(90 days)
The Select 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 pain control.
The provided text describes a 510(k) summary for the SELECT STIM™ neuromuscular stimulator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for a novel AI/software device.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Bench Testing) |
|---|---|
| Output characteristics substantially equivalent to predicate device (Ortho Dx K971542) | Output characteristics of SELECT STIM™ are substantially equivalent to the predicate device. |
| Compliance with FDA's Final Rule "Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables." | The SELECT STIM™ uses jacks and cables which comply with FDA's Final Rule. |
2. Sample Size for Test Set and Data Provenance
This is not applicable as no clinical or performance study involving a "test set" in the context of device performance metrics (e.g., accuracy, sensitivity, specificity) was conducted or reported. The assessment was based on bench testing for "technological comparison" and "labeling comparison."
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
This is not applicable for the same reasons as above. No ground truth for a test set was established as no such study was performed.
4. Adjudication Method for the Test Set
This is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Testing: Not applicable." The review is based on substantial equivalence through bench testing.
6. Standalone (Algorithm Only) Performance Study
This is not applicable. The device is a physical neuromuscular stimulator, not an algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" for the device's performance was established via bench testing to compare its electrical output characteristics and cable/jack compliance to the predicate device (Ortho Dx K971542) and relevant FDA regulations.
8. Sample Size for the Training Set
This is not applicable as the device is not an AI/software device that undergoes training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
Summary of the Study:
The "study" described in the 510(k) summary is a premarket notification process for a medical device (SELECT STIM™ Neuromuscular Stimulator). The primary objective was to demonstrate substantial equivalence to a previously cleared predicate device (Ortho Dx, K971542).
- Study Type: This was a nonclinical study focused on bench testing and labeling comparison.
- Methodology:
- Technological Comparison: The SELECT STIM™'s technological characteristics, specifically its output characteristics, were compared to those of the predicate device through bench testing. Additionally, its jacks and cables were verified for compliance with FDA's Final Rule on electrode lead wires and patient cables.
- Labeling Comparison: The labeling of the SELECT STIM™ was compared to that of the predicate device.
- Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion was that the device's electrical output and technological characteristics, as demonstrated by bench testing, are substantially equivalent to the predicate device, and any differences do not raise new questions of safety or effectiveness. Additionally, compliance with the FDA's Final Rule for cables/jacks was an acceptance point.
- Results: The bench testing demonstrated that the output characteristics of the SELECT STIM™ are substantially equivalent to the predicate device. The jacks and cables comply with the relevant FDA rule. The labeling was also found to be substantially equivalent.
- Conclusion: The SELECT STIM™ was deemed substantially equivalent in electrical output to the predicate device, and its differences do not pose new questions of safety and effectiveness. Clinical testing was not deemed applicable for this submission.
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MAY 2 8 2002
1
10 Appendix D: 510 (k) Summary
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: | February 26, 2002 | |
| Proprietary Name: | SELECT STIM™ | |
| Common Name: | Neuromuscular Stimulator | |
| Classification Name: | Powered Muscle Stimulator21 CFR 890.5850 | |
| Device Classification: | Class II | |
| Predicate Device: | Ortho Dx (K971542) | |
| Description of Device: | A portable NMS device for pain control. | |
| Intended Use: | - Relaxation of muscle spasms- Prevention or retardation of disuse atrophy- Increasing local blood circulation- Muscle re-education- Immediate post-surgical simulation of calfmuscles to prevent venous thrombosis- Maintaining or increasing range of motion | |
| Technological Comparison: | The SELECT STIM™ has technological characteristics that aresubstantially equivalent to those of the predicate device, as determinedby bench testing. It differs technologically only by the use of jacks andcables which comply with FDA's Final Rule "Medical Devices;Establishment of a Performance Standard for Electrode Lead Wires andPatient Cables." | |
| Labeling Comparison: | The labeling of the SELECT STIM™ is substantially equivalent to that ofthe predicate device. | |
| Nonclinical Testing: | Bench testing demonstrated that the output characteristics or SELECTSTIM™ are substantially equivalent to that of the predicate device. | |
| Clinical Testing: | Not applicable. | |
| Conclusions from Testing: | The SELECT STIM™ is substantially equivalent in electrical output tothe predicate device and any differences between the devices do not posenew questions of safety and effectiveness. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three curved lines that resemble a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the graphic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2002 -
Mr. Christian E. Hunt Care Rehab 1124 Dominion Ct. McLean, VA 22102
Re: K020637
Trade/Device Name: SELECT STIM Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: February 25, 2002 Received: February 27, 2002
Dear Mr. Hunt:
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 (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. This
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Page 2 - Mr. Hunt
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 (301) 594-. 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" (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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Millenson
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
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Indications for Use 4 20637 510(k) Number: Device Name: SELECT STIM™
Statement of Indication of Use:
The Select 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 3.
- Muscle re-education 4.
- Immediate post-surgical simulation of calf muscles to prevent venous thrombosis રું.
- Maintaining or increasing range of motion 6.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark A. Milken
Division Sign-Off General, F. Storative
510(k) Number K0200
6
§ 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).