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510(k) Data Aggregation
(99 days)
VALUTRODE NEUROSTIMLATION ELECTRODES
ValuTrode® reusable, self-adhering, over-the-counter Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.
The ValuTrode® reusable self-adhering electrode is used as a transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS or EMS. The device functions as a passive device by carrying an electrical signal from a neurostimulation device through the device cable and electrode lead wire to the user skin. It is composed of a cover, connector lead wire, or snap, conductive carbon film, conductive hydrogel, and an electrode carrier liner. Proper current distribution is delivered via a connector lead wire stripped to an additional length, or use of a printed silver pattern.
The provided document is a 510(k) summary for the ValuTrode® Neurostimulation Electrodes (K130987). It states that "No performance data is required to support this or the proposed over the counter claim, as the Electrode has identical technological characteristics including design and materials to its predicate device."
Therefore, the study that proves the device meets acceptance criteria is a demonstration of substantial equivalence to predicate devices, rather than a separate performance study with specific acceptance criteria. This means the device relies on the established safety and effectiveness of its predicate devices: Lifecare Electrodes (K083302) and ValuTrode® Neurostimulation Electrodes (K970426).
Here's the breakdown of the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since no new performance data was required, the "acceptance criteria" for the ValuTrode® Neurostimulation Electrodes (K130987) are largely demonstrated by its substantial equivalence to the predicate devices and their established safety and effectiveness.
| Acceptance Criteria (inferred from predicate) | Reported Device Performance (inherent by substantial equivalence) |
|---|---|
| Biocompatibility of skin-contacting hydrogel | Meets biocompatibility standards (by using same hydrogel as predicate). |
| Electrical performance of insulated leadwire components | Meets electrical performance standards (by using similar components as predicate). |
| Electrode current distribution | Achieves proper current distribution (by using similar design principles and materials as predicate). |
| Maximum average power density | Does not exceed 0.1 W/cm² (manufacturer's labeling, consistent with predicate's established limit). |
| General safety and effectiveness as a transcutaneous electrical stimulation electrode | Deemed safe and effective for its intended use (by being substantially equivalent to predicate devices, which are safe and effective). |
| Intended Use as an OTC device | Marketed for OTC use, supported by equivalence to predicate already cleared for OTC. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical data was generated for the K130987 submission. The claim of substantial equivalence is based on the device having "identical technological characteristics including design and materials" to its predicate devices. Therefore, there is no "sample size" or "data provenance" in the traditional sense of a new study for this submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. No new study requiring experts to establish ground truth was conducted for this 510(k) submission. The safety and effectiveness are established through substantial equivalence to previously cleared devices.
4. Adjudication Method for the Test Set
Not applicable. As no new test set was used, there was no adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study was conducted. The device is a passive electrode, and the submission primarily focuses on physical and material equivalence to existing devices.
6. Standalone Performance Study (algorithm only without human-in-the-loop)
Not applicable. The device is a passive electrode and does not involve an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the current submission is the established safety and effectiveness of the identified predicate devices (K083302 and K970426), as determined by the FDA's previous clearances. This is based on the successful biocompatibility testing, electrical performance, and current distribution tests performed on the predicate devices.
8. Sample Size for the Training Set
Not applicable. No new training set was used. The submission relies on the established performance of predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set for this submission. The "ground truth" for the predicate devices, which this submission relies upon, was established through their own respective 510(k) processes, which included biocompatibility testing, electrical performance testing, and current distribution tests as detailed in their summaries. For instance, the K970426 predicate had its power density calculated and reviewed by an FDA Biologist.
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