Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.

Device Description

Adhesive electrodes are intended for use as the disposable, conductive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuancous Electrical Nerver Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.

The proposed device. Adhesive Electrode, is intended to be used with U.S. legally marketed Electrical Stimulator. i.e. TENS and EMS, as a conductive adhesive interface between the patient's skin and such stimulators. It is for single patient use only.

The proposed device mainly consists of substrate and wire. The substrate is available in rectangular shape and round shape.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Adhesive Electrodes". This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness for a new medical device. Therefore, the information typically found in a clinical study for a new device (like specific performance metrics, sample sizes for test/training sets, expert qualifications, MRMC studies, or detailed ground truth establishment) is not present in this document.

The "study" that proves the device meets acceptance criteria, in this context, is a non-clinical test that demonstrates compliance with relevant standards and substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for an adhesive electrode, the acceptance criteria are generally compliance with recognized standards and demonstration of substantial equivalence to a predicate device. Specific numerical performance metrics against acceptance criteria are not detailed in this summary for the product itself beyond standard compliance.

Acceptance Criteria (from predicate/standards)	Reported Device Performance (Proposed Device)
Intended Use: Disposable, conductive adhesive interface between patient's skin and electrical stimulator (TENS/EMS)	Intended Use: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use. (Matches predicate, with clarification for OTC use).
Design Feature: Substrate / Wire / Hydro-Gel / Scrim / Conductive Fiber / Carbon Conductive Film / Liner	Design Feature: Substrate / Wire / Hydro-Gel / Scrim / Conductive Fiber / Carbon Conductive Film / Liner (Identical to predicate)
Labeling: Conforms to 21 CFR 801	Labeling: Conforms to 21 CFR 801 (Identical to predicate)
Biocompatibility: Complies with ISO 10993	Biocompatibility: Complies with ISO 10993 (Identical to predicate)
Performance: Complies with ANSI/AAMI HF18:2001	Performance: Complies with ANSI/AAMI HF18:2001 (Identical to predicate)
Overall substantial equivalence to predicate (K070612)	Conclusion: The proposed device, Adhesive Electrodes, is determined to be Substantially Equivalent (SE) to the predicate device, Top-Rank Adhesive Electrodes (K070612), in respect of safety and effectiveness.

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

Sample Size for Test Set: Not specified. The document only mentions "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." These would likely involve testing of manufactured units, but the number of units is not provided.
Data Provenance: The tests are "Non clinical tests", implying laboratory testing of the device itself rather than data from human subjects. The manufacturing company, Top-Rank Health Care Co., Ltd, is located in China.

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

This type of information is not applicable to this 510(k) submission. "Ground truth" in the context of expert consensus or pathology is relevant for diagnostic or AI-driven devices. For an adhesive electrode, the "ground truth" is established by adherence to recognized performance standards (like ANSI/AAMI HF18:2001) and material biocompatibility standards (ISO 10993). No human experts are described as establishing "ground truth" for the performance of the adhesive electrode itself.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or evaluators in diagnostic studies. This is not a diagnostic device and the referenced "Non clinical tests" are likely laboratory-based.

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. This is not a diagnostic device, and there is no mention or implication of AI or human readers being involved in its evaluation.

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

No. This is not an algorithm-based device.

7. The Type of Ground Truth Used

For this device, the "ground truth" for proving it meets acceptance criteria is primarily:

Compliance with established industry performance standards (ANSI/AAMI HF18:2001 for electrosurgical devices).
Compliance with biocompatibility standards (ISO 10993).
Demonstration of functional and material correspondence to a legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. 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. See point 8.

Summary

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Section 3 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21. CFR Section 807.92.

The assigned 510(k) Number: K132588

Date of Submission: Jul 20, 2013
Sponsor Identification

Top-Rank Health Care Co., Ltd Chencun Village, Dongguan Street, Shangyu, Zhejiang, 312352, China

Establishment Registration Number: 3006626283

Contact Person: Liubo Shen Position: Management Representative Tel:+86-575-82576147 Fax: +86-575-82563750 Email: liubo.shen@ctop-rank.com

Submission Correspondent

Ms. Diana Hong& Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120. China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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Proposed Device Identification 4.

Proposed Device Name: Adhesive Electrodes Proposed Device Common Name: Electrode

Regulatory Information: Classification Name: Cutaneous Electrode; Classification: 11; Product Code: GXY: Regulation Number: 21 CFR 882.1320: Review Panel: Neurology:

Intended Use Statement:

Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.

Predicate Device Identification న.

510(k) Number: K070612 Product Name: Top-Rank Adhesive Flectrodes Manufacturer: Top-Rank Health Care Co., Ltd.

Device Description 6.

The proposed device mainly consists of substrate and wire. The substrate is available in rectangular shape and round shape.

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7. Non-Clinical Test Conclusion

Non clinical tests were conducted 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:

ANSI/AAMI HF18:2001 Electrosurgical devices

Substantially Equivalent (SE) Conclusion 8.
The following table compares the DEVICE to the predicate device with respect to intended use, design feature and performance, etc.

Table 3-1 Comparison of Technology Characteristics
ITEM	PROPOSED DEVICE	PREDICATE DEVICE
Device Name	Adhesive Electrodes	Top-Rank Adhesive Electrodes, K070612
Device Name	Adhesive Electrodes	Top-Rank Adhesive Electrodes
Regulation Number	882.1320	882.1320
Product Code	GXY	GXY
Classification Name	Cutaneous Electrode	Cutaneous Electrode
Device Class	CLASS II	CLASS II
Intended Use	Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcuancous Electrical Nerver Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.	Top-Rank Adhesive Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed Electrical Stimulators. i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
Design Feature	Substrate / Wire / Hydro-GelScrim / Conductive FiberCarbon Conductive Film / Liner	Same
Labeling	Conforms to 21 CFR 801	Same
OTC or Prescription	For OTC use	For prescription use
Biocompatibility	Complies with ISO 10993	Complies with ISO 10993
Performance	Complies with ANSI/AAMI HF18:2001	Complies with ANSI/AAMI HF18:2001 E

Table 3-1 Comparison of Technology Characteristics

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The proposed device. Adhesive Electrodes. is determined to be Substantially Equivalent (SF) to the predicate device. Top-Rank Adhesive Electrodes (K070612), in respect of safety and effectiveness.

the state of the state of the states

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

November 22, 2013

Top Rank Health Care Equipment Co., Ltd C/O Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai 200120 China

Re: K132588

Trade Name: Adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: November 8, 2013 Received: November 12, 2013

Dear Ms. Hong:

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. Iisting 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

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Page 2 - Ms. Diana Hong

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-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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/dcfault.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 Small Manufacturers, International and Consumer Assistance 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.

Joyce M. Whang -S

Victor Krauthamer, Ph.D. for Acting 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): K132588

Device Name: Adhesive Electrodes

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

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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).