PALS PLATINUM NEUROSTIMULATION ELECTRODES

K132422 · Axelgaard Mfg. Co., Ltd. · GXY · Feb 13, 2014 · Neurology

Device Facts

• Record ID: K132422
• Device Name: PALS PLATINUM NEUROSTIMULATION ELECTRODES
• Applicant: Axelgaard Mfg. Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Feb 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Indications for Use

PALS® 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

PALS® Neurostimulation Electrodes are passive, reusable, self-adhering cutaneous electrodes. They function as an interface between a user's skin and an external neurostimulation device (TENS or EMS). The device receives electrical signals from the stimulator via a lead wire or snap connector, disperses the signal across a stretchable conductive fabric, and transmits it through a conductive hydrogel layer to the user's skin. The device is intended for over-the-counter use. By providing a stable electrical interface, the electrodes facilitate the delivery of therapeutic stimulation to the patient, potentially aiding in pain management or muscle stimulation as determined by the connected stimulator.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including biocompatibility testing of the conductive hydrogel and electrical performance testing of the lead wire components and current distribution.

Technological Characteristics

Passive cutaneous electrode; components include top cover, connector lead wire, stretchable conductive fabric, and conductive hydrogel. Connectivity via lead wire or snap connector to external neurostimulation devices. No active electronic components or software.

Indications for Use

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

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

• PALS® Flex Neurostimulation Electrodes (K874469)
• Life Care Electrodes (K083302)
• ValuTrode® Neurostimulation Over the Counter Electrodes (K130987)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Axelgaard Manufacturing Co., LTD. The logo features a stylized "A" with horizontal lines inside, followed by the text "AXELGAARD" in bold, uppercase letters. Below "AXELGAARD" is the text "MANUFACTURING CO., LTD." in a smaller font size.

FEB 1 3 2014

005 PALS 510K_Summary_2_5_2014

510(k) Summary 807.92(c)

| 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: | PALS® Neurostimulation Electrodes |
| Regulation No.: | 21CFR 882.1320 Electrodes, Cutaneous |
| Classification: | Class II |
| Product Code: | GXY |

### Device Description (807.92[a] [4])

The Axelgaard PALS® Neurostimulation 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, strelchable conductive fabric, conductive hydrogel, and an electrode carrier distribution is delivered via a connector lead wire stripped to an additional length.

Axelgaard Manufacturing manufactures the PALS® Neurostimulation Over the Counter Electrode and the ValuTrode Over the Counter Neurostimulation Electrodes (K13987) with the same conductive hydrogel, and electrode carrier.

Everyway Medical manufactures the Lifecare Electrode (K083302) with the same conductive hydrogel and conductive carbon film as Axelgaard's ValuTrode Neurostimulation Electrodes (K130987). Axelgaard Manufacturing supplies these components to Everyway.

