measure a known input signal and the measured value was compared to the known input signal. Bench tests show the devices accurately measure EMG signals and perform similarly to the predicate device, with readings generally within 2% of the predicate device.

Clinical Performance Data: A series of simple clinical tests were performed to show the sensors accurately measured EMG signals and provided stimulation and were equivalent to the predicate device. A test subject performed contractions and relaxations using the subject devices and the predicate device. EMG sessions were recorded. The test subject also used various stimulators with the sensors to generate contractions, and resulting contractions were monitored using a pressure perineometer sensor in the alternate placement (vagina or rectum). Clinical tests show the devices accurately monitor and provide stimulation to the pelvic floor muscles and perform similarly to the predicate device.

Biocompatibility Testing: Laboratory tests were performed for the safety of the materials. Tests performed include:

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

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.

K974036, K891773, K930530

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

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).

Summary

0

The Prometheus Group
----------------------

One Washington Street, #303 Dover , NH 03801
Phone:	603-749-0733
Fax:	603-749-0511

K993976 PG. 1 of 5

FEB 2 2 2 2000

510(k) SUMMARY Safety and Effectiveness Summary

Pathway Vaginal EMG/Stimulation Perineometer Sensor Pathway Anal EMG/Stimulation Perineometer Sensor

Submitted by:

Peter A Sullivan One Washington Street Suite 303 Dover, NH 03820 Phone: [phone] Fax: [phone]

Contact Person:

Richard Horton

Date Submitted: Feb 4, 2000

A-11

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NAME OF DEVICE

Pathway Vaginal EMG/Stimulation Perineometer Sensor Trade name: Pathway Anal EMG/Stimulation Perineometer Sensor Common name: Perineometer Sensor Classification name: Perineometer (per 21 CFR section 884,1425)

IDENTIFICATION OF PREDICATE DEVICE

The device to which we claim substantial equivalence is the Pathway Vaginal/Rectal EMG Perineometer Sensor 510(k) number K974036, the InCare Vaginal EMG/Stimulation Perineometer Sensor and the InCare Anal EMG/Stimulation Perineometer Sensor 510(k) numbers K891773 and K930530. The Pathway Vaginal/Rectal EMG Perineometer Sensor, the InCare Vaginal EMG/Stimulation Sensor and the InCare Anal EMG/Stimulation Sensor are also singleuser plastic sensors with stainless steel electrode contacts.

DESCRIPTION OF DEVICE

The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are EMG OR Stimulation perineometer sensors used to monitor OR stimulate the pelvic floor muscles for the treatment of incontinence. This sensor 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. This sensor is connected to a stimulator device to provide stimulation to the patient. This assists the patient with muscle contractions.

The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are single-user plastic sensors with stainless steel electrode contacts. The patient inserts the sensor 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 patient can instead use a stimulator 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
• • Fecal Incontinence (EMG use only)

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2

SUMMARY OF TECHNICAL CHARACTERISTIC COMPARISON TO PREDICATE DEVICE

| Feature | Pathway
Vaginal | Pathway
Anal | Pathway
Vag/Rect | InCare
Vaginal | InCare
Anal |
|----------------------------------------------------------------------------|--------------------|-----------------|---------------------|-------------------|----------------|
| Single-User Perineometer Sensor | Yes | Yes | Yes | Yes | Yes |
| Plastic Sensor with Metal Contacts | Yes | Yes | Yes | Yes | Yes |
| Three Electrode Contacts | Yes | Yes | Yes | No | No |
| Two Active, One Ground Contact | Yes | Yes | Yes | No | No |
| Separate Ground Connection for EMG | No | No | No | Yes | Yes |
| Shielded Cable | Yes | Yes | Yes | Yes | Yes |
| Safety 1/8" Stereo Plug Connector | Yes | Yes | Yes | No | No |
| 1/8" Stereo Plug Connector | No | No | No | Yes | Yes |
| Urinary Incontinence | Yes | Yes | Yes | Yes | Yes |
| Fecal Incontinence
(EMG use only) | Yes | Yes | Yes | No | No |
| Vaginal Use | Yes | No | Yes | Yes | No |
| Rectal Use | No | Yes | Yes | No | Yes |
| Clinic, Hospital & Home Use | Yes | Yes | Yes | Yes | Yes |
| Bulb at Tip of Sensor to Assist Retention
of Sensor During Use | Yes | Yes | No | No | Yes |
| Tab at Base of Sensor for Insertion/Removal
and Control Insertion Depth | Yes | Yes | Yes | No | No |
| Arrow on Bottom of Sensor for Orientation | Yes | Yes | No | No | No |
| Tab at Base of Sensor for Orientation | Yes | Yes | Yes | No | No |
| Use for EMG measurement | Yes | Yes | Yes | Yes | Yes |
| Use for Stimulation | Yes | Yes | No | Yes | Yes |
| Overall Length | 2.9" | 2.4" | 2.9" | 4.3" | 2.3" |
| Sensing Diameter | .70" | .50" | .73" | 1.0" | .47" |

