The proposed device is intended for use as the disposable, conductive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with legally marketed electrical stimulators, i.e. TENS (Transutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for Over-the-Counter (OTC) use.

Device Description

The proposed Electrodes with snap / Electrodes with pigtail are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydro gel, no securing materials are required to secure the product to the patient's skin. The proposed product mainly consists of electrode pad and snap or pigtail. The electrode pad is available in Round Shape Electrode, Rectangular Shape Electrode, Palm shape Electrode, Elliptical Shape Electrode, and Calabash Shape Electrode.

AI/ML Overview

The provided document is a 510(k) summary for medical electrodes, not an AI/ML device. Therefore, it does not contain the information requested in points 2-9 regarding AI/ML model performance, training, and validation.

However, I can extract the acceptance criteria and reported device performance for the physical electrodes as presented in the "Test Summary" and "Comparison to predicate device" sections.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Subject Device)	Reported Device Performance (Subject Device)
Biocompatibility: According to ISO 10993-5 and ISO 10993-10 standards	Complied with ISO 10993
Electrode wire compliance: According to Sub-Clause 56.3 (c) in IEC 60601-1:1988 + A2:1995 (2nd edition)	The electrode wire is compliance with 21 CFR 898 by construction review according to Sub-Clause 56.3 (c) in IEC 60601-1:1988 + A2:1995 (2nd edition)
Individual pad impedance: Below 3000 ohms @ 10 Hz	Below 3000 ohms @ 10 Hz (as per "Electrical Impedance" under "Comparison to predicate device")
Adhesive performance on To (Tackiness): >= No. 14 steel ball (Diameter: 11.112 mm) following AS07-003 / GB/T4852-200	>= No. 14 steel ball (Diameter: 11.112 mm) following AS07-003 / GB/T4852-200
Adhesive holding strength performance: A sample pad with 40mm length and 40 mm width; Hang a weight of 500g without detach within 1min	A sample pad with 40mm length and 40 mm width; Hang a weight of 500g without detach within 1min
Tensile Strength: Electrode is held up with a weight of 500g hung on the wire, and can hold on at least 1 minutes	Electrode is held up with a weight of 500g hung on the wire, and can hold on at least 1 minutes
Conformability: No more than 10% of the adhesive area of the device shall have separated from the skin surface at 1 h after application	No more than 10% of the adhesive area of the device shall have separated from the skin surface at 1 h after application
Impedance Distribution uniformity test: 1) No significant deviation between resistance values measured for each combination mode; 2) The maximum value and the minimum value should be within ±10% of average value	1) No significant deviation between resistance values measured for each combination mode; 2) The maximum value and the minimum value should be within ±10% of average value
Sterility: Non-sterile	Non-sterile
Stability and shelf life: 2 years	2 years
Re-usable: For single patient	For single patient
Labeling: Conform to 21 CFR Part 801	Confirm to 21 CFR Part 801

Study Details (for physical device, not AI/ML):

The document describes a 510(k) submission, which demonstrates "substantial equivalence" to a legally marketed predicate device, rather than a clinical study proving new performance. The "Test Summary" indicates that safety and performance were evaluated by "lab bench testing."

Sample size used for the test set and the data provenance: Not specified in terms of sample size for the tests, but the data would be from lab bench testing (likely within China, given the company's location). This is not retrospective or prospective in the sense of a clinical trial; it's product testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical/electrical tests with objective measurements, not judgment-based assessments requiring experts for ground truth.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is for a physical medical device (electrodes), not an AI/ML diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Physical measurements and adherence to specified performance standards (e.g., ISO 10993, IEC 60601-1, specific impedance/strength values).
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

January 10, 2018

Shenzhen Konmed Technology Co., Ltd % Cecilia Ceng Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, Guangdong, 510006 China

Re: K171722

Trade/Device Name: Electrodes with snap / Electrodes with pigtail Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: October 21, 2017 Received: October 30, 2017

Dear Cecilia Ceng:

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

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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); good manufacturing practice requirements as set forth in the quality systems (OS) 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) K171722

Device Name

Electrodes with snap / Electrodes with pigtail

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
[Checkbox 1] [Checkbox 2]

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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Chapter 5. 510(k) Summary

510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

510(k) Owner's Name: Shenzhen Konmed Technology Co., Ltd Establishment Registration Number: Applying Address: 703B, Haide building A, Nanxin Road, Nanshan, Shenzhen, China Tel: +86-755-86704558 Fax: +86-755-86704558 Contact Person: Tony (Manager) Email: 2519021651 @qq.com

Application Correspondent:

Application Correspondent: Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: +86-20-61099984 Email: regulatory@glomed-info.com

2. Subject Device Information

Trade Name: Electrodes with snap / Electrodes with pigtail Model: Model A: Round Shape Electrode; Model B: Rectangular Shape Electrode; Model C: Palm shape Electrode; Model D: Elliptical Shape Electrode; Model E: Calabash Shape Electrode Common Name: Cutaneous Electrode Classification name: Cutaneous Electrode Review Panel: Neurology Models: Round Shape Electrode, Rectangular Shape Electrode, Palm Shape Electrode, Elliptical Shape Electrode, Calabash Shape Electrode Product Code: GXY Regulation Class: 2 Regulation Number: 882.1320

3. Predicate Device Information

510(K) Number: K160081 Company Name: CATHAY MANUFACTURING CORP. Trade/Device Name: TENS Electrodes Requlation Number: 882.1320 Regulatory Class: 2 Product Code: GXY

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Sponsor:	Shenzhen Konmed Technology Co., Ltd
Subject Device:	Electrodes with snap / Electrodes with pigtail
File No.:	510(k) Summary

4. Device Description

5. Intended Use / Indications for Use

The proposed product is intended for use as the disposable, conductive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with legally marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for Over-the-Counter (OTC) use.

6. Test Summary

The proposed Electrodes with snap / Electrodes has been evaluated the safety and performance by lab bench testing as following:

Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards �
� The electrode wire is compliance with 21 CFR 898 by construction review according to Sub-Clause 56.3 (c) in IEC 60601-1:1988 + A2:1995 (2nd edition)

7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of the proposed Electrodes with snap / Electrodes is substantially equivalent to the predicate devices quoted below. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Elements ofComparison	Subject device	Primary Predicate	Remark
Device Name	Electrodes with snap /Electrodes with pigtail	TENS Electrodes	--
510(K) Number	Applying	K160081	--
Product Code	GXY	GXY	SE
Intended Use /Indications for Use	The proposed device isintended for use as thedisposable, conductiveadhesive interface betweenthe patient's skin and theelectrical stimulator to applyelectrical stimulation current,and is intended to be usedwith legally marketedelectrical stimulators, i.e.	The proposed device isintended for use as thedisposable, conductiveadhesive interface betweenthe patient's skin and theelectrical stimulator to applyelectrical stimulation current,and is intended to be usedwith marketed electricalstimulators, i.e. TENS	SE
	TENS (TranscutaneousElectrical Nerve Stimulation)and EMS (ElectricalMuscular Stimulation). It'sfor Over-the-Counter (OTC)use.	(Transcutaneous ElectricalNerve Stimulation) and EMS(Electrical MuscularStimulation).It's for OTC use.
Models of electrodepad	Mode A: Round ShapeElectrodeModel B: Rectangular ShapeElectrodeModel C:Palm ShapeElectrodeModel D:Elliptical ShapeElectrodeModel E: Calabash ShapeElectrode	Model A: Round shapeelectrodeModel B: Rectangular shapeElectrodeModel C: Crescent shapeElectrodeModel D: Square shapeElectrodeModel E:Calabash ShapeElectrode	SENote1
Surface area(Conductivesurface)	Model A: 5 cm in diameterModel B: 5 x 11; 6 x 11(cm2)Model C: 7.6 x 4.8 (cm2)Model D: 3 x 4.3 (cm2)Model E: 8.4 x 4.8 (cm2)	Model A: 5cm in diameterModel B: 510;610(cm2)Model C: 2.44.2(cm2)Model D: 3.23.2(cm2)Model E: 8.0*5.5 (cm2)	SENote1
OTC or prescription	For OTC Use	For OTC Use	SE
Design features	Substrate/Wire/Hydro-GelScrim/Conductive FiberCarbon Conductive Film/liner	Substrate/Wire/Hydro-GelScrim/Conductive FiberCarbon Conductive Film /liner	SE
Materials:	Non-woven fabric+ adhesive	Non-woven fabric+ adhesive
Substrate;Wire;	Wire & Terminal coated PVC	Wire & Terminal coated PVC	SE
Hydro-gel;	Hydro-gel	Hydro-gel	Note1
Scrim;	nylon	PET fabric
Conductive fiber;	Silver filaments	Carbon fiber + reinforcing fiber
Carbon conductiveFilm;	Carbon Black	Poly-isobutylene, CarbonBlack
Biocompatibility	Complied with ISO 10993	Conforms to ISO10993	SE
Labeling	Confirm to 21 CFR Part 801	Confirm to 21 CFR Part 801	SE
Electrical	Individual pad impedance	Individual pad impedance	SENote2

