Mailuokang Self-adhesive Electrode is intended for use as reusable, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Example electrical stimulation devices for current applications of the electrodes, but are not limited to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Self-adhesive Electrode is for prescription use and over-the-counter use, for single patient use only.

Device Description

Mailuokang Self-adhesive Electrode is used as a reusable and re-positionable transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Self-adhesive Electrode is for prescription use and over-the-counter use, for single patient use only.

AI/ML Overview

The provided text is a 510(k) summary for the Mailuokang Self-adhesive Electrode. It describes the device, its intended use, and compares it to a predicate device (THERATRODE, K112312) to demonstrate substantial equivalence.

Here's an analysis of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by device manufacturer or standard)	Reported Device Performance (Mailuokang Self-adhesive Electrode)
Biocompatibility: Skin irritation	Passed (Mailuokang's hydrogel has passed skin irritation test)
Biocompatibility: Sensitization	Passed (Mailuokang's hydrogel has passed sensitization test)
Biocompatibility: Cytotoxicity	Passed (Mailuokang's hydrogel has passed cytotoxicity test)
Electrode Contact Impedance (10 Hz, ≤100 µA p-p)	Average value for 12 electrode pairs connected gel-to-gel: ≤ 2 kilohms (kΩ). None of individual pair impedances: ≤ 3 kΩ. (Passed self-evaluation test)
Adhesion	Passed self-evaluation test for adhesiveness.
Compliance with ANSI/AAMI EC 12:2000/(R)2005 standard	Comparison testing between predicate device and subject device was performed according to this standard, and both devices passed.

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

Sample Size for impedance test: 12 electrode pairs.
Data Provenance: The document does not explicitly state the country of origin for the impedance and adhesion self-evaluation tests. It refers to "self-evaluation tests," which implies these were conducted by the manufacturer. The biocompatibility tests are also stated as "Mailuokang's hydrogel has passed three biocompatibility tests," suggesting these were likely conducted by or for the manufacturer. The study is prospective in the sense that these tests were conducted to demonstrate equivalence for this submission.

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

There is no mention of experts or ground truth established by experts for the test set. The performance tests (impedance, adhesion, biocompatibility) are objective measurements based on established standards or internal evaluations, not expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. The performance tests are objective measurements, not subjective evaluations 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 is not a study involving human readers or AI assistance. It's a medical device submission for an electrical stimulation electrode.

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. The device itself is a physical electrode.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by:

Objective Measurements: Impedance values, adhesion force, and observation of biological response in biocompatibility tests.
Compliance with Standards: Adherence to established industry standards like ANSI/AAMI EC 12:2000/(R)2005.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training" set in the context of machine learning or algorithms. Its performance is based on material properties and design, validated through direct testing.

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

Not applicable, as there is no training set involved. The performance (ground truth) is established through physical and electrical testing of the electrodes.

Summary

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

March 8, 2016

Shenzhen Mailuokang Technology Co., Ltd. % Ms. Elena Lu Senior Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 2032, International Mayors Communication Centre Shenzhen, Guangdong, 518000 China

Re: K152815

Trade/Device Name: Mailuokang Self-adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: January 28, 2016 Received: February 4, 2016

Dear Ms. Lu:

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 -A

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) K152815

Device Name Mailuokang Self-adhesive Electrode

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)

| X 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 submitted as required by requirements of SMDA and 21 CFR §807.92.

Administrative Information

Date ofprepared	Summary	Sep., 21, 2015
Manufacturerinformation	Company title:Shenzhen Mailuokang Technology Co., Ltd.Company address:Rm 602, 6/F, Building B, Nanchang Jianyu No.2Industrial Zone, Gushu Village, Xixiang Street,Baoan District, Shenzhen, China
	Phone: +86-755-8525 8460
	Fax: +86-755-8525 8461
	Contact Person: Mr. Pandeng. HuE-mail: 1962807321@qq.com
SubmissionCorrespondent	Shenzhen Joyantech Consulting Co., Ltd.Address: Room 2032, International MayorsCommunication Centre, No. 55 Shizhou middleroad, Nanshan District, Shenzhen
Image: [logo]卓远天成	Contact person: Ms. Elena. Lu; Mr. Field. FuE-Mail: elena@cefda.com;cefda13485@163.com
Establishment registrationnumber

number

Device Information

Type of 510(k)
submission:
Trade Name:
Model:
Classification name:
Review Panel:

Traditional

Mailuokang Self-adhesive Electrode Lead Wire Style Electrode, Snap Style Electrode Electrode, cutaneous Neurology

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Product Code:	GXY
Device Class:	II
Regulation Number:	882.1320

Predicate Device Information

Sponsor:	Phoenix Medical Devices, LLC
Device:	THERATRODE
510(K) Number:	K112312

Device Description

Intended Use

Mailuokang Self-adhesive Electrode is intended for use as reusable, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Example of electrical stimulation devices for current applications of the electrodes includes, but are not limited to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Selfadhesive Electrode is for prescription use and over-the-counter use, for single patient use only.

Technological characteristics of the subject device compared to the predicate device

The subject device and the predicate device have the same intended use, similar technological characteristics, and similar material composition. Moreover, information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or

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effectiveness. Thus, the subject device is substantially equivalent to the predicate device.

The detailed substantially equivalent table is shown as follows:

Items	PredicateDevice(K112312)	Subject Device	Comparison
General Characteristics
IndicationsforUse	To conduct electricalstimulation fromcommercially availablenerve stimulation devicesto the patient's skin.Single patient use - re-usable. Self adhering andre-positionable. Over thecounter use.	Mailuokang Self-adhesiveElectrode is intended foruse as reusable, conductiveadhesive interface betweenthe patient's skin and theelectrical stimulationdevices. Example electricalstimulation devices forcurrent applications of theelectrodes includes, but arenot limited to, TENS(Transcutaneous ElectricalNerve Stimulation) andEMS (Electrical MuscleStimulation). MailuokangSelf-adhesive Electrode isfor prescription use andover-the-counter use, forsingle patient use only.	SubstantiallyEquivalent(Note 01)
OTCorPrescription	OTC or OTC Use	Prescription use and Over-the-Counter use	SubstantiallyEquivalent(Note 02)
ClassificationName	Cutaneous Electrode	Cutaneous Electrode	Same
Product Code	GXY 882.1320	GXY 882.1320	Same
Device Class	Class II	Class II	Same
Reusable	Yes	Yes	Same
SinglepatientUse	Yes	Yes	Same
MultipleApplications	Yes	Yes	Same
Sterility Status	Non-sterile	Non-sterile	Same
Technical Characteristics
Design Features	Four basic components:* A patient contactinglayer of hydrogel material	Six basic components forLead Wire Style Electrode:* non-woven fabrics;	SubstantiallyEquivalent(Note 03)
Items	Predicate Device(K112312)	Subject Device	Comparison
	which has been tested and found to be bio-compatible with humans and provides both the electrically conductive medium necessary to aid in the transmission of electrical current to the patient plus the adhesive properties necessary to maintain sufficient contact with the patient's skin;* A carbon dispersion pad middle layer that evenly distributes the electrical current across the surface of the electrode;* A non-conductive top layer of various materials such as spun lace (fabric), polyethylene or polypropylene foam or other similar materials that form a protective and flexible top layer to the electrode	double sides adhesive tape; conducting film; hydrogel; plastic film; carbon fiber wire. Six basic components for Snap Style Electrode: non-woven fabrics; double sides adhesive tape conducting film; hydrogel; plastic film and snap.
	* A wire or conductive carbon fiber lead wire which is glued to the assembly of the middle and top layer and terminates in a .080" (2mm) female connector common to the electrotherapy industry and which mates with the plurality of commercially available nerve stimulation devices on the market today.
HydrogelComposition	Unknown	Glyrol, Polyacrylic acid, Water and Salt.	Substantially Equivalent (Note 04)
Biocompatibility	Theratrode's hydrogel has passed three biocompatibility tests: skin	Mailuokang's hydrogel has passed three biocompatibility tests: skin	Same
Items	PredicateDevice(K112312)	Subject Device	Comparison
	irritation,cytotoxicity and delayedcontact sensitization	irritation, sensitization andcytotoxicity
Performance test	Measuring the electricalconductivity (inverse ofimpedance)	Measuring the electrodecontact impedance andadhesion	SubstantiallyEquivalent(Note 05)
ConductiveSurface Shapes	Various shapes(square,round, rectangular, oval)	Various shapes(rectangular, oval, circle)	SubstantiallyEquivalent(Note 06)
ElectrodeImpedance	Unknown	The average value of 10-hertz (Hz) impedance for 12electrode pairs connectedgel-to-gel, at a level ofimpressed current notexceeding 100microamperes (µA) peak-to-peak (p-p), shall notexceed 2 kilohms (kΩ).None of the individual pairimpedances shall exceed 3kΩ.	SubstantiallyEquivalent(Note 07)

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Discussion about the similarities and differences between the subject device and the predicate device:

Note 01:

The only difference between the subject device and the predicate device are the wordings.

Note 02:

The differences are: the subject device is for prescription use and over-the-counter use while the predicate device is only for OTC use. However, many cutaneous electrodes intended for use with transcutaneous electrical nerve stimulators have been cleared by the FDA for prescription use, e.g., the Axelgaard ValuTrode Neurostimulation Electrodes (K970246), Jiajian Self- adhesive Electrode (K090198). Thus the intended use of the subject device and predicate device are substantially equivalent.

Note 03:

The subject device and predicate device are similar in construction. They both contain four basic components: a non-conductive top layer, a patient contacting layer, a carbon dispersion pad middle layer (similar function for conducting film of Mailuokang Lead Wire

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Style and Snap Style electrode,) and conductive carbon fiber lead wire (or snap for Snap Style Electrode); while the Mailuokang electrode also contains two additional layer: double sides adhesive tape which is used for attaching the non-woven fabrics and conducting film, and plastic film is a protective layer for the hydrogel. Which the differences will not effect the safety and effectiveness of the Mailuokang Self-adhesive Electrode.

Note 04:

Though the hydrogel composition of the predicate device is unknown, the Mailuokang's hydrogel composition is the same with Electrode pads of GYMFORM ABS&CORE Electrode (K142055) which has been cleared by the FDA. What's more, Mailuokang's electrode and the predicate device's electrode both passed three biocompatibility tests: skin irritation, cytotoxicity and delayed contact sensitization.

Note 05:

Although the subject device and the predicate device conducting different electrical performance tests, they are both used to demonstrate the same performance of the electrode: good conductivity. For the predicate device, the electrical conductivity (inverse of impedance) is measured, while for the subject device, the electrode contact impedance is measured. Many cutaneous electrodes intended for use with transcutaneous electrical nerve stimulators have been cleared by the FDA by passing impedance testing, e.g., SOF-PACH™ Reusable Neurostimulation Electrodes (K020735), Jiajian Self- adhesive Electrode (K090198). Because the Mailuokang Self-adhesive Electrode has the same intended use and fundamental technology as these other electrodes, it is substantially equivalent to them. Moreover, the subject device also considered the adhesion performance. The subject device has passed self-evaluation tests for impedance and adhesiveness. Thus, the performance of subject device is substantially equivalent to the predicate device.

Note 06:

The differences in shapes will not effect the safety and effectiveness of the Mailuokang Selfadhesive Electrode.

Note 07:

Although electrode impedance of the predicate device is unknown, the comparison testing between the predicate device and the subject device was performed according to ANSI/AAMI EC 12:2000/(R)2005 standard, and both the devices passed the testing. Which the

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differences will not effect the safety and effectiveness of the Mailuokang Self-adhesive Electrode.

Brief discussion of the nonclinical tests

The Mailuokang Self-adhesive Electrode passed self-evaluation tests for impedance and adhesiveness. Mailuokang's electrode has passed three biocompatibility tests: skin irritation, sensitization and cytotoxicity.

Brief discussion of clinical tests

Not applicable.

Other information (such as required by FDA guidance)

No other information.

Conclusions

The subject device Mailuokang Self-adhesive Electrode is substantially equivalent to THERATRODE whose 510(k) number is K112312.

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).