NORODYN 8000 SEMG SYSTEM, ND-8000 by MYOTRONICS-NOROMED, INC.

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.

Device Description

The Norodyn: 8000 is a surface electromyographic device that measures and records the electrical potential emanating from muscle. The feature being added to the software of this device, Fast Fourier Transformation (FFT) of captured data, has the same technological characteristics as other legally marketed devices described in the Special 510(k).

AI/ML Overview

The provided text is a 510(k) summary for the Norodyn 8000 SEMG System and an FDA clearance letter. It outlines the device's purpose and its substantial equivalence to other legally marketed devices, specifically regarding the addition of Fast Fourier Transformation (FFT) to its software.

However, this document does not contain any information about acceptance criteria, device performance metrics, or a study (clinical or otherwise) that proves the device meets specific acceptance criteria. It is a regulatory submission for market clearance based on substantial equivalence, not a performance study report.

Therefore, I cannot provide the requested information from the given text.

To be clear:

There is no table of acceptance criteria and reported device performance.
There is no sample size used for a test set.
There is no data provenance mentioned.
There is no mention of experts establishing ground truth.
There is no adjudication method described.
There is no MRMC comparative effectiveness study mentioned.
There is no standalone performance study described.
There is no type of ground truth mentioned for any performance evaluation.
There is no sample size for a training set.
There is no information on how ground truth for a training set was established.

The document's purpose is to argue for substantial equivalence based on technological characteristics, not to provide detailed performance metrics against pre-defined acceptance criteria.

Summary

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AUG 13 1999

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MYOTRONICS-NOROMED, INC. Leading in Musculoskeletal Evaluation Technologies For Over 25 Years

Attachment 4

510 (k) SUMMARY

K 99243
<6022270

1. Submitter's Information
  Date of Submission: July 20, 1999 Name & Address: Myotronics-Noromed, Inc 15425 - 53rd Ave., S. Tukwila, WA 98188 Tel: (206) 243-4214 Fax: (206) 243-3625

Contact Name: Mr. Fray Adib

Norodyn : 8000 SEMG System 2. Device Trade Name: Common Name: Surface EMG System Device, Biofeedback Classification Name:
1. Myotronics-Noromed's intended addition of Fast Fourier Transformation (FFT) of data to the Norodyn 8000 software is substantially equivalent to that feature found in:

ProComp DSP & ProComp mfd. by Thought Technology, Inc. Myosystem 1000 Electromyograph mfd. by Noraxon I-330 Physiological Monitor mfd. by J & J Engineering

1. Description of the Device:
  The Norodyn: 8000 is a surface electromyographic device that measures and records the electrical potential emanating from muscle.
1. The feature being added to the software of this device, Fast Fourier Transformation (FFT) of captured data, has the same technological characteristics as other legally marketed devices described in the Special 510(k).
  Image /page/0/Picture/15 description: The image shows two logos. The first logo on the left has the text "CERTIFIED ISO 9001" on top of the logo. The logo itself has the text "INTERTEK" on top of a globe. The second logo on the right has the text "Accredited by the Council for Accreditation (RvA)" below the logo. The logo itself has a triangle inside of a circle.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1:3 1999

Mr. Fray Adib President Myotronics - Noromed, Inc. 15425 53rd Avenue South Tukwila, Washington 98188

Re: K992439

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.

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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

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99-2439 510(k) Number (if known): _ Δ

Norodyn 8000 SEMG System Device Name: _

Indications for use

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Regulation Number and Section

§ 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.