(192 days)
Not Found
No
The device description explicitly states it is a "passive device" and the text does not mention any AI or ML terms or functionalities.
No
This device is described as a "passive device" that serves as an "interface" between the user's skin and a transcutaneous electrical stimulation device (like TENS or EMS devices). It carries an electrical signal but does not generate or modify it to produce a therapeutic effect on its own. The therapeutic effect comes from the separate neurostimulation device it connects to.
No
The device is described as a "passive device serving as an interface between a user's skin and a neurostimulation device" for delivering electrical stimulation, not for gathering diagnostic information.
No
The device description clearly states it is composed of physical components like a cover, connector lead wire, fabric, hydrogel, and carrier, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for use with transcutaneous electrical stimulation devices (TENS and EMS) on the user's skin. This is a direct application to the body for therapeutic purposes, not for examining specimens from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The device functions as a passive interface to carry an electrical signal to the skin. It does not analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is purely electrical stimulation applied externally.
Therefore, this device falls under the category of a medical device used for therapy, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
GXY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance data is required to support the proposed over-the-counter PALS® Neurostimulation Electrode as it has identical technical characteristics (including design) as compared to the predicated devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
Axelgaard Manufacturing Co., Ltd.
520 Industrial Way
Fallbrook, CA 92028
Phone: 760-451-8000 Fax: 760-723-2350
Dan.jeffery@axelgaard.com |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
Axelgaard PALS® Neurostimulation OTC | Axelgaard PALS Flex
(K874469) | Everyway Lifecare
(K083302) | Axelgaard ValuTrode OTC
(K130987) | | Subject Device
Axelgaard PALS® Neurostimulation
OTC | Axelgaard PALS® Flex
(K874469) | Everyway Lifecare
(K083302) | Axelgaard ValuTrode OTC
(K130987) |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PALS® Flex Neurostimulation Electrodes | Axelgaard Manufacturing Co., Ltd. | K874469 | 1998 | | Cutaneous electrode which conducts an
electrical signal from a neurostimulation
device through a leadwire; which is
dispersed from the leadwire across a
stretchable conductive fabric then
transmitted through the conductive
adhesive gel to the surface of the user's
skin. | Cutaneous electrode which conducts
an electrical signal from a
neurostimulation device through a
leadwire; which is dispersed from the
wire across a stretchable conductive
fabric then transmitted through the
conductive adhesive gel to the surface
of the user's skin. | Cutaneous electrode which
conducts an electrical signal
from a neurostimulation
device through a leadwire;
which is dispersed from the
wire across a conductive
surface; then transmitted
through the conductive
adhesive gel to the surface
of the user's skin. The
electrode connection point
(leadwire) is compatible with
standard, marketed
Neurostimulation devices.
The device is safe and
effective as the predicate
devices cited (within their
510(k) submittal). | Cutaneous electrode which conducts
an electrical signal from a
neurostimulation device through a
leadwire (or snap); which is
dispersed from the leadwire/snap
across a conductive surface; then
transmitted through the conductive
adhesive gel to the surface of the
user's skin. | Features /
Materials | Four basic components:
Top cover material Lead wire connection Lead wire has insulation on female connector Stretchable conductive fabric Conductive hydrogel | Four basic components:
Top cover material Lead wire connection Lead wire has insulation on female connector Stretchable conductive fabric Conductive hydrogel | Four basic components:
Top cover material Lead wire connection Lead wire has insulation on female connector Conductive carbon film Conductive hydrogel | Four basic components:
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-
Based on successful biocompatibility
testing of the skin contacting conductive
hydrogel, the electrical performance of
the insulated leadwire components and
electrode current distribution test results,
the PALS® Neurostimulation devices
are safe and effective when used as an
interface between a user's skin and an
approved neurostimulation devices. | Safety & Effectiveness-
Based on successful biocompatibility
testing of the skin contacting
conductive hydrogel, the electrical
performance of the insulated leadwire
components and electrode current
distribution test results, the PALS®
Flex neurostimulation devices are safe
and effective when used as an
interface between a user's skin and an
approved neurostimulation devices. | | Safety & Effectiveness-
Based on successful biocompatibility
testing of the skin contacting
conductive hydrogel, the electrical
performance of the snap/insulated
leadwire components and electrode
current distribution test results, the
ValuTrode neurostimulation devices
are safe and effective when used as
an interface between a user's skin
and an approved neurostimulation
devices. | Indications of
Use | PALS® reusable, self-adhering, over-the-counter Neurostimulation
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
Electrodes are indicated for use with transcutaneous electrical stimulation devices. |
| ValuTrode® Neurostimulation Over the
Counter Electrodes | Axelgaard Manufacturing Co., Ltd. | K130987 | 2013 | | Our labeling indicates consulting the
stimulator manual for proper electrode
size and placement. Do not exceed 0.1
watts/cm2. | Our labeling states: "Consult stimulator
manual for proper electrode size. Do
not exceed 0.1 watts/cm2." | | Our labeling indicates consulting the
stimulator manual for proper
electrode size and placement. Do not
exceed 0.1 watts/cm2. | Principles of
Operation | 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. | | Some common type of neurostimulation devices include, but are not limited to, TENS and EMS devices.
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.
Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device. |
| | FDA max power guidelines draft
guidance 2010 states in Section D.(vi)
a maximum average power density
that does not exceed .025 watts per
square centimeter of electrode
conductive surface area. | FDA max power guidelines draft
guidance 2010 states in Section
D.(vi) a maximum average power
density that does not exceed .025
watts per square centimeter of
electrode conductive surface area. | | FDA max power guidelines draft
guidance 2010 states in Section
D.(vi) a maximum average power
density that does not exceed .025
watts per square centimeter of
electrode conductive surface area. | Differences | PALS® Neurostimulation electrodes will offer lead wire connection configurations.
PALS® electrodes utilize a stretchable conductive fabric.
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
PALS® Flex electrodes utilize a stretchable conductive fabric.
The devices are sold as prescription only devices. | The Lifecare Electrode 510(k) only offers lead wire connection electrodes.
Lifecare Electrodes utilize conductive film.
Lifecare Electrodes are sold as over-the-counter devices. | ValuTrode® over the counter electrodes offer lead wire and snap connection configurations.
Axelgaard ValuTrode® electrodes utilize conductive film.
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.)
1
JA = AXELGAARD
Substantial Equivalence Summary (807.92[a] [6])
2
NS MANUFACTURING CO., LTD.
005-3
3
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
4
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
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 (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 Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
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 (301) 443-6740 2
7
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
...