Intended for use with electric stimulation therapy devices, such as TENS and EMS. Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode and the skin.

Device Description

Conductive Gel can be used with any of dozens of stimulating devices that are legally sold, to reduce the impedance between the skin and the stimulating device. It consists of Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2% and Triclosan: 0.05%. And the Purified water used as the solvent, the Carbopol as a gel forming material, the Glycerin as a Moisturizing, the Sodium hydroxide as a Buffering and the Triclosan as a preservative. The Conductive Gel is used on intact skin surfaces. The entire surface of Conductive Gel is very conductive, smeared evenly on the stimulation device, so that the current is evenly distributed. The gel is to be generously applied to the area where an electrode will be used. The gel can be washed off the skin after use.

AI/ML Overview

This document describes the validation of a "Conductive Gel" medical device. Here's a breakdown of the acceptance criteria and the study conducted to prove it:

1. Table of Acceptance Criteria and Reported Device Performance

Test Item	Purpose of the Test	Reference Standard	Acceptance Criteria	Test Results
In vitro Cytotoxicity Test	Determine if the target device extract is cytotoxic	ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Non-cytotoxicity to L929 cells	Pass
Skin Sensitization Test	Evaluate skin sensitization after topical applications	ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Frequency of positive challenge results in sample extract and Negative control animals are 0%, Positive control is 100%	Pass
Skin Irritation Test	Evaluate skin irritation after single topical applications	ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Negligible irritation in a rabbit skin single exposure test	Pass
Usability Study	Study how usability will be performed	IEC 62366-1 Edition 1.0 2015-02, Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]	The subject device can meet the usability goal of IEC 62366-1 standards	Pass
Shelf Life Test	Study if performance meets 2-year shelf life requirements	ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices; Guidance document for the "Shelf Life of Medical Devices" issued in April 1991	All items (Exterior, Package, pH, Impedance and conductivity) tested on both before and after aging samples meet the performance required	Pass

Additional Performance Data from Comparison to Predicate Device:

Item	Acceptance Criteria (Predicate)	Reported Device Performance (Subject Device)
Impedance (at 1 MHz)	≤ 500 Ω	≤ 500 Ω
pH	7.0 - 7.5	6.5 - 7.5
Percent Concentration of Ingredients	Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2%, Triclosan: 0.05%	Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2%, Triclosan: 0.05%

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample sizes for each non-clinical test (cytotoxicity, sensitization, irritation, usability, shelf life). However, it refers to standard biological evaluation and aging test methods (ISO 10993-5, ISO 10993-10, IEC 62366-1, ASTM F1980-16), which inherently define sample sizes for their respective procedures, typically involving animal models for biological tests or specific numbers of units for usability/shelf life.

Data Provenance: The studies were identified as "lab bench testing." The location of these labs or the country of origin for the data is not specified beyond the submitter's and correspondent's addresses (China). The tests are non-clinical, meaning they were not conducted on human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided as the validation is based on non-clinical (lab bench) testing against established standards, not on expert consensus or human reader performance.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the validation is based on objective lab bench testing against predefined acceptance criteria, not subjective interpretations requiring adjudication.

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

Not applicable. This device is a conductive gel, which is a physical product, not an AI or software device that would involve human readers or comparative effectiveness studies with AI assistance.

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

Not applicable. As mentioned, this is a physical medical device (conductive gel), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established scientific and regulatory standards and their defined criteria.

For biological tests (cytotoxicity, sensitization, irritation), the ground truth is whether the device elicits a toxic or adverse biological response as determined by standardized in-vitro and in-vivo (animal) models.
For usability, the ground truth is compliance with IEC 62366-1 usability engineering principles.
For shelf life, the ground truth is the maintenance of specified physical and chemical properties (like pH, impedance, conductivity, exterior, package integrity) over the declared shelf life based on accelerated aging models.
For material composition, the ground truth is the precise percentage concentration of each ingredient.
For impedance and pH, the ground truth is the measured value compared to the specified range or limit.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, there is no training set for this type of device.

Summary

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December 13, 2022

Top-Rank Health Care Co.,Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technoloy Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510000 China

Re: K222770

Trade/Device Name: Conductive Gel Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive media Regulatory Class: Class II Product Code: GYB Dated: September 14, 2022 Received: September 14, 2022

Dear Cassie Lee:

We have reviewed your 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.

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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 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) K222770

Device Name Conductive Gel

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Date of the summary prepared: December 8, 2022

2. Submitter's Information

Sponsor Name: Top-Rank Health Care Co. Ltd.

Address: Mashan Village, Dongguan Street, Shangyu District, Shaoxing City, Zhejiang

Province, China. 312300

Establishment Registration Number: Applying

Contact name: Gangfeng Lou

Title: Chairman of the board

Tel: +86-0575-82912999

Fax: +86-0575-82912999

E-mail: info@etop-rank.com

Application Correspondent:

Contact Person: Ms. Cassie Lee Company: Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com

3. Subject Device Information

Type of 510(k): Traditional Company Name: Top-Rank Health Care Co. Ltd. Trade/Device Name: Conductive Gel

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Model Name: TG01-50, TG01-65, TG01-90, TG01-100, TG01-125, TG01-160, TG01-200, TG01-250 510k Review Panel: Neurology Classification Name: Media, Electroconductive Product Code: GYB Regulation Number: 21 CFR 882.1275 Regulatory Class: II

Intended Use / Indications for Use:

Intended for use with electric stimulation therapy devices, such as TENS and EMS. Conductive Gel is used with external electrode to reduce the impedance of the contact between the electrode and the skin.

4. Predicate Device Information

Predicate Device:

Sponsor: Guangzhou Xinbo Electronic Co., Ltd. Common Name: Media, Electroconductive Trade/Device Name: DR-HO'S Electro Therapy Conductive Gel Classification Name: Media, Electroconductive 510(K) Number: K200402 510k Review Panel: Neurology Product Code: GYB Regulation Number: 21 CFR 882.1275 Regulatory Class: II

Intended Use / Indications for Use:

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.

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5. Device Description

Elements ofComparison	Subject Device	Predicate Device	Remark
Device Nameand Model	Conductive GelModel: TG01-50, TG01-65, TG01-90, TG01-100,TG01-125, TG01-160,TG01-200, TG01-250	DR-HO'S Electro TherapyConductive GelModel: DHGEL	--
510(k) Number	K222770	K200402	--
Product Code	GYB	GYB	SE
Intended Use /Indications forUse	Intended for use withelectric stimulation therapydevices, such as TENSand EMS. Conductive Gelis used with externalelectrode to reduce theimpedance of the contact	DR-HO'S Electro TherapyConductive Gel is intendedfor use with TENS(transcutaneous electricalnerve stimulation) and EMS(electric muscle stimulation)therapy. The Conductive Gel	SimilarNote 1

	between the electrode andthe skin.	is used with external toreduce the impedance of thecontact between theelectrode surface and theskin.
RegulationNumber	882.1275	882.1275	SE
Body contact	Intact Skin	Intact Skin	SE
Sterilization	Non-Sterile	Non-Sterile	SE
Shelf life	2 years	2 years	SE
Impedance (at 1MHz)	$\leq500\Omega$	500Ω	SimilarNote 2
Material	Purified water (solvent);Carbopol (gel forming);Glycerin (Moisturizing);Sodium hydroxide(Buffering); Triclosan(preservative)	Purified water (solvent);Carbopol (gel forming);Glycerin (Moisturizing);Sodium hydroxide(Buffering); Triclosan(preservative)	SE
Percentconcentration ofeach ingredient	- Purified water:98.25%;- Carbopol: 0.5%;- Glycerin: 1%;- Sodium hydroxide:0.2%;- Triclosan: 0.05%	- Purified water: 98.25%- Carbopol: 0.5%- Glycerin: 1%- Sodium hydroxide: 0.2%- Triclosan: 0.05%	SE
pH	6.5 ~ 7.5	7.0-7.5	SimilarNote 3
Preservative	Triclosan	Triclosan	SE
Biocompatibility	Complied with ISO 10993-5, ISO 10993-10	Complied with ISO 10993-5,ISO 10993-10	SE
Cytotoxicity	Yes	Yes	SE
Irritation	Yes	Yes	SE
Sensitization	Yes	Yes	SE
OperatingEnvironment	Temperature: 5~~40°CHumidity: ≤80%RHAtmospheric Pressure:86~~106kPa	Temperature: 5~~40°CHumidity: ≤80%RHAtmospheric Pressure:86~~106kPa	SE
StorageEnvironment	Temperature: 5~~40°CHumidity: ≤95% RHAtmospheric Pressure:50~~106 kPa	Temperature: 5~~40°CHumidity: ≤95% RHAtmospheric Pressure:50~~106 kPa	SE

