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The Avologi Gel Primer is a clear, viscous and chloride-free formulation. The gel is to be applied to the area under an electrode to reduce the impedance of the contact interface between the electrode surface and the skin.

AI/ML Overview

This document describes the Avologi Gel Primer (Model: Av25), an electroconductive gel intended for use with the Luminice device to improve skin conductivity. The submission demonstrates substantial equivalence to the predicate device, NuFACE Gel Primer (K161654), through performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Parameter)	Predicate Device (NuFACE Gel Primer - K161654)	Avologi Gel Primer (Av25) Performance	Comparison
Regulation Number	21CFR 882.1275	21CFR 882.1275	SE (Substantially Equivalent)
Regulation Name	Electroconductive Media	Electroconductive Media	SE
Regulatory Class	Class II	Class II	SE
Product Code	GYB	GYB	SE
Regulation Medical Specialty	Neurology	Neurology	SE
Intended Use	To be used with NuFACE microcurrent devices to improve skin conductivity.	To be used with Luminice device to improve skin conductivity.	SE
Use	Over-the-Counter cosmetic use	Over-the-Counter cosmetic use	SE
Environment of use	Home	Home	SE
Target population	Adults 18 years of age or older	Adults 18 years of age or older	SE
Where used	Topically on intact skin	Topically on intact skin	SE
Sterilization	Non-sterile	Non-sterile	SE
Color	Colorless	Colorless	SE
Appearance	Clear	Clear	SE
Odour	Odourless	Odourless	SE
Volume	2 fl.oz. and 5 fl.oz. tube	3.38 fl.oz.	Note 1 (Difference in packaging, does not affect performance)
Weight(g)	Not publicly available	170 - 200	Note 1 (Difference in packaging, does not affect performance)
Specific gravity	Not publicly available	0.900 - 1.100	SE
Viscosity(cps)	Not publicly available	30000-80000	Note 1 (Difference, does not affect performance)
pH	6.0-7.0	5.0-7.0	Note 1 (Difference, does not affect performance)
Biocompatibility	Complies with ISO 10993-5 and ISO 10993-10	Complies with ISO 10993-5 and ISO 10993-10 (and ISO 10993-23)	SE
Chemical Safety	Non-OSHA PEL	Non-OSHA PEL	SE
Conductive material	Salt (Magnesium Sulfate)	Salt (Magnesium Sulfate)	SE
Impedance	Not publicly available	154 Ω ± 10%	SE (Note 2 - acceptable based on performance study)
Shelf-life	Not publicly available	3 years	Note 2 (acceptable based on real-time stability testing)
Conductivity (mS/cm)	2-5	3.38	Note 3 (similar to predicate, higher than some cleared devices, which is more conductive)
Microbiological growth (Total Aerobic Microbial Count)	<1.0E+02 cfu/g	Complies with "Satisfactory" classification	SE (Note 4 - similar testing results)
Microbiological growth (Molds & Yeasts)	<10 cfu/g	Complies with "Satisfactory" classification	SE (Note 4 - similar testing results)
Microbiological growth (Pseudomonas aeruginosa)	Absence	Complies with "Satisfactory" classification	SE (Note 4 - similar testing results)
Microbiological growth (Staphylococcus aureus)	Absence	Complies with "Satisfactory" classification	SE (Note 4 - similar testing results)
Microbiological growth (Escherichia coli)	Absence	Complies with "Satisfactory" classification	SE (Note 4 - similar testing results)
Microbiological growth (Candida albicans)	Absence	Complies with "Satisfactory" classification	SE (Note 4 - similar testing results)

Notes from the document:

Note 1: Differences in pH, viscosity, and packaging do not affect device performance, and packaging compatibility has been tested. Therefore, these differences do not raise issues of safety or effectiveness.
Note 2: Although predicate impedance and shelf life are not publicly available, the proposed device underwent 3 years of real-time stability testing and impedance testing. The impedance (154 Ω ± 10%) is acceptable, even if different from other reference devices, and does not raise issues of safety or effectiveness.
Note 3: Conductivity is similar to the predicate and higher (more conductive) than some cleared devices, thus not raising safety or effectiveness issues.
Note 4: Both the proposed device and predicate conducted microbiological growth tests (per USP61/62) and biocompatibility tests, indicating no adverse reactions.

2. Sample size used for the test set and the data provenance:

The document describes non-clinical testing for the Avologi Gel Primer but does not specify a "test set" in the context of a clinical study or expert review for a diagnostic algorithm. The tests performed are laboratory-based and relate to the physical, chemical, and biological properties of the gel.

Biocompatibility Testing:
- In vitro Cytotoxicity Test: Used L929 cells. (Details on sample size of cells not provided, but standard for in vitro assays).
- Intracutaneous Reactivity Test: Performed in a rabbit model. (Specific number of rabbits not provided, but "a rabbit" implies at least one).
- Skin Sensitization Test: Performed in a guinea pig model. (Specific number of guinea pigs not provided, but "the guinea pig" implies at least one).
Shelf-life testing: Real-time stability testing for 3 years. (Details on number of samples or batches tested not provided).
Physical property testing: Includes microbiological growth, packaging compatibility, conductivity, and stability testing. (Details on specific sample sizes for these tests are not provided).

Data Provenance: The tests are described as non-clinical testing, implying they were conducted in a laboratory setting by the manufacturer or a contracted lab. The document does not specify the country of origin for these tests. It is retrospective in nature, summarizing completed tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable (N/A) as the submission is for an electroconductive gel and its substantial equivalence and does not involve an AI device requiring expert-established ground truth for a diagnostic test set. The "ground truth" here is established through scientific laboratory testing results against established standards (e.g., ISO, USP).

4. Adjudication method for the test set:

This information is not applicable (N/A) for the same reasons as above. No expert adjudication method (like 2+1, 3+1) was used as there's no diagnostic output from an AI algorithm being evaluated.

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 (N/A). The device is an electroconductive gel, not an AI-powered diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable (N/A). The device is a physical product (gel), not an algorithm or AI system.

7. The type of ground truth used:

The ground truth for the performance of the Avologi Gel Primer is established through objective laboratory testing against recognized standards (e.g., ISO 10993 standards for biocompatibility, USP 61/62 for microbiological growth, and internal specifications for physical properties like pH, viscosity, impedance, and conductivity). The comparison is primarily against the predicate device's characteristics and general requirements for electroconductive media.

8. The sample size for the training set:

This information is not applicable (N/A). The device is a physical product and does not involve AI model training.

9. How the ground truth for the training set was established:

This information is not applicable (N/A) for the same reasons as above.

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