(277 days)
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No
The description focuses on signal recording and display, with no mention of AI/ML terms or functionalities.
No
The device is described as a recorder and display of EMG signals for muscle re-education and relaxation training, not for providing direct therapeutic intervention or treatment.
Yes
This device is a diagnostic device as it records and displays EMG sensory feedback signals from muscle activity, which are used in muscle re-education and relaxation training. This process involves gathering information about the body's state, which is a form of diagnosis. The device's function is to analyze existing biological signals rather than to treat, stimulate, or affect the body directly.
No
The device description explicitly states it is a "portable, battery powered EMG recorder" and an "electronic device" that receives signals via "conductive adhesive skin electrodes" and uses a "standard fiber optic cable" for data transfer. These are all hardware components, indicating it is not a software-only device.
Based on the provided information, the Model ME3000P Professional Muscle Tester is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to record EMG signals for muscle re-education and relaxation training. This involves measuring electrical activity from the body (in vivo), not analyzing samples taken from the body (in vitro).
- Device Description: The device description explicitly states it's an "EMG recorder" that gathers and displays electrophysiological signals obtained from muscle activity. It receives signals via skin electrodes and does not analyze biological samples.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The ME3000P does not perform this function.
Therefore, the ME3000P falls under the category of a medical device that interacts with the body directly to measure physiological signals, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Model ME3000P Professional Muscle Tester is to record EMG sensory feedback signals to be used in various programs of muscle re-education and relaxation training.
Product codes
84HCC
Device Description
The ME3000P is a portable, battery powered EMG recorder. The ME3000P 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 or more 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The ME300P 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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MAY 1 9 1997
510(k) Summary
General Information
Class II Classification Biofeedback device, EMG Device Common Name ME3000P Professional Muscle Tester Trade Name Mega Electronics, Ltd. Manufacturer Savilahdentie 6 PO Box 1750 70211 Kuopio Finland tel: 358 71 282 8959 Submitted by Regulatory Strategies. Inc. Consultant to Mega Electronics, Ltd.
Predicate Devices
| Myotrac from Thought Technology | K881416 |
|---|---|
| Myoexcerciser from Verimed | K832714 |
| Myosystem 1000/2000 from Noraxon | K895635 |
Device Description
The ME3000P is a portable, battery powered EMG recorder.
Technological Characteristics
The ME3000P 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 or more 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 ME3000P Professional Muscle Tester is to record EMG sensory feedback signals to be used in various programs of muscle re-education and relaxation training.
Testing
The ME300P 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 ME3000P 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 1997
Mr. Gregory J. Mathison President Regulatory Strategies, Inc. 1660 Riverton Point Eagan, Minnesota 55122-3138
Re : K963202 ME3000P Professional Muscle Tester Trade Name: Requlatory Class: II Product Code: 84HCC March 28, 1997 Dated: 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 (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 Good Manufacturing Practice for Medical Devices: -General --(GMP) regulation (21 CFR Part 920) and that, through periodic GMP 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 requlations.
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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. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number:
Device Name:
ME3000P Professional Muscle Tester
Indications for Use:
The intended use of the Model ME3000P Professional Muscle Tester is the interestion as a so sory feedback signals to be used in various programs of muscle re-education and relaxation training
Thomas J. Callahan
(Division Sign-Off) (Cordion of Cardiovascular, Respiratory,
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)