Adhesive electrodes are intended for use as the disposable, conductive interface between the patient's skin and the Electrical Stimulator. 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.

Device Description

Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. 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.

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 intended environment for the proposed device includes home use and hospital use. The intended population for the proposed device includes children and adults.

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 is a 510(k) summary for Reno Medical Ltd.'s Adhesive Electrodes, and it specifically states: "No clinical study is included in this submission."

Therefore, a detailed description of acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment related to a clinical study cannot be provided from this document. The submission relies entirely on non-clinical testing to demonstrate substantial equivalence to a predicate device.

However, based on the non-clinical tests mentioned, we can infer the reported approach to meeting performance criteria.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with reported performance metrics for the proposed device in a clinical context. Instead, it states that "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 comparison table (Table 1) shows that the proposed device is considered "Identical" to the predicate device (K132588) across various characteristics, including:

Product Code: GXY
Regulation Number: 21 CFR 880.1320
Class: II
Intended Use: Adhesive electrodes for use as disposable, conductive interface between patient's skin and Electrical Stimulators (TENS/EMS) for OTC use.
Design Feature: Substrate / Wire / Hydro-Gel Scrim / Conductive Fiber Carbon Conductive Film / Liner
OTC or Prescription: For OTC use
Biocompatibility: Conforms to ISO 10993 series standards
Label/Labeling: Complied with 21 CFR part 801

The acceptance criteria for these aspects are implicitly that the proposed device's characteristics match those of the predicate device and comply with relevant standards and regulations.

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

This information is not provided because no clinical study was conducted. The "test set" in this context refers to the non-clinical tests' samples. The document does not specify the sample sizes or data provenance for these non-clinical tests.

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, as no clinical study with human subject data requiring expert ground truth was performed.

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

Not applicable, as no clinical study with human subject data requiring adjudication was performed.

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. The device is an adhesive electrode, not an AI-powered diagnostic tool, and no MRMC study was conducted.

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

This is not an AI algorithm. The device performance was assessed via non-clinical tests, not an algorithm's standalone performance.

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

Not applicable, as no clinical study with human subject data requiring ground truth was performed. For the non-clinical tests, the "ground truth" would be established by validated test methods and reference standards for material properties, electrical performance, biocompatibility, etc.

8. The sample size for the training set

Not applicable, as this is not an AI-powered device and no training set was used.

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

Not applicable, as this is not an AI-powered device and no training set was used.

Summary

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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three faces in profile, stacked on top of each other.

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

Mav 8, 2017

Reno Medical Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China

Re: K170744

Trade/Device Name: Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: March 4, 2017 Received: March 10, 2017

Dear Diana 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, 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

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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 devicerelated 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,

Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for 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) K170744

Device Name Adhesive Electrodes

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Tab #7 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: -

1. Date of Preparation: 2/20/2017
1. Sponsor Identification

Reno Medical Ltd.

MNC2246 RM1007, 10/F, Ho King Comm CTR , 2-16Fa Yuen Street, Mongkok, KL. Hongkong, CHINA, 999077

Establishment Registration Number: 3008799799

Contact Person: LiMing Ren Position: Management Representative Tel: +86-575-82576147 Fax: +86-575-82563750 Email: liubo.shen@etop-rank.com

Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Ms. Betty Xiao (Alternative Contact Person)

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

1. Identification of Proposed Device
  Trade Name: Adhesive Electrodes Common Name: Electrode

Regulatory Information Classification Name: 882.1320 - Cutaneous electrode.

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Classification: II Product Code: GXY Regulation Number: 21 CFR 882.1320 Review Panel: Neurology

Intended Use Statement:

Device Description

The intended environment for the proposed device includes home use and hospital use. The intended population for the proposed device includes children and adults.

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

Identification of Predicate Device 5.
510(k) Number: K132588 Product Name: Adhesive Electrodes Manufacturer: Top-Rank Health Care Co., Ltd.

Non-Clinical Test Conclusion 6.

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.

1. Clinical Test Conclusion
  No clinical study is included in this submission.

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Ref.: M3702016

8. Substantially Equivalent (SE) Comparison

The following table compares the DEVICE to the predicate device with respect to intended use, design feature and performance, etc

Item	Proposed Device	Predicate Device
Product Code	GXY	Identical
Regulation Number	21 CFR 880.1320	Identical
Class	II	Identical
Intended Use	Adhesive electrodes are intended for use asthe disposable, conductive adhesive interfacebetween the patient's skin and the ElectricalStimulator. Adhesive Electrodes are intendedto be used with marketed ElectricalStimulators, i.e. TENS (TranscutaneousElectrical Nerve Stimulation) and EMS(Electrical Muscular Stimulation). It is forOTC use.	Identical
Design Feature	Substrate / Wire / Hydro-GelScrim / Conductive FiberCarbon Conductive Film / Liner	Identical
OTC orPrescription	For OTC use	Identical
Biocompatibility	Conforms to ISO 10993 series standards	Identical
Label/Labeling	Complied with 21 CFR part 801	Identical

Table 1 Comparison of Technology Characteristics

9. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) 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).