Wandy Self-adhesive Electrode is intended to transmit electrical current to patient skin, for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications, for OTC (Over-The -Counter) or Prescription use. The Electrode are used for adults only.

Device Description

Wandy Self-adhesive Electrode is intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications, for OTC (Over-The -Counter) or Prescription use. The Electrode are used for adults only.

The Wandy Self-adhesive Electrodes transmits electrical current to patient skin, the electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin.

The Wandy Self-adhesive Electrodes is used as an accessory with the TENS or EMS device units.

AI/ML Overview

The provided text describes a 510(k) submission for "Wandy Self-adhesive Electrodes" and focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML device requiring complex acceptance criteria and a detailed study proving performance against those criteria. Therefore, many of the requested categories are not applicable to this submission.

Here's an analysis based on the provided text, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Impedance	Passed self-evaluation tests for Impedance.
Wire pull	Passed self-evaluation tests for Wire pull.
Adhesiveness	Passed self-evaluation tests for adhesiveness.
Substantial Equivalence	Deemed substantially equivalent to predicate devices (K002219, K002227, K090198).
Safety & Effectiveness	No new questions of safety or effectiveness raised by differences to predicates.
Clinical Experience (Predicate)	Thousands of marketing clinical experience with predicate devices without adverse events.

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

Not Applicable (N/A). The submission does not describe a test set or data provenance in the context of an AI/ML device evaluation. The evaluation was based on self-evaluation tests (bench testing) and comparison to existing predicate devices.

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

N/A. This information is not relevant to the type of device and evaluation described.

4. Adjudication Method for the Test Set

N/A. No test set or expert adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

N/A. This is not an AI/ML device; therefore, no MRMC study with AI assistance was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is a physical medical device (electrodes), not an algorithm.

7. The Type of Ground Truth Used

For the self-evaluation tests (Impedance, Wire pull, Adhesiveness), the "ground truth" would be established by engineering specifications and standards for these physical properties.
For the substantial equivalence claim, the "ground truth" is the performance and safety profile of the predicate devices, which have "thousands of marketing clinical experience and didn't have adverse events occurred in the world."

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device; there is no training set in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

N/A. There is no training set for an AI/ML model. The comparable information is how the performance of the predicate devices (which serve as the basis for comparison) was established, which is through extensive clinical experience.

Summary

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DEC 2 0 2013

K132998

Chapter 5- 510(K) Summary

Submitter	Janis Yang
	Wandy Rubber Industrial Co., Ltd
	No.48, Lane 392, Fu Teh 1Rd, Shi-Chih City 221, Taipei
	Taiwan
	Tel: +886-2-26943185
	Fax: +886-2-26944574
Proprietary Name	Wandy Self-adhesive Electrodes
Common Name	Cutaneous electrode.
Classification Name	Cutaneous electrode.

Panel
Neurology

Classification

classification name	21 CFRsection	Product code	Class
Cutaneous electrode	882.1320	GXY	II

Predicate Device_

Wandy Self adhesive Neurostimulation electrode (K002219) Wandy Silicon Conductive Rubber Pad (K002227) Jiajian Self- adhesive Electrode (K090198)

Description and Indication for Use

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The Wandy Self-adhesive Electrodes is used as an accessory with the TENS or EMS device units.

. .

and the comments of the comments of

and the comments of the comments of the comments of the comments of

and the comments of the comments of the comments of

. .

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Substantial Equivalency

After analyzing both bench and clinical testing data, it is the conclusion of Wandy Self-adhesive Electrodes are substantial equivalent to the predicate device, Wandy Self adhesive Neurostimulation electrode (K002219), Wandy Silicon Conductive Rubber Pad (K002227) and Jiajian Self- adhesive Electrode (K090198).

Performance

The Wandy Self-adhesive Neurostimulation Electrode passed self-evaluation tests for Impedance, Wire pull and adhesiveness.

Discussion of Clinical Tests Performed:

All design specification are exactly equivalent between new devices (Wandy Self-adhesive Electrodes) and predicate devices (Wandy Self-Adhesive Neurostimulation Electrode and Wandy Silicon Conductive Rubber Pad), except claimed indication for use and proposed labeling. Two predicate devices have thousands of marketing clinical experience and didn't have adverse events occurred in the world.

Conclusions:

Wandy Self-adhesive Electrodes have the same intended use and similar technological characteristics as the above predicate devices. Moreover, information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, Wandy Self-adhesive Electrodes are substantially equivalent to the predicate devices

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Public Health Service

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

December 20, 2013

Wandy Rubber Industrial Co., Ltd. Jack Yu No.48, Lane 392, Fu Teh 1 Rd, Xi Zhi Dist New Taipei City Taiwan 221

Re: K132998

Trade/Device Name: Wandy Self-Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulatory Class: Class II Product Code: GXY Dated: September 9, 2013 Received: September 24, 2013

Dear Mr. Yu:

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 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

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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/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 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

Carlos L. Peña. PhD 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): K132998

Device Name: Wandy Self-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)

Joyce M. Whang -S

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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).