NON-CLINICAL PERFORMANCE DATA

A series of bench tests were performed using the Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor to show the sensor accurately measures EMG signals and is substantially equivalent to the predicate device, The sensors were used to measure a known input signal and the measured value was compared to the known input signal to check the accuracy of the measurement. The same bench tests were performed on the predicate device.

The bench tests show the Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor accurately measure EMG signals. The bench tests also show that the Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor perform similarly to the predicate device. The readings obtained using the Pathway Vaginal EMG/Stimulation Perineometer Sensor and the

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Pathway Anal EMG/Stimulation Perineometer Sensor were generally within 2% of the readings obtained using the predicate device.

CLINICAL PERFORMANCE DATA

The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor were used in a series of simple clinical tests to show the sensors accurately measured EMG signals and provided stimulation and to show they were equivalent to the predicate device. A test subject was instructed to perform a series of contractions and relaxations using the Pathway Vaginal EMG/Stimulation Perineometer Sensor, the Pathway Anal EMG/Stimulation Perineometer Sensor, and also the predicate device. These EMG sessions were recorded using a personal computer. The test subject also used a viariety of stimulators with the sensors to generate contractions. The resulting contractions were monitored using a pressure perineometer sensor in the alternate placement (vagina or rectum) to compare the performance of the sensors.

The clinical tests show the Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor accurately monitor and provide stimulation to the pelvic floor muscles. The clinical tests also show the Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor perform similarly to the predicate device

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 Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor 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 TEST
Date of Test: 9/25/97	0% Sensitization;
Weak allergenic potential
SYSTEMIC INJECTION TEST
Date of Test: 9/9/97	Negative;
No significant biological
reaction
L929 MEM ELUTION TEST
Date of Test: 8/21/97	Non-cytotoxic
PYROGEN TEST (Material Mediated)
Date of Test: 9/3/97	Non-pyrogenic
PRIMARY VAGINAL TEST - REPEATED EXPOSURE
Date of Test: 10/14/97	Minimal irritant

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RECTAL IRRITATION TEST - REPEATED EXPOSURE Non-irritant Date of Test: 9/26/97

CONCLUSION

The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are safe and effective for their intended use. The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are substantially equivalent to the predicate device.

END OF 510(k) SUMMARY

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Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird.

FEB 2 2 2000

Mr. Richard Horton The Prometheus Group 2 Mallards Cove Duxbury, MA 02332

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K993976 Pathway Vaginal EMG/Stimulation Perineometer Sensor and Pathway Anal EMG/Stimulation Perineometer Sensor Dated: February 4, 2000 Received: February 8, 2000 Requiatory Class: II 21 CFR §876.5320/Procode: 78 KPI 21 CFR §884.1425/Procode: 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 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). 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 (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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult 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 the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 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 and additionaily 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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STATEMENT OF INDICATIONS FOR USE

K993976 510(k) Number (if known): Pathway Vaginal EMG/Stimulation Perineometer Sensor and Device Name: _________________________________________________________________________________________________________________________________________________________________ Pathway Anal EMG/Stimulation Perineometer Sensor

Indications for Use:

Indications For Use

• • Urinary Incontinence : Stress, Urge and Mixed Incontinence
• • Neuromuscular Reeducation
• • Fecal Incontinence (EMG Use only)

Torish a. Hegeman

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:_ X (Per 21 CFR 801.109)

OR

Over-the-Counter Use:_

A-S