MLS ELECTROMYOGRAPHIC PREAMPLIFIER

K974385 · Motion Lab Systems, Inc. · IKN · Feb 19, 1998 · Physical Medicine

Device Facts

• Record ID: K974385
• Device Name: MLS ELECTROMYOGRAPHIC PREAMPLIFIER
• Applicant: Motion Lab Systems, Inc.
• Product Code: IKN · Physical Medicine
• Decision Date: Feb 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1375
• Device Class: Class 2

Intended Use

The MLS Electromyographic preamplifier enables researchers and clinicians to acquire EMG signals from active subjects. It is intended to be used in hospital, university and other research facilities to acquire EMG signals for display and analysis by, or under the direction of, a health care professional.

Device Story

Device is an electromyographic (EMG) preamplifier; captures myoelectric signals generated by muscle contractions. Input: surface EMG signals from skin; Output: amplified electrical signals for display/analysis. Used in hospitals, universities, and research facilities; operated by clinicians or researchers. Provides signal conditioning to facilitate EMG monitoring; enables healthcare professionals to analyze muscle activity for clinical or research purposes.

Clinical Evidence

Bench testing only. Comparison of myographic recordings from the skin surface over a single muscle between the MLS Electromyographic preamplifier and the B&L Active Electrode. Results showed substantially identical frequency content and power spectrum.

Technological Characteristics

Polyethylene case with stainless steel sensor pads. Isolated external power source (500 uA). Input impedance >100 MΩ. Signal bandwidth DC to 2,000 Hz. Gain of 20. CMRR 90 dB.

Indications for Use

Indicated for researchers and clinicians to acquire EMG signals from active subjects in hospital, university, and research facilities for display and analysis under the direction of a healthcare professional.

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

• B&L Active Electrode (K952655)

Submission Summary (Full Text)

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510(k) Marketing Clearance Application

# 510(k) Summary

Premarket Notification [510(k)] summary prepared on November 14, 1997

## Establishment Information

Manufacturer/Summiteer:
Motion Lab Systems, Inc.
4326 Pine Park Drive,
Baton Rouge, LA 70809

Contact Name/Phone #
Edmund Cramp
Motion Lab Systems, Inc.
Phone: [phone]
Fax: [phone]

K974385
FEB 19 1998

## General Device Information

Common/Usual Name: EMG Electrode
Trade/Proprietary Name: MLS Electromyographic preamplifier
Classification Name: Electromyography, Diagnostic - 21 CFR 890.1375
Device Classification: Class II
Performance Standards: None established under section 514

## Substantial Equivalence:

The MLS Electromyographic preamplifier is substantially equivalent to the B&L Electrode which is currently legally manufactured under 510(k) K952655

## Device Description:

The purpose of the MLS Electromyographic preamplifier is to amplify the myoelectric signals that are generated by muscles when they contract.

## Intended Use:

The MLS Electromyographic preamplifier enables researchers and clinicians to acquire EMG signals from active subjects. It is intended to be used in hospital, university and other research facilities to acquire EMG signals for display and analysis by, or under the direction of, a health care professional.

## Testing:

A sample of both the predicate B&L Active Electrode and the proposed MLS Electromyographic preamplifier were tested to determine substantial equivalence and relative performance. Myographic recordings from the skin surface over a single muscle were found to be substantially identical in frequency content and power spectrum for both devices.

Motion Lab Systems, Inc.,

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510(k) Marketing Clearance Application

# 510(k) Summary

Comparison to legally marketed predicate device:

| Characteristic | B&L Active Electrode | Proposed MLS device |
| --- | --- | --- |
| Intended Use | Ambulatory myoelectric EMG monitoring. | Ambulatory myoelectric EMG monitoring. |
| Power Source | Isolated external source. | Isolated external source. |
| Materials / Construction | Styrene case with stainless steel sensor pads. | Polyethylene case with stainless steel sensor pads. |
| CMRR | 95 dB | 90 dB |
| Input Impedance | Greater than 100 MΩ | Greater than 100 MΩ |
| Power requirements | not stated | 500 uA |
| Signal Bandwidth | 20 Hz to 2,000 Hz | DC to 2,000 Hz |
| Gain | 330 | 20 |

# Conclusion:

Testing done on the MLS Electromyographic preamplifier and the predicate B&L Electrode indicates the proposed MLS Electromyographic preamplifier is as safe and effective and performs a substantially equivalent function to the predicate B&L Electrode.

Motion Lab Systems, Inc.,

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

FEB 19 1998

Mr. Edmund Cramp
President
Motion Lab Systems, Inc.
4326 Pine Park Drive
Baton Rouge, Louisiana 70809

Re: K974385
Trade Name: MLS Electromyographic Preamplifier
Regulatory Class: II
Product Code: IKN
Dated: November 18, 1997
Received: November 21, 1997

Dear Mr. Cramp:

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 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 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 (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 (QS) inspections, the Food and Drug 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Edmund Cramp

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 marketed 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 questions on the promotion 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 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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FEB-09-1998 15:23 FROM MOTION CAB 14

10018274336 P.02

510(k) Number (if known): K974385

Device Name: MLS Electromyographic preamplifier

Indications for Use:

The MLS Electromyographic preamplifier enables researchers and clinicians to acquire EMG signals from active subjects. It is intended to be used in hospital, university and other research facilities to acquire EMG signals for display and analysis by, or under the direction of, a health care professional.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)

Division of General Restorative Devices

510(k) Number K974385

Prescription Use ☑

(Per 21 CFR 801.109)

OR

Over-The-Counter Use