(90 days)
TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.
A portable TENS device for pain control.
This K984025 submission describes a TENS (Transcutaneous Electrical Nerve Stimulation) device called CARE TENS. It's important to note that this is a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device, rather than a de novo submission that establishes new performance criteria. Therefore, the "acceptance criteria" here are primarily based on equivalence to the predicate.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance |
|---|---|
| Output Characteristics: Substantially equivalent electrical output to the predicate device (Matrix I, K895473). | Bench testing demonstrated that the output characteristics of CARE TENS are substantially equivalent to that of the predicate device. |
| Safety: No new questions of safety compared to the predicate device. | Any differences between the devices do not pose new questions of safety. |
| Effectiveness: No new questions of effectiveness compared to the predicate device. | Any differences between the devices do not pose new questions of effectiveness. |
| Technological Characteristics: Substantially equivalent to the predicate device, differing only in jacks and cables that comply with FDA's Final Rule on electrode lead wires and patient cables. | 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: Substantially equivalent to the predicate device. | The labeling of the CARE TENS is substantially equivalent to that of the predicate device. |
| Intended Use: Consistent with the predicate device. | TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This submission relies on bench testing for technological comparison, not a clinical test set with patient data.
- Data Provenance: Not applicable, as no clinical data was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set with ground truth was established, as the evaluation was based on bench testing for substantial equivalence to a predicate device.
4. Adjudication method for the test set:
- Not applicable. No clinical test set or adjudication method was used.
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 is a TENS device, not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device itself is a standalone TENS unit. Its "performance" was assessed by comparing its electrical output characteristics to a predicate device through bench testing. There is no "algorithm" in the context of AI being evaluated here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the traditional sense of clinical ground truth. The "ground truth" for the comparison was the electrical output specifications and performance characteristics of the predicate device (Matrix I, K895473), as determined through bench testing.
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI models that require a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the CARE TENS device meets its acceptance criteria (implicitly, substantial equivalence to the predicate) was nonclinical bench testing.
- Methodology: Bench testing was performed to compare the output characteristics of the CARE TENS to its predicate device, Matrix I (K895473). The comparison also included verifying compliance with FDA's Final Rule regarding electrode lead wires and patient cables, which was the only stated technological difference.
- Results: The bench testing demonstrated that the electrical output characteristics of the CARE TENS were "substantially equivalent" to those of the predicate device. The report concluded that any differences between the devices (specifically, the updated jacks and cables) did not raise new questions of safety and effectiveness.
- Conclusion: Based on this nonclinical testing, the FDA determined that the CARE TENS was substantially equivalent to the predicate device, allowing it to be marketed.
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12 Appendix F: 510(k) Summary
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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: | November 9, 1998 | |
| Proprietary Name: | CARE TENSTM | |
| Common Name: | TENS device | |
| Classification Name: | Stimulator, Nerve, Transcutaneous, For Pain Relief84GZJ; 21 CFR 882.5890. | |
| Device Classification: | Class II | |
| Predicate Device: | Matrix I (K895473) | |
| Description of Device: | A portable TENS device for pain control. | |
| Intended Use: | TENS is used for symptomatic relief and management ofchronic intractable pain and/or as an adjunctive treatment in themanagement of postsurgical and posttraumatic acute pain. | |
| Technological Comparison: | The CARE TENS has technological characteristics whichare substantially equivalent to those of the predicate device,as determined by bench testing. It differs technologicallyonly by the use of jacks and cables which comply withFDA's Final Rule "Medical Devices; Establishment of aPerformance Standard for Electrode Lead Wires and PatientCables" | |
| Labeling Comparison: | The labeling of the CARE TENS is substantially equivalent tothat of the predicate device. | |
| Nonclinical Testing: | Bench testing demonstrated that the output characteristicsor CARE TENS are substantially equivalent to that of thepredicate device. | |
| Clinical Testing: | Not applicable. | |
| Conclusions from Testing: | The CARE TENS is substantially equivalent in electricaloutput to the predicate device and any differences between thedevices do not pose new questions of safety and effectiveness. |
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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 eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is facing right, and the text is in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1999
Mr. Christian E. Hunt President Care Rehab and Orthopaedic Products, Inc. P.O. Box 580 22101 McLean, Virginia
Re: K984025 Trade Name: CARE TENS™ Regulatory Class: II Product Code: GZJ November 9, 1998 Dated: November 12, 1998 Received:
Dear Mr. Hunt:
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 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 regulation may result in regulatory In addition, FDA may publish further announcements action. 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. Christian E. Hunt
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
[signature]
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use 4
984025 510(k) Number:
Device Name: CARE TENS
Indications for Use:
TENS is used for symptomatic relief and management of chronic intractable pain and/or as an I ENO is used for symptomatio reast and of postsurgical and posttraumatic acute pain.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off) Division General Re 510(k) Number
§ 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).