(34 days)
The FT-615 is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorthea (menstrual cramps) when used with over-the-counter pain medication, it also provides a heat function intended to temporarily relief of minor aches and pains.
The subject device is a self-adhesive TENS device with 15 adjustable intensity levels for pain relief. Moreover, it also provides a heat function which can be used alone, or in conjunction with the TENS function simultaneously. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS self-treatment regime.
This FDA 510(k) premarket notification is for a medical device (HEATING TENS, Model FT-615), not an AI/ML powered device. Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/ML performance metrics (sample size for test/training sets, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth type, how ground truth was established) is not applicable to this document.
The document discusses the device's substantial equivalence to a predicate device (HIVOX OTC Electrical Stimulator, FT610-B) based on non-clinical testing.
Here's a summary of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):
| Test Category | Standard/Guidance | Reported Performance |
|---|---|---|
| Shelf life | ASTM F1980-16 | Meets requirements of pre-defined acceptance criteria and intended use. |
| Biocompatibility | ISO 10993-1 Edition 4.0, ISO 10993-5 Edition 3.0, ISO 10993-10 Edition 3.0 | Meets requirements of pre-defined acceptance criteria and intended use. |
| Software validation | IEC 62304 Edition 1.1 | Meets requirements of pre-defined acceptance criteria and intended use. |
| Electromagnetic compatibility & electrical safety | ANSI/AAMI ES60601-1:2015/(R)2012, IEC 60601-1-2 Edition 4.0, IEC 60601-1-11 Edition 2.0, IEC 60601-2-10 Edition 2.1 | Meets requirements of pre-defined acceptance criteria and intended use. |
| Function test | Guidance Document for Powered Muscle Stimulator 510(K)s. (June 9, 1999) | Meets requirements of pre-defined acceptance criteria and intended use. |
| Usability test | IEC 60601-1-6 Edition 3.1, IEC 62366-1 Edition 1.0 | Meets requirements of pre-defined acceptance criteria and intended use. |
2. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML study. Performance was evaluated through non-clinical laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML study.
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 as this is not an AI/ML study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML study. This is a physical device (TENS unit). The mentioned "software validation" refers to the intrinsic software of the device itself, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as this is not an AI/ML study. Ground truth was established by conformance to recognized medical device standards and internal requirements for safety and performance (e.g., electrical safety standards, biocompatibility standards, functional specifications).
8. The sample size for the training set: Not applicable as this is not an AI/ML study.
9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML study.
§ 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).