(90 days)
Not Found
No
The summary describes a preamplifier for acquiring EMG signals, focusing on signal amplification and equivalence to a predicate device. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No
The device is described as an electromyographic preamplifier that acquires and amplifies EMG signals for display and analysis. Its intended use is for research and clinical analysis of muscle contraction, not for treating any condition or providing therapy.
Yes
The device acquires EMG signals for display and analysis by, or under the direction of, a health care professional, which is used for diagnostic purposes. It amplifies myoelectric signals generated by muscles, which are then analyzed to understand muscle function, often in the context of diagnosing neuromuscular disorders or injuries.
No
The device description explicitly states it is an "Electromyographic preamplifier," which is a hardware component designed to amplify electrical signals. The testing also involves physical devices (the preamplifier and electrode).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The MLS Electromyographic preamplifier acquires EMG signals from active subjects. This involves measuring electrical activity directly from the body's muscles, not analyzing specimens taken from the body.
- Intended Use: The intended use is to acquire EMG signals for display and analysis, which is a physiological measurement, not an in vitro test.
Therefore, the device falls under the category of a physiological measurement device rather than an IVD.
N/A
Intended Use / 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.
Product codes
IKN
Device Description
The purpose of the MLS Electromyographic preamplifier is to amplify the myoelectric signals that are generated by muscles when they contract.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
researchers and clinicians / hospital, university and other research facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.1375 Diagnostic electromyograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
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. (504) 928-4248 Phone: (504) 928-0261 Fax:
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.
1
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.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments, representing health, services, and people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
2Cella 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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にとができる。 1つ・ささ
Page 1 of 1 .
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)
A
Division (Sign-On)
Division of General Restorative Devices
510(k) Number K974365
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_