(408 days)
HIVOX self-adhesive electrode gel pads are intended for use as disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The device is a gel pad for use with an electrode itself.
HIVOX self-adhesive electrode gel pads are series of cutaneous electrodes with various shapes and sizes, which use the same materials from the predicate suppliers, i.e. K070612 (Top-Rank Health Care Equipment Co., Ltd. ) and K000947 (Axelgaard Mfg. Co., Ltd.). HIVOX self-adhesive electrode gel pads are non-sterile, self-adhesive, for single patient use only, and to be disposable.
The provided text describes HIVOX self-adhesive electrode gel pads and their substantial equivalence to predicate devices, rather than an AI/algorithm-based device. Therefore, many of the requested categories (e.g., test set sample size, number of experts, adjudication method, MRMC study, standalone performance, training set) are not applicable or cannot be extracted from this document, as they pertain to algorithm performance evaluation.
However, I can extract information related to the device's technical specifications and the non-clinical tests performed to demonstrate its safety and effectiveness.
Here's the available information presented in the requested format, with "N/A" for criteria not applicable to this type of device or not found in the documentation:
Acceptance Criteria and Device Performance
| Acceptance Criteria (from predicate devices & standards) | Reported Device Performance (HIVOX Self-Adhesive Electrode Gel Pads) |
|---|---|
| Biocompatibility: Meets Tripartite Biocompatibility Guidance for Medical Devices & ISO 10993-5 (In Vitro Cytotoxicity) & ISO 10993-10 (Irritation and Skin Sensitization). | Biocompatibility: Meets Tripartite Biocompatibility Guidance for Medical Devices & ISO 10993-5:2009 (Tests for in vitro cytotoxicity) & ISO 10993-10:2010 (Tests for in irritation and skin sensitization). As stated in the conclusion, "all of four devices had passed the Tripartite Biocompatibility Guidance for Medical Devices and the ISO 10993 relevant requirements for skin contact. Thus the subject device and predicate devices have the same safety and effectiveness." |
| Material Composition: Uses same materials as predicate devices (K070612 and K000947), with suppliers Top Rank and Axelgaard providing all component materials. (Implicitly, the expectation is that using the same materials will result in similar performance to the predicates.) | Material Composition: "HIVOX self-adhesive electrode gel pads are series of cutaneous electrodes with various shapes and sizes, which use the same materials from the predicate suppliers, i.e. K070612 (Top-Rank Health Care Equipment Co., Ltd. ) and K000947 (Axelgaard Mfg. Co., Ltd.)." "The subject device, HIVOX self-adhesive electrode gel pads, uses the same materials from the suppliers, predicate devices' manufacturers. And the suppliers, Top Rank and Axelgaard will provide all components materials of the HIVOX self-adhesive electrode gel pads." |
| Intended Use: Disposable, conductive adhesive interface between patient's skin and electrical stimulator (TENS, EMS, IF). For use as a gel pad with an electrode, not an electrode itself. (Predicate devices have similar intended uses, with some variations in prescription/OTC and specific stimulator types). | Intended Use: "HIVOX self-adhesive electrode gel pads are intended for use as disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The device is a gel pad for use with an electrode and not an electrode itself." (Stated to be similar to K000947, with K132588 added to cover OTC use). "Intended to be used with marketed Electrical Stimulators, including: TENS(Transcutaneous Electrical Nerve Stimulator), EMS (Electrical Muscular Stimulator), and IF (Interferential Stimulator)." "All of the devices are for gel pads use with an electrode and not an electrode itself." |
| Physical & Technological Characteristics: Similar to predicate devices (e.g., shapes, sizes, non-sterile, single-patient use, multiple applications). | Physical & Technological Characteristics: Non-sterile, self-adhesive, for single patient use only, and to be disposable. "HIVOX self-adhesive electrode gel pads are series of cutaneous electrodes with various shapes and sizes." "The subject device and the predicate devices have the same physical and technological characteristics." (Comparison table shows alignment on Single-Patient Use, Multiple Applications, Sterility Status, Conductive Surface Shapes). |
| Safety and Effectiveness: Demonstrated to be as safe and effective as legally marketed predicate devices. | Safety and Effectiveness: "The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed devices identified in the submission. Thus the subject device is substantially equivalent to the predicate devices." |
Study Details:
- Sample size used for the test set and the data provenance: N/A (This is a medical device, not an algorithm, and its performance is established through non-clinical testing and comparison to predicates, not a clinical "test set" in the AI sense).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No external "ground truth" or expert consensus dataset for evaluating an algorithm; safety and performance are evaluated against established medical device standards and predicate devices).
- Adjudication method for the test set: N/A
- 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: N/A (Not an AI device).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI device).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" for this device's safety and effectiveness is established by compliance with ISO 10993 standards for biocompatibility and comparison to the established performance and materials of legally marketed predicate devices.
- The sample size for the training set: N/A (Not an AI device).
- How the ground truth for the training set was established: N/A (Not an AI device).
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).