(550 days)
No
The summary describes a gel primer intended to improve skin conductivity for use with an electrical stimulation device. There is no mention of AI, ML, image processing, or any data-driven algorithms. The performance studies focus on biocompatibility, shelf life, and physical properties of the gel itself.
No
The device, Avologi Gel Primer, is a conductive gel used to improve skin conductivity for another device (Luminice). Its intended use and description indicate it is an accessory or component that facilitates the function of another device, rather than directly providing a therapeutic effect itself. The performance studies focus on its biocompatibility, shelf life, and physical properties, not on treating or preventing a disease or condition.
No
The device is a conductive gel used with another device (Luminice) to improve skin conductivity, not to diagnose a condition or disease.
No
The device description clearly states it is a "clear, viscous and chloride-free formulation" which is a physical substance (gel), not software.
Based on the provided information, the Avologi Gel Primer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "improve skin conductivity" when used with a specific device (Luminice) for topical application on intact skin. This is a physical interaction with the body's surface, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description focuses on its physical properties (clear, viscous, chloride-free) and its function in reducing impedance at the skin-electrode interface. This aligns with a topical medical device, not a diagnostic reagent or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
- Anatomical Site: The application is "Topically on intact skin," which is typical for external medical devices, not IVDs.
- Performance Studies: The performance studies focus on biocompatibility, shelf life, and physical properties related to its function as a conductive gel. These are relevant for a topical medical device, not an IVD.
In summary, the Avologi Gel Primer is a topical medical device intended to facilitate the function of another device (Luminice) by improving skin conductivity. It does not perform any diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The Avologi Gel Primer is intended to be used with Luminice device to improve skin conductivity.
Product codes (comma separated list FDA assigned to the subject device)
GYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Topically on intact skin
Indicated Patient Age Range
Adults 18 years of age or older
Intended User / Care Setting
Home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Shelf life testing:
- The shelf life of Avologi Gel Primer is 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: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
1
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
2
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 the | |
| impedance of the contact interface between the electrode surface and the | |
| skin. | |
| Indications for use: | The Avologi Gel Primer is intended to be used with Luminice device to |
| 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. |
4
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.
5
| 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 | |||
| Therapy Conductive Gel | Tech Dots -Conductive | |||||
| gel | -- | |||||
| Model | Av25 | / | DHGEL | / | -- | |
| 510(k) Owner | Premier North America Inc. | Carol Cole Company | Guangzhou Xinbo | |||
| 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 | ||||||
| Specialty | Neurology | Neurology | Neurology | Neurology | SE | |
| Intended Use | The Avologi Gel Primer is | |||||
| intended to be used with | ||||||
| Luminice device to improve | ||||||
| skin conductivity. | The NuFACE Gel Primer is | |||||
| intended to be used with | ||||||
| NuFACE microcurrent devices | ||||||
| to improve skin conductivity. | DR-HO'S Electro | |||||
| Therapy Conductive Gel | ||||||
| is intended for use with | ||||||
| TENS (transcutaneous | ||||||
| electrical nerve | ||||||
| stimulation) and EMS | ||||||
| (electric muscle | ||||||
| stimulation) therapy. The | ||||||
| Conductive Gel is used | ||||||
| with external to reduce | ||||||
| the impedance of the | ||||||
| contact between the | ||||||
| electrode surface and the | ||||||
| skin. | Tech Dots are intended | |||||
| for use in clinical and | ||||||
| research EEG/EP | ||||||
| recordings from humans. | ||||||
| They are used with | ||||||
| external electrodes as the | ||||||
| conductor between the | ||||||
| scalp and recessed | ||||||
| electrodes to reduce | ||||||
| impedance between the | ||||||
| electrode surface and the | ||||||
| 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, | |||||
| Hydrolyzed Hyaluronic Acid, | ||||||
| Tremella Fuciformis Sporocarp | ||||||
| Extract, Bentaine | ||||||
| Glycerin, magnesium sulfate, | ||||||
| carbomer, | ||||||
| hydroxyethylcellulose, | ||||||
| ethylhexylglycerin, potassium | Water/Aqua/Eau, Propanediol, | |||||
| Hydrolyzed Hyaluronic Acid, | ||||||
| Tremella Fuciformis Sporocarp | ||||||
| Extract, Bentaine | ||||||
| Glycerin, 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), Potassium | ||||||
| chloride | SE | |||||
| sorbate, Caprylyl Glycol, | ||||||
| phenoxyethanol, sodium | ||||||
| hydroxide | sorbate, Caprylyl Glycol, | |||||
| phenoxyethanol, sodium | ||||||
| hydroxide | ||||||
| Conductivity | ||||||
| (mS/cm) | 2-5 | 3.38 | 2 | 2 | SE | |
| Note 3 | ||||||
| Microbiological | ||||||
| growth | Total Aerobic | |||||
| Microbial Count | ||||||
| (cfu/g) |