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 electrodes to reduce the impedance of the contact between the electrode surface and the skin.

Device Description

DR-HO'S Electro Therapy 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 DR-HO'S Electro Therapy Conductive Gel is used on intact skin surfaces. The entire surface of DR-HO'S Electro Therapy Conductive Gel is very conductive, sprayed 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

Your request asks for information about the acceptance criteria and study proving a medical device meets these criteria, based on the provided text.

The provided text is a 510(k) summary for DR-HO'S Electro Therapy Conductive Gel. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting a full clinical trial to prove de novo improved effectiveness or benefit. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to the bench testing conducted to demonstrate safety and performance equivalence to established standards and predicate devices.

Here's the breakdown of the information you requested, based on the provided document:

1. A table of acceptance criteria and the reported device performance

Test Item	Purpose of the Test	Reference Standard	Acceptance Criteria	Reported Device Performance
In vitro Cytotoxicity Test	Determine whether the target device extract is cytotoxic under research conditions.	ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Under the conditions of the study, the subject device extract was determined to be non-cytotoxic.	Pass
Skin Sensitization Test	Determine whether the non-polar and polar extracts of the target device are sensitive under research conditions.	ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing.	Pass
Skin Irritation Test	Determine whether the non-polar and polar extracts of the target device are irritating under research conditions.	ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating.	Pass
Usability Study	To study how usability will be performed in subject device in order to comply with IEC 62366-1 and IEC 60601-1-6	IEC 60601-1-6 Edition 3.1 2013-10 (Usability) & IEC 62366-1 Edition 1.0 2015-02 (Usability Engineering), including CORRIGENDUM 1 (2016)	The subject device can meet the usability goal of IEC 60601-1-6 and IEC 62366-1 standards.	Pass
Shelf Life Test	To study whether the performance of subject device can meet the 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 (Visual Inspection, pH, conductivity, Impedance and Microbiological indicators) tested on both before and after aging samples meet performance required.	Pass
Impedance	Not explicitly stated as a test item in the dedicated "Test Summary" table, but compared in section 7.	Not specified as a reference standard for this specific comparison.	The subject device's impedance ($500\Omega$) is "very similar" to predicate device K161715 ($527.68\Omega$) and $\leq500\Omega$ of predicate K111717.	$500\Omega$
Conductivity (S/m)	Not explicitly stated as a test item in the dedicated "Test Summary" table, but compared in section 7.	Not specified.	The subject device's conductivity ($2 mS/cm$) is the same as predicate device K190050.	$2 mS/cm$
pH	Not explicitly stated as a test item in the dedicated "Test Summary" table, but compared in section 7.	Not specified.	The subject device's pH (7.0 - 7.5) is "a little different" from predicate K161715 (7.15 - 7.33), but "slight" and "close to the pH value of human skin surface" and "close to 7 (neutral)".	7.0 - 7.5

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the individual bench tests (In vitro Cytotoxicity, Skin Sensitization, Skin Irritation, Usability, Shelf Life).
Data provenance (country of origin, retrospective/prospective) is not stated. These are laboratory bench tests and typically do not involve human subject data provenance in the same way clinical studies do. The tests were performed to specific ISO and ASTM standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This document describes performance based on bench testing against international standards (ISO, ASTM, IEC), not clinical studies requiring expert ground truth for interpretation of patient data. Therefore, there were no "experts used to establish the ground truth for the test set" in the context of clinical reads, nor are their qualifications mentioned, as this is not applicable here. The "ground truth" for these tests is the defined acceptance criteria within the standards themselves.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where multiple readers interpret images or data and discrepancies need to be resolved. This document reports laboratory bench tests, not clinical studies with multiple readers. Therefore, no adjudication method is mentioned or applicable.

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

No MRMC comparative effectiveness study was done. This is a 510(k) submission for a conductive gel, which is a Class II medical device. The submission focuses on demonstrating substantial equivalence in terms of safety and basic performance characteristics (biocompatibility, shelf-life, electrical properties) with existing predicate devices, rather than proving a comparative effectiveness outcome with human readers or AI assistance.

