(87 days)
The NEBA® Compact EEG 2R Mobile Headset) is intended to capture, amplify, and wirelessly transmit electrical brain activity for review by a trained medical professional using the CEEG2R recording software. The NEBA Headset comprises an electrode positioning system for placing single-use disposable electrodes on the head (Vermed® A10005, ANSI/AAMI EC12 compliant silver/silver-chloride (Ag/AgCl) electrodes). Contained within the headset is a wireless EEG amplifier module. The NEBA Headset and its associated software do not provide any diagnostic conclusion or automated alerts of any clinical event about a patient's condition. The NEBA Headset transmits electrophysiological signals from the electrodes to a CEEG 2R IEC/UL 60950-1 safety compliant computer running the NEBA CEEG 2R recording software. The system supports six electrode locations (CZ, left ocular, right ocular, left ear, right ear, and ground) on four flat flexible leads and one plastic tab (the latter to support the CZ electrode). The CEEG2 Headset is intended for use in clinical settings in individuals six years of age and older. (Rx only).
The NEBA® Compact EEG2R Mobile Headset is a battery powered (3.7v Lithium-lon battery wirelessly charged using a Qi-compliant receiver) wireless (Bluetooth LE) EEG headset which facilitates the placement of EEG electrodes. The NEBA® Compact EEG2R Mobile Headset (CEG2R) has both hardware and software components. Hardware comprises an EEG electrode system that serves to conduct EEG potentials from the human scalp for transfer to a built-in wireless EEG amplifier. The software provides EEG amplifier hardware control, recording, storage, and user interfaces for waveform monitoring, patient information entry and storage, and accessing stored EEG data. The CEEG2R Headset has two primary purposes: To aid in EEG electrode positioning on the head such that electrodes are positioned in intended locations accurately and reliably per the standard 10-20 International Electrode Placement System. The default leads configuration includes CZ, left ocular (OC-L), right ocular (OC-R), left ear (E-L), right ear (E-R), and Ground (GND) positions; To transmit electrophysiological signals from positioned electrodes to an EEG recording and monitoring device via an internal EEG amplifier with wireless transfer communication. The CEEG2R Headset is constructed using biocompatible patient contact surfaces, the major components formed of polyurethane and polyester. The headset is held in place using a flexible platform at the top of the head and adjustable arms that terminate at lateral supports at the sides of the head. The headset is designed for use with accessory disposable silver/silver-chloride (Ag/AgCl) electrodes (K781430). An integral, counter posing pressure tab accepts a disposable electrode for placement at the top medial portion of the head (at location CZ of the 10-20 International Electrode Placement System). Connection components facilitate the quick insertion and removal of the electrodes and flexible leads. Electrodes for use on the scalp and hair bearing scalp region use a low-viscosity integrated wet-gel conductive medium embedded in the electrodes along with integrated low-tack adhesive optimized for hair compatibility and system stability. The system is stabilized on the head through use of low tack adhesive-lined electrodes, conformable lateral support linings, spring hinges, and a flexible headband platform. The system interfaces with the CEG2R recording and monitoring software for signal acquisition, signal measurement, and electrode impedance measurement by way of a built-in wireless amplifier. The battery, wireless battery charger, wireless communication transmitter and amplifier printed circuit board (PCB) are located atop a midline-located headband platform of the headset.
The NEBA® Compact EEG2R Mobile Headset is intended to capture, amplify, and wirelessly transmit electrical brain activity for review by a trained medical professional. The device itself does not provide diagnostic conclusions or automated alerts. The FDA letter and K223628 Summary provide information about the device's technical specifications and the testing performed to demonstrate its safety and performance relative to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the primary acceptance criteria revolve around demonstating substantial equivalence to predicate devices, focusing on safety and effectiveness. The document lists performance testing against recognized standards rather than specific acceptance metrics like sensitivity/specificity for a diagnostic claim, as it's not a diagnostic device.
