(550 days)
The Avologi Gel Primer is intended to be used with Luminice device to improve skin conductivity.
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.
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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Image /page/0/Picture/2 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in blue, with 'ADMINISTRATION' written below.
September 15, 2023
Premier North America Inc. % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China
Re: K220735
Trade/Device Name: Avologi Gel Primer (Model: Av25) Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive Media Regulatory Class: Class II Product Code: GYB Dated: August 17, 2023 Received: August 17, 2023
Dear Doris Dong:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220735
Device Name Avologi Gel Primer
Indications for Use (Describe)
The Avologi Gel Primer is intended to be used with Luminice device to improve skin conductivity
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary [As required by 21 CFR 807.92]
1. Submission Information K220735 510(k) Number: Date: August 17, 2023 Type of 510(k) Submission: Traditional 510(k) New device Basis for 510(k) Submission: Owner: Premier North America Inc. 3301 SW 42ND ST., FORT LAUDERDALE, FL 33312-6828, USA Tel: 404-4928133-11 E-mail: Premiershai@Premierna.Com Doris Dong Contact: [Consultant, from Shanghai CV Technology Co., Ltd.] Add: Room 602, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China E-mail: doris.d@ceve.org.cn Tel: 86 21-31261348 / Fax: 86 21-57712250
2. Device Description
| Proprietary Name: | Avologi Gel Primer |
|---|---|
| Model: | Av25 |
| Regulation Name: | Electroconductive Media |
| Common Name: | Electroconductive Gel |
| Device Classification Name: | Media, Electroconductive |
| Regulation Number: | 21 CFR 882.1275 |
| Product Code: | GYB |
| Device Class: | II |
| Review Panel: | Neurology |
| 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 theimpedance of the contact interface between the electrode surface and theskin. |
| Indications for use: | The Avologi Gel Primer is intended to be used with Luminice device toimprove skin conductivity. |
3. Predicate device Information
| Predicate 510(k) Number: | K161654 |
|---|---|
| Marketing clearance date: | December 30, 2016 |
| Product name: | NuFACE Gel Primer |
| Manufacturer: | Carol Cole Company |
4. Reference device Information
| Reference510(k) Number: | K200402 |
|---|---|
| Marketing clearance date: | November 25, 2020 |
| Product name: | DR-HO'S Electro Therapy Conductive Gel |
| Manufacturer: | Guangzhou Xinbo Electronic Co., Ltd. |
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K190050 Reference510(k) Number: Marketing clearance date: July 19, 2019 Product name: Tech Dots -Conductive gel Manufacturer: Spes Medica S.r.1.
5. Substantial Equivalence to Predicate device
The proposed device Avologi Gel Primer has the same, or similar, technological characteristics as the predicate device NuFACE Gel Primer.
