ValuTrode® reusable, self-adhering, over-the-counter Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.

Device Description

The ValuTrode® reusable self-adhering electrode is used as a transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS or EMS. The device functions as a passive device by carrying an electrical signal from a neurostimulation device through the device cable and electrode lead wire to the user skin. It is composed of a cover, connector lead wire, or snap, conductive carbon film, conductive hydrogel, and an electrode carrier liner. Proper current distribution is delivered via a connector lead wire stripped to an additional length, or use of a printed silver pattern.

AI/ML Overview

The provided document is a 510(k) summary for the ValuTrode® Neurostimulation Electrodes (K130987). It states that "No performance data is required to support this or the proposed over the counter claim, as the Electrode has identical technological characteristics including design and materials to its predicate device."

Therefore, the study that proves the device meets acceptance criteria is a demonstration of substantial equivalence to predicate devices, rather than a separate performance study with specific acceptance criteria. This means the device relies on the established safety and effectiveness of its predicate devices: Lifecare Electrodes (K083302) and ValuTrode® Neurostimulation Electrodes (K970426).

Here's the breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since no new performance data was required, the "acceptance criteria" for the ValuTrode® Neurostimulation Electrodes (K130987) are largely demonstrated by its substantial equivalence to the predicate devices and their established safety and effectiveness.

Acceptance Criteria (inferred from predicate)	Reported Device Performance (inherent by substantial equivalence)
Biocompatibility of skin-contacting hydrogel	Meets biocompatibility standards (by using same hydrogel as predicate).
Electrical performance of insulated leadwire components	Meets electrical performance standards (by using similar components as predicate).
Electrode current distribution	Achieves proper current distribution (by using similar design principles and materials as predicate).
Maximum average power density	Does not exceed 0.1 W/cm² (manufacturer's labeling, consistent with predicate's established limit).
General safety and effectiveness as a transcutaneous electrical stimulation electrode	Deemed safe and effective for its intended use (by being substantially equivalent to predicate devices, which are safe and effective).
Intended Use as an OTC device	Marketed for OTC use, supported by equivalence to predicate already cleared for OTC.

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

No specific test set or clinical data was generated for the K130987 submission. The claim of substantial equivalence is based on the device having "identical technological characteristics including design and materials" to its predicate devices. Therefore, there is no "sample size" or "data provenance" in the traditional sense of a new study for this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No new study requiring experts to establish ground truth was conducted for this 510(k) submission. The safety and effectiveness are established through substantial equivalence to previously cleared devices.

4. Adjudication Method for the Test Set

Not applicable. As no new test set was used, there was no adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study was conducted. The device is a passive electrode, and the submission primarily focuses on physical and material equivalence to existing devices.

6. Standalone Performance Study (algorithm only without human-in-the-loop)

Not applicable. The device is a passive electrode and does not involve an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the current submission is the established safety and effectiveness of the identified predicate devices (K083302 and K970426), as determined by the FDA's previous clearances. This is based on the successful biocompatibility testing, electrical performance, and current distribution tests performed on the predicate devices.

8. Sample Size for the Training Set

Not applicable. No new training set was used. The submission relies on the established performance of predicate devices.

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

Not applicable. There was no training set for this submission. The "ground truth" for the predicate devices, which this submission relies upon, was established through their own respective 510(k) processes, which included biocompatibility testing, electrical performance testing, and current distribution tests as detailed in their summaries. For instance, the K970426 predicate had its power density calculated and reviewed by an FDA Biologist.

Summary

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005 510K Summary_ValuTrode 7 13 13

	510(k) Summary K130987807.92(c)	JUL 17 2013
Submitter/Contact Person	Dan Jeffery, PresidentAxelgaard Manufacturing Co., Ltd.520 Industrial WayFallbrook, CA 92028Phone: 760-451-8000 Fax: 760-723-2356Dan.jeffery@axelgaard.com
Device Identification
Common Name:	Electrodes, Cutaneous
Trade Name/Common Name:	ValuTrode® Neurostimulation Electrodes
Regulation No.:	21CFR 882.1320 Electrodes, Cutaneous
Classification:Product Code:	Class IIGXY

Device Description (807.92[a] [4])

The ValuTrode® reusable self-adhering electrode is used as a transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS or EMS.