Here's a table summarizing the performance standards the device was tested against and, where available, reported values. Explicit acceptance criteria in terms of performance thresholds (e.g., "noise must be less than X" or "dynamic range must be at least Y") are not detailed as specific numerical targets being met, but rather compliance with the standards' requirements.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Electrical Safety | |
| IEC 60601-1:2005/A1:2012 (Basic electrical safety & essential performance) | Compliance demonstrated |
| IEC 60601-2-26:2012 (Safety of electroencephalographs) | Compliance demonstrated |
| Electromagnetic Compatibility (EMC) | |
| IEC 60601-1-2:2015 (EMC - Requirements and tests) | Compliance demonstrated |
| 47 CFR Part 15 Subpart B (Emissions) | Compliance demonstrated |
| ANSI C63.4:2014 (Wireless Headset Emission and Exposure) | Compliance demonstrated |
| Wireless Charger RF Exposure | |
| KDB 680106 D01 V03 | Compliance demonstrated (Waltek Testing Group conducted) |
| 47 CFR Part 15 Subpart C (Wireless Charger) | Compliance demonstrated (ANSI C63.10-2013 used) |
| Biocompatibility | |
| ISO 10993-1:2018 (Biological evaluation of medical devices) | Biological evaluation planned and tests selected |
| ISO 10993-5:2009 (Cytotoxicity) | Cytotoxicity testing performed (Nelson Labs), material risk analysis indicated materials did not put patient or operator at risk. |
| ISO 10993-10:2010 (Irritation & Sensitization) | Sensitization and Irritation were ruled out |
| Risk Management | |
| ISO 14971:2007 (Risks associated with materials) | Risks determined; each material requiring biological review was evaluated. |
| Software Verification | |
| IEC 62304:2006/A1:2016 (Medical device software life-cycle processes) | Compliance demonstrated |
| IEC 60601-1-6:2006/A1:2013 (Usability) | Compliance demonstrated |
| Technical Specifications (Comparison with Predicates) | |
| Input Dynamic Range | ±187.5 mV peak-to-peak input (vs. 1 mVp-p for predicates) - Difference deemed negligible for EEG signals |
| Input Noise | ± 4 µV maximum peak-peak 0.5 Hz through 50 Hz a noise limit (vs. 5 µVp-p or less for predicates) - Deemed same |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not detail any patient-based test sets or data provenance (country of origin, retrospective/prospective) for clinical performance evaluation. The device is cleared through a 510(k) pathway by demonstrating substantial equivalence to predicate devices primarily through engineering and bench testing, as well as software validation and biocompatibility assessments.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that "clinical testing was not performed to demonstrate substantial equivalence," there was no ground truth established by experts for a patient test set. The performance evaluations were laboratory-based, adhering to recognized standards.
4. Adjudication Method for the Test Set
As no clinical test set requiring human interpretation or adjudication was conducted for performance claims, there was no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done. The device emphasizes capturing and transmitting EEG data for review by a trained medical professional; it does not provide diagnostic conclusions or automated alerts, and therefore, its "effectiveness" in improving human reader performance with AI assistance is not applicable to its current stated intended use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is an EEG headset with an amplifier and software for recording/review. It does not perform automated diagnostic algorithms. Therefore, no standalone algorithm performance study was conducted. The performance assessed relates to the hardware and software functioning correctly to acquire and transmit EEG signals according to engineering standards.
7. The Type of Ground Truth Used
The "ground truth" for the various performance tests was defined by the specifications and requirements of the relevant industry standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, ISO 10993-5) and internal design specifications (e.g., input dynamic range, input noise). For biocompatibility, the chemical composition and biological response of materials according to ISO standards served as the ground truth.
8. The Sample Size for the Training Set
There is no mention of a training set because this device does not utilize machine learning or AI algorithms that would require training data for diagnostic or interpretive functions.
9. How the Ground Truth for the Training Set Was Established
Since no training set was used, there is no information on how its ground truth would have been established.