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| Parameters | New Device | Predicate Device | Reference Device 1 | Reference Device 2 | Comparison | |
|---|---|---|---|---|---|---|
| 510(k) Number | K220735 | K161654 | K200402 | K190050 | -- | |
| Device name | Avologi Gel Primer | NuFACE Gel Primer | DR-HO'S ElectroTherapy Conductive Gel | Tech Dots -Conductivegel | -- | |
| Model | Av25 | / | DHGEL | / | -- | |
| 510(k) Owner | Premier North America Inc. | Carol Cole Company | Guangzhou XinboElectronic Co., Ltd. | Spes Medica S.r.l. | -- | |
| Regulation Number | 21CFR 882.1275 | 21CFR 882.1275 | 21CFR 882.1275 | 21CFR 882.1275 | SE | |
| Regulation Name | Electroconductive Media | Electroconductive Media | Electroconductive Media | Electroconductive Media | SE | |
| Regulatory Class | Class II | Class II | Class II | Class II | SE | |
| Product Code | GYB | GYB | GYB | GYB | SE | |
| Regulation MedicalSpecialty | Neurology | Neurology | Neurology | Neurology | SE | |
| Intended Use | The Avologi Gel Primer isintended to be used withLuminice device to improveskin conductivity. | The NuFACE Gel Primer isintended to be used withNuFACE microcurrent devicesto improve skin conductivity. | DR-HO'S ElectroTherapy Conductive Gelis intended for use withTENS (transcutaneouselectrical nervestimulation) and EMS(electric musclestimulation) therapy. TheConductive Gel is usedwith external to reducethe impedance of thecontact between theelectrode surface and theskin. | Tech Dots are intendedfor use in clinical andresearch EEG/EPrecordings from humans.They are used withexternal electrodes as theconductor between thescalp and recessedelectrodes to reduceimpedance between theelectrode surface and theskin. | SE | |
| Use | Over-the-Counter cosmetic use | Over-the-Counter cosmetic use | Over-the-Counter use | Prescription use | SE | |
| Environment of use | Home | Home | Home | Hospital | SE | |
| Target population | Adults 18 years of age or older | Adults 18 years of age or older | Not publicly available | Adult and children | SE | |
| Where used | Topically on intact skin | Topically on intact skin | Intact Skin | Topically on intact skin | SE | |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile | SE | |
| Color | Colorless | Colorless | Not publicly available | Not publicly available | SE | |
| Appearance | Clear | Clear | Clear | Clear | SE | |
| Odour | Odourless | Odourless | Odourless | Odourless | SE | |
| Volume | 3.38fl.oz | 2 fl.oz. and 5 fl.oz. tube | Not publicly available | Not publicly available | SE | |
| Weight(g) | 170 - 200 | Not publicly available | 250g / bottle | 0.14 ± 0.01 g per Dot | Note 1 | |
| Specific gravity | 0.900 - 1.100 | Not publicly available | Not publicly available | Not publicly available | SE | |
| Viscosity(cps) | 30000-80000 | Not publicly available | Not publicly available | Not publicly available | SE | |
| pH | 5.0-7.0 | 6.0-7.0 | 7.0 - 7.5 | 4.1 ± 0.1 | SE | |
| Biocompatibility | Complies with ISO 10993-5 and ISO 10993-10 | Complies with ISO 10993-5 and ISO 10993-10 | Complies with ISO 10993-5 and ISO 10993-10 | Complies with ISO 10993-5 and ISO 10993-10 | SE | |
| Chemical Safety | Non-OSHA PEL | Non-OSHA PEL | Non-OSHA PEL | Non-OSHA PEL | SE | |
| Conductive material | Salt (Magnesium Sulfate) | Salt (Magnesium Sulfate) | Purified water with Sodium hydroxide | Salt (NaCl) | SE | |
| Impedance | $154\Omega\pm10%$ | Not publicly available | $500\Omega$ | 80 ± 10 Ohm | SE | |
| Shelf-life | 3 years | Not publicly available | 2 years | 3 years | Note 2 | |
| Gel composition | Deionized water, Propanediol,Hydrolyzed Hyaluronic Acid,Tremella Fuciformis SporocarpExtract, BentaineGlycerin, magnesium sulfate,carbomer,hydroxyethylcellulose,ethylhexylglycerin, potassium | Water/Aqua/Eau, Propanediol,Hydrolyzed Hyaluronic Acid,Tremella Fuciformis SporocarpExtract, BentaineGlycerin, magnesium sulfate,carbomer,hydroxyethylcellulose,ethylhexylglycerin, potassium | Purified water (solvent);Carbopol (gel forming);Glycerin (Moisturizing);Sodium hydroxide(Buffering); Triclosan(preservative) | Water, Glycerol(vegetable origin),Polyacrylate copolymer(proprietary), Potassiumchloride | SE | |
| sorbate, Caprylyl Glycol,phenoxyethanol, sodiumhydroxide | sorbate, Caprylyl Glycol,phenoxyethanol, sodiumhydroxide | |||||
| Conductivity(mS/cm) | 2-5 | 3.38 | 2 | 2 | SENote 3 | |
| Microbiologicalgrowth | Total AerobicMicrobial Count(cfu/g) | <1.0E+02 | Not publicly available | Not publicly available | Not publicly available | SENote 4 |