Technical Characteristics

The device functions as a passive device by carrying an electrical signal from a neurostimulation device through the device cable and electrode lead wire to the user skin. It is composed of a cover, connector lead wire, or snap, conductive carbon film, conductive hydrogel, and an electrode carrier liner. Proper current distribution is delivered via a connector lead wire stripped to an additional length, or use of a printed silver pattern.

Everyway Medical manufactures the Lifecare Electrode (K083302) with the same conductive hydrogel, conductive carbon film and electrode carrier liner as Axelgaard's ValuTrode Neurostimulation Electrodes. Axelgaard Manufacturing supplies these components to Everyway.

Intended Use (807.92[a] [5])

Legally Marketed Predicate Devices (807.92[a] [3])

Device Name	Manufacturer	510(k)No.	Date Cleared
Life Care Electrodes	Everyway MedicalInstruments Company	K083302	2009
ValuTrode® Neurostimulation Electrodes	Axelgaard ManufacturingCo., Ltd.	K970426	1997

(The Substantial Equivalency Summary and subsequent pages are formatted in landscape orientation for ease of reading.)

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イモディメモレGAARD

Substantial Equivalence Summary (807.92[a] [6])

Technology	Subject DeviceAxelgaard ValuTrode OTC (K130987)	Everyway Lifecare (K083302)	Axelgaard ValuTrode (K970426)
	Cutaneous electrode which conducts anelectrical signal from a neurostimulationdevice through a leadwire; which isdispersed from the wire across aconductive surface; then transmittedthrough the conductive adhesive gel to thesurface of the patient's skin.	Cutaneous electrode which conducts anelectrical signal from a neurostimulationdevice through a leadwire; which isdispersed from the wire across aconductive surface; then transmittedthrough the conductive adhesive gel to thesurface of the patient's skin. The electrodeconnection point (leadwire) is compatiblewith standard, marketed Neurostimulationdevices. The device is safe and effective asthe predicate devices cited (within their510(k) submittal.	Cutaneous electrode which conducts anelectrical signal from a neurostimulationdevice through a leadwire; which isdispersed from the wire across aconductive surface; then transmittedthrough the conductive adhesive gel to thesurface of the patient's skin.
Safety &Effectiveness	Safety & Effectiveness-Based on successful biocompatibilitytesting of the skin contacting conductivehydrogel, the electrical performance of theinsulated leadwire components andelectrode current distribution test results,the ValuTrode neurostimulation devicesare safe and effective when used as aninterface between a user's skin and anapproved neurostimulation devices.Our labeling states: "Consult electrodemanual for proper electrode size. Do notexceed 0.1watts/cm²."FDA max power guidelines draftguidance 2010 states in Section D.(vi) amaximum average power density thatdoes not exceed .025 watts per squarecentimeter of electrode conductivesurface area.	Safety & Effectiveness-Based on successful biocompatibility testingof the skin contacting conductive hydrogel,the electrical performance of the insulatedleadwire components and electrode currentdistribution test results, the ValuTrodeneurostimulation devices are safe andeffective when used as an interface betweena user's skin and an approvedneurostimulation devices.	See FDA comment below:"All leadwire connectors are safety protectedwith insulated shrink wrapping. Cables arenot supplied with the device.Maximum energy density was calculated forthe smallest electrode size using an averagecurrent of 30 mA (90 or 60 mA, with dutycycles of 33 and 50 percent, respectively)across a 2 Kohm resistance and found thepower to be 0.10 W/cm² well below the limitconservatively established for thermal burns.The manufacturer has added a prominentstatement to the labeling not to exceed 0.1watts/cm²."John Francis Glass, FDA BiologistK970426 submittal reviewer, 5/8/1997.

