(84 days)
LEKTROGEL™ is an electroconductive gel media used with external electrodes to reduce the impedance (resistance to alternative current) of the contact between the electrode surface and the skin.
LEKTROGEL™ is an electroconductive gel media used with external electrodes to reduce the impedance (resistance to alternative current) of the contact between the electrode surface and the skin. It is supplied in 250 grams dispensers with a 3-year shelf life.
The provided text is a 510(k) Summary for a medical device called LEKTROGEL™ (Model LK3001), an electroconductive gel media. This document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting full performance study data with specific acceptance criteria and detailed study designs.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission claims identical performance to the predicate device. Therefore, the "acceptance criteria" appear to be defined by the performance characteristics of the predicate device. However, no specific quantitative acceptance criteria or numerical performance metrics are provided for either device.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (LEKTROGEL™) |
|---|---|---|
| Indications for use | Identical to predicate device (Contact Conductive Adhesive Gel) | Identical |
| Target population | Identical to predicate device | Identical |
| Design | Identical to predicate device | Identical |
| Materials | Identical to predicate device | Identical |
| Performance | Identical to predicate device | Identical |
| Sterility | Identical to predicate device | Identical |
| Biocompatibility | Identical to predicate device | Identical |
| Mechanical safety | Identical to predicate device | Identical |
| Chemical safety | Identical to predicate device | Identical |
| Anatomical sites | Identical to predicate device | Identical |
| Human factors | Identical to predicate device | Identical |
| Energy used and/or delivered | Identical to predicate device | Identical |
| Compatibility with environment | Identical to predicate device | Identical |
| Standards met | Identical to predicate device | Identical |
| Electrical safety | Identical to predicate device | Identical |
| Thermal safety | Identical to predicate device | Identical |
| Radiation safety | Identical to predicate device | Identical |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific test set or a study with a sample size in the traditional sense of clinical or performance testing. The basis for the substantial equivalence claim is the asserted "identical" nature of the device to its predicate. There's no mention of country of origin for test data, or whether it was retrospective or prospective, as no such study is detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As no independent test set with performance evaluation is described, there's no mention of experts establishing ground truth for such a set. The "ground truth" for the submission is the established characteristics and performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring expert adjudication is described.
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
Not applicable. This device is an electroconductive gel, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant and not discussed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (gel), not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is the established characteristics, safety, and performance of the legally marketed predicate device (Contact Conductive Adhesive Gel from Parker Laboratories, Inc., 510k # K852956). The entire submission argues that LEKTROGEL™ is "IDENTICAL" to this predicate.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI/ML algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" or evidence provided to prove the device meets acceptance criteria is based on a comparative analysis of technological characteristics between LEKTROGEL™ and a predicate device (Contact Conductive Adhesive Gel from Parker Laboratories, Inc., 510k # K852956). The submission asserts that the new device is "IDENTICAL" to the predicate device across all critical technological characteristics, including indications for use, design, materials, performance, sterility, biocompatibility, safety, and other factors.
The acceptance criteria are implicitly defined as matching all characteristics of the predicate device. By demonstrating identity, the manufacturer aims to prove substantial equivalence, thereby meeting the regulatory requirements without needing to conduct extensive independent performance studies that would be required for a novel device. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates the FDA accepted the claim of identical characteristics as sufficient evidence for substantial equivalence in this context.
§ 882.1275 Electroconductive media.
(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).