(203 days)
The Adhesive Electrodes are 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 (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.
Adhesive Electrodes manufactured by GMDASZ are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:
First layer: Insulating backing material: Fabric/foam/tan fabric
Second layer: Conductive film/Carbon film coated with silver/Aluminum foil film
Third layer: Biocompatible self-adhesive conductive hydrogel
Protective liner: PET
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. The electrode is connected to the electrical stimulator by lead wire, with a standard .080" recessed female terminal with insulating outer jacket. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly is incompliance with FDA performance standard 21 CFR Part 898.
This document is a 510(k) premarket notification for "Adhesive Electrodes" manufactured by GMDASZ Manufacturing Co., Ltd. The submission seeks to expand the sales of their existing electrodes (previously cleared under K092546) to include Over-The-Counter (OTC) use, and also introduces new electrodes with an Aluminum foil film conductive layer, comparing them to the predicate device K132998 (Wandy self-adhesive electrodes).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria." Instead, it compares the subject device's performance against two predicate devices (K092546 and K132998) across various technical specifications, which implicitly serve as acceptance criteria. The key performance metrics and their comparison are:
| Acceptance Criteria (Implied from Predicate Devices) | Reported Device Performance (K160138) | Comparison/Remark |
|---|---|---|
| Material/Design Features: | ||
| Insulation backing material: Fabric/Foam/Tan fabric | Same: Fabric/Foam/Tan fabric | Same |
| Conductive film (K092546 D-pred): Carbon film/Carbon film coated with silver | Carbon film/Carbon film coated with silver/Aluminum foil film | Similar; new option of Aluminum foil film, justified by K132998 predicate. |
| Conductive hydrogel (A, T or U gel) | Same: (A, T or U gel) | Same |
| Electrical Connection: Leadwire | Leadwire | Same or Similar. Some K132998 models had snap, but subject device uses leadwire. |
| Protective Liner: PET | PET | Same |
| Lead Wire Connector: .080" female socket connector | .080" female socket connector | Same |
| Reusable | Reusable | Same |
| Packaging: Re-sealable bag packed | Re-sealable bag packed | Same |
| Self-adhesive | Self-adhesive | Same |
| Performance Characteristics: | ||
| Biocompatibility: Complies with ISO10993 | Complies with ISO10993 | Same. For new aluminum foil models, no new tests were conducted as materials for other layers were identical to K092546. |
| A.C. Impedance: 6 pounds of force | More than 6 pounds of force | Same |
| Regulatory/Indications: | ||
| OTC or Prescription use (K092546 Pred: Prescription, K132998 Pred: OTC & Rx) | OTC and Prescription | Expanded from K092546, aligned with K132998. |
| Single Patient Use | Single Patient Use | Same |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for any conducted tests.
The data provenance is from GMDASZ Manufacturing Co., Ltd., which is based in Guangdong Province, P.R. China. The studies appear to be prospective testing conducted by the manufacturer to demonstrate substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. The device is an adhesive electrode, and the evaluation relies on technical and performance testing against established standards and predicate devices, not on expert interpretation of medical images or conditions where "ground truth" is typically established by medical professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or image interpretation studies where multiple readers assess cases and discrepancies are resolved. The studies described here are laboratory/performance tests.
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/not provided. An MRMC study is for evaluating diagnostic performance, often with AI. The device is a medical accessory (adhesive electrode) and is not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This device is an electrode, not an algorithm. Therefore, "standalone" algorithm performance is not relevant. The device's performance is inherently tied to its physical and electrical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests appears to be established industry standards (e.g., EC12/EC53, ISO10993) and the documented performance characteristics of legally marketed predicate devices. The tests conducted (safety, adhesion, current dispersion, reusability, stability) evaluate whether the device meets these pre-defined technical specifications.
8. The sample size for the training set
This information is not applicable/not provided. This medical device is a physical product (electrode) and does not involve machine learning or AI models that require a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided, as there is no training set for this type of device.
§ 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).