(260 days)
The Classic Stim is recommended for use for the following conditions:
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical simulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion
A portable NMS device for muscle re-education.
This document describes the 510(k) summary for the CARE STIM™ muscle stimulator, and it declares non-clinical testing was sufficient to show substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate) | Reported Device Performance (CARE STIM™) |
|---|---|
| Output characteristics of the predicate device (Ortho Dx muscle stimulator). | Output characteristics are substantially equivalent. |
| Intended Use of the predicate device. | Intended Use is substantially equivalent. |
| Labeling of the predicate device. | Labeling is substantially equivalent. |
| No new questions of safety and effectiveness compared to the predicate device. | No new questions of safety and effectiveness are posed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The study relies on bench testing comparisons to a predicate device, not a human test set.
- Data Provenance: Bench testing data comparing the output characteristics of the CARE STIM™ to the Ortho Dx. The country of origin and whether it's retrospective or prospective are not specified, but it would inherently be a prospective bench test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth for device characteristics was established via engineering bench testing, not expert clinical assessment.
4. Adjudication Method for the Test Set
- Not applicable. This was a technical comparison, not a clinical study requiring adjudication of expert opinions.
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 muscle stimulator, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm. Bench testing was done on the device's electrical output.
7. The Type of Ground Truth Used
- Bench Test Comparison Records: The "ground truth" for the CARE STIM™ was the established output characteristics, intended use, and labeling of the predicate device (Ortho Dx). This was determined through non-clinical (bench) testing.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning device and therefore does not have a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
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KO 22417
12 Appendix F: 510 (k) Summary
APR 1 0 2003
510(k) Summary
| Submitter's Information: | Christian E. HuntCare Rehab®1124 Dominion CtMcLean, VA 22102 | Phone: 1-703-448-9644FAX: 1-703-356-2182. |
|---|---|---|
| Date of preparation: | July 23, 2002 | |
| Proprietary Name: | CARE STIM™ | |
| Common Name: | Muscle Stimulator | |
| Classification Name: | Powered Muscle Stimulator21 CFR 890.5850. | |
| Device Classification: | Class II | |
| Predicate Device: | Ortho Dx | |
| Description of Device: | A portable NMS device for muscle re-education. | |
| Intended Use: | The Classic Stim is recommended for use for the following conditions:• Relaxation of muscle spasms• Prevention or retardation of disuse atrophy• Increasing local blood circulation• Muscle re-education• Immediate post-surgical simulation of calf muscles to prevent venousthrombosis• Maintaining or increasing range of motion | |
| Technological Comparison: | The CARE STIM™ has technological characteristics that aresubstantially equivalent to those of the predicate device, as determinedby bench testing. | |
| Labeling Comparison: | The labeling of the CARE STIM™ is substantially equivalent to that of thepredicate device. | |
| Nonclinical Testing: | Bench testing demonstrated that the output characteristics or CARESTIM™ are substantially equivalent to that of the predicate device. | |
| Clinical Testing: | Not applicable. | |
| Conclusions from Testing: | The CARE STIM™ is substantially equivalent in electrical output to thepredicate device and any differences between the devices do not pose newquestions of safety and effectiveness. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three human profiles, representing the department's focus on health and human services.
APR 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Christian E. Hunt President Care Rehab and Orthopaedic 1124 Dominion Court McLean, Virginia 22102
Re: K022417
Trade Name: Care™ Stim Regulation Number: 21 CFR 890.5380 Regulation Name: Powered Exercise Equipment Regulatory Class: II Product Code: GZJ Dated: January 9, 2003 Received: January 13, 2003
Dear Mr. Hunt:
We have reviewed your Section 510(k) premarket 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) 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.
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Page 2 -- Mr. Christian E. Hunt
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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,
for Mark N. Mikkelsen
elia 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
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Indications for Use 4
510(k) Number:
Device Name: CARE STIM1M
Statement of Indication of Use:
The Classic Stim is recommended for use for the following conditions:
- Relaxation of muscle spasms 1.
- Prevention or retardation of disuse atrophy 2.
-
- Increasing local blood circulation
- Muscle re-education 4.
- Immediate post-surgical simulation of calf muscles to prevent venous thrombosis ર.
- Maintaining or increasing range of motion 6.
(PLEASE DO NOT WRITE EELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED)_
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Milken
Division Sign-Off) Division of General. Restorative and Neurological Devices
510(k) Number K022417
6
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).