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510(k) Data Aggregation
(90 days)
Intended for use with electric stimulation therapy devices, such as TENS and EMS. Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode and the skin.
Conductive Gel can be used with any of dozens of stimulating devices that are legally sold, to reduce the impedance between the skin and the stimulating device. It consists of Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2% and Triclosan: 0.05%. And the Purified water used as the solvent, the Carbopol as a gel forming material, the Glycerin as a Moisturizing, the Sodium hydroxide as a Buffering and the Triclosan as a preservative. The Conductive Gel is used on intact skin surfaces. The entire surface of Conductive Gel is very conductive, smeared evenly on the stimulation device, so that the current is evenly distributed. The gel is to be generously applied to the area where an electrode will be used. The gel can be washed off the skin after use.
This document describes the validation of a "Conductive Gel" medical device. Here's a breakdown of the acceptance criteria and the study conducted to prove it:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Purpose of the Test | Reference Standard | Acceptance Criteria | Test Results |
|---|---|---|---|---|
| In vitro Cytotoxicity Test | Determine if the target device extract is cytotoxic | ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Non-cytotoxicity to L929 cells | Pass |
| Skin Sensitization Test | Evaluate skin sensitization after topical applications | ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Frequency of positive challenge results in sample extract and Negative control animals are 0%, Positive control is 100% | Pass |
| Skin Irritation Test | Evaluate skin irritation after single topical applications | ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Negligible irritation in a rabbit skin single exposure test | Pass |
| Usability Study | Study how usability will be performed | IEC 62366-1 Edition 1.0 2015-02, Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)] | The subject device can meet the usability goal of IEC 62366-1 standards | Pass |
| Shelf Life Test | Study if performance meets 2-year shelf life requirements | ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices; Guidance document for the "Shelf Life of Medical Devices" issued in April 1991 | All items (Exterior, Package, pH, Impedance and conductivity) tested on both before and after aging samples meet the performance required | Pass |
Additional Performance Data from Comparison to Predicate Device:
| Item | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Impedance (at 1 MHz) | ≤ 500 Ω | ≤ 500 Ω |
| pH | 7.0 - 7.5 | 6.5 - 7.5 |
| Percent Concentration of Ingredients | Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2%, Triclosan: 0.05% | Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2%, Triclosan: 0.05% |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes for each non-clinical test (cytotoxicity, sensitization, irritation, usability, shelf life). However, it refers to standard biological evaluation and aging test methods (ISO 10993-5, ISO 10993-10, IEC 62366-1, ASTM F1980-16), which inherently define sample sizes for their respective procedures, typically involving animal models for biological tests or specific numbers of units for usability/shelf life.
- Data Provenance: The studies were identified as "lab bench testing." The location of these labs or the country of origin for the data is not specified beyond the submitter's and correspondent's addresses (China). The tests are non-clinical, meaning they were not conducted on human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided as the validation is based on non-clinical (lab bench) testing against established standards, not on expert consensus or human reader performance.
4. Adjudication Method for the Test Set
This information is not applicable/provided as the validation is based on objective lab bench testing against predefined acceptance criteria, not subjective interpretations requiring 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
Not applicable. This device is a conductive gel, which is a physical product, not an AI or software device that would involve human readers or comparative effectiveness studies with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. As mentioned, this is a physical medical device (conductive gel), not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on established scientific and regulatory standards and their defined criteria.
- For biological tests (cytotoxicity, sensitization, irritation), the ground truth is whether the device elicits a toxic or adverse biological response as determined by standardized in-vitro and in-vivo (animal) models.
- For usability, the ground truth is compliance with IEC 62366-1 usability engineering principles.
- For shelf life, the ground truth is the maintenance of specified physical and chemical properties (like pH, impedance, conductivity, exterior, package integrity) over the declared shelf life based on accelerated aging models.
- For material composition, the ground truth is the precise percentage concentration of each ingredient.
- For impedance and pH, the ground truth is the measured value compared to the specified range or limit.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, there is no training set for this type of device.
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