(99 days)
Not Found
No
The device description explicitly states it is a "passive device" and its function is to carry an electrical signal. There is no mention of any computational or analytical capabilities that would involve AI or ML.
No.
The device is described as a "passive device serving as an interface between a user's skin and a neurostimulation device" and "carrying an electrical signal from a neurostimulation device through the device cable and electrode lead wire to the user skin". It does not generate the therapeutic stimulation itself.
No.
Explanation: The documentation states that the device is a passive interface for transcutaneous electrical stimulation devices (TENS/EMS) and carries an electrical signal. Its function is to deliver stimulation, not to diagnose a condition.
No
The device is described as a physical electrode composed of various materials (cover, connector lead wire, conductive carbon film, conductive hydrogel, etc.) that serves as a passive interface between a neurostimulation device and the user's skin. It is a hardware component, not software.
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" and serves as an "interface between a user's skin and a neurostimulation device." This describes a device that interacts with the body externally for therapeutic purposes (neurostimulation), not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details the components and function of an electrode that conducts electrical signals to the skin. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition based on sample analysis.
The device is clearly described as a passive electrical interface for neurostimulation, which falls under the category of medical devices used for therapy, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
GXY
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.
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
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
Key Metrics
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
005 510K Summary_ValuTrode 7 13 13
| | 510(k) Summary K130987
807.92(c) | JUL 17 2013 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submitter/Contact Person | Dan Jeffery, President
Axelgaard Manufacturing Co., Ltd.
520 Industrial Way
Fallbrook, CA 92028
Phone: 760-451-8000 Fax: 760-723-2356
Dan.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 II
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)
No. | Date Cleared |
|----------------------------------------|-----------------------------------------|---------------|--------------|
| Life Care Electrodes | Everyway Medical
Instruments Company | K083302 | 2009 |
| ValuTrode® Neurostimulation Electrodes | Axelgaard Manufacturing
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
Axelgaard ValuTrode OTC (K130987) | Everyway Lifecare (K083302) | Axelgaard ValuTrode (K970426) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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 patient'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 patient'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; which is
dispersed from the wire across a
conductive surface; then transmitted
through the conductive adhesive gel to the
surface of the patient's skin. |
| Safety &
Effectiveness | 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 ValuTrode neurostimulation devices
are safe and effective when used as an
interface between a user's skin and an
approved neurostimulation devices.
Our labeling states: "Consult electrode
manual for proper electrode size. Do not
exceed 0.1watts/cm²."
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. | 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 ValuTrode
neurostimulation devices are safe and
effective when used as an interface between
a user's skin and an approved
neurostimulation devices. | See FDA comment below:
"All leadwire connectors are safety protected
with insulated shrink wrapping. Cables are
not supplied with the device.
Maximum energy density was calculated for
the smallest electrode size using an average
current of 30 mA (90 or 60 mA, with duty
cycles of 33 and 50 percent, respectively)
across a 2 Kohm resistance and found the
power to be 0.10 W/cm² well below the limit
conservatively established for thermal burns.
The manufacturer has added a prominent
statement to the labeling not to exceed 0.1
watts/cm²."
John Francis Glass, FDA Biologist
K970426 submittal reviewer, 5/8/1997. |
: ·
005-2
2
NANUPACITING CO., LTD
SIS
| Features / Materials | Indications of Use
Principles of
Operation | | Differences |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device
Axelgaard ValuTrode OTC (K130987) | ValuTrodes® are intended for use with
Transcutaneous Electrical
Neurostimulation (TENS) units as over the
counter devices. | Some common type of neurostimulation
devices include, but are not limited to,
TENS and EMS devices. | ValuTrode® electrodes will offer lead wire
and snap connection configurations |
| Four basic components:
■ Top cover material
■ Lead wire or snap connection
■ Lead wire has insulation on female
connector
■ Conductive carbon film
■ Conductive hydrogel | Transcutaneous Electrical
Neurostimulation electrodes are passive
devices serving as an interface between a
users' skin and a neurostimulation device. | | Change in product labeling only to allow
the product to be sold for over-the-counter. |
| Everyway Lifecare (K083302) | Electrodes are intended for use with
transcutaneous neurostimulation devices
as over the counter devices. | Some common type of neurostimulation
devices include, but are not limited to,
TENS and EMS devices. | The Lifecare Electrode 510(k) only offers
lead wire connection electrodes. |
| Four basic components:
■ Top cover material
■ Lead wire connection
■ Lead wire has insulation on female
connector
■ Conductive carbon film
■ Conductive hydrogel | Transcutaneous neurostimulation
electrodes are passive devices serving as
an interface between a patient's skin and a
neurostimulation device. | | Lifecare Electrodes are sold as over-the-
counter devices. |
| Axelgaard ValuTrode (K970426) | ValuTrodes™ are intended for use with
FDA approved Transcutaneous Electrical
Neurostimulation (TENS) devices. | | ValuTrode™ electrodes offer lead wire and
snap connection configurations |
| Four basic components:
■ Top cover material
■ Lead wire or snap connection
■ Lead wire has insulation on female
connector
■ Conductive carbon film
■ Conductive hydrogel | Transcutaneous Electrical Neurostimulation
electrodes are passive devices serving as
an interface between a patient's skin and a
neurostimulation device. | | The devices are currently being sold as
prescription medical devices. |
| | | | 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. |
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 (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
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
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