(44 days)
Not Found
No
The 510(k) summary describes a passive electrode device for signal acquisition and does not mention any AI/ML components or data processing capabilities. The performance studies focus on biocompatibility, electrical properties, shelf-life, and basic electrical safety, not algorithmic performance.
No
The device is described as being for "recording and monitoring equipment" of various electrical signals, not for treatment.
No
The device is described as electrodes used for "recording and monitoring equipment" of various electrical signals (EMG, EEG, EP). It does not state that it analyzes or interprets these signals for diagnostic purposes, but rather serves as a component in a system that would perform the recording/monitoring.
No
The device description clearly states it is a physical electrode with adhesive, lead wires, and a connector, 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 electrodes are for "non-invasive use with recording and monitoring equipment" for acquiring signals for EMG, EEG, and EP. These are physiological signals measured from the body surface, not tests performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces the non-invasive nature and use for acquiring signals from the skin.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other components typically associated with in vitro diagnostic devices.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is used to acquire electrical signals directly from the body surface.
N/A
Intended Use / Indications for Use
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.
Product codes
GXY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Surface
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
Non-Clinical Test Summary:
- 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
- Performance Testing
- Electrical property: AAMI/ANSI EC12: Disposable ECG Electrodes
- Shelf-life Testing
- ASTM F1980-02, Standard guide for accelerated aging of sterile medical device package.
- Basic Safety and Essential Performance
- 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.
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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, |
| Gyeonggido, 15421, Korea, Republic of | |
| • Contact Name: | Seolmin Jeong / RA Manager |
| - Telephone No.: | +82 10 2022 6445 |
| - Fax No.: | +82 31 498 0429 |
| - Email Address: | dckim@electrode-market.com |
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.
-
- 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.
- Intended Use [21 CFR 807.92(a)(5)]
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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 | ||
| Surface Electrodes | Disposable Adhesive Surface | ||
| Electrodes | -- | ||
| Manufacturer | Electrode Market Co.,Ltd. | Technomed Europe | -- |
| Device Class | Class II | Class II | Same as predicate |
| device | |||
| Product code | GXY | GXY | Same as predicate |
| device | |||
| Intended Use | The Electrode Market | ||
| Disposable Surface Electrodes | |||
| are intended for noninvasive | |||
| 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. | The Disposable Adhesive | ||
| Surface | |||
| Electrodes are intended for | |||
| use with | |||
| stimulating/recording of | |||
| biopotential signals. | |||
| Electrodes are applied in the | |||
| study of biopotentials such | |||
| as Electromyography | |||
| (EMG), | |||
| Electroencephalograph | |||
| (EEG) and nerve conduction | |||
| and Evoked Potentials (EP). | |||
| Electrodes are non-invasive | |||
| as they are applied to the | |||
| patient's skin using a self- | |||
| adhesive solid-gel surface. | |||
| The electrodes are non- | |||
| sterile and for single patient | |||
| use only. | Similar to predicate. | ||
| Anatomical sites | Surface | Surface | Same as predicate |
| device | |||
| Patch Dimensions | 20 mm diameter (disc | ||
| electrode) and 40mm*50mm | |||
| (ground electrode) | Not publicly available | -- | |
| Conductive surface | |||
| area | 3.14cm² (disc electrode) | ||
| 20cm² (ground electrode) | Not publicly available | -- | |
| Lead Wire Length | 1.0 to 2.5m | Not publicly available | -- |
| Construction | |||
| electrode | Three layers |
- Top sheet: Non-woven
Fabric - Conductive film: Carbon
film coated with silver
chloride - Conductive hydrogel | Not publicly available | -- |
| Lead wire material | PVC insulated tin plated with
copper | Not publicly available | -- |
| Impedance |