VALUTRODE NEUROSTIMLATION ELECTRODES

K130987 · Axelgaard Mfg. Co., Ltd. · GXY · Jul 17, 2013 · Neurology

Device Facts

• Record ID: K130987
• Device Name: VALUTRODE NEUROSTIMLATION ELECTRODES
• Applicant: Axelgaard Mfg. Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Jul 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

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 Story

ValuTrode® are reusable, self-adhering cutaneous electrodes used as a passive interface between a user's skin and a neurostimulation device (TENS or EMS). The device conducts electrical signals from the stimulator through a lead wire or snap connector, across a conductive carbon film, and through a conductive hydrogel layer to the skin. The device is intended for over-the-counter use. It does not contain active electronics; it serves solely to distribute current from an external stimulator. The device benefits the patient by providing a consistent, reusable interface for neurostimulation therapy. Users apply the electrodes to the skin as directed by the stimulator's manual, ensuring current density does not exceed 0.1 watts/cm².

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing of the skin-contacting conductive hydrogel, electrical performance testing of lead wire components, and electrode current distribution analysis. No clinical data required.

Technological Characteristics

Passive cutaneous electrode. Components: top cover, lead wire/snap connector, conductive carbon film, conductive hydrogel, carrier liner. Connectivity: standard lead wire/snap interface to external stimulators. No active energy source. Sterilization: not specified.

Indications for Use

Indicated for use with transcutaneous electrical stimulation devices (e.g., TENS, EMS) as an interface between user skin and the stimulator. Intended for over-the-counter use.

Regulatory Classification

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.

Predicate Devices

• Life Care Electrodes (K083302)
• ValuTrode® Neurostimulation Electrodes (K970426)

Submission Summary (Full Text)

{0}------------------------------------------------

005 510K Summary_ValuTrode 7 13 13

| | 510(k) Summary K130987<br>807.92(c) | JUL 17 2013 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submitter/Contact Person | Dan Jeffery, President<br>Axelgaard Manufacturing Co., Ltd.<br>520 Industrial Way<br>Fallbrook, CA 92028<br>Phone: [phone] Fax: [phone]<br>[e-mail] | |
| Device Identification | | |
| Common Name: | Electrodes, Cutaneous | |
| Trade Name/Common Name: | ValuTrode® Neurostimulation Electrodes | |
| Regulation No.: | 21CFR 882.1320 Electrodes, Cutaneous | |
| Classification:<br>Product Code: | Class II<br>GXY | |

## 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])

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.

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

| Device Name | Manufacturer | 510(k)<br>No. | Date Cleared |
|----------------------------------------|-----------------------------------------|---------------|--------------|
| Life Care Electrodes | Everyway Medical<br>Instruments Company | K083302 | 2009 |
| ValuTrode® Neurostimulation Electrodes | Axelgaard Manufacturing<br>Co., Ltd. | K970426 | 1997 |

