(176 days)
Self-Adhesive Electrode is intended for use as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC(Interferential current) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.
Self-Adhesive Electrode are composed of conductive carbon film and adhesive Electrodes composed of Aluminum foil film,Adhesive Electrodes manufactured by Roundwhale are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:
- Top layer: Fabric/Foam/ Tan fabric
- Middle layer: Conductive film (Silver coated Carbon Film/Carbon film/Aluminum foil film)
- Bottom layer: Biocompatible self-adhesive conductive hydrogel
- Connection: Leadwire/snap button/magnetic button
- double sides adhesive tape: Which is used for attaching the non-woven fabrics and conducting film
- Release film: Release film is a protective layer for the hydrogel.
The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
For the electrical connection, Roundwhale provides lead wire type and snap button/Magnetic button type:
- Leadwire assembly: The electrode is connected to the electrical stimulator by lead wire, at least 40 mm long wire with a standard connector: 0.08"/0.1"(2mm/2.5mm) diameter female socket connector with insulating outer.
- Snap button/Magnetic button assembly: With 2.5~5mm diameter male socket.
This document is an FDA 510(k) summary for the Shenzhen Roundwhale Technology Co., Ltd. "Self-adhesive Electrode" device. It outlines the device's indications for use, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: This document pertains to a cutaneous electrode, which is a relatively simple medical device. Therefore, the "acceptance criteria" and "study" described are focused on physical and electrical performance and biocompatibility, not on complex diagnostic accuracy metrics like those for AI-powered imaging devices (e.g., sensitivity, specificity, AUC). The request's points regarding MRMC studies, expert concensus for ground truth, and training data are typically applicable to AI/ML device submissions, which are not relevant to this electrode device.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on established industry standards and comparisons to legally marketed predicate devices. The "reported device performance" demonstrates that the proposed device meets or is comparable to these criteria.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from Predicate/Standard) | Reported Device Performance (Subject Device) | Study/Section Proving Compliance |
|---|---|---|
| Material/Composition: | ||
| Biocompatibility (ISO 10993) | Complies with ISO10993 | 7.2 Biocompatibility testing |
| Physical Characteristics: | ||
| Adhesion Testing (Peel Strength) ≥ 7N | ≥ 7N | 6. Technical and Performance (Comparison Table), 10. NE adhesion |
| Force to remove wire from electrode > 6 pounds | More than 6 pounds of force | 6. Technical and Performance (Comparison Table) |
| Electrical Characteristics: | ||
| 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).