(90 days)
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.
Disposable EEG Electrodes includes three models: DL, E-CAP, FLEX-CAP. The models E-CAP and FLEX-CAP are EEG electrode positioning systems used to place a number of EEG electrodes in a uniform and consistent manner on the head in order to transmit electrophysiological signals from an individual to data collection devices. The model E-CAP is made from spandex type material with silver/silver chloride-plated ABS electrodes in silicone base attached to the cap. The model FLEX-CAP is made from spandex type material with silver/silver chloride ink printed electrodes on PET in silicone base attached to the cap, the cap covering the entire scalp and is held in place with chin straps. The spandex type material holds the electrodes securely in position during an EEG recording. The electrodes on the caps connect to the EEG equipment either through an adapter cable or in some instances, special connector on match EEG equipment. The electrical activity of the brain is transferred via the electrolyte to the electrode and then to the EEG equipment for evaluation. The models E-CAP and FLEX-CAP have been built with the placement of 2-128 electrodes, the size of cap is from 26 to 66 cm. The model DL is a silver/silver chloride-plated ABS electrode with shrink tubing and connector, which is used on the model E-CAP. In addition, model DL can be used alone on the scalp for EEG monitoring. The electrodes on the Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) are positioned according to the International Ten-Twenty System (10-20) of Electrode Placement. In addition, Disposable EEG Electrodes (MODEL: DL, FLEX-CAP) with as a few as 2 or as many as 128 electrodes, have been mounted in a place according to the 10-10 American Electroencephalographic Society positioning system. Disposable EEG Electrodes (MODEL: DL, FLEX-CAP) can also be custom-made, in which the numbers of electrodes and placement of electrodes are made under an instruction from customs.
This document describes a 510(k) submission for Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP). The submission asserts substantial equivalence to a predicate device and includes performance data based on non-clinical testing.
Here's an analysis of the acceptance criteria and the supporting study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from FDA guidance "Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway") | Reported Device Performance (from "Performance Data" section and Comparison Table) |
|---|---|
| Resistance < 100 Ω | The performance of the subject device met the requirements of FDA guidance. Specific value not given, but compliance asserted. |
| AC impedance < 2 kΩ (at 10 Hz) | The performance of the subject device met the requirements of FDA guidance. Specific value not given, but compliance asserted. |
| DC offset voltage < 100 mV | The performance of the subject device met the requirements of FDA guidance. Specific value not given, but compliance asserted. |
| Combined offset instability and internal noise: < 150 µV | The performance of the subject device met the requirements of FDA guidance. Specific value not given, but compliance asserted. |
| Bias current tolerance < 100 mV | The performance of the subject device met the requirements of FDA guidance. Specific value not given, but compliance asserted. |
| Biocompatibility: Meeting ISO 10993-1, ISO 10993-5, ISO 10993-10 | Device was performed biocompatibility test according to ISO 10993-1, ISO 10993-5, ISO 10993-10, and showed compliance. |
| Electrical Safety: Conformance with 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). | The design of the Disposable EEG Electrodes is in conformance with subclause 8.5.2.3 of 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). |
| Shelf Life Validation | Shelf life validation was carried out. Specific results not provided, but compliance asserted. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify a separate "test set" sample size in terms of the number of electrodes or subjects used for electrical performance testing. It refers to "electrode characterization test" and "performance test," implying these were conducted on the device models. No human subjects were involved.
- Data Provenance: The tests were conducted by Wuhan Greentek Pty Ltd in China. The data would be considered prospective for the purposes of this submission, as they were generated to support the 510(k).
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. This device is an EEG electrode, and the performance characteristics (resistance, impedance, offset voltage, noise, bias current tolerance) are objective electrical measurements, not subjective interpretations requiring expert consensus for ground truth. Biocompatibility testing follows established ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no subjective human interpretation or diagnostic ground truth was established for the performance tests. The performance criteria are quantitative and based on physical measurements against established electrical and biocompatibility standards.
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
No MRMC comparative effectiveness study was done. This device is an EEG electrode, a hardware component for signal acquisition, not an imaging or analytical AI software that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance evaluation was done for the device's electrical characteristics and biocompatibility. The performance tests ("electrode characterization test", "performance test") and biocompatibility tests assess the device itself, without human interpretation or intervention in the performance measurement. The clinical test section explicitly states "Clinical testing is not required."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance criteria is derived from established engineering and biocompatibility standards:
- Electrical Performance: The ground truth is the quantitative limits defined in the FDA guidance "Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway." This is an objective, standardized metric.
- Biocompatibility: The ground truth is compliance with the pass/fail criteria specified in ISO 10993-1, ISO 10993-5, and ISO 10993-10 standards. This is also an objective, standardized metric.
- Electrical Safety: Conformance with AAMI / ANSI ES60601-1 is the ground truth.
8. The sample size for the training set
Not applicable. This submission concerns a physical medical device (EEG electrodes), not a machine learning or AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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April 21, 2020
Wuhan Greentek Pty Ltd. Yarong Liu Rm 03-2, Floor 3, Dingye Bldg, Phase III International Enterprise Center, Special No.1 Guanggu Ave Donghu New Technology Development Zone Wuhan, Hubei, 430074 China
Re: K200162
Trade/Device Name: Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: January 1, 2020 Received: January 22, 2020
Dear Yarong Liu:
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.
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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200162
Device Name
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
Indications for Use (Describe)
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: March 8, 2020
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Wuhan Greentek Pty Ltd |
|---|---|
| Address: | Room 03-2, Floor 3, Dingye Building, Phase III, InternationalEnterprise Center, Special No.1, Guanggu Avenue, Donghu NewTechnology Development Zone, Wuhan, CHINA 430074 |
| Contact person: | Yarong Liu |
| Title: | Manager |
| E-mail: | lyr@gtsensor.com |
| Tel: | +86-27-88185488 |
2. Device Identification
| Trade/Device Name: | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) | |
|---|---|---|
| Models: | DL, E-CAP, FLEX-CAP | |
| Common Name | Disposable EEG Electrodes system | |
| Regulation Number: | 21 CFR 882.1320 | |
| Regulation Name: | cutaneous electrode | |
| Regulation Class: | Class II | |
| Product Code: | GXY |
3. Predicate Device
| 510(K) number: | K112319 |
|---|---|
| Trade Name: | Electro-Cap System |
| Common Name | EEG electrode positioning system |
| Manufacturer: | Electro-Cap International, Inc. |
| Regulation Number: | 21 CFR 882.1320 |
| Regulation Name: | cutaneous electrode |
| Regulation Class: | Class II |
| Product Code: | GXY |
4. Device Description
Disposable EEG Electrodes includes three models: DL, E-CAP, FLEX-CAP.
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The models E-CAP and FLEX-CAP are EEG electrode positioning systems used to place a number of EEG electrodes in a uniform and consistent manner on the head in order to transmit electrophysiological signals from an individual to data collection devices. The model E-CAP is made from spandex type material with silver/silver chloride-plated ABS electrodes in silicone base attached to the cap. The model FLEX-CAP is made from spandex type material with silver/silver chloride ink printed electrodes on PET in silicone base attached to the cap, the cap covering the entire scalp and is held in place with chin straps. The spandex type material holds the electrodes securely in position during an EEG recording. The electrodes on the caps connect to the EEG equipment either through an adapter cable or in some instances, special connector on match EEG equipment. The electrical activity of the brain is transferred via the electrolyte to the electrode and then to the EEG equipment for evaluation. The models E-CAP and FLEX-CAP have been built with the placement of 2-128 electrodes, the size of cap is from 26 to 66 cm.
The model DL is a silver/silver chloride-plated ABS electrode with shrink tubing and connector, which is used on the model E-CAP. In addition, model DL can be used alone on the scalp for EEG monitoring.
The electrodes on the Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) are positioned according to the International Ten-Twenty System (10-20) of Electrode Placement. In addition, Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) with as a few as 2 or as many as 128 electrodes, have been mounted in a place according to the 10-10 American Electroencephalographic Society positioning system. Disposable EEG Electrodes (MODEL: DL, FLEX-CAP) can also be custom-made, in which the numbers of electrodes and placement of electrodes are made under an instruction from customs.
5. Indication for use
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.
6. Comparison to Predicate Device
Compared to the predicate devices, the subject device has same intended use, similar product design, and same performance effectiveness as the predicate device as summarized in the following table.
| Feature | Subject device | Predicate device | Discussion |
|---|---|---|---|
| 510(k)Number | - | K112319 | - |
| Indicationfor Use | Disposable EEGElectrodes (MODEL:DL, E-CAP, FLEX-CAP) is intended foruse in routine clinicalsettings where rapidplacement of a numberof EEG electrodes isdesired. | The Electro-Cap isintended for use in routineclinical settings whererapid placement of anumber of EEG electrodesis desired. | Same |
| Classification | Class II per21CFR882.1320, | Class II per21CFR882.1320, | Same |
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| Regulation | cutaneous electrode | cutaneous electrode | |
|---|---|---|---|
| ProductCode | GXY, Electrode,cutaneous | GXY, Electrode,cutaneous | Same |
| Environment ofuse | Electrophysiological | Electrophysiological | Same |
| Intendeduser | Neurologists | Neurologists | Same |
| Targetpatient | Adults and Children | Adults and Children | Same |
| Whereused | On the head | On the head | Same |
| Numberofcontacts | 2-128 | 2-256 | The placement of theelectrodes is according to theInternational (10-20) System ofElectrode Placement or (10-10) AmericanElectroencephalographicSociety positioning system.The number of the electrodesin use is according to theneeds of clinic practice. Byusing 19 electrodes and 32electrodes (or 19 channels and32 channels can meet majorityneeds, while using channelsup to 128 can satisfy mostmedical applications as thepredicate K112319 does. Thedisposable electrodes canadapt to most EEG equipmentas the predicate K112319does. Both of the subjectdevice and the predicatedevice are applied to recordEEG signals on patients' scalp,and the bioelectrical signalsare in microvolts-level. Theelectrodes only transfer tinybioelectrical signals to theEEG recording equipment. Thedoctors can read the signalsaccording the channelsassigned, such as 19 channelsor 32 channels. The safetyissue only concerns the bio- |
| compatibility of the electrodematerials, while theeffectiveness mainly concernsthe electrode surfacematerials. The number ofelectrodes in the products isirrelevant to the safety andalso doesn't affect theeffectiveness compared topredicate devices. Therefore,the difference in numbers ofelectrodes does not raise anynew safety risk oreffectiveness issue. | |||
| Size ofCaps | Various - babies tolarge 26cm to 66cm | Various - babies to large26cm to 66cm | Same |
| Style ofCaps | Full head cap | Full head cap | Same |
| Ear Slits | Yes | Yes | Same |
| Capmaterial | Spandex | Spandex | Same |
| ElectrodeMounts | Silicone | Polyethylene | The mount base used in theDisposable Electrodes isdesigned for fastening theelectrodes on the cap fabric,and the base don't involve inthe bioelectrical signalrecording. Silicone is acommon material used inmedical device. The siliconemount base can be made softthan the base made bypolyethylene in the predicatedevice. Therefore, by usingsilicone materials as the mountbase offers more comfortableexperience to the users.Furthermore, the siliconemount bases used in thisDisposable Electrodes havepassed the bio-compatibilitytest. Thus, the use of siliconeas electrode mount base doesnot raise new safety andeffectiveness issues. |
| CableLength | 0.1 m - 3.0 m | Various - 3 to 5 feet | The length of the cable in theDisposable electrodes isdifferent from the predicatedevice but it doesn't raise newsafety and effectiveness issue.Because the cable is used fortransferring EEG signals (thetiny bioelectrical signal in ~several ten microvolts peak topeak) from the patients' scalpto the data record devices. Thecable is designed inconformance with AAMI / ANSIES60601-1:2005/(R)2012 andA1:2012, C1:2009/(R)2012and A2:2010/(R)2012(consolidated text) Medicalelectrical equipment - Part 1:General requirements for basicsafety and essentialperformance (IEC 60601-1:2005, mod). |
| Type ofCables | Standard ribbon cableand lead wires | Standard ribbon cable andlead wires | Same |
| ElectrodeMetal | 1. FLEX-CAP:silver/silver chloride inkprinted electrodes onPET (Polyethyleneterephthalate)2. DL and E-CAP:silver/silver chloride –plated ABS base | Pure tin, silver, silver/silverchloride, gold plated | Electrode material need tohave good electricalconducting and non-polarizedcharacteristic on the surface(low interface impedance). Thepredicate device has fourelectrode materials, but thebest electrode material issilver/silver chloride as itpossesses non-polarizedsurface. The surface materialof disposable electrodes issilver/silver chlorides, which isprinted or plated on plastic(PET, Polyethyleneterephthalate or ABS). Theplastic provides a supportingsubstrate, the surfacesilver/silver chloride provideelectrode function as electricalconducting and low impedanceas the one of the bestelectrodes in the predicatedevices. These plastics don't |
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| Type ofConnectors | Touch-proof safetysocket DIN42-802( $ Φ $ =1.5mm) | D-Sub connectors, touchproof DIN sockets andspecial connectors onmatch EEG equipmentand computers | contact to scalp and don'tinvolve in bioelectrical signalrecording either.Further, the electrodes withsilver/silver chloride ink printedon PET substrate andsilver/silver chloride plated onABS substrate have passedbio-compatibility tests inaccordance with ISO 10993-1and as well as performancetest in accordance with ASTMEC 12. The test result showsthat subject device meets theperformance requirements ofFDA guidance, so thedifference in materials doesnot raise new safety andeffectiveness issues. |
|---|---|---|---|
| Biocompatibilitytest | ISO 10993-1,ISO 10993-5,ISO 10993-10 | None was conducted | The subject device has beenperformed biocompatibility testaccording to the FDAguidance, this difference doesnot raise any new safety oreffectiveness. |
| Performancerequirements | 1. Resistance <100 Ω2. AC impedance <2kΩ (at 10 Hz)3. DC offset voltage<100 mV4. Combined offsetinstability and internalnoise: <150 µV5. Bias currenttolerance <100 mV | Needs to transmitelectrophysiologicalsignals from an individualto data collection deviceswith a maximumimpedance of 5 K/Ohms.Does not transmitelectrical current, nor arethey intended to be usedfor stimulation. | The subject device wasperformed electrodecharacterization test accordingto the FDA guidance, theperformance of subject devicemet the requirements of FDAguidance "CutaneousElectrodes for RecordingPurposes - PerformanceCriteria for Safety andPerformance Based Pathway".we have done more details intests according to the FDAguidance. |
All the differences do not affect the safety and effectiveness of the subject device which is concluded after all the required testing, so there are no safety and effectiveness issues relating to the subject system.
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7. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
Performance:
We performed electrical safety. The design of the Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) is in conformance with subclause 8.5.2.3 of 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). We carried out the performance test and shelf life validation according to the <Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and Food and Drug Administration Staff> and ANSI EC12-2000 Disposable ECG electrodes.
Biocompatibility:
-
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
- 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
8. Conclusion
Based on the comparison with predicate device, our Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) has the same intended use, structure, and technologies, which is substantially equivalent to predicated device.
§ 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).