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

{1}------------------------------------------------

イモディメモレGAARD

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

| Technology | Subject Device<br>Axelgaard ValuTrode OTC (K130987) | Everyway Lifecare (K083302) | Axelgaard ValuTrode (K970426) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Cutaneous electrode which conducts an<br>electrical signal from a neurostimulation<br>device through a leadwire; which is<br>dispersed from the wire across a<br>conductive surface; then transmitted<br>through the conductive adhesive gel to the<br>surface of the patient's skin. | Cutaneous electrode which conducts an<br>electrical signal from a neurostimulation<br>device through a leadwire; which is<br>dispersed from the wire across a<br>conductive surface; then transmitted<br>through the conductive adhesive gel to the<br>surface of the patient's skin. The electrode<br>connection point (leadwire) is compatible<br>with standard, marketed Neurostimulation<br>devices. The device is safe and effective as<br>the predicate devices cited (within their<br>510(k) submittal. | Cutaneous electrode which conducts an<br>electrical signal from a neurostimulation<br>device through a leadwire; which is<br>dispersed from the wire across a<br>conductive surface; then transmitted<br>through the conductive adhesive gel to the<br>surface of the patient's skin. |
| Safety &<br>Effectiveness | Safety & Effectiveness-<br>Based on successful biocompatibility<br>testing of the skin contacting conductive<br>hydrogel, the electrical performance of the<br>insulated leadwire components and<br>electrode current distribution test results,<br>the ValuTrode neurostimulation devices<br>are safe and effective when used as an<br>interface between a user's skin and an<br>approved neurostimulation devices.<br><br>Our labeling states: "Consult electrode<br>manual for proper electrode size. Do not<br>exceed 0.1watts/cm²."<br><br>FDA max power guidelines draft<br>guidance 2010 states in Section D.(vi) a<br>maximum average power density that<br>does not exceed .025 watts per square<br>centimeter of electrode conductive<br>surface area. | Safety & Effectiveness-<br>Based on successful biocompatibility testing<br>of the skin contacting conductive hydrogel,<br>the electrical performance of the insulated<br>leadwire components and electrode current<br>distribution test results, the ValuTrode<br>neurostimulation devices are safe and<br>effective when used as an interface between<br>a user's skin and an approved<br>neurostimulation devices. | See FDA comment below:<br>"All leadwire connectors are safety protected<br>with insulated shrink wrapping. Cables are<br>not supplied with the device.<br>Maximum energy density was calculated for<br>the smallest electrode size using an average<br>current of 30 mA (90 or 60 mA, with duty<br>cycles of 33 and 50 percent, respectively)<br>across a 2 Kohm resistance and found the<br>power to be 0.10 W/cm² well below the limit<br>conservatively established for thermal burns.<br>The manufacturer has added a prominent<br>statement to the labeling not to exceed 0.1<br>watts/cm²."<br><br>John Francis Glass, FDA Biologist<br>K970426 submittal reviewer, 5/8/1997. |

: ·

005-2

{2}------------------------------------------------

NANUPACITING CO., LTD

SIS

| Features / Materials | Indications of Use<br>Principles of<br>Operation | | Differences |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device<br>Axelgaard ValuTrode OTC (K130987) | ValuTrodes® are intended for use with<br>Transcutaneous Electrical<br>Neurostimulation (TENS) units as over the<br>counter devices. | Some common type of neurostimulation<br>devices include, but are not limited to,<br>TENS and EMS devices. | ValuTrode® electrodes will offer lead wire<br>and snap connection configurations |
| Four basic components:<br>■ Top cover material<br>■ Lead wire or snap connection<br>■ Lead wire has insulation on female<br>connector<br>■ Conductive carbon film<br>■ Conductive hydrogel | Transcutaneous Electrical<br>Neurostimulation electrodes are passive<br>devices serving as an interface between a<br>users' skin and a neurostimulation device. | | Change in product labeling only to allow<br>the product to be sold for over-the-counter. |
| Everyway Lifecare (K083302) | Electrodes are intended for use with<br>transcutaneous neurostimulation devices<br>as over the counter devices. | Some common type of neurostimulation<br>devices include, but are not limited to,<br>TENS and EMS devices. | The Lifecare Electrode 510(k) only offers<br>lead wire connection electrodes. |
| Four basic components:<br>■ Top cover material<br>■ Lead wire connection<br>■ Lead wire has insulation on female<br>connector<br>■ Conductive carbon film<br>■ Conductive hydrogel | Transcutaneous neurostimulation<br>electrodes are passive devices serving as<br>an interface between a patient's skin and a<br>neurostimulation device. | | Lifecare Electrodes are sold as over-the-<br>counter devices. |
| Axelgaard ValuTrode (K970426) | ValuTrodes™ are intended for use with<br>FDA approved Transcutaneous Electrical<br>Neurostimulation (TENS) devices. | | ValuTrode™ electrodes offer lead wire and<br>snap connection configurations |
| Four basic components:<br>■ Top cover material<br>■ Lead wire or snap connection<br>■ Lead wire has insulation on female<br>connector<br>■ Conductive carbon film<br>■ Conductive hydrogel | Transcutaneous Electrical Neurostimulation<br>electrodes are passive devices serving as<br>an interface between a patient's skin and a<br>neurostimulation device. | | The devices are currently being sold as<br>prescription medical devices. |
| | | | We claim that these electrodes can be sold<br>as OTC (over-the-counter) under the<br>510(k) regulation (21 CFR 801 Subpart C)<br>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

{3}------------------------------------------------

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

{4}------------------------------------------------

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

{5}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{6}------------------------------------------------

# Indications for Use

510(k) Number (if known): K130987

## Device Name: ValuTrode® Neurostimulation Electrodes

Indications For Use:

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.

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