(105 days)
- 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 in treating patients relaxation state
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.
The provided text is a 510(k) summary for the Myotronics-Noromed Model MES 9200 EMG System. This submission focuses on demonstrating substantial equivalence to a predicate device (Model MES 9000 EMG System) rather than clinical performance against specific acceptance criteria. The key change is the introduction of wireless (Bluetooth) technology and battery operation to improve safety and data transfer.
Therefore, the document does not contain a detailed study proving the device meets specific performance acceptance criteria in the manner you've described for AI/CADe devices. There are no reported device performance metrics, sample sizes for test or training sets, expert consensus, or information on adjudication methods for clinical performance.
Here's a breakdown of what can be extracted based on your request, and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics. The implicit acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device. This means demonstrating that the new device has the same intended use, fundamental scientific technology, and does not raise new questions of safety or effectiveness.
- Reported Device Performance: Not provided in terms of diagnostic accuracy, sensitivity, specificity, etc. The document highlights the functional equivalence and safety improvements over the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Missing: No information about a test set for clinical performance evaluation is mentioned. The submission focuses on engineering design changes and comparing them to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Missing: No clinical "ground truth" establishment is described for a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Missing: No clinical performance study requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable / Missing: This is not an AI/CADe device. No MRMC study was conducted or is relevant for this type of 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Missing: This device is an EMG system, not an algorithm, so this concept does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Missing: No clinical ground truth is established or discussed as the focus is on device modification and safety.
8. The sample size for the training set
- Not Applicable / Missing: This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not Applicable / Missing: As above, no training set or associated ground truth establishment is relevant to this submission.
Summary of the Study (as described in the 510(k) Summary):
The "study" or justification for substantial equivalence presented in the 510(k) summary is a comparison of the new device (Model MES 9200) to its legally marketed predicate device (Model MES 9000).
- Objective: To demonstrate that the Model MES 9200 EMG System is substantially equivalent to the Model MES 9000.
- Methodology: The comparison highlights that the new device has the "same intended uses and fundamental scientific technology." The primary design change addressed is the incorporation of "wireless (Bluetooth) technology to transfer EMG data to host computer without a cable and to eliminate any connection between the patient and line voltage." This change is presented as an improvement in safety and convenience without altering the core functionality or intended use.
- Proof of Meeting (Implicit) Acceptance Criteria: The FDA's issuance of a substantial equivalence determination (K111687) serves as the "proof" that the device meets the regulatory acceptance criteria for market clearance under the 510(k) pathway. This determination is based on the provided comparison and assurances that the changes do not raise new questions of safety or effectiveness.
In essence, this 510(k) is about establishing regulatory clearance for a device modification, not a clinical performance study of a new diagnostic algorithm.
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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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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
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.
fa
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 |
|---|---|
| ---------------- | --------- |
§ 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.