(60 days)
Not Found
No
The summary describes a passive electrode and its physical properties and performance, with no mention of AI or ML.
No.
The device itself, an adhesive electrode, is a conductive interface for electrical stimulators (like TENS or EMS), which are therapeutic. However, the electrode's function is to facilitate the delivery of electrical pulses, not to provide therapy independently.
No
The device is an adhesive electrode used to deliver electrical stimulation, not to diagnose a condition. Its function is to facilitate therapy, not diagnosis.
No
The device description explicitly states it is made of physical components (conductive hydrogel, fabric cloth, carbon film) and is an adhesive electrode, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the product is an "adhesive electrode which is intended for use as the re-usable, conductive interface between the patient's skin and the Electrical Stimulator." This describes a device used for delivering electrical stimulation to the body, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical components and how the electrode works in conjunction with an electrical stimulator to deliver pulses to the skin. This aligns with a therapeutic or stimulation device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of an electrical stimulation accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This product is an adhesive electrode which is intended for use as the re-usable, conductive interface between the patient's skin and the Electrical Stimulator. It is intended to be used with legally marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The Reusable and Self-Adhesive Electrodes are made of conductive hydrogel, fabric cloth and carbon film. They work when sticking to human skin and connecting with electrical stimulators by lead wires. During the treatment, electrical pulses are passed across the intact surface of the skin to activate the underlying nerves.
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)
The proposed Cutaneous Electrodes are evaluated through Electrode Performance testing (Electrical Impedance Performance, Adhesive Performance, and Tensile Strength), Biocompatibility testing, Stability testing, and Reusability testing.
Biocompatibility of the electrodes was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface-contacting devices: Skin" with a contact duration of "Limited (
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 22, 2018
Shaoxing DongZhi Electrical Technology Co., Ltd. Haze XU Quality Manager Xinsha Village, Cao E Street, Shangyu Area Shaoxing, Zhejiang 312352 Cn
Re: K180773
Trade/Device Name: Reusable and Self-Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: March 14, 2018 Received: March 23, 2018
Dear Haze XU:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180773
Device Name
Reusable and Self-Adhesive Electrodes
Indications for Use (Describe)
This product is an adhesive electrode which is intended for use as the re-usable, conductive interface between the patient's skin and the Electrical Stimulator. It is intended to be used with legally marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
Type of Use (Select one or both, as applicable)
| ☒ Research Use (Part 21 CFR 361. Subpart B) | ☒ Over-The-Counter Use (21 CFR 331 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section5 510(k) summary
I Submitter
Device submitter: Shaoxing DongZhi Electrical Technology Co.,Ltd Xinsha Village, Cao E Street, Shangyu Area, Shaoxing City, Zhejiang Province, P.R.CHINA 312352
Contact person: Haze XU Quality Manager Phone: +86 575 82597860 Email: haze@sxdongzhi.com
II Device
Trade Name of Device: Reusable and Self-Adhesive Electrodes Common name: Cutaneous Electrode Classification: Class II, 21 CFR 882.1320 Product Code: GXY
III Predicate Device
| Trade name: | TENS Electrodes |
|---|---|
| Common name: | Cutaneous Electrode |
| Classification: | Class II, 21 CFR 882.1320 |
| Product Code: | GXY |
| Premarket Notification: | K160081 |
| Company name: | CATHAY MANUFACTURING CORP |
IV Device description
The Reusable and Self-Adhesive Electrodes are made of conductive hydrogel, fabric cloth and carbon film. They work when sticking to human skin and connecting with electrical stimulators by lead wires. During the treatment, electrical pulses are passed across the intact surface of the skin to activate the underlying nerves.
V Indications for use
This device is an adhesive electrode which is intended for use as the re-usable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. It is intended to be used with legally marketed Electrical Simulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
4
VI Comparison of technological characteristics with the predicate devices
The Reusable and Self-Adhesive Electrodes have the same intended use and principle operation, the technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Reusable and Self-Adhesive Electrodes and predicate devices do not alter suitability of the proposed device for its intended use.
| Device feature | Reusable and Self-Adhesive
Electrodes (subject device) | TENS Electrodes K160081
(predicate device) | Discussion |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Intended use | The proposed device is an
adhesive electrode which is
intended for use as the re-
usable, conductive adhesive
interface between the
patient's skin and the
Electrical Stimulator. It is
intended to be used with
marketed Electrical
Simulators, i.e. TENS
(Transcutaneous Electrical
Nerve Stimulation) and EMS
(Electrical Muscular
Stimulation). | The proposed device is
intended for use as the
disposable, conductive
adhesive interface between
the patient's skin and the
electrical stimulator to apply
electrical stimulation
current, and is intended to
be used with marketed
electrical stimulators, i.e.
TENS (Transcutaneous
Electrical Nerve Stimulation)
and EMS (Electrical Muscular
Stimulation).It's for OTC use. | Identical |
| Shapes | Round, Rectangular, Square,
Oval, Butterfly | Round, Rectangular, Square,
Crescent, Calabash | Substantially
equivalent. The shape
of the device does not
alter its intended use. |
| Surface area | Round: 2.5cm, 2.8cm, 3.2cm,
4.5cm, 5.0cm, 7.0cm, 7.5cm in
diameter:
Square: 4.0cm4.0cm,
4.5cm4.5cm, 5.0cm5.0cm;
Rectangular: 4.0cm6.0cm,
4.0cm8.0cm, 4.0cm10.0cm,
4.0cm15.0cm,
4.0cm35.0cm, 4.5cm9.5cm,
5.0cm6.0cm, 5.0cm9.0cm,
5.0cm10.0cm,
7.0cm12.0cm,
7.0cm13.0cm,7.5cm10.0cm,
7.5cm13.0cm,
8.0cm13.0cm,
10.0cm20.0cm;
Oval: 4.0cm6.0cm,
5.0cm10.5cm 5.0cm13.0cm; | Round: 5cm in diameter;
Rectangular: 5cm10cm,
6cm10cm;
Crescent: 2.4cm4.2cm;
Square: 3.2cm3.2cm;
Calabash: 8.0cm5.5cm | Substantially
equivalent. The
surface area of the
device does not alter
its intended use. |
| | Butterfly: 9.3cm*15.0cm | | |
| Components | Substrate/Wire/Hydro-
gel/Scrim/Conductive
Fiber/Carbon conductive
film/Liner | Substrate/Wire/Hydro-
gel/Scrim/Conductive
Fiber/Carbon conductive
film/Liner | Identical |
| Materials | Non-woven Fabric + Adhesive | Non-woven Fabric + Adhesive | Identical |
| | Wire and Terminal coated PVC | Wire and Terminal coated PVC | Identical |
| | Hydro-gel | Hydro-gel | Identical |
| | PET Fabric | PET Fabric | Identical |
| | Carbon fiber + Reinforcing fiber | Carbon fiber + Reinforcing
fiber | Identical |
| | Poly-isobutylene, Carbon Black,
Graphite, Additives | Poly-isobutylene, Carbon
Black | Substantially
equivalent. |
| Biocompatibilit
y | Comply with ISO 10993 series | Comply with ISO 10993
series | Identical |
| Sterility | Non-sterile | Non-sterile | Identical |
| Re-usable | For single patient | For single patient | Identical |
| Shelf life | 3 years | 2 years | Substantially
equivalent. |
5
VII Summary of Non-clinical tests:
Compare to primary predicate product specified in K160081, our device and the predicate device are substantially equivalent. The proposed Cutaneous Electrodes are evaluated through Electrode Performance testing (Electrical Impedance Performance, Adhesive Performance, and Tensile Strength), Biocompatibility testing, Stability testing, and Reusability testing.
Biocompatibility testing
Biocompatibility of the electrodes was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface-contacting devices: Skin" with a contact duration of "Limited (