(177 days)
Reusable, self-adhering Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.
The FlexStim Neurostimulation Electrode is used as a transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS or EMS and available in backing materials such as, non-woven cloth and PE foam, conductive carbon film (low impedance and standard impedance) with lead wire and snap connection configurations. The device functions as a passive device by carrying an electrical signal from a neurostimulation device through the device cable and electrode lead wire or snap button to the user's skin.
Here's an analysis of the acceptance criteria and supporting study for the FlexStim Neurostimulation Electrodes, based on the provided document:
Device: FlexStim Neurostimulation Electrodes (Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W)
This document is a 510(k) Summary, which is a premarket notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing ones rather than establishing novel acceptance criteria in a traditional sense with specific numerical thresholds for effectiveness. Instead, the acceptance is based on demonstrating comparable safety and performance to the predicate devices through various tests.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission and not a clinical trial establishing effectiveness, the "acceptance criteria" are implied by the standards and predicate device characteristics, and performance is demonstrated through in-vitro and bench tests rather than clinical outcomes.
| Acceptance Criteria Category | Specific Criteria (Implied from standards/predicate comparison) | Reported Device Performance |
|---|---|---|
| 1. Biocompatibility | Safe for skin contact; non-cytotoxic, non-sensitizing, non-irritating (per ISO 10993-1). | The skin-contacting material (conductive hydrogel) was found to be biocompatible for its intended use based on tests for cytotoxicity, sensitization, and irritation, conducted in accordance with ISO 10993-1. |
| 2. Electrical Performance | Conductive properties appropriate for intended use with neurostimulation devices; lead wire assembly compliant with FDA performance standards (21 CFR Part 898) and IEC 60601-1, sub-clause 56.3 (c). | Impedance testing performed with Surface Electrode Analysis Meter (SEAM 10) confirmed appropriate conductive properties. The lead wire assembly's Certificate of Compliance (CoC) confirmed compliance with FDA performance standard 21 CFR Part 898 (via IEC 60601-1, sub-clause 56.3 (c)). |
| 3. Adhesive Performance | Ability to adhere to the patient's skin for a duration compatible with the intended use of the device. | Peel Test performed as per International Standard Afera 5001. Results concluded that the design ensures adherence to patient's skin for a duration compatible with intended use. (Specific peel strength values are not provided in this summary but were presumably met.) |
| 4. Stability/Shelf-Life | Maintain electrical and adhesive performance over a specified shelf-life (e.g., 24 months when stored at 5°C - 30°C); hydrogel resists physical and chemical breakdown from electrical current and storage. | Accelerated shelf-life study (40°C ± 2°C, 75% ± 5% RH, tested at 0, 3, & 6 months) and ambient temperature study (25°C ± 2°C, 60% ± 5% RH, tested up to 11 months) demonstrated the product passes electrical (impedance) and adhesive performance tests. Concluded suitable for use up to 24 months when stored at 5°C - 30°C. Implies hydrogel stability against breakdown. |
| 5. Substantial Equivalence | Demonstrably safe and effective as predicate devices (PROTENS Reusable Stimulating Electrodes (K142099) and Reusable Stimulating Electrodes (K111270)); identical indications for use, similar technological characteristics (design and materials), and comparable performance specifications; no new questions of safety and effectiveness. | The device states identical indications for use, similar technological characteristics (design, materials like backing, carbon film, hydrogel), and comparable performance specifications as the predicate devices. The performance data (biocompatibility, electrical, adhesive, stability) supports that the device is as safe and effective as the predicate devices, posing no new safety or effectiveness concerns. (The report highlights minor differences in backing materials and conductivity film type (carbon vs. carbon/silver), method of sale/supply, but asserts these do not raise new questions of safety/effectiveness). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample sizes used for each of the performance tests (Biocompatibility, Electrical Performance, Adhesive Performance, Stability). It refers to "samples" being tested.
- Data Provenance: The studies appear to be conducted by or for Medico Electrodes International Ltd. in India ("Manufactured by Medico Electrodes International Ltd., India"). The studies are in-vitro and bench testing, not human clinical trials. Thus, there is no "country of origin of the data" in terms of patient population, nor is it retrospective or prospective in the clinical sense. It's pre-clinical, lab-based data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this document. The "ground truth" for these types of tests (biocompatibility, electrical, adhesive, stability) is established by adherence to recognized international standards (ISO 10993-1, Afera 5001, IEC 60601-1) and comparison with predicate devices. There wouldn't be "experts" establishing a clinical ground truth for a test set in a 510(k) bench study. The "truth" is objective measurement against engineering and material science standards.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication typically refers to expert review of clinical cases. These are bench tests against predetermined standards. The results of the tests either meet the standard/predicate comparison or they don't.
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 section is not applicable. The device is an inanimate neurostimulation electrode, not an AI-powered diagnostic or assistive tool for human readers. There is no AI component, and thus no MRMC study performed to evaluate human reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The device is a passive neurostimulation electrode, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance data presented is derived from:
- International Standards: e.g., ISO 10993-1 for biocompatibility, IEC 60601-1 for electrical safety, Afera 5001 for adhesive performance.
- Predicate Device Characteristics: Comparison of technical specifications and performance to legally marketed predicate devices (PROTENS Reusable Stimulating Electrodes (K142099) and Reusable Stimulating Electrodes (K111270)).
- Engineering Specifications: Internal design and material specifications that define acceptable ranges for electrical impedance, adhesion strength, and material composition.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical medical device, not an AI model that requires a training set. The manufacturing process is validated (which is akin to "training" in a broad sense for consistent product quality), but this is not discussed in terms of a "training set" here.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
§ 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).