(90 days)
The V TENS Plus is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of the pain signal travelling to the brain.
This 510(k) summary describes a Transcutaneous Electrical Nerve Stimulator (TENS) device called the V-TENS Plus. The submission focuses on demonstrating substantial equivalence to a predicate device, the FUJI TENS 804SIII (K893874), rather than conducting an independent study to establish device performance against specific acceptance criteria.
Therefore, many of the requested sections regarding a standalone study proving device performance against acceptance criteria are "Not Applicable" or cannot be extracted directly from the provided text, as the application relies on equivalence.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Substantial Equivalence:
The primary "acceptance criteria" for this 510(k) submission are that the V-TENS Plus is substantially equivalent to the predicate device (FUJI TENS 804SIII) in terms of:
- Intended Use
- Technological Characteristics
- Safety and Effectiveness (not raising new questions)
Reported Device Performance (against the predicate):
| Feature/Characteristic | Predicate Device (FUJI TENS 804SIII) | V-TENS Plus (Subject Device) | Equivalence Assessment |
|---|---|---|---|
| Intended Use | Symptomatic relief and management of chronic intractable pain; adjunctive treatment in post-surgical and post-traumatic acute pain. | Symptomatic relief and management of chronic intractable pain; adjunctive treatment in post-surgical and post-traumatic acute pain. | Equivalent (Stated directly in 10.9) |
| Pulse Rate Control | Independent controls for left and right channels. | One dial for pulse rate adjustment controlling both left and right channels. | Different (but not deemphasized from safety/effectiveness) |
| Pulse Width Adjustment | Not explicitly mentioned but assumed to be present based on TENS functionality. | Capable of Pulse Width Adjustment. | Equivalent (or improved functionality without raising new safety questions) |
| Modulation Mode | Present. | Does not have modulation mode. | Different (but compensated by booster button or not critical for safety/effectiveness) |
| Booster Button | Not mentioned. | Has jack plug for a booster button; changes to constant mode when depressed in burst mode. | Different (additional feature without raising new safety questions) |
| Patient Cable Connectors | Not explicitly mentioned regarding compliance. | Uses "shrouded patient cable connectors" to comply with FDA Final Rule. | Equivalent/Improved (compliance with safety standards) |
| Non-clinical Standards | Assumed to meet relevant standards. | Met AAMI/ANSI NS-4 Standard; Met IEC 60601-1:1990 + a1:1993 + A2: 1995; Met IEC 601-1:1988 + a1:1991 + A2:1995. | Equivalent/Met (demonstrates compliance with recognized standards) |
| Clinical Performance | Assumed to be safe and effective. | "Not Applicable as there are no new or innovative aspects that have been introduced." | Equivalent (based on lack of new safety/effectiveness concerns) |
Conclusion from 510(k) Summary (10.9): The V-TENS Plus has the same intended use and similar technical characteristics as the FUJI TENS 804SIII (K893874). The information supplied illustrates that the device does not pose any new questions of safety and effectiveness, thus it is substantially equivalent to the predicate device.
Study Information (Based on Substantial Equivalence Submission)
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This submission did not involve a clinical trial or "test set" in the sense of a new study to prove device performance. The assessment was a comparison to an existing legally marketed device.
- Data Provenance: Not applicable for a new clinical test set. The data provenance is effectively the existing regulatory approval and performance history of the predicate device (FUJI TENS 804SIII).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth for a new clinical test set was established. The review relies on regulatory and technical experts within the FDA and the manufacturer's engineering/regulatory personnel for the comparison.
4. Adjudication method for the test set:
- Not applicable. There was no clinical test set requiring adjudication.
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 TENS unit, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The V-TENS Plus is a medical device for direct patient use, not an algorithm. Its "standalone performance" is implicitly established by its equivalence to the predicate device and compliance with electrical safety standards.
7. The type of ground truth used:
- The "ground truth" for this submission is the established safety and effectiveness of the predicate device (FUJI TENS 804SIII), as determined by its prior market clearance (K893874). The submission aims to show that the new device is sufficiently similar to share this ground truth.
- For the non-clinical testing, the "ground truth" is compliance with recognized engineering and safety standards (AAMI/ANSI NS-4, IEC 60601-1, IEC 601-1).
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).