Electrodes with silver conductive as Glove style, Wristbands Style, Wrist sleeve, Elbow Pads Style and Knee Pads Style, Elbow Sleeve, are intended for use with legally marketed TENS stimulating device. The electrodes with silver conductive will deliver stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include such as hands (gloves), feet (socks), wrist, elbow and knee.

Device Description

Electrodes with silver conductive are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, wrist sleeve and knee sleeve. The conductivity is derived from the silver content of the Nylon yarn. The electrodes are available in free size. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The electrodes can be used dry or wet when in contact with the skin. The entire surface of each electrode is very conductive having a resistance of less than 2ohms per inch. This low resistance provides low current density with uniform current distribution.

AI/ML Overview

This document is a 510(k) Summary for a medical device (Electrodes with silver conductive) and focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets new acceptance criteria through extensive clinical studies. Therefore, much of the requested information regarding detailed study design, ground truth establishment, reader studies, and sample sizes for training and test sets is not available in this type of regulatory submission.

The document primarily relies on bench testing and a comparison of technical specifications to a previously cleared predicate device to assert safety and effectiveness.

Here's the information that can be extracted or inferred from the provided text, along with an explanation of why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, "acceptance criteria" predominantly revolve around demonstrating substantial equivalence to a predicate device, as well as meeting basic biocompatibility standards and electrical resistance specifications. The performance is reported in terms of these comparisons.

Acceptance Criterion (Inferred from comparison)	Reported Device Performance (Subject Device)	Comparison to Predicate (Neurotron Medical, Inc. - Theraknit Garments, K053214)
Intended Use	Deliver stimulation signals generated by a legally marketed TENS stimulating device to the body surface (hands, feet, wrist, elbow, knee).	Substantially Equivalent (SE)
Product Code	GXY	SE (Both GXY)
Regulation Number	882.1320	SE (Both 882.1320)
Regulation Class	Class II	SE (Both Class II)
Design (Shape)	Glove, Socks, Wristbands, Elbow Pads, Knee Pads Style	SE (Predicate also has Glove, Socks, Sleeve, Pads Styles - Note 1 explains differences do not raise safety/effectiveness issues)
Size	One size (Specific unstretched areas provided in cm2)	SE (Predicate had "All sizes" - Note 1 explains differences do not raise safety/effectiveness issues)
Conductive Surface	One size (Specific unstretched areas provided in cm2)	SE (Predicate had "All sizes" - Note 1 explains differences do not raise safety/effectiveness issues)
Impedance Parameters	2 ohms resistance per inch	SE (Predicate: 7 ohms resistance per inch. Note 2 explains both are very low relative to stimulation current and considered safe/effective.)
Patient Contacting Material	Silver plated nylon	SE (Both silver plated nylon)
Biocompatibility	Complied with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization & Irritation)	SE (Predicate also complied with these standards)
Washable	Washable	SE (Both washable)
Labeling	Conform to 21 CFR Part 801	SE (Both conform to 21 CFR Part 801)
Re-usable	For single patient	SE (Both for single patient)

Regarding the specific questions you asked for deeper study details:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided: This document relies on bench testing and comparison to a predicate device, not a large-scale clinical test set for performance evaluation in the way an AI/software device would. The "test summary" only mentions "Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards." These would involve in vitro (cell culture) and potentially in vivo (animal, not human) tests, but not a "test set" of human data in the context of device performance as you might expect for an AI algorithm. The provenance would be the lab where these biocompatibility tests were conducted.

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)

Not applicable/Not provided: There is no "ground truth" derived from expert consensus on patient data described, as this is a physical device (electrodes) and not an AI or diagnostic tool requiring such expert review of images or clinical outcomes.

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

Not applicable/Not provided: See explanation for #3.

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/Not provided: This device is physical conductive electrodes, not an AI software. Therefore, MRMC studies are irrelevant here.

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

Not applicable/Not provided: This is not an algorithm. Bench tests were done to evaluate electrical properties and biocompatibility.

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

Not applicable/Not provided: For the physical and chemical properties assessed (e.g., impedance, biocompatibility), the "ground truth" is established by laboratory measurement standards (e.g., resistance meters, cell viability assays, irritation scores) rather than clinical expert consensus or pathology data.

8. The sample size for the training set

Not applicable/Not provided: There is no "training set" as this is not an AI/machine learning device.

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

Not applicable/Not provided: See explanation for #8.

Summary regarding the nature of this submission:

This document is a 510(k) Pre-market Notification, which primarily aims to demonstrate substantial equivalence to a predicate device already legally marketed. For devices like these electrodes, this often means showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The "study" here is not a clinical performance trial in the sense of evaluating diagnostic accuracy or clinical outcomes, but rather a series of bench tests (e.g., impedance, physical dimensions) and biocompatibility tests to ensure the device performs as expected and is safe for contact with the human body, compared against established standards and the predicate device's performance.

Summary

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January 5, 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: K171721

Trade/Device Name: Electrodes with silver conductive Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: October 15, 2017 Received: October 30, 2017

Dear Ms. 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

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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); 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.

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) K171721

Device Name Electrodes with silver conductive

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☐ For activities identified in 33 CFR 323.4(a)(2)	☑ In waters where the Corps has regulatory authority

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

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

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Sponsor:	Shenzhen Konmed Technology Co., Ltd.
Subject Device:	Electrodes with silver conductive, model: KM-406: Glove Style; KM-407: Socks Style;KM-408: Wristbands Style;KM-409: Elbow pads Style; KM-410 : Knee Pads Style
Document Name:	FDA 510(k) Submission Report

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, China Tel: +86-020-66393598 Fax: +86-755-86704558 Contact Person: Tony (Manager) Email: 2519021651 @qq.com

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 silver conductive Common Name: Cutaneous Electrode Review Panel: Neurology Model: KM-406: Glove Style: KM-407: Socks Style: KM-408: Wristbands Style: KM-409: Elbow pads Style: Product Code: GXY Regulation Class: II Regulation Number: 882.1320

3. Predicate Device Information

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Sponsor:	Shenzhen Konmed Technology Co., Ltd.
Subject Device:	Electrodes with silver conductive, model: KM-406: Glove Style; KM-407: Socks Style;KM-408: Wristbands Style;KM-409: Elbow pads Style; KM-410 : Knee Pads Style
Document Name:	FDA 510(k) Submission Report

Sponsor	Neurotron Medical, Inc
Device Name	Theraknit Garments
510(k) Number	K053214
Product Code	GXY
Regulation Number	882.1320
Regulation Class	II

4. Device Description

5. Intended Use / Indications for Use

Electrodes with silver conductive as Glove style, Wristbands Style, Elbow Pads Style and Knee Pads Style, are intended for use with legally marketed TENS stimulating device. The electrodes with silver conductive will deliver stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include such as hands (gloves), feet (socks), wrist, elbow and knee.

6. Test Summary

Electrodes with snap / Electrodes with pigtail 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 �

7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, and intended use of Electrode is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device	Remark
Device Name andModel	Electrodes with silver conductiveModel:KM-406: Glove StyleKM-407: Socks Style	Theraknit Garments	--

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Sponsor:	Shenzhen Konmed Technology Co., Ltd.
Subject Device:	Electrodes with silver conductive, model: KM-406: Glove Style; KM-407: Socks Style;KM-408: Wristbands Style;KM-409: Elbow pads Style; KM-410 : Knee Pads Style
Document Name:	FDA 510(k) Submission Report

	KM-408: Wristbands StyleKM-409: Elbow pads StyleKM-410 : Knee Pads Style
510(k) Number	Applying	K053214	--
Product Code	GXY	GXY	SE
Intended Use /Indications for Use	Electrodes with silver conductiveas Glove style, Socks style,Wristbands Style, Wrist sleeve,Elbow Pads Style and Knee PadsStyle, Elbow Sleeve, are intendedfor use with legally marketedTENS stimulating device. Theelectrodes with silver conductivewill deliver stimulation signalsgenerated by the stimulator to thebody surface with which they arein contact. These body parts caninclude such as hands (gloves),feet (socks), wrist, elbow andknee.	The TheralKnit Garment electrodesare cutaneous to be used withlegally marketed TENS stimulatingdevice. The knitted garmentelectrodes will deliver thestimulation signals generated by thestimulator to the body surface withwhich they are in contact. Thesebody parts can include hand(glove), feet (socks), elbow or knee(sleeve), arm, leg, shoulder, back(pads).	SE
Design (Shape)	KM-406: Glove StyleKM-407: Socks StyleKM-408: Wristbands StyleKM-409: Elbow pads StyleKM-410: knee Pads Style	Electrode A: Glove StyleElectrode B: Socks StyleElectrode C: Sleeve StyleElectrode D: Pads Style	SENote1
Size	One sizeBelow is size for when withoutstretched:KM-406: 200 (cm2)KM-407: 285 (cm2)KM-408: 95 (cm2)KM-409: 160 (cm2)KM-410: 236 (cm2)	All sizes	SENote 1
Conductive surface	One sizeBelow is size for when withoutstretched:KM-406: 400 (cm2)KM-407: 570 (cm2)KM-408: 190 (cm2)KM-409: 320 (cm2)KM-410: 472 (cm2)	All sizes	SENote 1
ImpedanceParameters	2 ohms resistance per inch	7 ohms resistance per inch	SENotes 2
Patient ContactingMaterial	Silver plated nylon	Silver plated nylon	SE
Biocompatibility	Complied with ISO 10993-5, ISO10993-10	Complied with ISO 10993-5, ISO10993-10	SE

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Sponsor:	Shenzhen Konmed Technology Co., Ltd.
Subject Device:	Electrodes with silver conductive, model: KM-406: Glove Style; KM-407: Socks Style;KM-408: Wristbands Style;KM-409: Elbow pads Style; KM-410 : Knee Pads Style
Document Name:	FDA 510(k) Submission Report

Washable or not	Washable	Washable	SE
Labeling	Confirm to 21 CFR Part 801	Confirm to 21 CFR Part 801	SE
Re-usable	For single patient	For single patient	SE

Comparison in Detail(s):

Note 1:

Although the "Shape", " Conductive surface" and "Size" of 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:

Although the "Impedance Parameters "are a little different from the predicate devices. The resistance of the knitted garment for both the subject device and the predicate devices are less than 7 ohms/inch which is very low relative to the delivery of the stimulation current. So they are both safe and effective.

Note 3:

" SE" means substantially equivalent.

Conclusion

The subject device Electrodes with silver conductive 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).