| Molds &Yeasts(cfu/g) | <10 | Not publicly available | Not publicly available | Not publicly available | ||
| Pseudomonasaeruginosa(cfu/g) | Absence | Not publicly available | Not publicly available | Not publicly available | ||
| Staphylococcusaureus(cfu/g) | Absence | Not publicly available | Not publicly available | Not publicly available | ||
| Escherichia coli(cfu/g) | Absence | Not publicly available | Not publicly available | Not publicly available | ||
| Candida albicans(cfu/g) | Absence | Not publicly available | Not publicly available | Not publicly available | ||
| Conclusion of Substantial Equivalence to the Predicate Device: |
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Note 1:
The proced device differs from the predicate device in pH, viscosty, and packaging. But these do not affect the performance of the product, and the packaging compatibility has been tested. Therefore, these differences will not raise of safety or effectiveness.
Note 2:
Although the impedance and shelf life of the productive available, the proposed device performed 3 years real-time stability testing and impedance testing. The inpedance of the proposed device is 1.540±10%. the impediation of 5.00402. which is larger than that of the proposed device. the impediate of K190050 is 80-100, which is smaller that of the proposed device. Therefore, will not raise any issues of safety or effectyenss.
Note 3:
Conductivity of our device is similar to the predice has a higher value of conductivity comparing to some cleared devices (2mScm), which will be more conductive. So no issues of safety or effectiveness will be raised.
Note 4:
Both our device and the predicate device are have conducted microbiological growth test per USP61/62, and the blocompatibility test results indicated that the skin had no adverse reaction to microbiological growth of the difference will not raise any issues of safety or effectiveness.
6.Summary of Non-clinical Testing
The safety and effectiveness of the Avologi Gel Primer were established and the substantial was supported by a series of performance testing, including biocompatibility testing, shelf life testing, and physical property testing.
Biocompatibility
In vitro Cytotoxicity Test:The test article were non cytotoxicity to L929 cells. Intracutaneous Reactivity Test:The test article induce negligible irritation in a rabbit intracutaneous test. Skin Sensitization Test: The test article showed no significant evidence of causing skin sensitization in the guinea pig.
The biocompatibility evaluation was conducted within the management framework and in compliance with ISO 1093 standards. This biocompatibility evaluation establishes the biological safety for the Avologi Gel Primer.
- . ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity)
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- ISO 1099-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility) ●
- ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices Part 23: Tests for irritation.(Biocompatibility) ●
Shelf life testing
The shelf ifte of Avologi Gel Primer is 3 years.To ensure the shelf life of Avologi Gel Primer, we have performed the reality testing (3 years). The result demonstrates that the Avologi Gel Primer meet intended specification.
Physical property testing
-
. Microbiological growth testing
Microbiological Complies with the classification "Satisfactory" for the parameters tested. -
. Packaging compatibility testing
Packaging compatibility test according to organoleptical tests. The test carried out viscosity determination, precific gravity determination, pH determination, weight determination. Test results Sensory tests of all samples did not show any differences. -
Conductivity testing
Test results all the samples pass conductivity test. -
Stability testing ●
Color, odor, appearance and impedance are as specified and equivalent to the predicate device.
7.Conclusion
The conclusions drawn from the nonomate that the device is as safe, as effective, and performs as well as or better than the legally market device. The device comparison and the results of the Non-clinical Testing indicate that the Avologi Gel Primer is substantially equivalent to the predicate devices, and the minor differences does not rafety or effectiveness.The subject device Avologi Gel Primer is substantial Equivalent to the predicate device K161654.
§ 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).