(136 days)
The i. Pro TENS; model WL-2407Rx is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain.
The Well Life TENS devices, WL-2407Rx is the model of prescription TENS intended for symptomatic relief of chronic intractable pain.
WL-2407Rx is a selectable dual channel, 4.5V (3xAA/Alkaline battery) operated TENS device with the following features:
- The operation of device is via the connection of wire and electrode through the dual operation channels.
- The stimulation electrode includes adhesive electrode and garment electrode. It may be chosen depending upon the prescription of physician.
- The output waveform is selectable pre-programming change among P1-P6.
- The output strength is adjustable at 0
80 mA, with setting time 560 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 describes a TENS device (Transcutaneous Electrical Nerve Stimulator) and focuses on demonstrating its substantial equivalence to a previously cleared predicate device, rather than providing an independent study proving the device meets specific acceptance criteria through a clinical trial or detailed performance study.
Therefore, many of the requested sections (acceptance criteria table, sample sizes for test/training sets, number of experts, adjudication methods, MRMC study, standalone performance, type of ground truth, ground truth establishment for training) cannot be fully populated from the provided document.
Instead, the submission relies on the successful clearance of the predicate device (WL-2402, K020020) and non-clinical tests to assert equivalence.
Here's a breakdown based on the information available:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Same intended use as predicate device (WL-2402). | "The i. Pro TENS/ model WL-2407Rx has the same intended use... as the cleared device of WL-2402 (K020020)." Intended Use: "symptomatic relief of chronic intractable pain." |
| Technological Characteristics Equivalence: Similar technological characteristics to predicate device. | "similar technological characteristics as the cleared device of WL-2402 (K020020)." Specific characteristics listed for WL-2407Rx: dual channel, 4.5V, selectable pre-programming P1-P6, output 0-80mA, time 5-60 min, LCD display. |
| Safety and Effectiveness Equivalence: Differences do not affect safety or effectiveness compared to predicate device. | "verification and validation tests contained in this submission demonstrate that the difference... could maintain the same safety and effectiveness as that of cleared device." "those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device." |
| Compliance to Applicable 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: Compliance with FDA software guidance. | "the software verification has been carried out according to the FDA software guidance." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This submission is for substantial equivalence based on non-clinical testing and comparison to a predicate device, not a clinical study involving a test set of data or patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No clinical test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set requiring adjudication is described.
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
- No. This is a TENS device, not an AI-assisted diagnostic or therapeutic device that would involve human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This TENS device is a physical medical device for pain relief, not an algorithm or software requiring standalone performance testing in that context. The "software verification" mentioned is likely for the embedded firmware controlling the device functions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this submission is adherence to engineering specifications, safety standards, and functional equivalence to the predicate device.
8. The sample size for the training set
- Not Applicable. No training set for a machine learning algorithm is discussed.
9. How the ground truth for the training set was established
- Not Applicable. No training set for a machine learning algorithm is discussed.
Summary of the Study performed (as described in the 510(k)):
The "study" undertaken for the WL-2407Rx device to meet acceptance criteria was a demonstration of substantial equivalence to a predicate device (WL-2402, K020020). This involved:
- Non-clinical tests: These included compliance with voluntary standards (ANSI/AAMI, NS4-1985, EN 60601-1, EN 60601-1-2) and software verification according to FDA guidance.
- Comparison of intended use and technological characteristics: The submission explicitly states the new device has "the same intended use and the similar technological characteristics" as the predicate.
- Assertion of safety and effectiveness: The submission concludes that "verification and validation tests... demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."
No human subjects studies, clinical trials, or expert-reviewed test sets were used or required for this 510(k) submission, as it falls under a Class II device and leverages the substantial equivalence pathway.
§ 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).