(216 days)
The Adhesive Electrodes are intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications. It is for OTC (Over-The -Counter) or Prescription use and is to be used for adults only.
The Adhesive Electrodes transmit electrical current to patient skin, the electrical current is first transmitted via the snap button then transmitted to the conductive gel which is adhered to patient skin. Adhesive Electrodes are multi-layer reusable, flexible structures, composed of laminated materials commonly used in this application: EVA foam First layer: Insulating backing material: Second layer: Conductive film: Carbon film Third layer: Biocompatible self-adhesive conductive hydrogel Protective liner: PET. The dimension of the adhesive electrode is 40 mm (L) × 70 mm (W) ×3mm (H).
The provided text describes ShenZhen Quality Medical Technology Co.,Ltd's "Adhesive Electrodes" (K171381) and indicates its substantial equivalence to predicate devices, rather than outlining a detailed study proving the device meets specific acceptance criteria in the manner requested. The document is a 510(k) summary for a medical device focusing on establishing substantial equivalence to previously cleared devices.
Therefore, many of the requested categories (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission.
Here's what can be extracted and inferred based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
According to the document, the acceptance criteria are largely based on equivalence to predicate devices and adherence to relevant ISO standards.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Remark on Equivalence |
|---|---|---|---|
| Intended Use | Transmit electrical current for TENS and EMS, OTC/Prescription, adults only. Similar to predicate devices. | The Adhesive Electrodes are intended to transmit electrical current to patient skin for TENS and EMS applications. It is for OTC or Prescription use and is to be used for adults only. | SE (Substantial Equivalence) |
| Material/Design | Three layers: Insulating backing, Conductive film, Conductive hydrogel. Similar in principle to predicates. | Three layers: EVA foam (insulation), Carbon film (conductive), Biocompatible self-adhesive conductive hydrogel. | SE (Substantial Equivalence) |
| Electrical Performance | A.C. Impedance |
§ 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).