6. Comparison to predicate device and conclusion

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Comparison in Detail(s):

Note 1:

Although the "Intended Use / Indications for Use" of subject device is slightly different from predicate device, it's just a difference in how they are described. So, the slight difference will not raise any safety or effectiveness issue.

Note 2:

Although the "Impedance" of the subject device is lower than the predicate device, it does not affect the effectiveness of the product in use. So, the slight difference in Impedance will not raise any safety or effectiveness issues.

Note 3:

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Although the "pH" of the subject device is a little different from the predicate device, both of them are close to the pH value of the human skin surface, the pH is closed to 7 (neutral). So, the slight difference in pH will not raise any safety or effectiveness issues.

7. Test Summary

7.1 Summary of Non-Clinical Testing

Conductive Gel (Model: TG01-50, TG01-65, TG01-90, TG01-100, TG01-125, TG01-160, TG01-200, TG01-250) has been evaluated the safety and performance by lab bench testing as following:

Test Item	Purpose of the test	Reference Standard	Acceptance criteria	Test results
In vitroCytotoxicityTest	Under the research conditions, determine whether the target device extract is cytotoxic.	ISO 10993-5:2009Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity	Under the conditions of this study, the Test Sample were non-cytotoxicity to L929 cells.	Pass
SkinSensitizationTest	Under the research conditions, to evaluate the possibility of skin sensitization after topical applications of the test sample on the skin of guinea pig.	ISO 10993-10:2010Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization	Under the conditions of this study, the frequency of positive challenge results in sample extract and Negative control animals are 0%, the Positive control is 100%.	Pass
Skin IrritationTest	Under theresearchconditions, toevaluate thepossibility of skinirritation aftersingle topicalapplications of thetest sample on theskin of rabbits.	ISO 10993-10:2010Biological evaluationof medical devices-Part 10: Tests forirritation and skinsensitization	Under theconditions of thisstudy, the testsample inducenegligible irritationin a rabbit skinsingle exposuretest.	Pass
UsabilityStudy	To study howusability will beperformed insubject device inorder to complywith IEC 62366-1	IEC 62366-1 Edition1.0 2015-02, Medicaldevices - Part 1:Application of usabilityengineering to medicaldevices [IncludingCORRIGENDUM 1(2016)]	The subject devicecan meet theusability goal ofIEC 62366-1standards.	Pass
Shelf LifeTest	To study whetherthe performanceof subject devicecan meet the 2-year shelf liferequirements	ASTM F1980-16:Standard Guide forAccelerated Aging ofSterile BarrierSystems for MedicalDevices;Guidance documentfor the "Shelf Life ofMedical Devices"issued in April 1991	All items (Exterior,Package, pH,Impedance andconductivity)tested on bothbefore and afteraging samplesmeet theperformancerequired.	Pass

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7.2 Summary of Non-Clinical Testing

No clinical study is included in this submission.

8. Final Conclusion

The subject device "Conductive Gel, (Model: TG01-50, TG01-65, TG01-90, TG01-100, TG01-125, TG01-160, TG01-200, TG01-250)" is as safe and effective and substantially equivalent to the legally marketed predicated K200402.

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).