(29 days)
No
The summary describes a standard EMG device and does not mention any AI or ML capabilities.
Yes
The device is used "as an aid in muscle re-education and muscle relaxation therapy," which are therapeutic applications.
Yes
Justification: The device's intended use includes "evaluation of the status of muscles" and "as an aid in muscle re-education and muscle relaxation therapy," which implies assessing or diagnosing a patient's condition to guide treatment. Additionally, comparing "new captured data with past data to assess progress" further indicates a diagnostic function for tracking patient status over time. The device description mentions "evaluating muscle groups" and quantifying "muscle activity," which are diagnostic activities.
No
The device description explicitly mentions "circuitry" and the use of "surface electrodes," indicating hardware components are integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device uses surface electromyography (EMG) to evaluate muscle activity. This is a non-invasive method that measures electrical signals from muscles directly on the body's surface. It does not involve analyzing samples taken from the body.
- Intended Use: The intended use focuses on evaluating muscle status, aiding in muscle re-education and relaxation therapy, and tracking patient progress. These are all related to the physiological function of muscles, not the analysis of biological samples for diagnostic purposes.
Therefore, this device falls under the category of a medical device but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- For evaluation of the status of muscles at rest and in function >
- As an aid in muscle re-education and muscle relaxation therapy A
- Provides ability to compare new captured data with past data to assess progress > in treating patients relaxation state
Product codes
HCC
Device Description
The device incorporates circuitry enabling the capabilities of the two predecessor devices to be offered as a single 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Muscle groups (via surface electromyography)
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)
ND-2000 (K922838A), ND-8000 (K922270 & K992439)
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.
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MYOTRONICS-NOROMED, INC. Leading in Musculoskeletal Evaluation Technologies For 30 Years
Special 510(k) Myotronics-Noromed, Inc
510(k) SUMMARY
NOV 1 3 2001
Model MES-9000/EMG System 210(k) #
Myotronics-Noromed, Inc. 15425 - 53td Avenue South Tukwila, WA 98188 Telephone (206) 243-4214 Contact: Mr. Fray Adib, President October 9,2001
Device: Model MES-9000/EMG System consisting of computer-based surface electromyography (SEMG).
Legally marketed predicate devices: Model ND-2000 (K922838A), ND-8000 (K922270 & K992439) Myotronics-Noromed, Inc.
Description of the Device: The device incorporates circuitry enabling the capabilities of the two predecessor devices to be offered as a single 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.
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-9000/EMG System will have the same intended uses and fundamental scientific technology as its predecessors, the Models ND-2000 and ND-8000. The design change which is the subject of this premarket notification is to update and enhance the electronic components and software to state-ofthe-art and to provide the capabilities of the two predecessor devices as a single device.
Image /page/0/Picture/13 description: The image shows two logos side by side. The logo on the left has the text "CERTIFIED ISO 9001" at the top and an image of a globe with a star on top. The logo on the right has an image of a triangle inside a circle with the text "Accredited by the Council for Accreditation (RvA)" below it. Both logos are black and white and are contained within a rectangular border.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, line-art style.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2001
Mr. Fray Adib President Myotronics-Noromed, Inc. 15425 53rd Avenue South Tukwila, Washington 98188
Re: K013399
Trade/Device Name: Model MES-9000/EMG System Regulation Number: 882.5050 Regulation Name: Biofeedback device Regulatory Class: II Product Code: HCC Dated: October 9, 2001 Received: October 15, 2001
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.
2
Page 2 - Mr. Fray Adib
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to ogen mains of substantial equivalence of your device to a legally premarket notification: "The PDF intelligention 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 11 you desire specific ad 1809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Fatt 007.10 for questions on the promotion and advertising of Comphance at (301) 591 1857 - 1887 - 1282 - 1282 - 114 - 11 - 11 - 17 - 17 - 17 - 17 - 10 - 10 - 10 your do roo, proad contranding by reference to premarket notification" (21CFR Part 807.97). Tegulation childred, "Misoranang of open responsibilities under the Act may be obtained from the Oinci general information on your respectional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Millerman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
NOV 1 3 2001
K013399 510(k) Number (if known):
Model MES-9000/EMG System Device Name: _________________________________________________________________________________________________________________________________________________________________
INDICATIONS FOR USE
- For evaluation of the status of muscles at rest and in function >
- As an aid in muscle re-education and muscle relaxation therapy A
- Provides ability to compare new captured data with past data to assess progress > 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)
Mark N. Mulkerson
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
K013399
OR
510(k) Number.
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use _
510(k) Number:
Model MES-9000/EMG System Device Name: