SM Electrodes are 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 limit to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.

Device Description

SM Electrode pad is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of electrode pad is first transmitted via the snap button then transmitted to the conductive gel which is adhered to patient skin.

SM Electrode Pad is composed of a top cover material, connector snap button, conductive carbon film, conductive hydrogel media, and a carrier line.

It is non-sterile and intended for single adult patient multiple application use. The SM Electrode has various shapes and sizes.

To connect with a nerve or muscle stimulator, this SM Electrode Pad has male snap button. The electrical pad connecting two separated gels together through a non-woven fabric has a pair of male snap button and the diameter is 3mm. The electrical pad with only one male snap button are to be used in pairs and the diameter of snap button is 4mm.

When not in use, the hydrogel face is covered by a PET(polyethylene terephthalate) carrier line.

AI/ML Overview

The provided text describes the submission for K183154, "SM Electrodes," a cutaneous electrode. It details non-clinical testing performed to establish substantial equivalence to predicate devices.

Here's the information broken down as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test	Reported Device Performance
Shelf life testing (ASTM F1980:2016)	Device complies with the standard. (Specific results like duration or remaining strength are not detailed, but compliance implies meeting the established criteria for shelf life.)
Biocompatibility (ANSI AAMI ISO 10993-5:2009/(R) 2014) - In Vitro Cytotoxicity	Device complies with the standard, indicating an absence of unacceptable cytotoxic effects.
Biocompatibility (ISO 10993-10 Third Edition 2010-08-01) - Irritation and Skin Sensitization	Device complies with the standard, indicating an absence of unacceptable irritation and skin sensitization potential.
Contact Impedance Test (per ANSI AAMI IEC 60601-2-2:2009, 201.15.101.6)	Test results demonstrated compliance with the standard (specific numerical values for impedance are not provided, but compliance is stated).
Adhesion Test (per ANSI AAMI IEC 60601-2-2:2009, 201.15.101.7)	Test results demonstrated compliance with the standard (specific numerical values for adhesion are not provided, but compliance is stated).
Connector Retention Force (snap button with male snap connector)	9.62 N (for the subject device, compared to 9.60 N and 9.61 N for predicates, implying this value falls within acceptable limits for substantial equivalence).
Hydrogel thickness	1.0mm ± 0.2mm (for the subject device, matching the predicates, implying it meets the specified thickness).
Electrical Conductivity & Adhesive Property	"Good electrical conductivity, good adhesive property" (Qualitative assessment, noted as equivalent to predicates).

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 explicitly state the sample sizes used for each specific bench test (e.g., how many electrodes were tested for impedance, adhesion, or biocompatibility). It only states that "Bench tests were conducted on SM Electrodes."

The data provenance is from non-clinical bench tests. The location where these tests were conducted is not specified, but the manufacturer is Hong Qiangxing (Shen Zhen) Electronics Limited in Guangdong, China.

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

Not applicable. This submission relies solely on non-clinical bench testing against established international and national standards, not on expert-driven ground truth for clinical performance. The "ground truth" here is the adherence to the defined parameters and limits within those standards.

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

Not applicable. There was no clinical study with a test set requiring adjudication. The assessment was based on objective measurements against engineering and biocompatibility standards.

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

No MRMC comparative effectiveness study was performed or included in this submission. The device is a cutaneous electrode, an accessory for stimulation devices, and does not involve AI or human "readers" in the context of image interpretation or diagnostic tasks.

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

Not applicable. The device is a physical cutaneous electrode, not an algorithm.

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

The "ground truth" for the non-clinical tests was established by recognized international and national standards. Compliance with these standards (ASTM, ISO, ANSI AAMI IEC) served as the basis for determining the device's acceptable performance and safety characteristics.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.

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

Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established for it.

Summary

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March 26, 2019

Hong Qiangxing (Shen Zhen) Electronics Limited % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, 201613 China

Re: K183154

Trade/Device Name: SM Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: March 8, 2019 Received: March 21, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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) K183154

Device Name SM 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)

বী।

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

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510(k) Summary

[As required by 21 CFR 807.92]

1. Submission Information:

510(k) Number:	K183154
Date:	March 26, 2019
Type of 510(k) Submission:	Traditional
Basis for 510(k) Submission:	New device
Submitter/Manufacturer:	Hong Qiangxing(Shen Zhen) Electronics Limited4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'anDistrict, Shenzhen City, Guangdong, China 518126
Contactor:	Doris Dong (Consultant)Shanghai CV Technology Co., Ltd.Rm. 903, No. 19 Dongbao Rd., Songjiang Area, Shanghai, 201613 ChinaE-mail: doris_d@126.comTel: 86 21-31261348

2. Device Description:

Proprietary Name:	SM Electrodes
Common Name:	Cutaneous electrode
Classification Name:	Cutaneous electrode
Product Code:	GXY
Device Class:	II
Regulation Number:	21 CFR 882.1320
Review Panel:	Neurology
Indications for use:	SM Electrodes are intended to transmit electrical current to patient skin foruse with transcutaneous electrical stimulation devices. Some commontypes of the stimulation devices include, but are not limit to TENS(Transcutaneous Electrical Nerve Stimulation) and EMS (ElectricalMuscular Stimulation). The electrode is for OTC (Over-The -Counter) orPrescription use.
Device Description:	SM Electrode pad is used as an accessory to the TENS or EMS deviceunit, which transmits electrical current to patient skin. The electricalcurrent of electrode pad is first transmitted via the snap button thentransmitted to the conductive gel which is adhered to patient skin.SM Electrode Pad is composed of a top cover material, connector snapbutton, conductive carbon film, conductive hydrogel media, and a carrierline.It is non-sterile and intended for single adult patient multiple applicationuse. The SM Electrode has various shapes and sizes.To connect with a nerve or muscle stimulator, this SM Electrode Pad hasmale snap button. The electrical pad connecting two separated gelstogether through a non-woven fabric has a pair of male snap button and thediameter is 3mm. The electrical pad with only one male snap button are to

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be used in pairs and the diameter of snap button is 4mm.

When not in use, the hydrogel face is covered by a PET(polyethylene terephthalate) carrier line.

3. Predicate Device Identification

K152648--Ennova Self-adhesive Electrode--January 12, 2016 K182111--DL Adhesive Electrode--January 17, 2019

4. Non-Clinical Test Conclusion

Bench tests were conducted on SM Electrodes 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:

Shelf life testing per ASTM F1980:2016.
ANSI AAMI 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)
ANSI AAMI IEC 60601-2-2:2009, 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

Contact Impedance test per 201.15.101.6

Adhesion test per 201.15.101.7

5. Substantial Equivalent Based on Assessment of Clinical Performance Data:

Clinical data was not including in this submission.

6. Substantially Equivalent Comparison Conclusion
	New Device	Predicate Device 1	Predicate Device 2
501(k) number	K183154	K152648	K182111
Trade Name:	SM Electrodes	Ennova Self-adhesive Electrode	DL Adhesive Electrode
CommonName:	Cutaneous electrode	Cutaneous electrode	Cutaneous electrode
ClassificationName:	Cutaneous electrode	Cutaneous electrode	Cutaneous electrode
Product Code:	GXY	GXY	GXY
RegulationNumber:	882.1320	882.1320	882.1320
MedicalSpecialty:	Neurology	Neurology	Neurology
Device Class:	II	II	II
Indications foruse:	SM Electrodes are intended totransmit electrical current topatient skin for use withtranscutaneous electrical	Ennova Self-adhesive Electrodeis intended to transmit electricalcurrent to patient skin for usewith transcutaneous electrical	DL Adhesive Electrode isintended to transmit electricalcurrent to patient skin for usewith transcutaneous electrical

6. Substantially Equivalent Comparison Conclusion

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SM Electrodes; Hong Qiangxing(Shen Zhen) Electronics Limited

Hong Qiangxing(Shen Zhen) Electronics Limited
		stimulation devices. Somecommon types of the stimulationdevices include, but are not limitto TENS (TranscutaneousElectrical Nerve Stimulation) andEMS (Electrical MuscularStimulation). The electrode is forOTC (Over-The -Counter) orPrescription use.	stimulation devices. Somecommon types of the stimulationdevices include, but are not limitto TENS (TranscutaneousElectrical Nerve Stimulation) andEMS (Electrical MuscularStimulation). The electrode is forOTC (Over-The -Counter) orPrescription use.	stimulation devices. Somecommon types of the stimulationdevices include, but are notlimited to TENS(Transcutaneous Electrical NerveStimulation) and EMS(Electrical MuscularStimulation). The electrode is forOTC (Over-The -Counter) orPrescription use.
Targetpopulation:	Single patient use and multipleapplication		Single patient use and multipleapplication		Single patient use and multipleapplication
Prescriptionuse	OTC and Prescription use		OTC and Prescription use		OTC and Prescription use
Design (shape& connection):	Round, rectangle, butterfly, oval,according to customizedspecification.Snap button with male snapconnector		Round, rectangle, oval, butterflyaccording to customizedspecification.Lead wire with female socket, orsnap button with male snapconnector		Round, rectangle, butterfly, oval,according to customizedspecification.Lead wire with female socket, orsnap button with male snapconnector
Materials:	- Top cover material- Electrically conductive carboncloth- Biocompatible conductivehydrogel- Electrode carrier liner		- Top cover material- Electrically conductive carboncloth- Biocompatible conductivehydrogel- Electrode carrier liner		- Top cover material- Electrically conductive carboncloth- Biocompatible conductivehydrogel- Electrode carrier liner
Electrode PadSize	Round	Min.Ø20mm;Max.Ø70mm	Round	Min.Ø32mm;Max.Ø70mm	Round	Min.Ø18mm;Max.Ø85mm
	Rectangle	Min.50×50mm;Max.170×100mm	Rectangle	Min.40×40mm;Max.100×130mm	Rectangle	Min.40×40mm;Max.40×350mm
	Oval	Min.43×30mm;Max.120×76mm	Oval	Min.50×120mm;Max.100×240mm	Oval	50×78mm
	Butterfly	165×79mm	Butterfly	Min.55×75mm;Max.95×165mm	Butterfly	Min.93×150mm;Max.110×150mm
Connector retention force
--Lead wirewith femalesocket	NA		10.80N		10.85N
--snap buttonwith male snapconnector	9.62N		9.60N		9.61N
Hydrogelthickness	1.0mm ± 0.2mm		1.0mm ± 0.2mm		1.0mm ± 0.2mm
Standards met:	1. Impedance test,		1. Lead wires test per 8.5.2.3 of		1.Lead wires test per8.5.2.3 of
	Conformability test and Fluid

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SM Electrodes; Hong Qiangxing(Shen Zhen) Electronics Limited

	tolerance test per 201.15.101.6and 201.15.101.7 of ANSI AAMIIEC 60601-2-2:2009;2. Impedance Test (DispersionTest) per FDA requirement;3. Peel strength test according tomanufacturer's requirement;4. Shelf life test per ASTMF1980:2016;	2. Impedance test,Conformability test and Fluidtolerance test per 201.15.101.6and 201.15.101.7 of IEC60601-2-2:20093. Impedance Test (DispersionTest) per FDA requirement;4. Peel strength test according tomanufacturer's requirement;5. Shelf life test per ASTMF1980:2011;	2.Impedance test, Conformabilitytest and Fluid tolerance test per201.15.101.6 and 201.15.101.7of ANSI AAMI IEC60601-2-2:20173. Impedance Test (DispersionTest) per FDA requirement;4. Peel strength test according tomanufacturer's requirement;5.Shelf life test per ASTMF1980:2016;
Biocompatibility	ISO10993-5:2009;ISO10993-10:2010	ISO10993-5:2009;ISO10993-10:2010	ISO10993-5:2009;ISO10993-10:2010
SterilityStatus:	Non-sterile	Non-sterile	Non-sterile
Electricalsafety	NA	Lead wire meets Clause 8.5.2.3of AAMI/ANSI ES60601-1	Lead wire meets Clause 8.5.2.3of AAMI/ANSI ES60601-1
OtherPerformance	Good electrical conductivity,good adhesive property	Good electrical conductivity,good adhesive property	Good electrical conductivity,good adhesive property

The Conclusions:

Based on the successful biocompatibility testing, electrode current distribution test results, SM Electrodes are safe and effective when used as an interface between a user's skin and an approved nerve and muscle stimulation device. The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed devices identified in the submission. Thus the subject device is 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).