: ·

005-2

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NANUPACITING CO., LTD

SIS

Features / Materials	Indications of UsePrinciples ofOperation		Differences
Subject DeviceAxelgaard ValuTrode OTC (K130987)	ValuTrodes® are intended for use withTranscutaneous ElectricalNeurostimulation (TENS) units as over thecounter devices.	Some common type of neurostimulationdevices include, but are not limited to,TENS and EMS devices.	ValuTrode® electrodes will offer lead wireand snap connection configurations
Four basic components:■ Top cover material■ Lead wire or snap connection■ Lead wire has insulation on femaleconnector■ Conductive carbon film■ Conductive hydrogel	Transcutaneous ElectricalNeurostimulation electrodes are passivedevices serving as an interface between ausers' skin and a neurostimulation device.		Change in product labeling only to allowthe product to be sold for over-the-counter.
Everyway Lifecare (K083302)	Electrodes are intended for use withtranscutaneous neurostimulation devicesas over the counter devices.	Some common type of neurostimulationdevices include, but are not limited to,TENS and EMS devices.	The Lifecare Electrode 510(k) only offerslead wire connection electrodes.
Four basic components:■ Top cover material■ Lead wire connection■ Lead wire has insulation on femaleconnector■ Conductive carbon film■ Conductive hydrogel	Transcutaneous neurostimulationelectrodes are passive devices serving asan interface between a patient's skin and aneurostimulation device.		Lifecare Electrodes are sold as over-the-counter devices.
Axelgaard ValuTrode (K970426)	ValuTrodes™ are intended for use withFDA approved Transcutaneous ElectricalNeurostimulation (TENS) devices.		ValuTrode™ electrodes offer lead wire andsnap connection configurations
Four basic components:■ Top cover material■ Lead wire or snap connection■ Lead wire has insulation on femaleconnector■ Conductive carbon film■ Conductive hydrogel	Transcutaneous Electrical Neurostimulationelectrodes are passive devices serving asan interface between a patient's skin and aneurostimulation device.		The devices are currently being sold asprescription medical devices.
			We claim that these electrodes can be soldas OTC (over-the-counter) under the510(k) regulation (21 CFR 801 Subpart C)requiring 510(k) submittal.

Performance Data

No renomance dat is required to suport his othe roposed over the counter ulair relevins idention Electrode has idenical
technological characteritics including design and mall

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Image /page/3/Picture/0 description: The image shows the word "SAXELGAARD" in a vertical orientation. Below the word, it says "MANUFACTURING CO., LTD." also in a vertical orientation. The text is in a simple, sans-serif font and appears to be a logo or company name.

Safety / Effectiveness and Conclusion Statement (860.7

Axelgaard Manufacuring Co., Ltd. considers the ValuTrode® over-the-counter Neurostimulation electrode to be as safe and effective as the predicated
device Lifecare Electrode

Based upon an evaluation of he Lifecare and Axelgard Manufacturing ValuTrode® electrodes, Avelgard Manufactuing Co.,
Ltd. believes hat the proposed ValuTrode® self adhering r

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

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

July 17, 2013

Axelgaard Manufacturing Co., Ltd. C/O Dan Jeffery, President 520 Industrial Way Fallbrook, CA 92028

Re: K130987

Trade/Device Name: ValuTrode® Neurostimulation Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Electrodes, Cutaneous Regulatory Class: Class II Product Code: GXY Dated: April 4, 2013 Received: April 19, 2013

Dear Mr. Jeffery:

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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Page 2 - Mr. Dan Jeffery

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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Victor Krauthamer -S

Victor Krauthamer, Ph.D. 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): K130987

Device Name: ValuTrode® Neurostimulation Electrodes

Indications For Use:

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Victor Krauthamer -S 2013.07.18 11:42:08 -04'00'

Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K130987

Page 1 of 1

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).