(105 days)
K-013399
K-013399
No
The summary describes a standard EMG system with wireless data transfer, and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is described as an aid in muscle re-education and muscle relaxation therapy, indicating a therapeutic purpose.
Yes
Explanation: The device evaluates the status of muscles and aids in muscle re-education and relaxation therapy, providing an assessment of the patient's relaxation state. It quantifies muscle activity, which qualifies it as a diagnostic device.
No
The device description explicitly states it incorporates "circuitry" and utilizes "surface electrodes" to acquire EMG data, indicating hardware components are integral to its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device uses surface electromyography (EMG) to measure electrical activity directly from the patient's muscles. It is applied externally to the body and does not involve the analysis of biological specimens.
The device's intended use and description clearly indicate it's a system for evaluating muscle function and aiding in muscle therapy, which falls under the category of physiological monitoring and therapy devices, not IVDs.
N/A
Intended Use / Indications for Use
Used in evaluation and recording of muscle status, at rest and in function, as an aid in muscle re-education and muscle relaxation therapy, and to provide ability to compare new captured data with past data to assess progress in treating patients relaxation state.
For evaluation of the status of muscles at rest and in function
As an aid in muscle re-education and muscle relaxation therapy
Provides ability to compare new captured data with past data to assess progress A in treating patients relaxation state
Product codes
HCC
Device Description
The device incorporates circuitry enabling the same capabilities as the predecessor device. It is a computer based system offering options capable of evaluating muscle groups at rest or in function by means of surface electromyography. Muscle activity is quantified by means of re-usable or disposable surface electrodes positioned over the muscle groups being studied. Up to eight sites can be monitored simultaneously and displayed in time or frequency domains. The device is essentially identical to the predecessor device except that it utilizes wireless (Bluetooth) technology to transfer EMG data to host computer without a cable and to eliminate any connection between the patient and line voltage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Muscle groups
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K-013399
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Special 510(k) Myotronics-Noromed, Inc
510(k) SUMMARY
SEP 2 9 2011
Model MES 9200/EMG System
KIII 187 510(k)
June 13, 2011
Myotronics-Noromed, Inc. 5870 S. 1940 St. Kent, WA 98032 Telephone (206) 243-4214 Contact: Fray Adib, President
Device: Model MES 9200 EMG System for surface electromyography (SEMG).
Legally marketed predicate device: Model MES 9000 EMG System, K-013399
Description of the Device: The device incorporates circuitry enabling the same capabilities as the predecessor device. It is a computer based system offering options capable of evaluating muscle groups at rest or in function by means of surface electromyography. Muscle activity is quantified by means of re-usable or disposable surface electrodes positioned over the muscle groups being studied. Up to eight sites can be monitored simultaneously and displayed in time or frequency domains. The device is essentially identical to the predecessor device except that it utilizes wireless (Bluetooth) technology to transfer EMG data to host computer without a cable and to eliminate any connection between the patient and line voltage.
Intended Use: Used in evaluation and recording of muscle status, at rest and in function, as an aid in muscle re-education and muscle relaxation therapy, and to provide ability to compare new captured data with past data to assess progress in treating patients relaxation state.
Comparison with predicate devices: The Model MES 9200/EMG System has the same intended uses and fundamental scientific technology as its predecessor, the Model MES 9000. The design change which is the subject of this premarket notification is to transfer EMG data to host computer without a cable and to further increase the device's safety through use of a battery operated EMG unit and Bluetooth wireless technology to eliminate any possible connection between the patient and line voltage.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Myotronics-Noromed, Inc. % Mr. Fray Adib President 5870 S. 194th Street Kent, WA 98032-2126
SEP 29 2011
Re: K111687
Trade/Device Name: Model MES 9200 EMG System Regulation Number: 21 CFR 882.5050 Regulation Name: Biofeedback device Regulatory Class: Class II Product Code: HCC Dated: August 22, 2011 Received: August 30, 2011
Dear Mr. Adib:
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, listing 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.
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 device
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Page 2 - Mr. Fray Adib
related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
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Sincerely yours,
Kesia Alexander
Malvina B. Eydelman. M.D. Director Division of Ophthalmic. Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KIII 687 510(k) Number (if known):
Model MES 9200/EMG System Device Name:
INDICATIONS FOR USE
- A For evaluation of the status of muscles at rest and in function
- A As an aid in muscle re-education and muscle relaxation therapy
- Provides ability to compare new captured data with past data to assess progress A in treating patients relaxation state
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | ---------- |
OR Over-The-Counter Use
| 510(k) Number: | K111687 |
|---|---|
| ---------------- | --------- |
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
| 510(k) Number: | K111687 |
|---|---|
| ---------------- | --------- |