(61 days)
The model WL-2407 are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
The Well Life TENS devices, WL-2407 is the model of OTC TENS intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
WL-2407 is a selectable dual channel, 4.5V (3xAA/Alkaline battery) operated TENS device with the following features:
The stimulation electrode is dual channels electrode.
- The output waveform is selectable pre-programming change among P1~P8.
- The output strength is adjustable at 0~80 mA, with setting time 21 minutes counting from switching ON.
- The LCD display is provided for the indication of operation status including operation mode, output wave form, output strength, time to cut-off, and battery low warning.
The provided 510(k) summary for the Well Life Healthcare Limited OTC TENS for Low Back Pain Relief / Model: WL-2407 (K063660) does not contain detailed information about specific acceptance criteria, a clinical study proving device performance against those criteria, or the methodology typically used for such studies (e.g., sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance).
Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (WL-2402 K040512, and WL-2406 K052785). The "study" referenced in the document is a comparison to these predicate devices and non-clinical testing.
Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is absent:
Acceptance Criteria and Device Performance Study
The document does not explicitly state acceptance criteria in terms of quantitative performance metrics for the device itself (e.g., pain reduction scores, specific levels of electrical output accuracy, or patient satisfaction thresholds). Instead, the "acceptance criteria" are implied by demonstrating:
- Compliance to applicable voluntary standards: ANSI/AAMI, NS4-1985, EN 60601-1, and EN 60601-1-2.
- Software verification: Carried out according to FDA software guidance.
- Substantial Equivalence: The primary "acceptance criterion" for this 510(k) pathway is that the device has the same intended use and similar technological characteristics, and that any differences do not affect intended use or alter fundamental scientific technology compared to the predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Temporary relief of pain associated with sore and aching muscles in the lower back. | WL-2407 TENS is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Matches predicate device's use). |
| Technological Characteristics Equivalence: Similar features and operational principles to predicate devices. | Similarities identified: OTC TENS device. |
| Differences identified: Selectable dual channel, 4.5V (3xAA/Alkaline battery) operated. Output waveform selectable pre-programming change (P1 | |
| Safety and Effectiveness Equivalence: Any engineering differences do not affect safety or effectiveness. | "Verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device." |
| Compliance to Voluntary Standards: Adherence to relevant electrical and medical device standards. | "Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, as well as EN 60601-1, and EN 60601-1-2 requirement." |
| Software Verification: Complies with FDA software guidance. | "In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance." |
Detailed Information Regarding the "Study" (Comparison to Predicate Devices and Non-Clinical Testing)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a clinical test set in this submission. The "test set" in this case refers to the technical specifications and performance data of the WL-2407 device itself, which were compared against the specifications and established performance of the predicate devices.
- Data Provenance: The document does not specify the origin of any clinical data (e.g., country) because a clinical study with human subjects validating the device's efficacy was not conducted or presented. The data provenance primarily relates to the technical specifications and verification/validation testing performed on the device itself. This would be considered "prospective" in the sense that the testing was performed on the WL-2407.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission relies on substantial equivalence to predicate devices and non-clinical testing. There was no "ground truth" derived from expert consensus on human data for a device performance test set. The efficacy of the predicate devices in relieving pain (the "ground truth" of performance) was previously established through their own clearance process.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication of findings was described in this submission.
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 Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device (TENS unit) and not an algorithm with standalone performance metrics. Its performance is inherent to its electrical stimulation capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the equivalence claim: The "ground truth" for the WL-2407's efficacy is the established safety and effectiveness of its predicate devices (WL-2402 K040512 and WL-2406 K052785) for the same intended use.
- For non-clinical testing: The "ground truth" would be objective measurements against established engineering standards (e.g., electrical output parameters, safety features) as per ANSI/AAMI, NS4-1985, EN 60601-1, and EN 60601-1-2.
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. This device is not an AI/ML algorithm that requires a training set with established ground truth.
In summary: K063660 is a 510(k) submission for a TENS device seeking clearance based on substantial equivalence to existing predicate devices. The "study" described is primarily a comparison of the new device's technical characteristics and intended use to the cleared predicates, supported by non-clinical verification and validation testing against recognized standards. It does not involve a clinical study with human subjects, nor does it pertain to AI or diagnostic software.
§ 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).