Zekang Self-Adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The-Counter) or Prescription use.

Device Description

Zekang Self-adhesive Electrode is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin.

Zekang Self-adhesive Electrode is composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient multiple application use. Zekang Self-adhesive Electrode has various shapes and sizes.

To connect with a nerve or muscle stimulator, this Electrode has lead wire type and snap button type. For lead wire type electrode, the wire is at least 40mm long, with 2.0~3.5mm diameter female socket. For snap button type electrode, the connector is male snap button. The individual electrodes are electrically connected in pairs. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) release liner.

The conductive hydrogel is imported from Covidien, USA, which was 510(k) cleared with number of K100418. And the whole Zekang Self-adhesive Electrode together with the conductive hydrogel has again passed the Biocompatibility test, Shelf life test, Impedance test, Adhesive test, and so on.

AI/ML Overview

This document is a 510(k) summary for the "Zekang Self-Adhesive Electrode" and does not describe a study involving algorithms, human readers, or image analysis. Instead, it focuses on the substantial equivalence of a physical medical device (an electrode). Therefore, many of the requested categories are not applicable.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document refers to "design specifications" and compliance with standards, but does not list specific numerical acceptance criteria values alongside corresponding device performance results in the way one might for an AI model's accuracy. Instead, it indicates successful completion of various tests deemed sufficient for substantial equivalence.

Acceptance Criteria Category	Reported Device Performance / Compliance
Biocompatibility	Passed ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization)
Sterility	Complies with ASTM F1980 (Accelerated Aging of Sterile Barrier Systems)
Electrical Performance	Bench tests demonstrate compliance with AAMI / ANSI ES60601-1 (General requirements for basic safety and essential performance) and IEC 60601-2-2 (Particular requirements for high frequency surgical equipment and accessories)
Shelf life	Passed (explicitly stated)
Impedance	Passed (explicitly stated)
Adhesive	Passed (explicitly stated)
Electrical distribution	Electrical current distribution test results contribute to conclusion of safety and effectiveness

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

This information is not provided in the document. The studies mentioned are bench tests and biocompatibility tests on the physical device, not on data.

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

This information is not applicable as the document describes testing of a physical electrode, not data, and does not involve establishing ground truth by medical experts in the context of an AI study.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes testing of a physical electrode, not a medical image analysis or similar AI evaluation that would require 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

This information is not applicable. This document is for a self-adhesive electrode, not an AI or imaging device involving human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable in the context of AI. For the physical device, "ground truth" would be defined by the standards and specifications it's tested against (e.g., a hydrogel causing no cytotoxicity is "ground truth" for biocompatibility).

8. The Sample Size for the Training Set

This information is not applicable as the document is about a physical device and makes no mention of AI or machine learning training sets.

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

This information is not applicable as the document is about a physical device and makes no mention of AI or machine learning training sets.

Summary of the Document's Purpose:

The provided document is an FDA 510(k) clearance letter and summary for a "Zekang Self-Adhesive Electrode." The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This is primarily done through bench testing, biocompatibility testing, and comparison of technical specifications, rather than clinical studies involving human patients or complex AI performance metrics.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 25, 2015

Jiangsu Zekang Medical Technology Co., Ltd. c/o Doris Dong Manager Shanghai Cv Technology Co., Ltd Room 1706, No. 128 Songle Rd., Songjiang Area Shanghai. 201600 CHINA

Re: K150971/S001 Trade/Device Name: Zekang Self-Adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: July 06, 2015 Received: July 13, 2015

Dear Doris Dong:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J.Hoffmann -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) K150971

Device Name Zekang Self-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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Section 5 510(k) Summary

[As required by 21 CFR 807.92]

1. Submission Information:

510(k) Number:	K150971
Date:	March 15th, 2015
Type of 510(k) Submission:	Traditional
Basis for 510(k) Submission:	New device
Submitter/Manufacturer:	Jiangsu Zekang Medical Technology Co., Ltd.Building 22, Wuxi Zhongguancun Software Park, Wuxi city, Jiangsu214135 China
Contactor:	Doris DongShanghai CV Technology Co., Ltd.Room 1706, No. 128 Songle Rd., Songjiang Area, Shanghai, 201600 ChinaE-mail: doris_d@126.comTel: 86 21-31261348 / Fax: 86 21-37824346

2. Device Description:

Proprietary Name:	Zekang Self-adhesive Electrode
Common Name:	Cutaneous electrode
Classification Name:	Cutaneous electrode
Product Code:	GXY
Device Class:	II
Regulation Number:	882.1320
Review Panel:	Neurology
Indications for use:	Zekang Self-adhesive Electrode is intended to transmit electrical current topatient skin for use with transcutaneous electrical stimulation devices.Some common types of the stimulation devices include, but are not limit toTENS (Transcutaneous Electrical Nerve Stimulation) and EMS (ElectricalMuscular Stimulation). The electrode is for OTC (Over-The -Counter) orPrescription use.
Device Description:	Zekang Self-adhesive Electrode is used as an accessory to the TENS orEMS device unit, which transmits electrical current to patient skin. Theelectrical current is first transmitted via the lead wire or snap button thentransmitted to the conductive gel which is adhered to patient skin.Zekang Self-adhesive Electrode is composed of a cover, connector leadwire or snap button, conductive carbon film, conductive hydrogel, and anelectrode carrier liner. It is non-sterile and intended for single adult patientmultiple application use. Zekang Self-adhesive Electrode has variousshapes and sizes.To connect with a nerve or muscle stimulator, this Electrode has lead wiretype and snap button type. For lead wire type electrode, the wire is at least40mm long, with 2.0~3.5mm diameter female socket. For snap button type

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electrode, the connector is male snap button. The individual electrodes are electrically connected in pairs. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) release liner.

3. Predicate Device Identification

510k number	Device name	Manufacturer	Date cleared
K130987	ValuTrode® Neurostimulation Electrodes	Axelgaard Manufacturing Co., Ltd.	2013
K090198	Jiajian Self-adhesive Electrode	Wuxi Jiajian Medical Instrument Co., Ltd	2009

4. Substantially Equivalent Comparison Conclusion

Detailed comparison data is included in Section 9 of "Substantial Equivalence Discussion" of this 510(k) submission.

	Comparison with K130987	Comparison with K090198
Similarities:	Same intended use, composition, safetyperformance	Same intended use, composition, safetyperformance, OTC and Prescription use
Differences:	Zekang Self-adhesive Electrode is for OTCand Prescription use, while ValuTrode®Neurostimulation Electrodes for OTC useonly.	Zekang Self-adhesive Electrode has leadwire and snap connectionconfigurations, while JiajianSelf-adhesive Electrode has lead wiretype only.
Conclusion:	Based on successful biocompatibility testing of the skin contacting conductivehydrogel, the electrical performance of the insulated lead wire components andelectrode current distribution test results, Zekang Self-adhesive Electrode is safe andeffective when used as an interface between a user's skin and an approved nerve andmuscle stimulation device.The conclusions drawn from the non-clinical tests demonstrate that the device is assafe, as effective, and performs as well as the legally marketed devices identified in thesubmission. Thus the subject device is substantially equivalent to the predicate devices.

5. Non-Clinical Test Conclusion

Bench tests were conducted on Zelf-adhesive Electrode to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM F1980 (Reapproved 2011), Standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility)
ISO 10993-5:2009/(R) 2014, Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity. (Biocompatibility)
ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization. (Biocompatibility)
AAMI / ANSI ES60601-1:2005/(R) 2012, Medical electrical equipment -- Part 1: General requirements

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for basic safety and essential performance

IEC 60601-2-2 Edition 5.0 2009-02, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

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).