PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE

K974036 · The Prometheus Group · HIR · Dec 22, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K974036
• Device Name: PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE
• Applicant: The Prometheus Group
• Product Code: HIR · Obstetrics/Gynecology
• Decision Date: Dec 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1425
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Pathway Vaginal/Rectal Perineometer Probe is a single-user plastic probe with three metal electrode contacts; designed for vaginal or rectal insertion. Device connects to external surface EMG instrument to monitor pelvic floor muscle activity. Provides biofeedback to patient during contraction/relaxation exercises; assists in neuromuscular reeducation and treatment of incontinence. Used in clinic, hospital, or home settings. Healthcare provider or patient uses EMG output to visualize muscle activity; facilitates pelvic floor strengthening and control. Benefits include improved muscle function and incontinence management.

Clinical Evidence

Clinical testing involved male and female subjects performing pelvic floor contractions/relaxations using both subject and predicate devices. Sessions recorded via PC. Results showed subject device accurately monitors pelvic floor muscles with performance similar to predicate. Subject device achieved an overall EMG contraction-to-relaxation ratio of 5.4:1 compared to 5.1:1 for the predicate.

Technological Characteristics

Single-user plastic probe with three metal electrode contacts (two active, one ground). Features shielded cable and 1/8" stereo plug connector. Biocompatibility confirmed via skin sensitization, systemic injection, L929 MEM elution, pyrogen, and repeated exposure vaginal/rectal irritation tests. Operates as a passive sensor for surface EMG devices.

Indications for Use

Indicated for patients with urinary incontinence (stress, urge, mixed), fecal incontinence, or those requiring neuromuscular reeducation of the pelvic floor muscles.

Regulatory Classification

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.

Predicate Devices

• Perrymeter Vaginal Perineometer Probe and Perrymeter Anal Perincometer Probe (K911190/A)

Submission Summary (Full Text)

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| | KY14036 |
|--|-------------|
| | page 1 of 6 |

The Prometheus Group

| 80 Bow Street | Portsmouth, NH 03801 |
|---------------------|----------------------|
| Phone: [phone] | Fax: [phone] |

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: [phone] Fax: [phone]

### 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 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.

#### Pathway Vaginal/Rectal Perineometer Probe

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#### 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 Assist<br>Retention of Probe During Use | No | Yes |
| Light Weight to Assist Retention<br>of Probe During Use | Yes | No |
| Bulb at Base of Probe<br>for Insertion/Removal<br>and Control Insertion Depth | No | Yes |
| Tab at Base of Probe<br>for Insertion/Removal<br>and Control Insertion Depth | Yes | No |
| Arrow on Bottom of Probe<br>for Orientation | No | Yes |
| Tab at Base of Probe<br>for 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 TEST<br>Date of Test: 9/25/97 | 0% Sensitization;<br>Weak allergenic potential |
| SYSTEMIC INJECTION TEST<br>Date of Test: 9/9/97 | Negative:<br>No significant biological<br>reaction |
| L929 MEM ELUTION TEST<br>Date of Test: 8/21/97 | Non-cytotoxic |
| PYROGEN TEST (Material Mediated)<br>Date of Test: 9/3/97 | Non-pyrogenic |
| PRIMARY VAGINAL TEST - REPEATED EXPOSURE<br>Date of Test: 10/14/97 | Minimal irritant |
| RECTAL IRRITATION TEST - REPEATED EXPOSURE<br>Date 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 [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

OR

Prescription Use:_ X (Per 21 CFR 801.109)

Over-the-Counter Use: _________________

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