HMS-DHR-3 NEUROMUSCULAR STIMULATOR

• K Number: K021472
• Device Name: HMS-DHR-3 NEUROMUSCULAR STIMULATOR
• Manufacturer: HOME MEDICAL SERVICES
• Date Cleared: 2002-08-06 ( 90 days)
• Product Code: IPF
• Regulation Number: 890.5850
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS :

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion

Device Description

Not Found

AI/ML Overview

This FDA 510(k) clearance letter for the HMS-DHR-3 Neuromuscular Stimulator is for a Class II medical device (Powered Muscle Stimulator, 21 CFR 890.5850). The letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document is a regulatory clearance letter and does not contain the detailed study information typically found in a clinical trial report or a scientific publication. As such, I cannot extract the information required to answer your questions about acceptance criteria and the study that proves the device meets those criteria from this text alone.

The information you are requesting would typically be found in the 510(k) submission itself, or in supplementary documents referenced within it. This letter primarily confirms the regulatory status and allowed indications for use.

Therefore, many of your specific questions about study design, sample sizes, ground truth establishment, and expert qualifications cannot be answered based on the provided text.

Here is what I can infer from the document and general 510(k) understanding:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided letter. 510(k) submissions typically involve demonstrating that a new device is "substantially equivalent" to a predicate device. This often involves showing comparable performance, safety, and efficacy, which might include specific performance metrics, but these are not enumerated here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in the provided text.

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 available in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in the provided text.

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. This device is a neuromuscular stimulator, not an AI-powered diagnostic imaging device. Therefore, MRMC studies involving human readers and AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is hardware, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available in the provided text. For a neuromuscular stimulator, ground truth might relate to objective physiological measurements (e.g., muscle contraction force, nerve conduction studies, range of motion improvements) or patient-reported outcomes, but the specifics are not detailed here.

8. The sample size for the training set: Not applicable and not available. This is not an AI/machine learning device that would typically have a "training set."

9. How the ground truth for the training set was established: Not applicable and not available.

Conclusion:

This FDA 510(k) clearance letter details the regulatory approval of the HMS-DHR-3 Neuromuscular Stimulator for specific indications based on substantial equivalence to a predicate device. It does not contain the detailed performance data, study design, or ground truth methodologies that are requested. This information would be found in the full 510(k) submission, which is not provided here.

Summary

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

AUG 0 6 2002

C. A. Teklinski Home Medical Services 9393 Activity Road. Suite F San Diego, California 92126

K021472 Trade/Device Name: HMS-DHR-3 Neuromuscular Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: May 6, 2002 Received: May 8, 2002

Dear Mr. Teklinski:

Re:

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 (OS) regulation (21 CFR Part 820); and if

{1}------------------------------------------------

Page 2 -- C. A. Teklinski

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Millican

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

{2}------------------------------------------------

HMS-DHR-3 NEUROMUSCULAR STIMULATOR

INDICATIONS FOR USE

THE INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS :

• Relaxation of muscle spasms 1.
• Prevention or retardation of disuse atrophy 2.

(510 (k)

• Increasing local blood circulation 3.
• 4 . Muscle re-education
• 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• 6. Maintaining or increasing range of motion

Mark N Millican

Division Sign T) ision of General, Restorative and Neurological Devi

510(k) Number.

000107

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).