(22 days)
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No
The document describes standard signal processing techniques (FFT) and data comparison, not AI/ML. There are no mentions of AI, ML, training sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is described as an aid in muscle re-education and muscle relaxation therapy, indicating a therapeutic purpose.
Yes
The device is described as aiding in the evaluation of muscle status and providing the ability to compare new captured data with past data to assess progress in treating a patient's relaxation state, which are all diagnostic functions. It measures and records electrical potential emanating from muscles, a common diagnostic technique.
No
The device description explicitly states "The Norodyn: 8000 is a surface electromyographic device that measures and records the electrical potential emanating from muscle," indicating it includes hardware for measurement. The software feature (FFT) is an addition to this hardware device.
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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The Norodyn: 8000 is a surface electromyographic device. It measures electrical signals directly from the muscle surface of a living patient. This is an in vivo measurement, not an in vitro test on a sample taken from the body.
- Intended Use: The intended use describes evaluating muscle status, aiding in muscle re-education and relaxation therapy, and comparing data to assess patient progress. These are all related to monitoring and treating the patient directly, not analyzing a biological sample.
Therefore, the Norodyn: 8000 falls under the category of a medical device used for physiological measurement and therapy, not 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 .
- Provides ability to compare new captured data with past data to assess progress in treating . patient's relaxation state
Product codes
HCC
Device Description
The Norodyn: 8000 is a surface electromyographic device that measures and records the electrical potential emanating from muscle.
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
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
ProComp DSP & ProComp mfd. by Thought Technology, Inc., Myosystem 1000 Electromyograph mfd. by Noraxon, I-330 Physiological Monitor mfd. by J & J Engineering
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.
0
AUG 13 1999
Image /page/0/Picture/1 description: The image shows a black and white drawing of a circle. The circle has a thick outline and a design inside. The design appears to be a series of horizontal lines that are jagged and uneven, resembling a sound wave or a seismograph reading. The lines are mostly black, but there are some white spaces in between them.
MYOTRONICS-NOROMED, INC. Leading in Musculoskeletal Evaluation Technologies For Over 25 Years
Attachment 4
510 (k) SUMMARY
K 99243
Trade Name: Norodyn 8000 SEMG System Regulatory Class: II Product Code: HCC Dated: July 20, 1999 Received: July 22, 1999
Dear Mr. Adib:
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 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 (QS) 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 regulations.
2
Page 2 - Mr. Fray Adib
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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
99-2439 510(k) Number (if known): _ Δ
Norodyn 8000 SEMG 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 .
- Provides ability to compare new captured data with past data to assess progress in treating . patient's relaxation state
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dccella Ja
eneral Restorative Devices
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use