MYO-TRAIN V (5)

• K Number: K980158
• Device Name: MYO-TRAIN V (5)
• Manufacturer: STERNE EQUIPMENT CO., LTD.
• Date Cleared: 1998-07-28 ( 193 days)
• Product Code: IPF , DAT
• Regulation Number: 890.5850
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Myo-train V may be used for the following indications:

• 1. Relaxation of muscle spasm.
• Prevention or retardation of disuse atrophy. 2)
• Increasing local blood circulation. 3)
• 4. Muscle re-education.
• Maintaining or increasing range of motion. 5)

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter for a medical device called "Myo-train V". This type of document does not typically contain detailed information about acceptance criteria, specific study designs, or performance metrics for the device.

510(k) clearance signifies that the device is substantially equivalent to a legally marketed predicate device. This process primarily focuses on demonstrating equivalence in terms of intended use, technological characteristics, and safety/effectiveness, rather than independent clinical trial data meeting specific performance acceptance criteria as might be seen for a PMA (Premarket Approval) or a more rigorous clinical study submission.

Therefore,Based on the provided document, I cannot answer the following questions:

1. A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) clearance letter.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not available. The 510(k) process typically relies on comparison to a predicate device, not necessarily new MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not available.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

The document states that the FDA "reviewed your Section 510(k) notification of intent to market the device... and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies that the device's performance was compared to existing predicate devices, but the specifics of how that equivalence was demonstrated (e.g., specific test data, statistical analyses, or human reader studies) are not disclosed in this letter.

Summary

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Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines that suggest the head and wings.

JUL 28 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas Wallace Technical Director Sterne Equipment Company Limited 7 Research Road Brampton, Ontario L6W 1P4

Re: K980158 Trade Name: Myo-train V (5) Requlatory Class: II IPFF Product Code: Dated: April 28, 1998 April 29, 1998 Received:

Dear Mr. Wallace:

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 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, Druq, 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 requlations 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 requirements, 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 requlation may result in requlatory 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. Thomas Wallace

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

sincerely yours,

la M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(K) Number: NA

Device Name: MYO-TRAIN V

INDICATIONS FOR USE

The Myo-train V may be used for the following indications:

• 1. Relaxation of muscle spasm.
• Prevention or retardation of disuse atrophy. 2)
• Increasing local blood circulation. 3)
• 4. Muscle re-education.
• Maintaining or increasing range of motion. 5)

tcoself

(Division Sign-Off) Division of General Restorative Devices 1980158 510(k) Number

Prescription Use (Pe: _ 1 CFR 801.109)

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).