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510(k) Data Aggregation
(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).
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(139 days)
The KFH Energy device is indicated for the symptomatic relief of:
- Chronic Intractable Pain
- Post-Traumatic Pain
- Post-Surgical Pain
The Kingfisher Healthcare NV KFH Energy model E1 is built in an ABS casing with controls and indicator integrated into a touch-sensitive opaque glass front panel, and designed to be comfortably held in the hand. The approximate dimensions of the unit are 190 x 80 x 30 mm and complete with batteries the unit weighs approximately 350 g (including batteries). The device is designed to deliver electric current in the range 300 to 600 microamperes at 100 Hz frequency to the body from four "AA" sized batteries (contained internally), for a predctermined time (30 or 60 minutes), through four adhesive skin electrodes (already found substantially equivalent through the 510(k) process). The output waveform is monophasic, rectangular with decay.
The provided text describes the 510(k) summary for the Kingfisher Healthcare NV KFH Energy model E1, a transcutaneous electrical nerve stimulator (TENS) device. The document explicitly states that no clinical testing was submitted to demonstrate substantial equivalence. Therefore, the device performance is based on non-clinical testing.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it lists the types of non-clinical testing performed and then broadly concludes that the device is "substantially equivalent to the predicate products" based on these tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Enclosure materials testing | Performed. Conclusion: Substantially equivalent to predicate devices. (Implies materials meet standards for safety, durability, and patient contact. Device uses ABS casing and "wipe-clean" glass surface.) |
| Battery life testing | Performed. Conclusion: Substantially equivalent to predicate devices. (Implies battery life is comparable and adequate for indicated use.) |
| Device extended use reliability testing | Performed. Conclusion: Substantially equivalent to predicate devices. (Implies device maintains functionality and safety over its expected lifespan.) |
| Firmware functional performance | Performed. Conclusion: Substantially equivalent to predicate devices. (Implies software/firmware operates as intended and controls the device output accurately.) |
| Device functional performance | Performed. Conclusion: Substantially equivalent to predicate devices. (Implies the device delivers the specified electrical current in the correct range, frequency, and waveform.) Specifically: delivers 300 to 600 microamperes at 100 Hz, output waveform is monophasic, rectangular with decay. |
| Functional testing to product specification | Performed. Conclusion: Substantially equivalent to predicate devices. (Implies the device meets all its designed specifications, including dimensions, weight, timer functions (30 or 60 minutes), and indications (power on, low battery, output set-point, countdown timer indicators).) |
| Connection testing | Performed. Conclusion: Substantially equivalent to predicate devices. (Implies secure and functional connection with legally marketed electrodes.) |
2. Sample Size Used for the Test Set and the Data Provenance
Since no clinical testing was performed or submitted, there is no "test set" in the context of patient data or clinical outcomes. The non-clinical testing would have involved specific units of the device and its components, but the sample sizes for these engineering tests are not specified in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable, as no clinical testing was performed, and thus no patient data required ground truth establishment by experts for a test set.
4. Adjudication Method for the Test Set
Not applicable, as no clinical testing was performed.
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. The device is a TENS unit for pain relief, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical TENS unit with firmware, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" would have been established by engineering specifications, regulatory standards (e.g., Guide for TENS 510(k) Content), and comparison to the performance characteristics of the predicate devices. This is an engineering ground truth, not a clinical one.
8. The sample size for the training set
Not applicable. The device does not employ machine learning or AI that would require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned for this TENS device.
In summary: The provided 510(k) summary for the Kingfisher Healthcare NV KFH Energy model E1 relies solely on non-clinical testing to demonstrate substantial equivalence to predicate devices, without any clinical studies or the involvement of expert adjudication or AI performance metrics.
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