PATHWAY ELECTROMYOGRAPH

K973537 · The Prometheus Group · HCC · Dec 17, 1997 · Neurology

Device Facts

• Record ID: K973537
• Device Name: PATHWAY ELECTROMYOGRAPH
• Applicant: The Prometheus Group
• Product Code: HCC · Neurology
• Decision Date: Dec 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Surface electromyography is a safe and effective technique for relaxation training and muscle re-education. Using internal perineometer electrodes such as the PerryVaginal: EMG biofeedback is a safe and effective technique for the assessment and treatment of pelvic floor dysfunction, monitoring the performance of Keyel exercises. The pelvic floor muscles include the Levator Ani group as well as the pubococcygeus (PC), ileococcygeus, and coccygeus. These are skeletal muscles which respond to re-education, strengthening, endurance building, and relaxation. Conditions that can be assessed or treated using this technique include: stress incontinence, mixed incontinence, and urge incontinence.

Device Story

Pathway TR-10, TR-10C, TR-20, and TR20C are EMG biofeedback devices. Input: surface or internal perineometer (e.g., PerryVaginal) electrodes detecting electrical activity from skeletal muscles. Operation: device processes EMG signals to provide real-time feedback to patients and clinicians for muscle re-education, strengthening, and relaxation training. Output: visual or auditory feedback representing muscle activity. Used in clinical settings by healthcare providers or patients under prescription to monitor Kegel exercises and treat pelvic floor dysfunction. Benefits: assists in assessment and rehabilitation of pelvic floor muscles to manage incontinence.

Clinical Evidence

No clinical data provided; device relies on established safety and effectiveness of EMG biofeedback techniques for muscle re-education and pelvic floor dysfunction treatment.

Technological Characteristics

EMG biofeedback system utilizing surface or internal perineometer electrodes. Operates by sensing electrical signals from skeletal muscles. System includes multiple models (TR-10, TR-10C, TR-20, TR20C) for biofeedback monitoring.

Indications for Use

Indicated for patients requiring relaxation training, muscle re-education, or treatment of pelvic floor dysfunction, including stress, mixed, and urge incontinence. Applicable to skeletal muscles of the pelvic floor (Levator Ani, pubococcygeus, ileococcygeus, coccygeus).

Regulatory Classification

Identification

A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Peter A. Sullivan Engineer The Prometheus Group 2 Mallards Cove Duxbury, Massachusetts 02332

DEC 17 1997

Re: K973537

> Trade Name: Pathway TR-10. TR-10C, TR-20, TR20C Regulatory Class: II Product Code: HCC Dated: September 16, 1997 Received: September 18, 1997

Dear Mr. Sullivan:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (QS) 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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 regulations.

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Page 2 - Mr. Peter A. Sullivan

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 questions on the promotion and advertising of your devices, 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 yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT of INDICATIONS for USE

510(k) Number (if known): K973537 Device Name: Pathway TR-10, TR-10C, TR-20, TR20C

## Indications for Use:

l

Surface electromyography is a safe and effective technique for relaxation training and muscle re-education.

Using internal perineometer electrodes such as the PerryVaginal: EMG biofeedback is a safe and effective technique for the assessment and treatment of pelvic floor dysfunction, monitoring the performance of Keyel exercises. The pelvic floor muscles include the Levator Ani group as well as the pubococcygeus (PC), ileococcygeus, and coccygeus. These are skeletal muscles which respond to re-education, strengthening, endurance building, and relaxation.

Conditions that can be assessed or treated using this technique include: stress incontinence, mixed incontinence, and urge incontinence.

Concurrence of CDRH, Office of Device Evaluation (ODE)

E)

(Division Sign-Off) Division of General Restorative Device 510(k) Number

10. 2

Prescription Use_ X ____________________________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________