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Sponsor:	Shenzhen Konmed Technology Co., Ltd
Subject Device:	Electrodes with snap / Electrodes with pigtail
File No.:	510(k) Summary

impedance	below 3000 ohms @ 10 Hz	below 200 ohms @ 60 kHz
Adhesiveperformance on To	>= No. 14 steel ball(Diameter: 11.112 mm)following AS07-003 /GB/T4852-200	>= No. 14 steel ball (Diameter:11.112 mm) following AS07-003 / GB/T4852-2002	SE
Adhesiveholding strengthperformance	A sample pad with 40mmlength and 40 mm width;Hang a weight of 500gwithout detach within 1min	A sample pad with 25mmlength and 25 mm width;Hang a weight of 200g withoutdetach within 30s	SENote 2
Tensile Strength	Electrode is held up with aweight of 500g hung on thewire, and can hold on atleast 1 minutes	Electrode is held up with aweight of 500g hung on thewire, and can hold on at least1 minutes	SE
Conformability	No more than 10% of theadhesive area of the deviceshall have separated fromthe skin surface at 1 h afterapplication	No more than 10% of theadhesive area of the deviceshall have separated from theskin surface at 1 h afterapplication	SE
ImpedanceDistributionuniformity test	1) No significant deviationbetween resistancevalues measured foreach combination mode.2) The maximum valueand the minimum valueshould be within ±10%of average value	1) No significant deviationbetween resistance valuesmeasured for eachcombination mode.2) The maximum value andthe minimum value shouldbe within ±10% of averagevalue	SE
Sterility	Non-sterile	Non-sterile	SE
Stability and shelflife	2 years	2 years	SE
Re-usable	For single patient	For single patient	SE
Intended population	Adult only	No specified population	SE Note 1

Comparison in Detail(s):

Note 1:

Although the "Model", " Surface area (Conductive surface)", "Materials" and " Intended population" of the subject device are different from the predicate devices, they are all complying with ISO 10993 requirements. So the differences of the function specifications will not raise any safety or effectiveness issue.

Note 2:

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Sponsor:	Shenzhen Konmed Technology Co., Ltd
Subject Device:	Electrodes with snap / Electrodes with pigtail
File No.:	510(k) Summary

Although the "Electrical Impedance" and "Adhesive holding strength performance" are not totally same, they all of the subject devices are different from the predicate devices, they are all complying with performance testing. So the differences of the function specifications will not raise any safety or effectiveness issue.

Note 3:

" SE" means substantially equivalent.

Conclusion

The subject device Electrodes with snap / Electrodes with pigtail has all features of the predicate devices. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate devices.

8. Date of the summary prepared: January 5, 2018

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).