(44 days)
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.
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.
This document describes the FDA's 510(k) clearance for Electrode Market Disposable Surface Electrodes (K211839). The information provided is primarily focused on demonstrating substantial equivalence to a predicate device rather than detailing studies to prove the device meets specific acceptance criteria in the context of AI/ML performance.
Therefore, the following information is not present in the provided text:
- A table of acceptance criteria and reported device performance (for AI/ML).
- Sample sizes for test sets, data provenance, number of experts, qualifications of experts, and adjudication methods for establishing ground truth for test sets.
- Information regarding a multi-reader, multi-case (MRMC) comparative effectiveness study, including effect size.
- Information regarding a standalone algorithm-only performance study.
- The type of ground truth used (e.g., pathology, outcomes data) in the context of AI/ML.
- Sample size for training sets and how ground truth for training sets was established.
However, the document does contain information about the non-clinical tests performed to demonstrate the safety and effectiveness of the device as a medical electrode. This can be interpreted as the studies done to meet the acceptance criteria for a medical electrode.
Here's a summary of what's provided related to device performance and testing:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a table of acceptance criteria in the explicit format requested for AI/ML performance metrics. Instead, it refers to compliance with established standards for medical electrodes. The "performance" is demonstrated by meeting these standards.
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance) |
|---|---|
| Biocompatibility: | |
| ISO 10993-5 (In vitro cytotoxicity) | Conforms |
| ISO 10993-10 (Irritation and skin sensitization) | Conforms |
| Electrical Property: | |
| AAMI/ANSI EC12 (Disposable ECG Electrodes) | Conforms |
| Shelf-life Testing: | |
| ASTM F1980-02 (Accelerated aging of sterile medical device package) | Conforms |
| Basic Safety and Essential Performance: | |
| AAMI/ANSI ES 60601-1:2005/(R)2012, CL 8.5.2.3 (Patient Leads) | Conforms |
| IEC 60601-1:2005 subclause 8.5.2.3 | Conforms |
| Impedance | < 3kΩ (This is a performance characteristic, not an acceptance criterion from a standard in the same way as the others, but it is listed as a property) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the tests mentioned (Biocompatibility, Electrical Property, Shelf-life, Electrical Safety), nor does it describe data provenance in terms of country of origin or whether the studies were retrospective or prospective. These tests are typically laboratory-based and performed on representative samples of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The tests performed are engineering and biological evaluations, not diagnostic interpretations requiring expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for human-in-the-loop diagnostic studies, which this is not.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a disposable surface electrode, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a disposable surface electrode, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the requirements and measurement methods specified in the cited international and national standards (ISO, AAMI/ANSI, ASTM, IEC). For example, a successful biocompatibility test means the material does not induce a harmful biological response above a certain threshold as defined by the standard.
8. The sample size for the training set
Not applicable. There is no AI model or training set described.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set described.
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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 (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 DisposableSurface Electrodes | Disposable Adhesive SurfaceElectrodes | -- |
| Manufacturer | Electrode Market Co.,Ltd. | Technomed Europe | -- |
| Device Class | Class II | Class II | Same as predicatedevice |
| Product code | GXY | GXY | Same as predicatedevice |
| Intended Use | The Electrode MarketDisposable Surface Electrodesare intended for noninvasiveuse with recording andmonitoring equipment, (activeand reference), ofElectromyography (EMG),Electroencephalograph (EEG)and Evoked Potentials (EP).The electrodes are designedfor single use. | The Disposable AdhesiveSurfaceElectrodes are intended foruse withstimulating/recording ofbiopotential signals.Electrodes are applied in thestudy of biopotentials suchas Electromyography(EMG),Electroencephalograph(EEG) and nerve conductionand Evoked Potentials (EP).Electrodes are non-invasiveas they are applied to thepatient's skin using a self-adhesive solid-gel surface.The electrodes are non-sterile and for single patientuse only. | Similar to predicate. |
| Anatomical sites | Surface | Surface | Same as predicatedevice |
| Patch Dimensions | 20 mm diameter (discelectrode) and 40mm*50mm(ground electrode) | Not publicly available | -- |
| Conductive surfacearea | 3.14cm² (disc electrode)20cm² (ground electrode) | Not publicly available | -- |
| Lead Wire Length | 1.0 to 2.5m | Not publicly available | -- |
| Constructionelectrode | Three layers1. Top sheet: Non-wovenFabric2. Conductive film: Carbonfilm coated with silverchloride3. Conductive hydrogel | Not publicly available | -- |
| Lead wire material | PVC insulated tin plated withcopper | 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:
-
- 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 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.
§ 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).