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March 2, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Neba Health, LLC Howard Merry President 2052 Gordon Highway, Ste B. Augusta. Georgia 30909
Re: K223628
Trade/Device Name: NEBA® Compact EEG2R Mobile Headset Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC, GXY Dated: October 26, 2022 Received: December 5, 2022
Dear Howard Merry:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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/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,
Patrick Antkowiak -S
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic 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) K223628
Device Name NEBA® Compact EEG2R Mobile Headset
Indications for Use (Describe)
The NEBA® Compact EEG 2R Mobile Headset) is intended to capture, amplify, and wirelessly transmit electrical brain activity for review by a trained medical professional using the CEEG2R recording software. The NEBA Headset comprises an electrode positioning system for placing single-use disposable electrodes on the head (Vermed® A10005, ANSI/AAMI EC12 compliant silver/silver-chloride (Ag/AgCl) electrodes).
Contained within the headset is a wireless EEG amplifier module.
The NEBA Headset and its associated software do not provide any diagnostic conclusion or automated alerts of any clinical event about a patient's condition.
The NEBA Headset transmits electrophysiological signals from the electrodes to a CEEG 2R IEC/UL 60950-1 safety compliant computer running the NEBA CEEG 2R recording software.
The system supports six electrode locations (CZ, left ocular, left ear, right ear, and ground) on four flat flexible leads and one plastic tab (the latter to support the CZ electrode).
The CEEG2 Headset is intended for use in clinical settings in individuals six years of age and older.
| 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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K223628 – Traditional 510(k) Summary
| Submitter: | NEBA Health, LLC2052B Gordon HighwayAugusta, GA 30909NEBA Health, LLC.Phone: (706) 736-5864Fax: (706) 650-2160 |
|---|---|
| Contact person: | E. Howard Merry,President NEBA Healthhmerry@NEBAHealth.net |
| Date summary prepared: | February 22, 2023 |
| Subject device | |
| Device trade name; proprietary name: | NEBA® Compact EEG2R Mobile Headset (CEEG2R) |
| Common name: | Electroencephalogram (EEG) |
| Product Code; Classification: | OMC (Primary); Reduced montageelectroencephalograph 21 CFR 882.1400;Electroencephalograph, Class II.GXY (Secondary); Cutaneous Electrode21 CFR 882.1320; Class II; Cutaneous Electrode |
| Review Panel: | Neurology; Diagnostic Devices |
Predicate and reference devices
| Predicate Type | 510K Number | Device | Manufacturer |
|---|---|---|---|
| Primary Predicate | K203827 | REMI | Epitel, Inc. |
| Secondary Predicate | K183529 | AE-120A EEG Headset | Nihon Kohden |
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Subject device description
The NEBA® Compact EEG2R Mobile Headset is a battery powered (3.7v Lithium-lon battery wirelessly charged using a Qi-compliant receiver) wireless (Bluetooth LE) EEG headset which facilitates the placement of EEG electrodes. The NEBA® Compact EEG2R Mobile Headset (CEG2R) has both hardware and software components. Hardware comprises an EEG electrode system that serves to conduct EEG potentials from the human scalp for transfer to a built-in wireless EEG amplifier. The software provides EEG amplifier hardware control, recording, storage, and user interfaces for waveform monitoring, patient information entry and storage, and accessing stored EEG data.
The CEEG2R Headset has two primary purposes:
- . To aid in EEG electrode positioning on the head such that electrodes are positioned in intended locations accurately and reliably per the standard 10-20 International Electrode Placement System. The default leads configuration includes CZ, left ocular (OC-L), right ocular (OC-R), left ear (E-L), right ear (E-R), and Ground (GND) positions;
- . To transmit electrophysiological signals from positioned electrodes to an EEG recording and monitoring device via an internal EEG amplifier with wireless transfer communication.
The CEEG2R Headset is constructed using biocompatible patient contact surfaces, the major components formed of polyurethane and polyester. The headset is held in place using a flexible platform at the top of the head and adjustable arms that terminate at lateral supports at the sides of the head.
The headset is designed for use with accessory disposable silver/silver-chloride (Ag/AgCl) electrodes (K781430).
An integral, counter posing pressure tab accepts a disposable electrode for placement at the top medial portion of the head (at location CZ of the 10-20 International Electrode Placement System). Connection components facilitate the quick insertion and removal of the electrodes and flexible leads. Electrodes for use on the scalp and hair bearing scalp region use a low-viscosity integrated wet-gel conductive medium embedded in the electrodes along with integrated low-tack adhesive optimized for hair compatibility and system stability.
The system is stabilized on the head through use of low tack adhesive-lined electrodes, conformable lateral support linings, spring hinges, and a flexible headband platform.
The system interfaces with the CEG2R recording and monitoring software for signal acquisition, signal measurement, and electrode impedance measurement by way of a built-in wireless amplifier. The battery, wireless battery charger, wireless communication transmitter and amplifier printed circuit board (PCB) are located atop a midline-located headband platform of the headset.
Subject device Intended Use
The NEBA® Compact EEG 2R Mobile Headset) is intended to capture, amplify, and wirelessly transmit electrical brain activity for review by a trained medical professional using the CEEG2R recording software. The NEBA Headset comprises an electrode positioning system for placing single-use disposable electrodes on the head (Vermed® A10005, ANSI/AAMI EC12 compliant silver/silver-chloride
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(Ag/AgCl) electrodes cleared in K781430). Contained within the headset is a wireless EEG amplifier module. The NEBA Headset and its associated software do not provide any diagnostic conclusion or automated alerts of any clinical event about a patient's condition. The NEBA Headset transmits electrophysiological signals from the electrodes to a CEEG 2R IEC/UL 60950-1 safety compliant computer running the NEBA CEEG 2R recording software. The system supports six electrode locations (CZ, left ocular, right ocular, left ear, right ear, and ground) on four flat flexible leads and one plastic tab (the latter to support the CZ electrode). The CEEG2 Headset is intended for use in clinical settings in individuals six years of age and older. (Rx only).
Comparison of predicate devices to subject device
The NEBA® Compact EEG2R Mobile Headset (CEEG2R) is substantially equivalent to the REMI device when combined with the Nihon Kohden AE-120A EEG headset. NEBA shares the same technological characteristics as the predicate devices, but there are some differences. Both battery-powered predicates are reduced montage EEG devices that wirelessly transmit EEG data to an accessory device running software.
The primary predicate is the REMI device. The NEBA® Compact EEG2R Mobile Headset (CEG2R) is designed to amplify, capture, and wirelessly transmit EEG data from the CZ channel to an accessory software intended for monitoring and reviewing EEG data. Similarly, the REM device is called out as the primary predicate as it is intended to wirelessly transmit a single channel of electrical activity for subsequent review. Both are intended for professional prescription use only and for patients 6 years and older.
Neither the REMI device nor the NEBA® Compact EEG2R Mobile Headset are indicated for making any diagnosis or diagnostic recommendations and both are intended only to facilitate the monitoring and review of physiological signals.
The secondary predicate, the Nihon Kohden AE-120A, is called out to achieve the NEBA® Compact EEG2R Mobile Headset positionality. Both the Nihon Kohden AE-120A and the NEBA® Compact EEG2R Mobile Headset use mechanical headsets to aid in EEG electrode positioning to approximate the 10-20 International Electrode Placement System.
The predicate systems and the NEBA® Compact EEG2R Mobile Headset were evaluated for safety and effectiveness in quality systems per FDA guidance and using compliance standards. The predicate systems and the NEBA® Compact EEG2R Mobile Headset were evaluated according to ISO 10993-1 biological evaluation and associated FDA guidance.
Given the discussion above and the substantial equivalence table below, NEBA Health asserts that the differences between the NEBA® Compact EEG2R Mobile Headset and the predicate devices do not raise different questions of safety and effectiveness based on the performance testing used to address the technological characteristics.
NEBA Health asserts the NEBA Health device (CEEG2R) is substantially equivalent to the combined predicate devices.
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Table 5a compares the technical characteristics of the subject device to the primary and secondary predicate devices.
Table 5a – Technical Characteristics Comparison
| Attribute | REMI | NKC | NEBA CEEG 2Rmobile Headset | Discussion |
|---|---|---|---|---|
| classificationregulation | K203827 | K183529 | K223628 | Same. |
| Class II per 21 CFR882.1400Electroencephalograph (HeadSet) | Class II per 21 CFR882.1400Electroencephalograph (HeadSet) Class II per 21 CFR882.1320 (forelectrodes withinheadset) | Class II per 21 CFR882.1400Electroencephalograph (HeadSet) Class II per 21 CFR882.1320 (forelectrodes withinheadset) | ||
| Product code | OMC / GXY | OMC/GXY | OMC/GXY | Same. |
| IFU | the REMI Platform isintended to be used inhealthcare settingswherenear real-time and/orremote EEG iswarranted. REMIconsists of epilogdisposable Sensors asingle use, singlepatient, disposable,wearable sensorintended to amplify,capture, andwirelessly transmit asinglechannel of electricalactivity of the brainfor up to 48 hours.The REMI-Mobilesoftware and REMI-Tablet are intended toreceive and transmitdata from four EpilogSensors to securecloud storage forsubsequent viewingand reviewing of EEGon third-partysoftware. REMI doesnot make any | The AE-120A EEGHead Set is intendedto amplify, capture,and wirelesslytransmit electricalactivity of the brainfor review by atrained medicalprofessional using thepreviously cleared andvalidated NihonKohdenelectroencephalograph systems (EEG-1200Aseries and EEG-9100)to assist in thediagnosis ofneurologicaldisorders. The AE-120A EEG Head Setand its associated EEGSoftware do notprovide any diagnosticconclusion orautomated alerts ofan adverse clinicalevent about apatient's condition.The device is intendedfor use by trainedmedical professionals | The NEBA® CompactEEG 2R MobileHeadset (NEBAHeadset) is intendedto capture, amplify,and wirelesslytransmit electricalbrain activity forreview by a trainedmedical professionalusing the CEEG2Rrecording software.The NEBA Headsetcomprises anelectrode positioningsystem for placingsingle-use disposableelectrodes on thehead (Vermed®A10005, ANSI/AAMIEC12 compliantsilver/silver-chloride(Ag/AgCl) electrodes).Contained within theheadset is a wirelessEEG amplifier module.The NEBA Headsetand its associatedsoftware do notprovide any diagnostic | The NEBA Headsetand the predicatedevices are allreduced montageEEGs with theintended use toamplify, record andwirelessly transmitEEG data toaccessories runningsoftware formonitoring andreviewing EEG data.All 3 devices are forprescription use onlyby professionals. Alldevices have similarintended useenvironments. Theprimary predicate, theREMI device and theNEBA Headset havethe same populationage range. The NihonKohden device andthe NEBA headsethave in common anEEG positioningsystem. |
| Attribute | REMI | NKC | NEBA CEEG 2R mobile Headset | Discussion |
| K203827 | K183529 | K223628 | ||
| diagnosis orrecommendationsand is intended onlyas a physiologicalsignal monitor. EpilogSensors are intendedfor use by trainedmedical professionalsin a professionalhealthcare facilityenvironment. EpilogSensors are intendedfor use with adult andpediatric patients(6+). (Rx only). | in a medical facilitysuch as a physician'soffice, laboratory, orclinic. The device isintended for use onadults (ages 18 andabove). (Rx Only). | conclusion orautomated alerts of aclinical event about apatient's condition.The NEBA Headsettransmitselectrophysiologicalsignals from theelectrodes to a CEEG2R IEC/UL 60950-1safety compliantcomputer running theNEBA CEEG 2Rrecording software.The system supportssix electrode locations(CZ, left ocular, rightocular, left ear, rightear, and ground) onfour flat flexible leadsand one plastic tab(the latter to supportthe CZ electrode).The CEEG2 Headset isintended for use inclinical settings inindividuals six years ofage and older. (Rxonly). | ||
| Physiological signalacquired | EEG | EEG | EEG | Same. |
| Type of patientcontact | Contacts patient scalp | contacts patient scalp | Contacts patient scalp | Same. |
| electrodes | 2 passive goldelectrodes using aconductive hydrogel | 10 passive Ag/AgClelectrodes | 6 passive Ag/AgClelectrodes | The electrodes for theNihon Kohden deviceand the NEBA Headsetare the same. Thedisposable electrodefor the NEBA Headsetis 510(k) approvedand ANSI/AAMI EC12compliant and ismanufactured by a |
| Attribute | REMI | NKC | NEBA CEEG 2Rmobile Headset | Discussion |
| K203827 | K183529 | K223628 | NEBA approvedvendor. | |
| type of use | Epilog Disposable issingle use, non-sterile,disposable | Electrodes: Single use,non-sterile,disposable. EEGDevice: AE-120A EEGHead set is reusableandnonpatientcontacting. Belts arepatient contactingand reusable. | Electrodes: Single use,non-sterile,disposable. The NEBAHeadset is reusableand comprises bothpatient and non-patient contactingparts. The headset isreusable and designedfor cleaning betweenuses. | The intended use ofthe Nihon Kohdendevice and the NEBAdevice are similar anddifferences do notraise questions ofsafety andeffectiveness. |
| Channel # | 0-10 | 8 | 1 | Same. The NEBAHeadset total EEGchannel number iswithin the rangeestablished by thepredicates. |
| Montage | 10/20 system - Epilog-Disposable can beplaced anywhere inthe 10/20 systemwhere each channelrepresents a bipolarderivationapproximation of the10/20 system | 10/20 System - AE-120A EEG Head Setapproximates the10/20 montage butmay deviate slightlydependingon the patient's headshape. | 10/20 System - theNEBA Headset isintended to facilitatethe placement ofelectrodes per the10/20 montage | Same. |
| Electrical safety andEMC | IEC 60601-1,IEC 60601-1-2,IEC 60601-2-26 | IEC 60601-1,IEC 60601-1-2,IEC 60601-2-26 | IEC 60601-1,IEC 60601-1-2,IEC 60601-2-26 | Same. |
| Input dynamic range | 1 mVp-p | 1 mVp-p | ±187.5 mV peak-to-peak input | The differencebetween thepredicate devices andthe CEEG2R device forthe Input DynamicRange is negligiblewhen compared toEEG signals in the lowmicro-volt range anddoes not affect safetyand effectiveness. |
| Attribute | REMI | NKC | NEBA CEEG 2Rmobile Headset | Discussion |
| K203827 | K183529 | K223628 | ||
| input noise | 5 µVp-p | 5 µVp-p or less (0.53to 60Hz) | ± 4 µV maximumpeak-peak 0.5 Hzthrough 50 Hz a noiselimit | Same. |
| data transfer | Bluetooth 2.4 GHz | Bluetooth 2.4 GHz | Bluetooth LE 2.4 GHz | Same. |
| power source | CR2016 primarylithium (notrechargeable) | 2 AA (LR6) alkalinebatteries (notrechargeable) | The NEBA CEEG 2Rmobile Headset has abuilt-in 3.7v Lithiumion battery which ischarged using a Qi-compliant wirelesspower receiver. | The NEBA Headsetuse a lithium batterylike the REMI device.Like both devices theNEBA Headset doesnot connect to mainspower for charging.The NEBA Headsethas no user accessiblecharging port orinterface and chargeswirelessly. Thedifferences do notraise issues of safetyand effectiveness. |
| data format | Lay-Dat (Persyst) | Nihon Kohden originalformat | European DataFormat (EDF) NEBAfile format 2.4 | The data format doesnot raise questions ofsafety andeffectiveness. |
| compatibility | Epilog Disposableworks only with REMIApp software andtablet | Works only withNihon Kohdenspecified EEG's: EEG-1200A series(KO80546) EEG-9100(KO 11204) | The NEBA CEEG 2Rmobile Headset worksonly with NEBAsoftware | Same. |
