Reusable and Self-Adhesive Electrodes

K180773 · Shaoxing Dongzhi Electrical Technology Co., Ltd. · GXY · May 22, 2018 · Neurology

Device Facts

• Record ID: K180773
• Device Name: Reusable and Self-Adhesive Electrodes
• Applicant: Shaoxing Dongzhi Electrical Technology Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: May 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This product 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 Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

Device Story

Reusable and self-adhesive electrodes function as conductive interface between patient skin and external electrical stimulators (TENS/EMS). Device consists of conductive hydrogel, fabric cloth, and carbon film. During treatment, device adheres to intact skin; electrical pulses from stimulator pass through electrode to activate underlying nerves or muscles. Used in clinical or home settings; operated by patient or healthcare provider. Benefits include providing stable electrical contact for stimulation therapy. No active electronic components; passive interface device.

Clinical Evidence

Bench testing only. Evaluated via electrode performance testing (electrical impedance, adhesive performance, tensile strength), biocompatibility testing (cytotoxicity, irritation, sensitization per ISO 10993-1:2009), stability testing, and reusability testing. All acceptance criteria met.

Technological Characteristics

Materials: Non-woven fabric, adhesive, PVC-coated wire/terminal, hydrogel, PET fabric, carbon fiber, reinforcing fiber, poly-isobutylene, carbon black, graphite. Sensing/actuation: Passive conductive interface. Form factor: Various shapes (round, rectangular, square, oval, butterfly). Connectivity: Wired connection to external stimulator. Sterility: Non-sterile. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for use as a conductive interface between patient skin and TENS or EMS electrical stimulators for patients requiring electrical stimulation therapy.

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

• TENS Electrodes (K160081)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

| <span style="text-decoration: overline;">☒</span> Research Use (Part 21 CFR 361. Subpart B) | <span style="text-decoration: overline;">☒</span> 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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## 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: [phone] Email: [e-mail]

#### 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).

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## 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<br>Electrodes (subject device) | TENS Electrodes k160081<br>(predicate device) | Discussion |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Intended use | The proposed device is an<br>adhesive electrode which is<br>intended for use as the re-<br>usable, conductive adhesive<br>interface between the<br>patient's skin and the<br>Electrical Stimulator. It is<br>intended to be used with<br>marketed Electrical<br>Simulators, i.e. TENS<br>(Transcutaneous Electrical<br>Nerve Stimulation) and EMS<br>(Electrical Muscular<br>Stimulation). | The proposed device is<br>intended for use as the<br>disposable, conductive<br>adhesive interface between<br>the patient's skin and the<br>electrical stimulator to apply<br>electrical stimulation<br>current, and is intended to<br>be used with marketed<br>electrical stimulators, i.e.<br>TENS (Transcutaneous<br>Electrical Nerve Stimulation)<br>and EMS (Electrical Muscular<br>Stimulation).It's for OTC use. | Identical |
| Shapes | Round, Rectangular, Square,<br>Oval, Butterfly | Round, Rectangular, Square,<br>Crescent, Calabash | Substantially<br>equivalent. The shape<br>of the device does not<br>alter its intended use. |
| Surface area | Round: 2.5cm, 2.8cm, 3.2cm,<br>4.5cm, 5.0cm, 7.0cm, 7.5cm in<br>diameter:<br>Square: 4.0cm*4.0cm,<br>4.5cm*4.5cm, 5.0cm*5.0cm;<br>Rectangular: 4.0cm*6.0cm,<br>4.0cm*8.0cm, 4.0cm*10.0cm,<br>4.0cm*15.0cm,<br>4.0cm*35.0cm, 4.5cm*9.5cm,<br>5.0cm*6.0cm, 5.0cm*9.0cm,<br>5.0cm*10.0cm,<br>7.0cm*12.0cm,<br>7.0cm*13.0cm,7.5cm*10.0cm,<br>7.5cm*13.0cm,<br>8.0cm*13.0cm,<br>10.0cm*20.0cm;<br>Oval: 4.0cm*6.0cm,<br>5.0cm*10.5cm 5.0cm*13.0cm; | Round: 5cm in diameter;<br>Rectangular: 5cm*10cm,<br>6cm*10cm;<br>Crescent: 2.4cm*4.2cm;<br>Square: 3.2cm*3.2cm;<br>Calabash: 8.0cm*5.5cm | Substantially<br>equivalent. The<br>surface area of the<br>device does not alter<br>its intended use. |
| | Butterfly: 9.3cm*15.0cm | | |
| Components | Substrate/Wire/Hydro-<br>gel/Scrim/Conductive<br>Fiber/Carbon conductive<br>film/Liner | Substrate/Wire/Hydro-<br>gel/Scrim/Conductive<br>Fiber/Carbon conductive<br>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<br>fiber | Identical |
| | Poly-isobutylene, Carbon Black,<br>Graphite, Additives | Poly-isobutylene, Carbon<br>Black | Substantially<br>equivalent. |
| Biocompatibilit<br>y | Comply with ISO 10993 series | Comply with ISO 10993<br>series | Identical |
| Sterility | Non-sterile | Non-sterile | Identical |
| Re-usable | For single patient | For single patient | Identical |
| Shelf life | 3 years | 2 years | Substantially<br>equivalent. |

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## 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 (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation and Sensitization. All evaluation acceptance criteria were met

## VIII Conclusion

The Reusable and Self-Adhesive Electrodes is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.