(1070 days)
The intended use of the Model ME300 Muscle Tester is to record EMG sensory feedback signals to be used in various programs of muscle reeducation and relaxation training.
The ME300 is a portable, battery powered EMG recorder. The ME300 is an electronic device used to gather and display electrophysiological signals obtained from muscle activity. These signals are used in programs related to muscle re-education and relaxation training. The signals are received via conductive adhesive skin electrodes and may be displayed or stored for display at a later time. Signals may be gathered from two channels. Data downloading or transfer is via a standard fiber optic cable to a PC. The product does not relay any electrical or stimulatory signals to the body. It is only a signal recorder with display capabilities.
This document, K943535, does not describe a study to prove the device meets specific performance acceptance criteria beyond safety and electromagnetic compatibility (EMC). Instead, it primarily focuses on establishing substantial equivalence to predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for the ME300 Muscle Tester's ability to record EMG signals. The "acceptance" is primarily based on meeting safety and EMC standards and demonstrating substantial equivalence in function to existing devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Electrical Safety | Meets the requirements of IEC 601-1-2 |
| EMC Safety | Meets the requirements of IEC 801-2, IEC 801-3, EN55011, and the EMC Directive |
| Functionality | Gathers electrophysiological signals (EMG) and displays them for muscle re-education and relaxation training, deemed substantially equivalent to predicate devices (Myotrac and Myoexcerciser). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical performance study with a "test set" in the context of device accuracy or effectiveness. The "testing" mentioned refers to electrical and EMC safety compliance. Therefore, information on sample size and data provenance for a performance test set is not applicable to this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
As there is no described clinical performance "test set" requiring ground truth establishment, this information is not applicable.
4. Adjudication Method for the Test Set
Since no clinical performance "test set" is described, an adjudication method is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is described in this document. The submission focuses on substantial equivalence based on technological characteristics and intended use, not on comparing a human reader's performance with and without AI assistance. Therefore, information about effect size is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The ME300 Muscle Tester is a signal recorder and display device. It does not incorporate an AI algorithm for interpretation or diagnosis. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
For the safety and EMC testing, the "ground truth" was compliance with established international and European safety standards (IEC, EN, EMC Directive). For the substantial equivalence claim, the "ground truth" was the functional and safety characteristics of the predicate devices (Myotrac and Myoexcerciser) as accepted by the FDA. There is no biological or clinical "ground truth" based on pathology or outcomes data mentioned for device performance itself.
8. Sample Size for the Training Set
The ME300 Muscle Tester is a hardware device for recording physiological signals; it does not utilize a machine learning algorithm that requires a "training set." Therefore, this information is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for a machine learning algorithm, this information is not applicable.
In summary: This 510(k) submission for the ME300 Muscle Tester is a pre-amendments substantial equivalence claim. It relies on demonstrating that the device is as safe and effective as legally marketed predicate devices by showing equivalent technological characteristics and intended use, along with compliance with relevant electrical and EMC safety standards. It does not present a clinical performance study with specific quantitative acceptance criteria or a "test set" in the way modern AI/ML device submissions would.
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K9435335
510(k) Summary
Class II
JUN 2 5 1997
General Information
Classification
Common Name
Trade Name
Manufacturer
Mega Electronics, Ltd. Savilahdentie 6 PO Box 1750 70211 Kuopio Finland
ME300 Muscle Tester
tel: 358 71 282 8959
Submitted by
Regulatory Strategies, Inc. Consultant to Mega Electronics, Ltd.
Biofeedback device, EMG Device
Predicate Devices
| Myotrac from Thought Technology | K881416 |
|---|---|
| Myoexcerciser from Verimed | K832714 |
Device Description
ﺗﻌﻤ
The ME300 is a portable, battery powered EMG recorder.
Technological Characteristics
The ME300 is an electronic device used to gather and display electrophysiological signals obtained from muscle activity. These signals are used in programs related to muscle re-education and relaxation training.
The signals are received via conductive adhesive skin electrodes and may be displayed or stored for display at a later time. Signals may be gathered from two channels. Data downloading or transfer is via a standard fiber optic cable to a PC. The product does not relay any electrical or stimulatory signals to the body. It is only a signal recorder with display capabilities.
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Intended Use
The intended use of the Model ME300 Muscle Tester is to record EMG sensory feedback signals to be used in various programs of muscle reeducation and relaxation training.
Testing
.. .
The ME300 was tested for electrical and EMC safety by a recognized third party testing facility. The product meets the requirements of IEC 601-1-2, IEC 801-2, IEC 801-3, EN55011 and the EMC Directive.
Summary of Equivalence
The ME300 offers the user a means to gather electrophysiological signals (EMG) and display these signals for the purpose of muscle reeducation and relaxation training. The indications for use and the basic overall design are either identical or substantially equivalent to the predicate products.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gregory J. Mathison Requlatory Strategies, Inc. 1660 Riverton Point Eagan, Minnesota -55122 ------------------------------------------------------------------------------------------------------------------------------------------------------
JUN 2 5 1997
Re : K943535 Model ME300 Muscle Tester Trade Name: Regulatory Class: II Product Code: 84HCC Dated: March 28, 1997 Received: March 28, 1997
Dear Mr. Mathison:
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 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 OS inspections, the Food and Druq 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. Gregory J. Mathison
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) 594-4648. 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,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
510(k) Number (if known): K943535
Device Name:
ME300 Muscle Tester
Indications For Use: --------------------------------------------------------------------------------------------------------------------------------------------------------electrophysiological signals obtained from muscle activity. These signals are used in programs related to muscle re-education and relaxation training.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahans
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_ K 94 35 35
Prescription Use X (Per 21 CFR 801.109)
§ 882.5050 Biofeedback device.
(a)
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.(b)
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.