Avologi Gel Primer (Model: Av25)

K220735 · Premier North America, Inc. · GYB · Sep 15, 2023 · Neurology

Device Facts

• Record ID: K220735
• Device Name: Avologi Gel Primer (Model: Av25)
• Applicant: Premier North America, Inc.
• Product Code: GYB · Neurology
• Decision Date: Sep 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1275
• Device Class: Class 2

Intended Use

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

Device Story

Avologi Gel Primer (Model Av25) is a clear, viscous, chloride-free electroconductive gel. Applied topically to intact skin under an electrode, it reduces impedance at the contact interface. Used in home settings by adults 18+ in conjunction with the Luminice device. The gel facilitates electrical conductivity for cosmetic applications. It is non-sterile and supplied in a 3.38 fl. oz. volume. Healthcare providers or users apply the gel to ensure effective device-skin coupling, potentially improving the performance of the associated microcurrent or electro-therapy device.

Clinical Evidence

No clinical data. Safety and effectiveness established via bench testing, including biocompatibility (ISO 10993-5, 10993-10, 10993-23), 3-year real-time shelf-life stability, microbiological growth testing (USP 61/62), and physical property testing (viscosity, pH, specific gravity, impedance, and conductivity).

Technological Characteristics

Clear, viscous, chloride-free gel. Composition: Deionized water, Propanediol, Hydrolyzed Hyaluronic Acid, Tremella Fuciformis Sporocarp Extract, Betaine, Glycerin, magnesium sulfate, carbomer, hydroxyethylcellulose, ethylhexylglycerin, potassium sorbate, Caprylyl Glycol, phenoxyethanol, sodium hydroxide. Impedance: 154Ω ± 10%. pH: 5.0-7.0. Viscosity: 30,000-80,000 cps. Non-sterile. Biocompatibility per ISO 10993-5, 10993-10, 10993-23.

Indications for Use

Indicated for adults 18 years of age or older to improve skin conductivity when used with the Luminice device.

Regulatory Classification

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.

Predicate Devices

• NuFACE Gel Primer (K161654)

Reference Devices

• DR-HO'S Electro Therapy Conductive Gel (K200402)
• Tech Dots -Conductive gel (K190050)

Submission Summary (Full Text)

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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 [phone] 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: [phone] E-mail: [e-mail] Doris Dong Contact: [Consultant, from Shanghai CV Technology Co., Ltd.] Add: Room 602, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China E-mail: [e-mail] Tel: [phone] / Fax: [phone]

#### 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.<br>The gel is to be applied to the area under an electrode to reduce the<br>impedance of the contact interface between the electrode surface and the<br>skin. |
| Indications for use: | The Avologi Gel Primer is intended to be used with Luminice device to<br>improve 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 Electro<br>Therapy Conductive Gel | Tech Dots -Conductive<br>gel | -- | |
| Model | Av25 | / | DHGEL | / | -- | |
| 510(k) Owner | Premier North America Inc. | Carol Cole Company | Guangzhou Xinbo<br>Electronic 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 Medical<br>Specialty | Neurology | Neurology | Neurology | Neurology | SE | |
| Intended Use | The Avologi Gel Primer is<br>intended to be used with<br>Luminice device to improve<br>skin conductivity. | The NuFACE Gel Primer is<br>intended to be used with<br>NuFACE microcurrent devices<br>to improve skin conductivity. | DR-HO'S Electro<br>Therapy Conductive Gel<br>is intended for use with<br>TENS (transcutaneous<br>electrical nerve<br>stimulation) and EMS<br>(electric muscle<br>stimulation) therapy. The<br>Conductive Gel is used<br>with external to reduce<br>the impedance of the<br>contact between the<br>electrode surface and the<br>skin. | Tech Dots are intended<br>for use in clinical and<br>research EEG/EP<br>recordings from humans.<br>They are used with<br>external electrodes as the<br>conductor between the<br>scalp and recessed<br>electrodes to reduce<br>impedance between the<br>electrode surface and the<br>skin. | 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,<br>Hydrolyzed Hyaluronic Acid,<br>Tremella Fuciformis Sporocarp<br>Extract, Bentaine<br>Glycerin, magnesium sulfate,<br>carbomer,<br>hydroxyethylcellulose,<br>ethylhexylglycerin, potassium | Water/Aqua/Eau, Propanediol,<br>Hydrolyzed Hyaluronic Acid,<br>Tremella Fuciformis Sporocarp<br>Extract, Bentaine<br>Glycerin, magnesium sulfate,<br>carbomer,<br>hydroxyethylcellulose,<br>ethylhexylglycerin, potassium | Purified water (solvent);<br>Carbopol (gel forming);<br>Glycerin (Moisturizing);<br>Sodium hydroxide<br>(Buffering); Triclosan<br>(preservative) | Water, Glycerol<br>(vegetable origin),<br>Polyacrylate copolymer<br>(proprietary), Potassium<br>chloride | SE | |
| | | sorbate, Caprylyl Glycol,<br>phenoxyethanol, sodium<br>hydroxide | sorbate, Caprylyl Glycol,<br>phenoxyethanol, sodium<br>hydroxide | | | |
| Conductivity<br>(mS/cm) | | 2-5 | 3.38 | 2 | 2 | SE<br>Note 3 |
| Microbiological<br>growth | Total Aerobic<br>Microbial Count<br>(cfu/g) | <1.0E+02 | Not publicly available | Not publicly available | Not publicly available | SE<br>Note 4 |
| | Molds &<br>Yeasts<br>(cfu/g) | <10 | Not publicly available | Not publicly available | Not publicly available | |
| | Pseudomonas<br>aeruginosa<br>(cfu/g) | Absence | Not publicly available | Not publicly available | Not publicly available | |
| | Staphylococcus<br>aureus<br>(cfu/g) | Absence | Not publicly available | Not publicly available | Not publicly available | |
| | Escherichia coli<br>(cfu/g) | Absence | Not publicly available | Not publicly available | Not publicly available | |
| | Candida albicans<br>(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.