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

This device is a conductive gel. It is a physical product, not an algorithm or AI. Therefore, no standalone algorithm performance study was conducted. The "performance" refers to its physical and chemical properties and biocompatibility.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench tests, the "ground truth" is defined by the specific requirements and endpoints set forth in the referenced international standards (ISO 10993-5, ISO 10993-10, IEC 60601-1-6, IEC 62366-1, ASTM F1980-16). For example, for cytotoxicity, the "ground truth" is whether the extract caused cell death as measured by the standard's methodology. For impedance, it's a measurable electrical property.

8. The sample size for the training set

This document describes bench testing and a 510(k) submission based on substantial equivalence, not an AI or machine learning model that would require a "training set." Therefore, no training set sample size is mentioned or applicable.

9. How the ground truth for the training set was established

As there is no training set for this type of device and submission, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue box, and the full name is in blue text.

November 25, 2020

Guangzhou Xinbo Electronic Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, 510700 China

Re: K200402

Trade/Device Name: DR-HO'S Electro Therapy Conductive Gel Regulation Number: 21 CFR 882.175 Regulation Name: Electroconductive Media Regulatory Class: Class II Product Code: GYB Dated: August 13, 2020 Received: August 28, 2020

Dear Cassie Lee:

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/cdrb/cfdocs/cfpmp/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 (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 mediation-emitting products, including information about labeling regulations, please see Device (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,

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) K200402

Device Name

DR-HO'S Electro Therapy Conductive Gel (Model: DHGEL)

Indications for Use (Describe)

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

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

1. Submitter's Information

510(k) Owner's Name: Guangzhou Xinbo Electronic Co., Ltd. Address: 23 Building, Phase-II, Huachuang Industry Park, Panyu, Guangzhou, China. Contact name: Sammy Li Title: Manager Tel: +86-020-66393598 Fax: +86-020-34822409 E-mail: drtvsammy@hotmail.com

Application Correspondent:

Contact Person: Ms. Cassie Lee 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

2. Date of the summary prepared: November 25, 2020

3. Subject Device Information

Company Name: Guangzhou Xinbo Electronic Co., Ltd. Trade/Device Name: DR-HO'S Electro Therapy Conductive Gel Model Name: DHGEL Classification Name: Media, Electroconductive Common Name: Electroconductive Media Product Code: GYB Regulation Number: 882.1275 Regulatory Class: 2

4. Predicate Device Information

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Sponsor	THE DEZAC GROUP	EndyMed Medical Ltd.	Spes Medica S.r.l.
Device Name	Conductive Gel	EndyGelTM	Tech Dots
510(k) Number	K022006	K161715	K190050
Product Code	GYB	GYB	GYB
Regulation Number	882.1275	882.1275	882.1275
Regulation Class	II	II	II

5. Device Description

The DR-HO'S Electro Therapy Conductive Gel is used on intact skin surfaces. The entire surface of DR-HO'S Electro Therapy Conductive Gel is very conductive, sprayed 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.

Intended Use / Indications for Use 6.

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.

7. Test Summary

DR-HO'S Electro Therapy Conductive Gel (Model: DHGEL) has been evaluated the safety and performance by lab bench testing as following:

Test Item	Purpose of thetest	ReferenceStandard	Acceptancecriteria	Test results
In vitro CytotoxicityTest	Under theresearchconditions,determine whetherthe target deviceextract is cytotoxic.	ISO 10993-5:2009Biologicalevaluation ofmedical devices-Part 5: Tests for invitro cytotoxicity	Under theconditions of thestudy, the subjectdevice extract wasdetermined to benon-cytotoxic.	Pass
Skin SensitizationTest	Under theresearchconditions,determine whetherthe non-polar andpolar extracts ofthe target deviceare sensitive.	ISO 10993-10:2010 Biologicalevaluation ofmedical devices-Part 10: Tests forirritation and skinsensitization	Under theconditions of thestudy, the subjectdevice non-polarand polar extractswere determinedto be non-sensitizing.	Pass
Skin Irritation Test	Under theresearchconditions,determine whetherthe non-polar andpolar extracts ofthe target deviceare irritating.	ISO 10993-10:2010 Biologicalevaluation ofmedical devices-Part 10: Tests forirritation and skinsensitization	Under theconditions of thestudy, the subjectdevice non-polarand polar extractswere determinedto be non-irritating.	Pass
Usability Study	To study howusability will beperformed insubject device inorder to complywith IEC 62366-1and IEC 60601-1-6	IEC 60601-1-6Edition 3.1 2013-10, Medicalelectricalequipment - Part1-6: Generalrequirements forbasic safety andessentialperformance -Collateralstandard: UsabilityIEC 62366-1Edition 1.0 2015-02, Medicaldevices - Part 1:Application ofusabilityengineering tomedical devices[IncludingCORRIGENDUM 1(2016)]	The subject devicecan meet theusability goal ofIEC 60601-1-6 andIEC 62366-1standards.	Pass
Shelf Life Test	To study whetherthe performance ofsubject device canmeet the 2-yearshelf liferequirements	ASTM F1980-16:Standard Guide forAccelerated Agingof Sterile BarrierSystems forMedical Devices;Guidancedocument for the"Shelf Life ofMedical Devices"issued in April1991	All items (VisualInspection,pH, conductivity,Impedance andMicrobiologicalindicators) testedon both before andafter agingsamplesmeet performancerequired.	Pass

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Comparison to predicate device and conclusion 8.

The technological characteristics, features, specifications, materials, and intended use of Electrode is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

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Elements ofComparison	Subject Device	PredicateDevice 1(Primarypredicate)	Predicate Device 2	Predicate Device3	Predicate Device 4	Remarks	Body contact	Intact Skin	Not publiclyavailable	Intact Skin	Intact Skin	Intact Skin	SE
Device Nameand Model	DR-HO'S ElectroTherapyConductive GelModel: DHGEL	Conductive Gel	EndyGel™	Tech Dots -Conductive gel	Electro-Gel	--	sterilization	non-sterile	Not publiclyavailable	non-sterile	non-sterile	non-sterile	SE
510(k) Number	Applying	K022006	K161715	K190050	K111717	--	Shelf life	2 years	Not publiclyavailable	2 years	3 years	1 year	SE
Product Code	GYB	GYB	GYB	GYB	GYB	SE	Weight	250g / bottle	Not publiclyavailable	Not publicly available	0.14 ± 0.01 g perDot	16 ounce, 32ounce, 128 ounce	--
Intended Use /Indications forUse	DR-HO'S ElectroTherapyConductive Gel isintended for usewith TENS(transcutaneouselectrical nervestimulation) andEMS (electronicmusclestimulation)therapy. It is to beuse to moisten theelectrodes and theskin, to reduceimpedance of thecontact betweenthe electrodesurface and theskin. This helps toprovide a morecomfortable andeffectivetreatment.	The ConductiveGel is intendedfor use withTENS(transcutaneouselectrical nervestimulators) andEMS(electricalmusclestimulators). TheConductive Gel isused withexternal toreduce theimpedance of thecontact betweenthe electrodesurface and theskin.	EndyGel™ is an Electroconductive gelmedia used with external electrode toreduce the impedance (resistance toalternating current) of the contactbetween the electrode surface and theskin.	Tech Dots areintended for use inclinical andresearch EEG/EPrecordings fromhumans. They areused with externalelectrodes as theconductorbetween the scalpand recessedelectrodes toreduce impedancebetween theelectrode surfaceand the skin.	This device isintended for use inclinical andresearch EEG/EPrecordings fromhumans. TheElectro-Gel is usedwith externalelectrodes as theconductor betweenthe scalp and the(recessed)electrodes. It alsoreduces impedance(resistance toalternating current)between theelectrode surfaceand the skin.	SENote 1	Impedance	$500Ω$	Not publiclyavailable	$527.68Ω$	$80 ± 10 Ohm$	$≤500Ω$	SENote 2
RegulationNumber	882.1275	882.1275	882.1275	882.1275	882.1275	SE	Conductivematerial	Purified water withSodium hydroxide	Not publiclyavailable	Water (Aqua) with immersedTriethanolamine	Salt (NaCl)	Salt (NaCl)	SENote 3
Composition	- Purified water(solvent);- Carbopol (gelforming);- Glycerin(Moisturizing);- Sodiumhydroxide(Buffering);- Triclosan(preservative)	Not publiclyavailable	- Water (solvent);- Carbomer (gel forming);- Triethanolamine (Buffering);- Methylisothiazolinone(preservative)	- Water- Glycerol(vegetableorigin)- Polyacrylateco-polymer(proprietary)- Potassiumchloride	- Aragum- Glycerine- Methyparaben- Propylprarben	SENote 4
Percentconcentrationof eachingredient	- Purified water:98.25%- Carbopol:0.5%- Glycerin: 1%- Sodiumhydroxide:0.2%- Triclosan:0.05%	Not publiclyavailable	Not publicly available	Not publiclyavailable	Not publiclyavailable	--
Conductivity(S/m)	2 mS/cm	Not publiclyavailable	Not publicly available	2 mS/cm	Not publiclyavailable	SE

