This product is an adhesive electrode which is intended for use as the re-usable, conductive interface between the patient's skin and the Electrical Stimulator. It is intended to be used with legally marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

Device Description

The Reusable and Self-Adhesive Electrodes are made of conductive hydrogel, fabric cloth and carbon film. They work when sticking to human skin and connecting with electrical stimulators by lead wires. During the treatment, electrical pulses are passed across the intact surface of the skin to activate the underlying nerves.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device: "Reusable and Self-Adhesive Electrodes." The primary purpose of this document is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to present a comprehensive study proving novel acceptance criteria for a new type of device or algorithm.

Therefore, many of the requested categories for AI/algorithm-based studies (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, effect size of AI assistance) are not applicable to this type of regulatory submission. This document details the non-clinical testing performed to show equivalence in basic device performance and biocompatibility.

Here's an analysis based on the information available:

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

Acceptance Criteria Category	Specific Test Performed	Acceptance Criteria (Implied)	Reported Device Performance
Electrode Performance	Electrical Impedance Performance	Met relevant standards/specifications for conductive electrodes.	"All evaluation acceptance criteria were met" for electrode performance testing.
	Adhesive Performance	Met relevant standards/specifications for medical adhesives.	"All evaluation acceptance criteria were met" for adhesive performance testing.
	Tensile Strength	Met relevant standards/specifications for device integrity.	"All evaluation acceptance criteria were met" for tensile strength testing.
Biocompatibility	Cytotoxicity (ISO 10993-5)	No evidence of cytotoxic potential.	"All evaluation acceptance criteria were met"
	Irritation (ISO 10993-10)	No evidence of irritation potential.	"All evaluation acceptance criteria were met"
	Sensitization (ISO 10993-10)	No evidence of sensitization potential.	"All evaluation acceptance criteria were met"
Stability	Shelf life	Maintained performance characteristics for claimed shelf life.	"3 years" shelf life reported for the subject device. (Predicate: 2 years, deemed substantially equivalent).
Reusability	Maintained performance after multiple uses (as reusable).	Maintained performance over specified reuses.	Device is "reusable" (for single patient), performance maintained for the intended reusability.

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

Sample Size: Not specified in the document. For non-clinical tests like material strength, impedance, and biocompatibility, sample sizes are typically determined by relevant ISO standards or internal quality procedures.
Data Provenance: Not explicitly stated, but the testing would have been conducted by the manufacturer (Shaoxing DongZhi Electrical Technology Co., Ltd. in China) or a certified testing laboratory. The standard for biocompatibility is ISO 10993-1:2009. These are prospective tests conducted on manufactured device samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. These are non-clinical device performance and material safety tests, not diagnostic or interpretive tasks requiring expert consensus. The "ground truth" is established by direct measurement and adherence to defined physical and biological standards.

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

Not applicable. Adjudication is for human interpretation and consensus. These tests involve objective measurement against predetermined criteria.

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 is a medical device for electrical stimulation, not an AI diagnostic or interpretive tool.

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

Not applicable. This is not an algorithm-based device.

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

The "ground truth" for the non-clinical tests is established by:
- Physical measurements: For electrical impedance, adhesive strength, and tensile strength, the ground truth is the direct measurement of these properties using calibrated equipment, compared against numerical specifications derived from relevant performance standards.
- Biological assays: For biocompatibility (cytotoxicity, irritation, sensitization), the ground truth is determined by standardized laboratory assays where effects on biological systems (e.g., cell cultures, animal models) are observed and evaluated against criteria defined in ISO 10993 series.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 22, 2018

Shaoxing DongZhi Electrical Technology Co., Ltd. Haze XU Quality Manager Xinsha Village, Cao E Street, Shangyu Area Shaoxing, Zhejiang 312352 Cn

Re: K180773

Trade/Device Name: Reusable and Self-Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: March 14, 2018 Received: March 23, 2018

Dear Haze XU:

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. 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 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180773

Device Name

Reusable and Self-Adhesive Electrodes

Indications for Use (Describe)

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

☒ Research Use (Part 21 CFR 361. Subpart B)	☒ Over-The-Counter Use (21 CFR 331 Subpart C)
---------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Section5 510(k) summary

I Submitter

Device submitter: Shaoxing DongZhi Electrical Technology Co.,Ltd Xinsha Village, Cao E Street, Shangyu Area, Shaoxing City, Zhejiang Province, P.R.CHINA 312352

Contact person: Haze XU Quality Manager Phone: +86 575 82597860 Email: haze@sxdongzhi.com

II Device

Trade Name of Device: Reusable and Self-Adhesive Electrodes Common name: Cutaneous Electrode Classification: Class II, 21 CFR 882.1320 Product Code: GXY

III Predicate Device

Trade name:	TENS Electrodes
Common name:	Cutaneous Electrode
Classification:	Class II, 21 CFR 882.1320
Product Code:	GXY
Premarket Notification:	K160081
Company name:	CATHAY MANUFACTURING CORP

IV Device description

V Indications for use

This device is an adhesive electrode which is intended for use as the re-usable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. It is intended to be used with legally marketed Electrical Simulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

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VI Comparison of technological characteristics with the predicate devices

The Reusable and Self-Adhesive Electrodes have the same intended use and principle operation, the technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Reusable and Self-Adhesive Electrodes and predicate devices do not alter suitability of the proposed device for its intended use.

Device feature	Reusable and Self-AdhesiveElectrodes (subject device)	TENS Electrodes K160081(predicate device)	Discussion
Intended use	The proposed device is anadhesive electrode which isintended for use as the re-usable, conductive adhesiveinterface between thepatient's skin and theElectrical Stimulator. It isintended to be used withmarketed ElectricalSimulators, i.e. TENS(Transcutaneous ElectricalNerve Stimulation) and EMS(Electrical MuscularStimulation).	The proposed device isintended for use as thedisposable, conductiveadhesive interface betweenthe patient's skin and theelectrical stimulator to applyelectrical stimulationcurrent, and is intended tobe used with marketedelectrical stimulators, i.e.TENS (TranscutaneousElectrical Nerve Stimulation)and EMS (Electrical MuscularStimulation).It's for OTC use.	Identical
Shapes	Round, Rectangular, Square,Oval, Butterfly	Round, Rectangular, Square,Crescent, Calabash	Substantiallyequivalent. The shapeof the device does notalter its intended use.
Surface area	Round: 2.5cm, 2.8cm, 3.2cm,4.5cm, 5.0cm, 7.0cm, 7.5cm indiameter:Square: 4.0cm4.0cm,4.5cm4.5cm, 5.0cm5.0cm;Rectangular: 4.0cm6.0cm,4.0cm8.0cm, 4.0cm10.0cm,4.0cm15.0cm,4.0cm35.0cm, 4.5cm9.5cm,5.0cm6.0cm, 5.0cm9.0cm,5.0cm10.0cm,7.0cm12.0cm,7.0cm13.0cm,7.5cm10.0cm,7.5cm13.0cm,8.0cm13.0cm,10.0cm20.0cm;Oval: 4.0cm6.0cm,5.0cm10.5cm 5.0cm*13.0cm;	Round: 5cm in diameter;Rectangular: 5cm10cm,6cm10cm;Crescent: 2.4cm4.2cm;Square: 3.2cm3.2cm;Calabash: 8.0cm*5.5cm	Substantiallyequivalent. Thesurface area of thedevice does not alterits intended use.
	Butterfly: 9.3cm*15.0cm
Components	Substrate/Wire/Hydro-gel/Scrim/ConductiveFiber/Carbon conductivefilm/Liner	Substrate/Wire/Hydro-gel/Scrim/ConductiveFiber/Carbon conductivefilm/Liner	Identical
Materials	Non-woven Fabric + Adhesive	Non-woven Fabric + Adhesive	Identical
	Wire and Terminal coated PVC	Wire and Terminal coated PVC	Identical
	Hydro-gel	Hydro-gel	Identical
	PET Fabric	PET Fabric	Identical
	Carbon fiber + Reinforcing fiber	Carbon fiber + Reinforcingfiber	Identical
	Poly-isobutylene, Carbon Black,Graphite, Additives	Poly-isobutylene, CarbonBlack	Substantiallyequivalent.
Biocompatibility	Comply with ISO 10993 series	Comply with ISO 10993series	Identical
Sterility	Non-sterile	Non-sterile	Identical
Re-usable	For single patient	For single patient	Identical
Shelf life	3 years	2 years	Substantiallyequivalent.

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VII Summary of Non-clinical tests:

Compare to primary predicate product specified in K160081, our device and the predicate device are substantially equivalent. The proposed Cutaneous Electrodes are evaluated through Electrode Performance testing (Electrical Impedance Performance, Adhesive Performance, and Tensile Strength), Biocompatibility testing, Stability testing, and Reusability testing.

Biocompatibility testing

Biocompatibility of the electrodes was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface-contacting devices: Skin" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation and Sensitization. All evaluation acceptance criteria were met

VIII Conclusion

The Reusable and Self-Adhesive Electrodes is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.

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).