EMG SYSTEM

K111687 · Myotronics-Noromed, Inc. · HCC · Sep 29, 2011 · Neurology

Device Facts

• Record ID: K111687
• Device Name: EMG SYSTEM
• Applicant: Myotronics-Noromed, Inc.
• Product Code: HCC · Neurology
• Decision Date: Sep 29, 2011
• 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 up to eight muscle sites simultaneously. Inputs: electrical signals from reusable or disposable surface electrodes. Processing: quantification of muscle activity; display in time or frequency domains. Output: visual data for clinician review. Usage: clinical setting; operated by healthcare professionals. Key feature: battery-operated EMG unit with Bluetooth wireless data transfer to host computer; eliminates physical cable connection between patient and line voltage to enhance electrical safety. Clinical utility: aids muscle re-education/relaxation therapy; allows longitudinal comparison of captured data to assess patient progress.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Computer-based SEMG system; 8-channel monitoring; Bluetooth wireless connectivity; battery-operated; surface electrodes (reusable/disposable); time and frequency domain signal processing.

Indications for Use

Indicated for evaluation of muscle status at rest and in function, as an aid in muscle re-education and muscle relaxation therapy, and for tracking progress in treating patient 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 MES 9000 EMG System (K013399)

Submission Summary (Full Text)

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Special 510(k) Myotronics-Noromed, Inc

## 510(k) SUMMARY

SEP 2 9 2011

Model MES 9200/EMG System

## KIII 187 510(k) #

June 13, 2011

Myotronics-Noromed, Inc. 5870 S. 1940 St. Kent, WA 98032 Telephone [phone] Contact: Fray Adib, President

Device: Model MES 9200 EMG System for surface electromyography (SEMG).

Legally marketed predicate device: Model MES 9000 EMG System, K-013399

Description of the Device: The device incorporates circuitry enabling the same capabilities as the predecessor 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. The device is essentially identical to the predecessor device except that it utilizes wireless (Bluetooth) technology to transfer EMG data to host computer without a cable and to eliminate any connection between the patient and line voltage.

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 9200/EMG System has the same intended uses and fundamental scientific technology as its predecessor, the Model MES 9000. The design change which is the subject of this premarket notification is to transfer EMG data to host computer without a cable and to further increase the device's safety through use of a battery operated EMG unit and Bluetooth wireless technology to eliminate any possible connection between the patient and line voltage.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Myotronics-Noromed, Inc. % Mr. Fray Adib President 5870 S. 194th Street Kent, WA 98032-2126

SEP 29 2011

Re: K111687

Trade/Device Name: Model MES 9200 EMG System Regulation Number: 21 CFR 882.5050 Regulation Name: Biofeedback device Regulatory Class: Class II Product Code: HCC Dated: August 22, 2011 Received: August 30, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device

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Page 2 - Mr. Fray Adib

related adverse events) (21 CFR 803): 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

fa

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman. M.D. Director Division of Ophthalmic. Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KIII 687 510(k) Number (if known):

Model MES 9200/EMG System Device Name:

## INDICATIONS FOR USE

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

| Prescription Use<br>(Per 21 CFR 801.109) | <b>X</b> |
|------------------------------------------|----------|
|------------------------------------------|----------|

OR Over-The-Counter Use

| 510(k) Number: | K111687 |
|----------------|---------|
|----------------|---------|

(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices

| 510(k) Number: | K111687 |
|----------------|---------|
|----------------|---------|