The Adhesive Electrodes are intended for use as a reusable, conductive interface between the patient's skin and the marketed electrical stimulators i.e. TENS (Transutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.

Device Description

Adhesive Electrodes are composed of non-woven fabric, carbon film coated with silver and conductive hydrogel; It is identical in technological characteristics compared to the predicate device, Adhesive Electrodes, OACWN serial cleared in K160138 and the subject devices are also to be sold for over-the-counter (OTC) use and prescription use, which is the same as the predicate device.

Adhesive Electrodes manufactured by Voncare Medical Device Co., Ltd are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application.

First layer: Insulating backing material-nonwoven coated with 30-50um bio-compatible medical adhesive tape
Second layer: Conductive film
Third layer: Bio-compatible self-adhesive conductive hydrogel, thickness 1.0+/-0.2mm
Protective silicon liner: PET

The electrodes are designed for single-patient/multiple application use. Because of the biocompatible conductive hydrogel's adhesive nature, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the electrical stimulator by lead wire, with a standard .080" female socket connector. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly complies with FDA performance standard 21 CFR Part 898.

AI/ML Overview

The provided text describes the regulatory clearance (K212191) for "Adhesive Electrodes" manufactured by Voncare Medical Device Co., Ltd. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness. Therefore, the study details are primarily related to non-clinical performance and safety testing.

Here's a breakdown of the requested information based only on the provided text:

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

Performance Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (Subject Device)	Difference Discussion
A.C. Impedance	<300 ohms	<200 ohms A.C. Impedance of Pair electrode	The difference does not raise any new safety and effectiveness questions and complies with the same performance and safety requirements.
Force required to remove the wire from the electrode	>6 pounds of force	>7 pounds of force	The difference does not raise any new questions of safety and effectiveness which meet the design requirement.
Biocompatibility	Complies with ISO10993	Complies with ISO10993	Identical
Sterility Status	Non-sterile	Non-sterile	Identical
Single Patient Use	Single Patient Use	Single Patient Use	Identical

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

Sample Size for Test Set: The document does not specify the sample size for individual tests. It states that "Non-clinical tests were conducted."
Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. Given that the manufacturer is based in China, it's highly probable the testing was conducted there or overseen by the manufacturer.

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 information is not applicable and not provided in the document. The tests performed are non-clinical (e.g., electrical impedance, mechanical strength, biocompatibility), which rely on standardized measurement methods rather than expert interpretation of a "ground truth" in the clinical sense.

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

This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies involving human interpretation or challenging endpoints.

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 study was conducted. The device is an adhesive electrode, a passive component, not an AI-powered diagnostic or assistive tool for human readers. The document explicitly states: "No clinical study is included in this submission."

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

Not applicable. The device is an adhesive electrode, not an algorithm, and does not involve AI or standalone performance in the context of diagnostic or interpretive tasks.

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

For the non-clinical tests, the "ground truth" is defined by the applicable standards requirements (e.g., ANSI/AAMI ES60601-1 for safety/performance, ISO10993 for biocompatibility) and the predicate device's performance characteristics. The tests verify that the subject device meets these established performance and safety benchmarks.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm and therefore does not have a training set.

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

Not applicable. This device is not an AI algorithm and therefore does not have a training set.

Summary

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October 6, 2021

Voncare Medical Device Co., Ltd % Charles Mack Principal Engineer IRC 2950 E Lindrick Drive Chandler, Arizona 85249

Re: K212191

Trade/Device Name: Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: July 10, 2021 Received: July 12, 2021

Dear Charles Mack:

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.

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) K212191

Device Name Adhesive Electrodes

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Device 510k number: K212191 Preparation Date: October 6, 2021

Submitter Information:

Voncare Medical Device Co., Ltd Shiwan Science and Technology Industrial Park, Yongshi Avenue East, Boluo County, Huizhou City, Guangdong Province, China 516127 Tel:+86-752-6730765 Contact person: Mr. Jimmy Zhai (General Manager)

Corresponding Official: Charles Mack Telephone number: 931-625-4938

FDA Registration Number:

Owner/Operator Number: 10047792 Establishment Registration Number: 3011307234

Regulatory Information:

Trade name: Adhesive Electrodes Common Name: Reusable Neurostimulation Electrodes Classification Name: Electrodes, cutaneous Regulation Number: 882.1320 Product Code: GXY Classification: Class II

Predicate Device:

K160138 GMDASZ Adhesive Electrodes (GMDASZ Manufacturing Co., Ltd.)

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Device Description:

Adhesive Electrodes manufactured by Voncare Medical Device Co., Ltd are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application.

First layer: Insulating backing material-nonwoven coated with 30-50um bio-

compatible medical adhesive tape

Second layer: Conductive film

Third layer: Bio-compatible self-adhesive conductive hydrogel, thickness 1.0+/-0.2mm

Protective silicon liner: PET

Indications for Use:

The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e., TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential), or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.

