M-SCAN

K130158 · Bio-Research Associates, Inc. · KZM · Jul 25, 2013 · Physical Medicine

Device Facts

• Record ID: K130158
• Device Name: M-SCAN
• Applicant: Bio-Research Associates, Inc.
• Product Code: KZM · Physical Medicine
• Decision Date: Jul 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1375
• Device Class: Class 2

Intended Use

1. To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter in To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system 3. To determine the degree of relaxation (intra-patient) of 2 muscles at rest To measure relative (intra-patient) levels of activity of 2 muscles during a functional act 4.

Device Story

M-Scan is a 2-channel, portable, battery-operated electromyographic (EMG) amplifier. It captures electrical signals from two muscles of the stomatognathic system. The device processes these inputs via high-gain differential input amplifiers, buffer amplifiers, full-wave rectifiers, and integrators. It provides bandwidth filtering (30-1000 Hz) and signal integration. The device is intended for use by clinicians to monitor muscle activity, assess relaxation, and evaluate treatment. Output is provided via a built-in digital display, allowing the clinician to observe relative muscle activity levels. The device is self-contained, requires no external connections, and is not connected to AC power, enhancing portability for clinical settings.

Clinical Evidence

No clinical data. Bench testing performed using a calibrated function generator and oscilloscope to verify amplification and band-pass filtering characteristics against the predicate device. Software validation testing was also conducted.

Technological Characteristics

Portable, battery-operated 2-channel EMG amplifier. Features high-gain differential input amplifiers, buffer amplifiers, full-wave rectifiers, and integrators. Bandwidth: 30-1000 Hz (± 3dB). Common mode rejection ratio ≥ 130 dB at 50/60 Hz. Includes built-in digital display. No external power or equipment interface. Hardware-based signal processing.

Indications for Use

Indicated for patients requiring clinical monitoring of stomatognathic system muscles (e.g., temporalis, masseter) to aid in diagnosis and treatment evaluation, including assessment of muscle relaxation at rest and relative activity levels during functional acts.

Regulatory Classification

Identification

A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

Predicate Devices

• BioEMG III (K082927)

Submission Summary (Full Text)

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# 510(k) Summary

BioResearch Associates, Inc. 9275 North 49th Street Suite 150 Brown Deer, WI 53223 Phone: [phone] Fax: [phone] Official Correspondent: John Radke 24 July 2013

Trade Name: M-Scan

Common Name: 2-channel, portable, battery operated electromyography

Regulation Number: 21 CFR 890.1375

Regulation Name: Diagnostic Electromyography

Regulatory Class: Class II

Product Code: KZM

Equivalent Device: BioEMG III (K082927)

Previous submissions: None

### Product Description:

The M-Scan is a 2-channel, portable, battery operated electromyographic amplifier which includes: a) two (2) identical high-gain differential input amplifiers, b) two (2) buffer amplifiers, c) two (2) full wave rectifiers, and d) two (2) integrators. The overall amplification of the M-Scan is calibrated to 2500. The bandwidth filtering is set (fixed) from 30 Hz to 1000 Hz (± 3dB). The common mode rejection ratio is ≥ 130 dB at the power line frequency (50/60 Hz). The M-Scan does not include isolated power converter since it is battery operated, portable, and does not interface with any external equipment (it is never connected to the a-c line). Only three (3) functions are provided by the M-Scan: 1) amplification, 2) bandwidth limiting, and 3) integration of the signal for the integrated display.

### Intended Use of electromyography: (same as for the BioEMG III - K082927)

- 1. To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter
- in To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system
- 3. To determine the degree of relaxation (intra-patient) of 2 muscles at rest
- To measure relative (intra-patient) levels of activity of 2 muscles during a functional act 4.

JUL 2 5 2013

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## Technological Characteristics:

The technological advantages of the M-Scan (compared to the predicate device) include:

- The M-Scan is a portable, self contained, battery operated unit with no requirement for any 1. external connections.
- The M-Scan is dedicated to simple tests comparing two muscles at rest or in function. 2.
- Due to its simplicity and low-power electronic components, the M-Scan will use less energy than 3. the predicate device.
- The functional characteristics of the M-Scan amplifiers are essentially identical to those of the 4. BioEMG III (K082927); literally the same I.C. components are used. See Appendix G.
- 5. New features of the M-Scan include: a) miniaturized, self contained operation, b) built-in rectification and averaging filter hardware, and c) built-in digital display

## Non-Clinical Test Data:

Utilizing a calibrated function generator and oscilloscope we have applied test signals to both instruments. In Appendix E we have supplied comparable graphic plots of the waveforms and the frequency response characteristics of both instruments. In the M-Scan it is clear that we have retained comparable levels of amplification and band-pass filtering as used in the BioEMG III predicate device. EMG testing was performed on the M-Scan. Software validation testing was performed on the software for the M-Scan. This submission does not contain clinical data.

# Conclusion:

Based on the information provided concerning the M-Scan is substantially equivalent to the declared predicate of the BioEMG III (K082927).

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

## July 25, 2013

BioResearch Associates, Incorporated C/O Mr. John Radke President 9275 North 49th Street, Suite 150 BROWN DEER WI 53223

Re: K130158

Trade/Device Name: M-Scan Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyography Regulatory Class: II Product Code: KZM Dated: June 25, 2013 Received: June 28, 2013

Dear Mr. Radke:

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. Ilsting 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.

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Page 2 - Mr. Radke

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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K | 30 15 8

M-Scan Device Name:

Indications for Use:

## Indications for use; 2 channel, hand held, mobile EMG amplifier

- 1. To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter
- 2. To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system
- 3. To determine the degree of relaxation (intra-patient) of 2 muscles at rest
- 4. To measure relative (intra-patient) levels of activity of 2 muscles during a function act

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ Yes (Pat 21 CFR 801 subpart D) AND/OR

1

Over-the-counter Use (Part 21 CFR 801 subpart D) Andrew I. Steen -S Andrew I. Steen -5

(Division Sign-Off) (Olvision of Anesthesiology, General Hospital Infection Control, Dental Devices

KISOIS

610{k) Number: