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.

Device Description

Adhesive Electrodes manufactured by GMDASZ are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:

First layer: Insulating backing material: Fabric/foam/tan fabric
Second layer: Conductive film/Carbon film coated with silver/Aluminum foil film
Third layer: Biocompatible self-adhesive conductive hydrogel
Protective liner: PET

The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, 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" recessed female terminal with insulating outer jacket. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly is incompliance with FDA performance standard 21 CFR Part 898.

AI/ML Overview

This document is a 510(k) premarket notification for "Adhesive Electrodes" manufactured by GMDASZ Manufacturing Co., Ltd. The submission seeks to expand the sales of their existing electrodes (previously cleared under K092546) to include Over-The-Counter (OTC) use, and also introduces new electrodes with an Aluminum foil film conductive layer, comparing them to the predicate device K132998 (Wandy self-adhesive electrodes).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria." Instead, it compares the subject device's performance against two predicate devices (K092546 and K132998) across various technical specifications, which implicitly serve as acceptance criteria. The key performance metrics and their comparison are:

Acceptance Criteria (Implied from Predicate Devices)	Reported Device Performance (K160138)	Comparison/Remark
Material/Design Features:
Insulation backing material: Fabric/Foam/Tan fabric	Same: Fabric/Foam/Tan fabric	Same
Conductive film (K092546 D-pred): Carbon film/Carbon film coated with silver	Carbon film/Carbon film coated with silver/Aluminum foil film	Similar; new option of Aluminum foil film, justified by K132998 predicate.
Conductive hydrogel (A, T or U gel)	Same: (A, T or U gel)	Same
Electrical Connection: Leadwire	Leadwire	Same or Similar. Some K132998 models had snap, but subject device uses leadwire.
Protective Liner: PET	PET	Same
Lead Wire Connector: .080" female socket connector	.080" female socket connector	Same
Reusable	Reusable	Same
Packaging: Re-sealable bag packed	Re-sealable bag packed	Same
Self-adhesive	Self-adhesive	Same
Performance Characteristics:
Biocompatibility: Complies with ISO10993	Complies with ISO10993	Same. For new aluminum foil models, no new tests were conducted as materials for other layers were identical to K092546.
A.C. Impedance: <300 ohms (K092546), <200 ohms (K132998)	<300 ohms	Within K092546 predicate. Although slightly higher than K132998, it's still <2kohm and deemed safe/effective.
Force required to remove wire from electrode: >6 pounds of force	More than 6 pounds of force	Same
Regulatory/Indications:
OTC or Prescription use (K092546 Pred: Prescription, K132998 Pred: OTC & Rx)	OTC and Prescription	Expanded from K092546, aligned with K132998.
Single Patient Use	Single Patient Use	Same

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 size for any conducted tests.
The data provenance is from GMDASZ Manufacturing Co., Ltd., which is based in Guangdong Province, P.R. China. The studies appear to be prospective testing conducted by the manufacturer to demonstrate substantial equivalence.

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/not provided. The device is an adhesive electrode, and the evaluation relies on technical and performance testing against established standards and predicate devices, not on expert interpretation of medical images or conditions where "ground truth" is typically established by medical professionals.

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

This information is not applicable/not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or image interpretation studies where multiple readers assess cases and discrepancies are resolved. The studies described here are laboratory/performance tests.

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/not provided. An MRMC study is for evaluating diagnostic performance, often with AI. The device is a medical accessory (adhesive electrode) and is not an AI diagnostic tool.

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

This information is not applicable/not provided. This device is an electrode, not an algorithm. Therefore, "standalone" algorithm performance is not relevant. The device's performance is inherently tied to its physical and electrical properties.

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

The "ground truth" for the performance tests appears to be established industry standards (e.g., EC12/EC53, ISO10993) and the documented performance characteristics of legally marketed predicate devices. The tests conducted (safety, adhesion, current dispersion, reusability, stability) evaluate whether the device meets these pre-defined technical specifications.

8. The sample size for the training set

This information is not applicable/not provided. This medical device is a physical product (electrode) and does not involve machine learning or AI models that require a "training set."

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

This information is not applicable/not provided, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

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 coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

August 11, 2016

GMDASZ Manufacturing Co., Ltd % Charles Mack Principal Engineer IRC 2250 Duportail Street, M275 Richland, Washington 99352

Re: K160138

Trade/Device Name: Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: June 28, 2016 Received: July 13, 2016

Dear Mr. 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. 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 801); medical device reporting (reporting of medical device

{1}------------------------------------------------

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.

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K160138

Device Name Adhesive Electrodes

Indications for Use (Describe)

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 (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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510k Summary

Device 510k number: K160138

Submitter Information:

GMDASZ Manufacturing Co., Ltd. Room E1308, Xihaimingzhu Building, Taoyuan Road , Nanshan District, ShenZhen City, Guangdong Province, P.R. China. Postcode: 518052 Tel: 86-755-86213939 Fax: 86-755-26669658 Contact person: Mr. Xiangjie Zhang (General Manager)

FDA Registration Number:

Owner/Operator Number: 10031210 Establishment Registration Number: 3008197884

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 Devices:

K092546	GMDASZ TENS Electrodes (GMDASZ Manufacturing Co., Ltd.)
K132998	Wandy self-adhesive electrodes (WANDY Rubber Industrial Co., Ltd.)

Device Description:

Adhesive Electrodes are composed of conductive carbon film, and carbon film coated with silver are identical in technological characteristics compared to our own previous 510K cleared electrodes in K092546, so this premarket notification supports a change to the product labeling only to allow the product to be sold for over-the-counter (OTC) use and prescription use.

Adhesive Electrodes composed of Aluminum foil film, are technologically equivalent to the predicate devices - K132998 Wandy self-adhesive electrodes for over-the-counter (OTC) use and prescription use.

Adhesive Electrodes manufactured by GMDASZ are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:

First layer: Insulating backing material: Fabric/foam/tan fabric Second layer: Conductive film/Carbon film coated with silver/Aluminum foil film Third layer: Biocompatible self-adhesive conductive hydrogel Protective liner: PET

{4}------------------------------------------------

Indications for Use:

Element ofcomparison	Subject Device(K160138)	Predicate Device(K092546)	Justification
Company	GMDASZ ManufacturingCo., Ltd.	GMDASZ ManufacturingCo., Ltd.	Same
Device Name	Adhesive Electrodes	GMDASZ TENSElectrodes	N/A
Model Name	OCWN1005, OCWN1007,OCWN2505, OCWN2509,OACWN1005,OACWN1007,OACWN2505,OACWN2509	CWN1005, CWN1007,CWN2505, CWN2509,ACWN1005,ACWN1007,ACWN2505,ACWN2509	N/A
Regulation Number	882.1320	882.1320	Same
Product Code	GXY	GXY	Same
ClassificationName	Cutaneous electrode	Cutaneous electrode	Same
OTC orPrescription	OTC and Prescription	Prescription	Predicate deviceK132998 (below)is both OTC andRx only.Additionally, thelabeling hasdefined restrictedareas ofapplication,exactly like thepredicate deviceK132998.
Intended Use	The adhesive electrodes	The GMDASZ TENS	Similar
	are intended for as a	Electrodes are intended
	reusable, conductive	for use as a reusable,
	adhesive interface between	conductive adhesive
	the patient's skin and the	interface between the
	marketed electrical	patient's skin and the
	stimulators (i.e. TENS	Electrical Stimulator.
	(Transcutaneous Electrical	GMDASZ's reusable
	Nerve Stimulation), EMS	electrodes are designed
	(Electrical Muscular	and intended to be used
	Stimulation), IF	with marketed, Electrical
	(Interferential) or PGF	Stimulators i.e. TENS
	(Pulsed Galvanic	(Transcutaneous
	Stimulation) for	Electrical Nerve
	transmitting electrical	Stimulation), EMS
	current. The electrode is	(Electrical Muscular
	for OTC (Over-The-	Stimulation), IF
	Counter) or Prescription	(Interferential) or PGF
	use.	(Pulsed Galvanic
		Stimulation).

		The electrotherapy
		electrodes are intended to
		be used to apply electrical
		stimulation current to the
		patient's skin.
Design Feature	Three layers:	Three layers:	1) Same2) Same exceptsubject devicehas the option ofan Aluminumfoil film. TheAluminum foilfilm is used as aconductive filmin predicateK132998(below).3) Same
	1. Insulation backing	1. Insulating backing
	material:	material:
	Fabric/Foam/Tan fabric	Fabric/Foam/Tan fabric

	2. Conductive film:	2. Conductive plastic
	Carbon film/Carbon film	film: Carbon film/ Carbon
	coated with	film coated with silver
	silver/Aluminum foil film
		3. Conductive hydrogel
	3. Conductive hydrogel	(A, T or U gel)
	(A, T or U gel)

ElectricalConnection	Leadwire	Leadwire	Same

Protective Liner	PET	PET	Same
Lead Wireconnector	Leadwire connector .080"female socket connector	Leadwire connector .080"female socket connector	Same


Reusable	Reusable	Reusable	Same
Packaging	Re-sealable bag packed	Re-sealable bag packed	Same
Self-adhesive	Self-adhesive	Self-adhesive	Same
Biocompatibility	Complies with ISO10993	Complies with ISO10993	Same
A.C. Impedance	<300 ohms	<300 ohms	Same
Force required toremove wire fromelectrode	More than 6 pounds offorce	More than 6 pounds offorce	Same
Single Patient Use	Single Patient Use	Single Patient Use	Same

Comparison to predicate device:

{5}------------------------------------------------

{6}------------------------------------------------

Element of	Subject Device	Predicate Device	Comment
comparison	(K160138)	(K132998)
Company	GMDASZ ManufacturingCo., Ltd.	Wandy Rubber IndustrialCo. Ltd	N/A
Device Name	Adhesive Electrodes	Wandy Self-adhesiveelectrodes	N/A
Model name	LWN1005, LWN1007,LWN2505, LWN2509	Type A, Type P, Type M	N/A
Regulation Number	882.1320	882.1320	Same
Product Code	GXY	GXY	Same
ClassificationName	Cutaneous electrode	Cutaneous electrode	Same
Intended Use	The adhesive electrodesare intended for as areusable, conductiveadhesive interface betweenthe patient's skin and themarketed electricalstimulators (i.e. TENS(Transcutaneous ElectricalNerve Stimulation), EMS(Electrical MuscularStimulation), IF(Interferential) or PGF(Pulsed GalvanicStimulation) fortransmitting electricalcurrent. The electrode isfor OTC (Over-The-Counter) or Prescriptionuse.	Wandy Self-adhesiveElectrode is intended totransmit electrical currentto patient skin for TENS(TranscutaneousElectrical Nerve-Stimulation) and EMS(Electrical muscularStimulation) application,for OTC (Over-the-Counter) or Prescriptionuse. The electrodes areused for adults only.	Similar
OTC orPrescription	OTC and Prescription	OTC and Prescription	Same
Design Feature	Three layers1. Insulation backingmaterial: Fabric/Foam/Tanfabric2. Conductive film:Carbon film/Carbon filmcoated withsilver/Aluminum foil film3. Conductive hydrogel(A, T or U gel)	Three layers:1. Insulating backingmaterial: WovenFabric/Foam2. Conductor:Aluminum/Carbon3. Conductive hydrogel(A, T or U gel)	1) Doesn'timpact safetyand effectivenessof subject device2) Subject devicecontainsaluminum foil asa conductivefilm.Predicateincludes 'TypeA' model whichhas usedaluminum foil asa conductivedevice3) Same
ElectricalConnection	Leadwire	Leadwire or Snap	SimilarSubject devicedoes not havesnap styleconnection butthis shouldn'timpact its safetyor effectiveness.
Protective Liner	PET	PET	Same
Lead Wireconnector	Leadwire connector .080"female socket connector	Leadwire connector .080"female socket connector	Same
Non-sterile	Non-sterile	Non-sterile	Same
Reusable	Reusable	Reusable	Same
Packaging	Re-sealable bag packed	Re-sealable bag packed	Same
Self-adhesive	Self-adhesive	Self-adhesive	Same
Biocompatibility	Complies with ISO10993	Complies with ISO10993	Same
A.C. Impedance	<300 ohms	<200 ohms	SimilarAlthough subjectdevice hasslightly higherimpedance, it isstill <2kohm andshould not affectsafety andeffectiveness ofsubject device
Force required toremove wire fromelectrode	More than 6 pounds offorce	More than 6 pounds offorce	Same
OTC orPrescription	OTC and Prescription	OTC and Prescription	Same
Single Patient Use	Single Patient Use	Single Patient Use	Same

{7}------------------------------------------------

{8}------------------------------------------------

Performance:

The Adhesive Electrodes are composed of conductive carbon film, and carbon film coated with silver. They are identical to GMDASZ's previous 510K cleared electrodes in K092546 This submission supports a change only to allow the product to be sold for Over-The-Counter (OTC) use. The electrodes are compared to the Wandy Rubber Industrial Co., Ltd. Self-adhesive electrodes. K132998. The mechanical and electrical properties of the submitted GMDASZ electrodes are the same as the Wandy Self-adhesive electrodes.

For Adhesive Electrodes composed of Aluminum foil film, all the materials are same as the previously cleared electrodes in K092546 except the conductive media, so no new biocompatibility tests were conducted. To verify the safety and performance of it, GMDASZ conducted new tests. These tests are the same as our previous cleared prescription electrode in K092546, including safety test, adhesion test, current dispersion test, reusability and stability test as well as some performance test by refer to EC12/EC53. The test result shows the new electrodes with aluminum foil film is identical to the both the GMDASZ and Wandy predicate devices in safety and performance characteristics.

Clinical:

No clinical tests were needed.

Conclusion:

The submitted new Adhesive Electrodes have the same intended use and similar technological characteristics as the predicate devices. Moreover, 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.

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).