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Comparison to predicate device:

Characteristics	Subject Device	Predicate Device	Difference Discussion
510K Applicant	Voncare Medical Device Co., Ltd	GMDASZ Manufacturing Co., Ltd.	-
510(K) Number	N/A	K160138	-
Device Name	Adhesive Electrodes	Adhesive Electrodes	-
Model	TS0020/TS0030/TS0050/TS5050/TS5089/TS50130	OACWN1005/OACWN1007/OACWN2505/ OACWN2509	-
RegulationNumber	882.1320	882.1320	Identical
Product Code	GXY	GXY	Identical
ClassificationName	Cutaneous electrode	Cutaneous electrode	Identical
OTC orPrescription	OTC & Prescription	OTC & Prescription	Identical
Medical Specialty	Neurology	Neurology	Identical
Intended Use	The Adhesive Electrodes areintended for use as a reusable,conductive adhesive interfacebetween the patient's skin and themarketed electrical stimulators(i.e., TENS (TranscutaneousElectrical Nerve Stimulation),EMS (Electrical MuscularStimulation), IF (Interferential), orPGF (Pulsed GalvanicStimulation) for transmittingelectrical current. The electrode isfor OTC (Over-The-Counter) orPrescription use.	The Adhesive Electrodes areintended for use as a reusable,conductive adhesive interfacebetween the patient's skin and themarketed electrical stimulators(i.e., TENS (TranscutaneousElectrical Nerve Stimulation), EMS(Electrical Muscular Stimulation),IF (Interferential), or PGF (PulsedGalvanic Stimulation) fortransmitting electrical current. Theelectrode is for OTC (Over-The-Counter) or Prescription use.	Identical
Characteristics	Subject Device	Predicate Device	Difference Discussion
Design Feature	Three layers:1 insulating backing material: non-woven fabric2 Conductive film: Carbon filmcoated with silver/Aluminum foilfilm3 Conductive hydrogel (VG100)	Three layers:1. Insulation backing material:Fabric/Foam/Tan fabric2. Conductive film: Carbon filmcoated with silver/Aluminum foil film3. Conductive hydrogel (A, T, or Ugel)	1. Same2. Same3. The material ofconductive hydrogel isdifferent.The difference does notraise any new safety andeffectiveness questionsand complies with thesame biocompatible,performance, and safetyrequirements.
ElectricalConnection	Leadwire	Leadwire	Identical
Protective Liner	PET	PET	Identical
Lead Wireconnector	Leadwire connector .080" femalesocket connector	Leadwire connector .080" femalesocket connector	Identical
Reusable	Reusable	Reusable	Identical
Packaging	Re-sealable bag packed	Re-sealable bag packed	Identical
Self-adhesive	Self-adhesive	Self-adhesive	Identical
Biocompatibility	Complies with ISO10993	Complies with ISO10993	Identical

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Characteristics	Subject Device	Predicate Device	Difference Discussion
A.C. Impedance	<200 ohms A.C. Impedance ofPair electrode	<300 ohms	The difference does notraise any new safety andeffectiveness questionsand complies with thesame performance andsafety requirements.
Force required toremove the wirefrom theelectrode	More than 7 pounds of force	More than 6 pounds of force	The difference does notraise any new questionsof safety andeffectiveness which meetthe design requirement
Sterility Status	Non-sterile	Non-sterile	Identical
Single PatientUse	Single Patient Use	Single Patient Use	Identical

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Test Summary:

To establish substantial equivalence to the identified predicate devices, we performed the following tests on the subject device, Adhesive Electrodes TS serial, and the testing results provide evidence that the device complies with the applicable standards requirement and it is substantially equivalent to the predicate devices.

Non-Clinical Study:

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrate that the proposed device complies with the following standards:

Safety and EMC

To verify the basic safety and essential performance of the subject device, we performed the test noted below:

। ANSI/AAMI ES60601-1: 2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
The test result shows the device complies with the standard's requirements.

Performance Data:

To verify the performance of the subject device, we conducted the tests noted below:

-Adhesion Test
Pair AC Impedance and Current Dispersion Test -
Retention Test -
Reusability and stability test -
Storability Test (Shelf Life) -
EC12 Disposable ECG electrodes -
EC53 ECG Cables and Leadwire -

The test results demonstrate the device meets the requirements.

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Biocompatibility

According to ISO10993-1 Fourth edition, 2009-10-15 Annex A Table A.1 -Evaluation tests for consideration, the subject device is classified as: Surface Device > Contact Intact Skin >> Limited Contact Duration(:524h)

We conducted the applicable tests noted below: Cytotoxicity Tests (ISO10993-5) Skin Irritation Test (ISO10993-10) Skin Sensitization Test (ISO10993-10)

The test result shows it complies with the requirement.

Sterility Information

Not applicable, the subject device is not sterile.

Clinical Study:

No clinical study is included in this submission.

Conclusion:

The submitted new Adhesive Electrodes have the same intended use and similar technological characteristics as the predicate devices. Moreover, the information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the submitted adhesive electrodes are substantially equivalent to the predicate devices.

END

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).