### Intended Use (807.92[a] [5])

PALS® 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) No. | Date Cleared | | Subject Device<br>Axelgaard PALS® Neurostimulation OTC | Axelgaard PALS Flex<br>(K874469) | Everyway Lifecare<br>(K083302) | Axelgaard ValuTrode OTC<br>(K130987) | | Subject Device<br>Axelgaard PALS® Neurostimulation<br>OTC | Axelgaard PALS® Flex<br>(K874469) | Everyway Lifecare<br>(K083302) | Axelgaard ValuTrode OTC<br>(K130987) |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PALS® Flex Neurostimulation Electrodes | Axelgaard Manufacturing Co., Ltd. | K874469 | 1998 | | Cutaneous electrode which conducts an<br>electrical signal from a neurostimulation<br>device through a leadwire; which is<br>dispersed from the leadwire across a<br>stretchable conductive fabric then<br>transmitted through the conductive<br>adhesive gel to the surface of the user's<br>skin. | Cutaneous electrode which conducts<br>an electrical signal from a<br>neurostimulation device through a<br>leadwire; which is dispersed from the<br>wire across a stretchable conductive<br>fabric then transmitted through the<br>conductive adhesive gel to the surface<br>of the user's skin. | Cutaneous electrode which<br>conducts an electrical signal<br>from a neurostimulation<br>device through a leadwire;<br>which is dispersed from the<br>wire across a conductive<br>surface; then transmitted<br>through the conductive<br>adhesive gel to the surface<br>of the user's skin. The<br>electrode connection point<br>(leadwire) is compatible with<br>standard, marketed<br>Neurostimulation devices.<br>The device is safe and<br>effective as the predicate<br>devices cited (within their<br>510(k) submittal). | Cutaneous electrode which conducts<br>an electrical signal from a<br>neurostimulation device through a<br>leadwire (or snap); which is<br>dispersed from the leadwire/snap<br>across a conductive surface; then<br>transmitted through the conductive<br>adhesive gel to the surface of the<br>user's skin. | Features /<br>Materials | Four basic components:<br>Top cover material Lead wire connection Lead wire has insulation on female connector Stretchable conductive fabric Conductive hydrogel | Four basic components:<br>Top cover material Lead wire connection Lead wire has insulation on female connector Stretchable conductive fabric Conductive hydrogel | Four basic components:<br>Top cover material Lead wire connection Lead wire has insulation on female connector Conductive carbon film Conductive hydrogel | Four basic components:<br>Top cover material Lead wire or snap connection Lead wire has insulation on female connector Conductive carbon film Conductive hydrogel |
| Life Care Electrodes | Everyway Medical Instruments Co. | K083302 | 2009 | | Safety & Effectiveness-<br>Based on successful biocompatibility<br>testing of the skin contacting conductive<br>hydrogel, the electrical performance of<br>the insulated leadwire components and<br>electrode current distribution test results,<br>the PALS® Neurostimulation devices<br>are safe and effective when used as an<br>interface between a user's skin and an<br>approved neurostimulation devices. | Safety & Effectiveness-<br>Based on successful biocompatibility<br>testing of the skin contacting<br>conductive hydrogel, the electrical<br>performance of the insulated leadwire<br>components and electrode current<br>distribution test results, the PALS®<br>Flex neurostimulation devices are safe<br>and effective when used as an<br>interface between a user's skin and an<br>approved neurostimulation devices. | | Safety & Effectiveness-<br>Based on successful biocompatibility<br>testing of the skin contacting<br>conductive hydrogel, the electrical<br>performance of the snap/insulated<br>leadwire components and electrode<br>current distribution test results, the<br>ValuTrode neurostimulation devices<br>are safe and effective when used as<br>an interface between a user's skin<br>and an approved neurostimulation<br>devices. | Indications of<br>Use | PALS® reusable, self-adhering, over-the-counter Neurostimulation<br>Electrodes are indicated for use with transcutaneous electrical stimulation devices. | The Axelgaard PALS® Flex electrode is a reusable disposable device which adheres to the patient over the entire surface of the electrode. The device is intended to be used in connection with any neurostimulation approved for distribution within the USA. | Electrodes are intended for use with transcutaneous neurostimulation devices as over the counter devices. | ValuTrode® reusable, self-adhering, over-the-counter Neurostimulation<br>Electrodes are indicated for use with transcutaneous electrical stimulation devices. |
| ValuTrode® Neurostimulation Over the<br>Counter Electrodes | Axelgaard Manufacturing Co., Ltd. | K130987 | 2013 | | Our labeling indicates consulting the<br>stimulator manual for proper electrode<br>size and placement. Do not exceed 0.1<br>watts/cm2. | Our labeling states: "Consult stimulator<br>manual for proper electrode size. Do<br>not exceed 0.1 watts/cm2." | | Our labeling indicates consulting the<br>stimulator manual for proper<br>electrode size and placement. Do not<br>exceed 0.1 watts/cm2. | Principles of<br>Operation | Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices.<br><br>Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device. | | Some common type of neurostimulation devices include, but are not limited to, TENS and EMS devices.<br><br>Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patient's skin and a neurostimulation device. | Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices.<br><br>Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device. |
| | FDA max power guidelines draft<br>guidance 2010 states in Section D.(vi)<br>a maximum average power density<br>that does not exceed .025 watts per<br>square centimeter of electrode<br>conductive surface area. | FDA max power guidelines draft<br>guidance 2010 states in Section<br>D.(vi) a maximum average power<br>density that does not exceed .025<br>watts per square centimeter of<br>electrode conductive surface area. | | FDA max power guidelines draft<br>guidance 2010 states in Section<br>D.(vi) a maximum average power<br>density that does not exceed .025<br>watts per square centimeter of<br>electrode conductive surface area. | Differences | PALS® Neurostimulation electrodes will offer lead wire connection configurations.<br><br>PALS® electrodes utilize a stretchable conductive fabric.<br><br>We claim that these electrodes can be sold as OTC (over-the-counter) under the 510(k) regulation (21 CFR 801 Subpart C) requiring 510(k) submittal. | PALS® Flex electrodes offer lead wire connection configurations<br><br>PALS® Flex electrodes utilize a stretchable conductive fabric.<br><br>The devices are sold as prescription only devices. | The Lifecare Electrode 510(k) only offers lead wire connection electrodes.<br><br>Lifecare Electrodes utilize conductive film.<br><br>Lifecare Electrodes are sold as over-the-counter devices. | ValuTrode® over the counter electrodes offer lead wire and snap connection configurations.<br><br>Axelgaard ValuTrode® electrodes utilize conductive film.<br><br>The devices are sold as over-the-counter devices. | | | | |

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

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JA = AXELGAARD

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

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NS MANUFACTURING CO., LTD.

005-3

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Image /page/3/Picture/0 description: The image shows the logo for AXELGAARD MANUFACTURING CO., LTD. The text is vertically oriented, with AXELGAARD stacked on top of each other on the left side of the image. MANUFACTURING CO., LTD. is stacked on top of each other on the right side of the image.

## Performance Data

No performance data is required to support the proposed overhe-counter PALS® Neustimulation Electode has ieafical technol
characteristics (including design) as compared to be

# Safety / Effectiveness and Conclusion Statement (860.

xelgaard Manufacturing Co., Ltd. considers the PALS® over the-counter Neurostimulation electrode to be as safe and effective as the predicated devices PAL
lex (K874469) and

upon an evaluation of the proposed PALS® electrode, compared with he Lifest on the closes, Axegard Manufacum
d. believes that the proposed PALS® self alheing reusable Neurost

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Image /page/4/Picture/0 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 stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 13, 2014

Axelgaard Manufacturing Co., Ltd. Mr. Dan Jeffery, President 520 Industrial Way Fallbrook, CA 92028

Re: K132422

Trade/Device Name: PALS® Neurostimulation Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrodes Regulatory Class: Class II Product Code: GXY Dated: November 18, 2013 Received: November 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

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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 [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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Joyce M. Whang -S

Carlos 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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

### 510(k) Number (if known) K132422

### Device Name

### PALS® Neurostimulation Electrodes

### Indications for Use (Describe)

PALS® 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 electical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.

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

] Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

.

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

PSC Publishing Scrivices [phone] 2

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