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pH	7.0 - 7.5	Not publiclyavailable	7.15 - 7.33	4 - 5	4.5 - 6.0	SENote 5
Biocompatibility	Complied withISO 10993-5, ISO10993-10	Not publiclyavailable	Complied with ISO 10993-5, ISO 10993-10	Complied with ISO10993-5, ISO10993-10	Complied with ISO10993-5, ISO10993-10	SE
Cytotoxicity	Yes	Not publiclyavailable	Yes	Yes	Yes	SE
Irritation	Yes	Not publiclyavailable	Yes	Yes	Yes	SE
Sensitization	Yes	Not publiclyavailable	Yes	Yes	Yes	SE
OperatingEnvironment	Temperature:5~~40°CHumidity:≤80%RHAtmosphericPressure:86~~106kPa	Not publiclyavailable	Not publicly available	Not publiclyavailable	Not publiclyavailable	--
StorageEnvironment	Temperature:5~~40°CHumidity: ≤95%RHAtmosphericPressure: 50~~106kPa	Not publiclyavailable	Not publicly available	Not publiclyavailable	Not publiclyavailable	--

Comparison in Detail(s):

Note 1:

Although the "Intended use" of subject device is a little different from predicate devices, we can find that their core is to reduce the impedance to the skin without affecting the use of the slight differences in description will not raise any safety or effectiveness issue.

Note 2:

Although the "Impedance" of the subject device is a little different from the predicate of 5002 which is very similar to the impedance 527.68Ω of the predicate device (K161715) and ≤500Ω of the predicate device (K11717). Considering that, no new questions of safety or effectiveness are raised.

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Note 3:

Although the "Conductive material" of the subject devices, but they all composed of water (solvent) and / or conductive buffer to achieve conductivity of the slight differences in description will not raise any safety or effectiveness issue.

Note 4:

Although the specific materials of subject devices, but both the materials for the materials for the subject device and for the predicate device have substantially equival, gel forming, Moisturizing, Buffering, preservative) in the process of producing the gel, so these differences do not raise different issue of safety or effectiveness.

Note 5:

Although the "ph" of the subject device is a little different from predicate device (K161715), but the difference is slight, and it is close to the pH value of human skin surface, the pH is closed to 7 (neutral), beside, even the water for drinking is required <8 (neutral to Alkaline), which can prove the pH of subject device is safe. So the slight differences in description will not raise any safety or effectiveness issue.

Finial Conclusion:

The subject device "DR-HO'S Electro Therapy Conductive Gel, (Model: DHGEL)" is Substantial Equivalent to the predicate devices K022006, K161715, K190050 and K11171.

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).