Avologi Gel Primer (Model: Av25)

• K Number: K220735
• Device Name: Avologi Gel Primer (Model: Av25)
• Manufacturer: Premier North America Inc.
• Date Cleared: 2023-09-15 ( 550 days)
• Product Code: GYB
• Regulation Number: 882.1275
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K200402 , K190050 , K161654

Intended Use

The Avologi Gel Primer is intended to be used with Luminice device to improve skin conductivity.

Device Description

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)

Regulation Number and Section

§ 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).