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510(k) Data Aggregation
(212 days)
Electrodes with snap / Electrodes with pigtail
The proposed device is intended for use as the disposable, conductive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with legally marketed electrical stimulators, i.e. TENS (Transutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for Over-the-Counter (OTC) use.
The proposed Electrodes with snap / Electrodes with pigtail are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydro gel, no securing materials are required to secure the product to the patient's skin. The proposed product mainly consists of electrode pad and snap or pigtail. The electrode pad is available in Round Shape Electrode, Rectangular Shape Electrode, Palm shape Electrode, Elliptical Shape Electrode, and Calabash Shape Electrode.
The provided document is a 510(k) summary for medical electrodes, not an AI/ML device. Therefore, it does not contain the information requested in points 2-9 regarding AI/ML model performance, training, and validation.
However, I can extract the acceptance criteria and reported device performance for the physical electrodes as presented in the "Test Summary" and "Comparison to predicate device" sections.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Subject Device) | Reported Device Performance (Subject Device) |
|---|---|
| Biocompatibility: According to ISO 10993-5 and ISO 10993-10 standards | Complied with ISO 10993 |
| Electrode wire compliance: According to Sub-Clause 56.3 (c) in IEC 60601-1:1988 + A2:1995 (2nd edition) | The electrode wire is compliance with 21 CFR 898 by construction review according to Sub-Clause 56.3 (c) in IEC 60601-1:1988 + A2:1995 (2nd edition) |
| Individual pad impedance: Below 3000 ohms @ 10 Hz | Below 3000 ohms @ 10 Hz (as per "Electrical Impedance" under "Comparison to predicate device") |
| Adhesive performance on To (Tackiness): >= No. 14 steel ball (Diameter: 11.112 mm) following AS07-003 / GB/T4852-200 | >= No. 14 steel ball (Diameter: 11.112 mm) following AS07-003 / GB/T4852-200 |
| Adhesive holding strength performance: A sample pad with 40mm length and 40 mm width; Hang a weight of 500g without detach within 1min | A sample pad with 40mm length and 40 mm width; Hang a weight of 500g without detach within 1min |
| Tensile Strength: Electrode is held up with a weight of 500g hung on the wire, and can hold on at least 1 minutes | Electrode is held up with a weight of 500g hung on the wire, and can hold on at least 1 minutes |
| Conformability: No more than 10% of the adhesive area of the device shall have separated from the skin surface at 1 h after application | No more than 10% of the adhesive area of the device shall have separated from the skin surface at 1 h after application |
| Impedance Distribution uniformity test: 1) No significant deviation between resistance values measured for each combination mode; 2) The maximum value and the minimum value should be within ±10% of average value | 1) No significant deviation between resistance values measured for each combination mode; 2) The maximum value and the minimum value should be within ±10% of average value |
| Sterility: Non-sterile | Non-sterile |
| Stability and shelf life: 2 years | 2 years |
| Re-usable: For single patient | For single patient |
| Labeling: Conform to 21 CFR Part 801 | Confirm to 21 CFR Part 801 |
Study Details (for physical device, not AI/ML):
The document describes a 510(k) submission, which demonstrates "substantial equivalence" to a legally marketed predicate device, rather than a clinical study proving new performance. The "Test Summary" indicates that safety and performance were evaluated by "lab bench testing."
- Sample size used for the test set and the data provenance: Not specified in terms of sample size for the tests, but the data would be from lab bench testing (likely within China, given the company's location). This is not retrospective or prospective in the sense of a clinical trial; it's product testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical/electrical tests with objective measurements, not judgment-based assessments requiring experts for ground truth.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is for a physical medical device (electrodes), not an AI/ML diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Physical measurements and adherence to specified performance standards (e.g., ISO 10993, IEC 60601-1, specific impedance/strength values).
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
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