Electrode Market Disposable Surface Electrodes

K211839 · Electrode Market Co., Ltd. · GXY · Jul 28, 2021 · Neurology

Device Facts

• Record ID: K211839
• Device Name: Electrode Market Disposable Surface Electrodes
• Applicant: Electrode Market Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Jul 28, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The Electrode Market Adhesive Surface Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP). The electrodes are designed for single use.

Device Story

Disposable surface electrodes; non-invasive; single-use. Input: biopotential signals from patient skin. Transformation: conductive hydrogel interface transfers electrical signals to recording/monitoring equipment via lead wires with DIN 42802 connectors. Output: electrical signal transmission to external diagnostic systems. Used in clinical settings by healthcare professionals. Benefit: enables non-invasive monitoring of EMG, EEG, and EP signals for diagnostic assessment.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization). Electrical performance testing per AAMI/ANSI EC12. Electrical safety testing per AAMI/ANSI ES 60601-1:2005/(R)2012. Shelf-life testing per ASTM F1980-02.

Technological Characteristics

Three-layer construction: non-woven fabric top sheet, carbon film coated with silver chloride, and conductive hydrogel. Lead wires: PVC-insulated tin-plated copper. Impedance <3kΩ. Connectors: DIN 42802 1.5mm touch-proof. Non-sterile. Dimensions: 20mm diameter (disc) or 40mm*50mm (ground).

Indications for Use

Indicated for non-invasive acquisition of biopotential signals (EMG, EEG, EP) for recording and monitoring purposes in patients requiring such diagnostic procedures.

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

• Disposable Adhesive Surface Electrodes (K073532)

Submission Summary (Full Text)

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July 28, 2021

Electrode Market Co., Ltd. Seolmin Jeong R&A Manager 205, Manhae-ro, Danwon-gu, A-dong 717 ho Ansan-Si, Gyeonggido 15421 South Korea

Re: K211839

Trade/Device Name: Electrode Market Disposable Surface Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: June 9, 2021 Received: June 14, 2021

Dear Seolmin Jeong:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 mediation-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/cdrl-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,

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) K211839

Device Name

Electrode Market Disposable Surface Electrodes

Indications for Use (Describe)

The Electrode Market Disposable Surface Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP). The electrodes are designed for single use.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------|--|
| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |
| <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |

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# 510(k) Summary

## K211839

[As required by 21 CFR 807.92]

#### Date Prepared [21 CFR 807.92(a)(a)] 1.

July 22, 2021

#### Submitter's Information [21 CFR 807.92(a)(1)] 2.

| • Name of Sponsor: | Electrode Market Co., Ltd. |
|--------------------|---------------------------------------------------------------------------------------------|
| - Address: | 205, Manhae-ro, Dan won-gu A dong 717 ho Ansan-si,<br>Gyeonggido, 15421, Korea, Republic of |
| • Contact Name: | Seolmin Jeong / RA Manager |
| - Telephone No.: | [phone] |
| - Fax No.: | [phone] |
| - Email Address: | [e-mail] |

#### Establishment Registration No.: 3017843150 ●

| • Name of Manufacturer: | Same as Sponsor |
|-------------------------|-----------------|
| - Address: | Same as Sponsor |

#### Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)] 3.

- Electrode Market Disposable Surface Electrode ● Trade Name:
- Regulation Name: Cutaneous electrode
- Classification: ●

| Classification Panel | Neurology |
|---------------------------|-----------------|
| Classification Regulation | 21 CFR 882.1320 |
| Product Code | GXY |
| Device Class | II |

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#### 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[

The identified predicate device within this submission is shown as follows:

- 510(k) Number: ● K073532
●

- Applicant: Technomed Europe
- Regulation Name: Cutaneous electrode
- Device Name: Disposable Adhesive Surface Electrodes

There are no significant differences between the Electrode Market Disposable Surface Electrodes and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, and technical characteristics.

#### 5. Description of the Device [21 CFR 807.92(a)(4)]

Electrode Market Disposable Surface Electrodes are non-invasive. Cutaneous devices are used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potentials (EP). The electrodes are designed for single use. Because of the adhesive nature of the gel, no securing material is required for fixating the electrode to the patient's skin. The electrodes with lead wire have a safety DIN 42802 connector, several lengths and color combinations.

- 6. Intended Use [21 CFR 807.92(a)(5)]
The Electrode Market Adhesive Surface Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP). The electrodes are designed for single use.

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#### 7. Technological Characteristics [21 CFR 807.92(a)(6)]

The Electrode Market Adhesive Surface Electrodes are based on a technical feature comparison, the proposed device was found to be similar to predicate device with regard to design, function, and technical characteristics.

| | Proposed Device | Predicate Device | Remark |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| K Number | K211839 | K073532 | -- |
| Model | Electrode Market Disposable<br>Surface Electrodes | Disposable Adhesive Surface<br>Electrodes | -- |
| Manufacturer | Electrode Market Co.,Ltd. | Technomed Europe | -- |
| Device Class | Class II | Class II | Same as predicate<br>device |
| Product code | GXY | GXY | Same as predicate<br>device |
| Intended Use | The Electrode Market<br>Disposable Surface Electrodes<br>are intended for noninvasive<br>use with recording and<br>monitoring equipment, (active<br>and reference), of<br>Electromyography (EMG),<br>Electroencephalograph (EEG)<br>and Evoked Potentials (EP).<br>The electrodes are designed<br>for single use. | The Disposable Adhesive<br>Surface<br>Electrodes are intended for<br>use with<br>stimulating/recording of<br>biopotential signals.<br>Electrodes are applied in the<br>study of biopotentials such<br>as Electromyography<br>(EMG),<br>Electroencephalograph<br>(EEG) and nerve conduction<br>and Evoked Potentials (EP).<br>Electrodes are non-invasive<br>as they are applied to the<br>patient's skin using a self-<br>adhesive solid-gel surface.<br>The electrodes are non-<br>sterile and for single patient<br>use only. | Similar to predicate. |
| Anatomical sites | Surface | Surface | Same as predicate<br>device |
| Patch Dimensions | 20 mm diameter (disc<br>electrode) and 40mm*50mm<br>(ground electrode) | Not publicly available | -- |
| Conductive surface<br>area | 3.14cm² (disc electrode)<br>20cm² (ground electrode) | Not publicly available | -- |
| Lead Wire Length | 1.0 to 2.5m | Not publicly available | -- |
| Construction<br>electrode | Three layers<br>1. Top sheet: Non-woven<br>Fabric<br>2. Conductive film: Carbon<br>film coated with silver<br>chloride<br>3. Conductive hydrogel | Not publicly available | -- |
| Lead wire material | PVC insulated tin plated with<br>copper | Not publicly available | -- |
| Impedance | <3kΩ | Not publicly available | -- |
| | Proposed Device | Predicate Device | Remark |
| duration of use | | | |
| Connectors | DIN 42 802 1.5mm and Touch proof connector | DIN 42 802 1.5mm and Touch proof connector | Same as predicate device |
| Sterilization Method | Non-Sterilization | Not publicly available | -- |

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## Non-Clinical Test Summary:

- 1) Biocompatibility
- ISO 10993-5: Biological evaluation of medical devices Part 5: tests for in vitro cytotoxicity ●
- ISO 10993-10: Biological evaluation of medical devices - Part 10: tests for irritation and skin sensitization
- 2) Performance Testing
- Electrical property: AAMI/ANSI EC12: Disposable ECG Electrodes ●
- 3) Shelf-life Testing
- ASTM F1980-02, Standard guide for accelerated aging of sterile medical device package.
- Basic Safety and Essential Performance 4)
- Electrical Safety: AAMI/ANSI ES 60601-1:2005/(R)2012, CL 8.5.2.3: Patient Leads ●
- Electrode Market Disposable Surface Electrodes were tested in accordance to the test requirements and test methods of subclause 8.5.2.3 of IEC 60601-1:2005 and are in conformance with AAMI/ANSI ES 60601-1:2005. The differences between IEC 60601-1:2005 and AAMI/ANSI ES 60601-1:2005 do not alter the safety and effectiveness of Electrode Market Disposable Surface Electrodes

#### 8. Substantial Equivalence [21 CFR 807.92(b)(1)]

When compared to the predicate device (K073532), the Electrode Market Disposable Surface Electrodes in this submission presented the substantial equivalence in terms of:

- Intended use
- Device design ●
- Components and materials ●
- Technological characteristics

#### Conclusion [21 CFR 807.92(b)(3)] 9.

In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Electrode Market Co., Ltd. concludes that the Electrode Market Disposable Surface Electrodes are substantially equivalent to predicate device as described herein.