MODEL MES-9000/EMG SYSTEM

K013399 · Myotronics-Noromed, Inc. · HCC · Nov 13, 2001 · Neurology

Device Facts

• Record ID: K013399
• Device Name: MODEL MES-9000/EMG SYSTEM
• Applicant: Myotronics-Noromed, Inc.
• Product Code: HCC · Neurology
• Decision Date: Nov 13, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used in evaluation and recording of muscle status, at rest and in function, as an aid in muscle re-education and muscle relaxation therapy, and to provide ability to compare new captured data with past data to assess progress in treating patients relaxation state.

Device Story

Computer-based surface electromyography (SEMG) system; monitors muscle activity via re-usable or disposable surface electrodes placed on muscle groups. System captures signals from up to eight sites simultaneously; processes data for display in time or frequency domains. Used by clinicians to evaluate muscle status, facilitate muscle re-education, and assist in relaxation therapy. Output allows comparison of current data with historical records to assess patient progress. Device integrates capabilities of predecessor models into a single platform with updated electronic components and software.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and intended use similarities to predicate devices.

Technological Characteristics

Computer-based SEMG system; monitors up to eight sites simultaneously. Uses surface electrodes (re-usable or disposable) for signal acquisition. Displays data in time or frequency domains. Electronic components and software updated to state-of-the-art specifications.

Indications for Use

Indicated for patients requiring muscle status evaluation, muscle re-education, or muscle relaxation therapy. Used to monitor muscle activity at rest or in function and to track progress in relaxation states.

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.

Predicate Devices

• Model ND-2000 (K922838A)
• Model ND-8000 (K922270)
• Model ND-8000 (K992439)

Submission Summary (Full Text)

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MYOTRONICS-NOROMED, INC. Leading in Musculoskeletal Evaluation Technologies For 30 Years

Special 510(k) Myotronics-Noromed, Inc

## 510(k) SUMMARY

NOV 1 3 2001

Model MES-9000/EMG System 210(k) #

Myotronics-Noromed, Inc. 15425 - 53td Avenue South Tukwila, WA 98188 Telephone [phone] Contact: Mr. Fray Adib, President October 9,2001

Device: Model MES-9000/EMG System consisting of computer-based surface electromyography (SEMG).

Legally marketed predicate devices: Model ND-2000 (K922838A), ND-8000 (K922270 & K992439) Myotronics-Noromed, Inc.

Description of the Device: The device incorporates circuitry enabling the capabilities of the two predecessor devices to be offered as a single device. It is a computer based system offering options capable of evaluating muscle groups at rest or in function by means of surface electromyography. Muscle activity is quantified by means of re-usable or disposable surface electrodes positioned over the muscle groups being studied. Up to eight sites can be monitored simultaneously and displayed in time or frequency domains.

Intended Use: Used in evaluation and recording of muscle status, at rest and in function, as an aid in muscle re-education and muscle relaxation therapy, and to provide ability to compare new captured data with past data to assess progress in treating patients relaxation state.

Comparison with predicate devices: The Model MES-9000/EMG System will have the same intended uses and fundamental scientific technology as its predecessors, the Models ND-2000 and ND-8000. The design change which is the subject of this premarket notification is to update and enhance the electronic components and software to state-ofthe-art and to provide the capabilities of the two predecessor devices as a single device.

Image /page/0/Picture/13 description: The image shows two logos side by side. The logo on the left has the text "CERTIFIED ISO 9001" at the top and an image of a globe with a star on top. The logo on the right has an image of a triangle inside a circle with the text "Accredited by the Council for Accreditation (RvA)" below it. Both logos are black and white and are contained within a rectangular border.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2001

Mr. Fray Adib President Myotronics-Noromed, Inc. 15425 53rd Avenue South Tukwila, Washington 98188

Re: K013399

Trade/Device Name: Model MES-9000/EMG System Regulation Number: 882.5050 Regulation Name: Biofeedback device Regulatory Class: II Product Code: HCC Dated: October 9, 2001 Received: October 15, 2001

Dear Mr. Adib:

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 such 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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Page 2 - Mr. Fray Adib

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to ogen mains of substantial equivalence of your device to a legally premarket notification: "The PDF intelligention 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 11 you desire specific ad 1809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Fatt 007.10 for questions on the promotion and advertising of Comphance at [phone] - 1887 - 1282 - 1282 - 114 - 11 - 11 - 17 - 17 - 17 - 17 - 10 - 10 - 10 your do roo, proad contranding by reference to premarket notification" (21CFR Part 807.97). Tegulation childred, "Misoranang of open responsibilities under the Act may be obtained from the Oinci general information on your respectional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Millerman

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

Enclosure

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NOV 1 3 2001

K013399 510(k) Number (if known):

Model MES-9000/EMG System Device Name: _________________________________________________________________________________________________________________________________________________________________

## INDICATIONS FOR USE

- For evaluation of the status of muscles at rest and in function >
- As an aid in muscle re-education and muscle relaxation therapy A
- Provides ability to compare new captured data with past data to assess progress > in treating patients relaxation state

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Mulkerson

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
K013399

OR

510(k) Number.

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _

510(k) Number:

Model MES-9000/EMG System Device Name: