Self-adhesive Electrode

K213879 · Bozhou Rongjian Medical Appliance Co., Ltd. · GXY · Jan 5, 2022 · Neurology

Device Facts

• Record ID: K213879
• Device Name: Self-adhesive Electrode
• Applicant: Bozhou Rongjian Medical Appliance Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Jan 5, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Self-adhesive Electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.

Device Story

Self-adhesive electrode transmits electrical stimulation current (TENS/EMS) to patient skin. Device consists of non-woven fabric tape, polyurethane conductive carbon cloth, and biocompatible conductive hydrogel. Available in various shapes (round, rectangle, elliptical, calabash, butterfly, palm) with lead wire or snap button connectors. Used in clinical or home settings; operated by patients or healthcare providers. Device acts as interface between external nerve/muscle stimulator and patient skin. Benefits include reliable electrical conduction and adhesion for stimulation therapy.

Clinical Evidence

No clinical data included. Bench testing only: biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety (AAMI/ANSI ES60601-1), impedance, conformability, fluid tolerance, peeling force, and accelerated aging (ASTM F1980-16).

Technological Characteristics

Non-sterile, flexible cutaneous electrode. Materials: non-woven fabric, PU conductive carbon cloth, biocompatible hydrogel. Connectivity: lead wire (female socket) or snap button (male socket). Standards: ISO 10993-5/10, AAMI/ANSI ES60601-1 (cl. 8.5.2.3), IEC 60601-2-2 (impedance/conformability/fluid tolerance), ASTM F1980-16. Hydrogel: 0.89mm thickness, pH 4.2, volume resistivity 1500 ohm-cm max.

Indications for Use

Indicated for patients requiring electrical stimulation therapy (e.g., TENS, EMS) via cutaneous electrodes. Suitable for single-patient, multiple-application use.

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

• JIAJIAN Self-adhesive Electrode (K090198)

Submission Summary (Full Text)

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January 5, 2022

Bozhou Rongjian Medical Appliance Co., Ltd. % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China

Re: K213879

Trade/Device Name: Self-adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: November 24, 2021 Received: December 13, 2021

Dear Doris Dong:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K213879

Device Name Self-adhesive Electrode

Indications for Use (Describe)

The Self-adhesive Electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

[As required by 21 CFR 807.92]

## 1. Submission Information

| 510(k) Number: | K213879 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | November 24, 2021 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Manufacturer/Applicant: | Bozhou Rongjian Medical Appliance Co.,Ltd.<br>Jianghuai Supply Base, Zhongkai Group, Mengcheng County, Bozhou<br>City, 233500 Anhui, China<br>Tel: [phone]<br>E-mail: [e-mail] |
| Contactor: | Doris Dong (Consultant)<br>Shanghai CV Technology Co., Ltd.<br>Rm. 903, No. 19 Dongbao Rd., Songjiang Area, Shanghai, 201613 China<br>E-mail: [e-mail]<br>Tel: [phone] |

# 2. Device Description

| 2. Device Description | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Self-adhesive Electrode |
| Common Name: | Cutaneous electrode |
| Classification Name: | Electrode, cutaneous |
| Product Code: | GXY |
| Device Class: | II |
| Regulation Number: | 21 CFR 882.1320 |
| Review Panel: | Neurology |
| Indications for use: | The Self-adhesive Electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS. |
| Device Description: | The Self-adhesive electrode, lead wire type and snap button type, are non-sterile flexible structures, composed of materials commonly used in this application:<br>First layer: Non-woven fabric tape<br>Second layer: Polyurethane (PU) electrically conductive carbon cloth (Hebei Kangshengda Electronic Technology Co., Ltd)<br>Third layer: Biocompatible conductive hydrogel coupling media (ValueTrode Carbon, K970426), which has passed the required skin sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specified in ISO 10993-5.<br>The electrodes are designed for single patient / multiple application use. It can be used for low-frequency or medium-frequency nerve or muscle stimulators, as the conduction film adhered to body skin. |

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There are six shapes of round, rectangle, elliptical, calabash, butterfly and palm shape. For the electrical connection, Rongjian provides lead wire type and snap button type:

Lead wire assembly - at least 40mm long wire with 2mm/2.5mm diameter female socket.

Snap button assembly - with 2.5~5mm diameter male socket.

The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR part 898 by testing under ANSI/AAMI ES60601-1, subclause 8.5.2.3.

### 3. Predicate Device Identification

K090198 - JIAJIAN Self-adhesive Electrode

### 4. Non-Clinical Test Conclusion

Bench tests were conducted on Self-adhesive Electrode to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The following tests were performed on the proposed device:

· ASTM F1980-16, Standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility)

• ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.

· ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization.

• AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And

Essential Performance (IEC 60601-1:2005, MOD).

· Impedance test, Conformability test and Fluid tolerance test per 201.15.101.6 and 201.15.101.7 of IEC 60601-2-2 Edition 6.0 2017-03.

· Impedance Test (Dispersion Test) according to FDA's requirement.

· Peeling force test and Simulation use test according to manufacturer's requirement.

### 5. Substantial Equivalent Based on Assessment of Clinical PerformanceData

Clinical data was not including in this submission

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| | Parameters | New Device | Predicate Device | Remark |
|----|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 1 | 510(k) Number | To be assigned | K090198 | -- |
| 2 | 510(k) Holder | Bozhou Rongjian Medical<br>Appliance Co.,Ltd. | Wuxi Jiajian Medical<br>Instrument Co., Ltd | -- |
| 3 | Trade Name | Self-adhesive Electrode | Jiajian Self- adhesive Electrode | -- |
| 4 | Common Name | Cutaneous electrode | Cutaneous electrode | Same |
| 5 | Classification<br>Name | Electrode, cutaneous | Electrode, cutaneous | Same |
| 6 | Product Code | GXY | GXY | Same |
| 7 | Regulation<br>Number | 882.1320 | 882.1320 | Same |
| 8 | Medical<br>Specialty | Neurology | Neurology | Same |
| 9 | Device Class | II | II | Same |
| 10 | Indications for<br>use | The Self-adhesive Electrode is<br>intended to be used to transmit<br>electrical stimulation current to the<br>patient's skin. Example electrical<br>stimulations for current<br>applications of the electrodes are:<br>TENS and EMS. | The self-adhesive electrode is<br>intended to be used to apply<br>electrical stimulation current to<br>the patient's skin. Example<br>electrical stimulations for<br>current applications of the<br>electrodes are: TENS and EMS. | Same |
| 11 | Target<br>population | Single patient use and multiple<br>application | Single patient use and multiple<br>application | Same |
| 12 | Type of use | OTC and Prescription use | OTC and Prescription use | Same |
| 13 | Design (shape &<br>connection) | Round, Rectangle, Elliptical,<br>Calabash, Butterfly, Palm shape<br>according to customized<br>specification.<br>Lead wire with female socket, or<br>snap button with male snap<br>connector. | Round, Rectangle, Oval, Gourd,<br>Butterfly, Saddle according to<br>customized specification.<br>Lead wire with female socket. | Similar |
| 14 | Materials | - Non-woven fabric tape<br>- Polyurethane (PU) electrically<br>conductive carbon cloth (Hebei<br>Kangshengda Electronic<br>Technology Co., Ltd)<br>- Biocompatible conductive<br>hydrogel coupling media<br>(ValueTrode Carbon, K970426) | - Non-woven fabric tape<br>- Electrically conductive carbon<br>cloth (ValueTrode Carbon,<br>K970426)<br>- Biocompatible conductive<br>hydrogel coupling media<br>(ValueTrode Carbon, K970426) | Similar |
| 15 | Electrode Pad<br>Size | Round Min.Ø20mm;<br>Max.Ø85mm | Round Min.Ø20mm;<br>Max.Ø80mm | Similar |
| | | Rectangle Min.26×26mm;<br>Max.190×110mm | Rectangle Min.3×10mm;<br>Max.80×130mm | |
| | | Elliptical Min.85×45mm; | Oval Min.50×120mm; | |

# 6. Substantially Equivalent Comparison Conclusion

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| | | | Max.240×100mm | | Max.100×240mm | |
|----|--------------------------------------------------------------------------------|--------------------------|-------------------------------------------|--------------------------|-----------------------------------------|---------|
| | | | Calabash<br>Min.90×47mm;<br>Max.200×88mm | Gourd | Min.85×50mm;<br>Max.170×100mm | |
| | | | Butterfly<br>Min.73×53mm;<br>Max.195×95mm | Butterfly | Min.55×75mm;<br>Max.95×165mm | |
| | | | Palm shape<br>74×47mm | Saddle | Min.75×110mm;<br>Max.150×220mm | |
| 16 | Electrode<br>Impedance of<br>Electrode Pad | Round | 302~577Ω | Round | 290~1000Ω | Similar |
| | | Rectangle | 303~646Ω | Rectangle | | |
| | | Elliptical | 407~676Ω | Oval | | |
| | | Calabash | 401~602Ω | Gourd | | |
| | | Butterfly | 402~626Ω | Butterfly | | |
| | | Palm shape | 402~638Ω | Saddle | | |
| 17 | --Patient contact<br>area of electrode | Round | Min.3.14cm²;<br>Max.56.716cm² | Round | Min.3.14cm²;<br>Max.50.24cm² | Similar |
| | | Rectangle | Min.6.76cm²;<br>Max.209cm² | Rectangle | Min.0.3cm²;<br>Max.104cm² | |
| | | Elliptical | Min.38.25cm²;<br>Max.240cm² | Oval | Min.60cm²;<br>Max.240cm² | |
| | | Calabash | Min.42.3cm²;<br>Max.176cm² | Gourd | Min.42.5cm²;<br>Max.170cm² | |
| | | Butterfly | Min.38.69cm²;<br>Max.185.25cm² | Butterfly | Min.41.25cm²;<br>Max.156.75cm² | |
| | | Palm shape | 34.78cm² | Saddle | Min.82.5cm²;<br>Max.330cm² | |
| 18 | Max. current<br>Density of<br>Electrode (Use<br>IRMS=10mA for<br>calculation ) | Round | 3.18mA/cm²<br>(Ø20mm: 3.14cm²) | Round | 3.18mA/cm²<br>(Ø20mm:<br>3.14cm²) | Similar |
| | | Rectangle | 1.48mA/cm²<br>(26×26mm: 6.76cm²) | Rectangle | 33.3mA/cm²<br>(3×10mm:<br>0.3cm²) | |
| | | Elliptical | 0.52mA/cm²<br>(85×45mm/2:<br>19.13cm²) | Oval | 0.17mA/cm²<br>(50×120mm:<br>60cm²) | |
| | | Calabash | 0.24mA/cm²<br>(90×47mm: 42.3cm²) | Gourd | 0.24mA/cm²<br>(85×50mm:<br>42.5cm²) | |
| | | Butterfly | 0.52mA/cm²<br>(73×53mm/2:<br>19.35cm²) | Butterfly | 0.48mA/cm²<br>(55×75mm/2:<br>20.625cm²) | |
| | | Palm shape | 0.29mA/cm²<br>(74×47mm:<br>34.78cm²) | Saddle | 0.24mA/cm²<br>(75×110mm/2:<br>41.25cm²) | |
| 19 | Hydrogel | 35mils ± 5mils (0.89mm ± | | 35mils ± 5mils (0.89mm ± | | Same |

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| | thickness | 0.13mm) | 0.13mm) | |
|----|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------|
| 20 | Hydrogel pH | 4.2 ± 1.0 | 4.2 ± 1.0 | Same |
| 21 | Hydrogel<br>volume<br>resistivity | 1500 ohm-cm max | 1500 ohm-cm max | Same |
| 22 | Standards meet | • Lead wires test per 8.5.2.3 of<br>AAMI/ANSI ES 60601-1;<br>• Impedance test, Conformability<br>test and Fluid tolerance test per<br>201.15.101.6 and 201.15.101.7 of<br>ANSI AAMI IEC 60601-2-2<br>Edition 6.0 2017-03;<br>• Impedance Test (Dispersion Test)<br>according to FDA's requirement;<br>• Peeling force test and Simulation<br>use test according to<br>manufacturer's requirement;<br>• Shelf life test per ASTM<br>F1980:2016 | ISO14971;<br>ISO 13485;<br>EN 980;<br>ANSI/AAMI EC12;<br>IEC 60601-1. | Similar |
| 23 | Biocompatibility | ISO10993-5; ISO10993-10 | ISO10993-5; ISO10993-10 | Same |
| 24 | Sterility Status | Non-sterile | Non-sterile | Same |
| 25 | Electrical safety | Lead wire meets Clause 8.5.2.3 of<br>AAMI/ANSI ES60601-1 | Lead wire meets IEC 60601-1 | Same |
| 26 | Other<br>Performance | Good electrical conductivity, good<br>adhesive property | Good electrical conductivity,<br>good adhesive property | Same |

### 7. Conclusions

Based on the conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed devices identified in the submission. Thus the subject device is substantially equivalent to the predicate device K090198.