(134 days)
Zekang Self-Adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The-Counter) or Prescription use.
Zekang Self-adhesive Electrode is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin.
Zekang Self-adhesive Electrode is composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient multiple application use. Zekang Self-adhesive Electrode has various shapes and sizes.
To connect with a nerve or muscle stimulator, this Electrode has lead wire type and snap button type. For lead wire type electrode, the wire is at least 40mm long, with 2.0~3.5mm diameter female socket. For snap button type electrode, the connector is male snap button. The individual electrodes are electrically connected in pairs. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) release liner.
The conductive hydrogel is imported from Covidien, USA, which was 510(k) cleared with number of K100418. And the whole Zekang Self-adhesive Electrode together with the conductive hydrogel has again passed the Biocompatibility test, Shelf life test, Impedance test, Adhesive test, and so on.
This document is a 510(k) summary for the "Zekang Self-Adhesive Electrode" and does not describe a study involving algorithms, human readers, or image analysis. Instead, it focuses on the substantial equivalence of a physical medical device (an electrode). Therefore, many of the requested categories are not applicable.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document refers to "design specifications" and compliance with standards, but does not list specific numerical acceptance criteria values alongside corresponding device performance results in the way one might for an AI model's accuracy. Instead, it indicates successful completion of various tests deemed sufficient for substantial equivalence.
| Acceptance Criteria Category | Reported Device Performance / Compliance |
|---|---|
| Biocompatibility | Passed ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization) |
| Sterility | Complies with ASTM F1980 (Accelerated Aging of Sterile Barrier Systems) |
| Electrical Performance | Bench tests demonstrate compliance with AAMI / ANSI ES60601-1 (General requirements for basic safety and essential performance) and IEC 60601-2-2 (Particular requirements for high frequency surgical equipment and accessories) |
| Shelf life | Passed (explicitly stated) |
| Impedance | Passed (explicitly stated) |
| Adhesive | Passed (explicitly stated) |
| Electrical distribution | Electrical current distribution test results contribute to conclusion of safety and effectiveness |
2. Sample Size Used for the Test Set and Data Provenance
- This information is not provided in the document. The studies mentioned are bench tests and biocompatibility tests on the physical device, not on data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as the document describes testing of a physical electrode, not data, and does not involve establishing ground truth by medical experts in the context of an AI study.
4. Adjudication Method for the Test Set
- This information is not applicable as the document describes testing of a physical electrode, not a medical image analysis or similar AI evaluation that would require adjudication.
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
- This information is not applicable. This document is for a self-adhesive electrode, not an AI or imaging device involving human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable. This describes a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- This information is not applicable in the context of AI. For the physical device, "ground truth" would be defined by the standards and specifications it's tested against (e.g., a hydrogel causing no cytotoxicity is "ground truth" for biocompatibility).
8. The Sample Size for the Training Set
- This information is not applicable as the document is about a physical device and makes no mention of AI or machine learning training sets.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as the document is about a physical device and makes no mention of AI or machine learning training sets.
Summary of the Document's Purpose:
The provided document is an FDA 510(k) clearance letter and summary for a "Zekang Self-Adhesive Electrode." The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This is primarily done through bench testing, biocompatibility testing, and comparison of technical specifications, rather than clinical studies involving human patients or complex AI performance metrics.
§ 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).