(90 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is a standard NMS device.
Yes
The device is intended for medical conditions such as muscle spasms, disuse atrophy, and for increasing blood circulation, which are therapeutic applications.
No
The device description and intended use indicate it is an NMS (Neuromuscular Stimulator) device used for therapeutic purposes such as muscle stimulation and pain control, not for diagnosing conditions. The predicate device "Ortho Dx" might sound like a diagnostic device, but "Dx" is often used broadly, and based on the intended use of the Select Stim, it's therapeutic.
No
The device description explicitly states it is a "portable NMS device," which implies a hardware component for delivering neuromuscular stimulation. The summary also mentions "output characteristics," further suggesting a physical output from a device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to neuromuscular stimulation for therapeutic purposes (muscle relaxation, atrophy prevention, circulation, re-education, thrombosis prevention, range of motion). These are direct treatments applied to the body.
- Device Description: It's described as a "portable NMS device for pain control." NMS stands for Neuromuscular Stimulator, which is a type of electrical stimulation device used for therapy.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information. IVDs are used to diagnose diseases or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. This device's function is therapeutic, not diagnostic.
- Predicate Device: The predicate device is K971542 Ortho Dx. While the name includes "Dx," the context of the Select Stim's intended use and description strongly suggests that the "Dx" in the predicate device's name likely refers to something other than in vitro diagnostics in this context (perhaps related to diagnosis of muscle function or condition, but not through in vitro analysis).
Therefore, the Select Stim is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
IPF
Device Description
A portable NMS device for pain control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing: Bench testing demonstrated that the output characteristics or SELECT STIMTM are substantially equivalent to that of the predicate device.
Clinical Testing: Not applicable.
Conclusions from Testing: The SELECT STIMTM is substantially equivalent in electrical output to the predicate device and any differences between the devices do not pose new questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ortho Dx (K971542)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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MAY 2 8 2002
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10 Appendix D: 510 (k) Summary
510(k) Summary
| Submitter's Information: | Christian E. Hunt
Care Rehab®
1124 Dominion Ct
McLean, VA 22102 | Phone: 1-703-448-9644
FAX: 1-703-356-2182. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Date of preparation: | February 26, 2002 | |
| Proprietary Name: | SELECT STIM™ | |
| Common Name: | Neuromuscular Stimulator | |
| Classification Name: | Powered Muscle Stimulator
21 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 calf
muscles to prevent venous thrombosis - Maintaining or increasing range of motion | |
| Technological Comparison: | The SELECT STIM™ has technological characteristics that are
substantially equivalent to those of the predicate device, as determined
by bench testing. It differs technologically only by the use of jacks and
cables which comply with FDA's Final Rule "Medical Devices;
Establishment of a Performance Standard for Electrode Lead Wires and
Patient Cables." | |
| Labeling Comparison: | The labeling of the SELECT STIM™ is substantially equivalent to that of
the predicate device. | |
| Nonclinical Testing: | Bench testing demonstrated that the output characteristics or SELECT
STIM™ 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 to
the predicate device and any differences between the devices do not pose
new 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
3
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
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