| software | Epilog Disposable usesintegrated firmwareonly for transmittingEEC to REMI Appsoftware and tablet | AE-120A EEG Head Setcomes with EEGsoftware to be placedon the compatibleEEG for interactionwith and viewing ofEEG data | The NEBA headsetuses integratedfirmware only fortransmitting EEG toNEBA software andcomputer accessory | Same. |
| connector | Epilog Disposable usesa USB protocol on anon-standardconnector forprogramming only | Single connector ofelectrodes to AE-120AHead Set | The CEEG 2R mobileHeadset is wireless.There is no patient oroperator accessibleconnector for theNEBA CEEG 2R mobileheadset. | Improved. The NEBAHeadset presents noexternal connectorand no user accessibleconnectors. |
| Attribute | REMI | NKC | NEBA CEEG 2R | Discussion |
| mobile Headset | ||||
| K203827 | K183529 | K223628 | ||
| sizes and dimensions | Epilog comes in onesize:27 mm x 27 mm x 7mm | AE-120A EEG Head Sethas flexible arms thatare adjusted to fitdifferent adult patienthead sizes along withadjustments from thebelts/ straps (chin). | Width, height, andanatomicallyconforming curvatureof The CEEG2 Headsetwere selected forcompatibility over ahead size range thatspans two standarddeviations below anage six mean headsize to two standarddeviations above anadult mean head size.The SupportSubassembliesmeasure, inside view,approximately 107mm in width and 70 | Same. Like the NihonKohden headset, theNEBA Headset isadjustable toaccommodate a rangeor head sizes. |
| conductive gel | Conductive electrolyteis in the form of ahydrogel converted ina one-piece adhesivesticker as an accessoryto Epilog-Disposable.The sticker isreplaceable andonetime use | Conductive electrolytepaste is included in apacket gel reservoirintegrated into eachelectrode. Userinserts electrode intothe electrodeattachment positionin Head Set with paste | mm in height.Conductive electrolytegel is integrated intoeach electrode. | Same. The NEBAHeadset useselectrodes withintegrated conductivegel like the NihonKhoden Device. |
| Biocompatibility | Biocompatibility ofpatient contactingcomponents verifiedwith Irritation,Sensitization, andCytotoxicity testingper ISO 10993- 5:2009and ISO 10993-10:2010 | Biocompatibility ofpatient contactingcomponents verifiedwith Cytotoxicity,Sensitization, andIrritation per ISO10993-S and ISO-10993-10 | Biocompatibility ofpatient contactingcomponents verifiedwith Cytotoxicity,Sensitization, andIrritation per ISO10993-S and ISO-10993-10 | ISO 10993-1:2009 wasused to evaluate thematerials. ISO 10993-5:2009 was used totest for Cytotoxicity.Material risk analysisindicated materialsdid not put patient oroperator at risk.Sensitization, andIrritation were ruledout. |
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Performance data
Table 5b summarizes the efforts to validate and verify the performance of the CEEG2R device.
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| Description | Industry Standard | FDARecognitionNumber | Testing Lab | CompleteDate |
|---|---|---|---|---|
| CEEG2 HeadsetAssembly Verification | IEC 60601-1-6:2006 | N/A | EvergreenResearch Inc | 02/25/2020 |
| CEEG2 HeadsetAssembly Verification | IEC 60601-1:2005/A1:2012IEC 60601-2-26:2012ISO 14971:2007 | N/AN/A5-40 | MECA /EvergreenResearch Inc | 10/28/2020 |
| CEEG2 HeadsetAssembly Verification | N/A | N/A | EvergreenResearch Inc | 11/03/2021 |
| CEEG2R MobileSoftware Verification | IEC 60601-1-6:2006 | N/A | EvergreenResearch Inc | 03/02/2020 |
| CEEG2R MobileSoftware Verification | N/A | N/A | EvergreenResearch Inc | 05/05/2020 |
| CEEG2R MobileSoftware Verification | IEC 60601-1-8:2006/A1:2012IEC 62304:2006/A1:2016 | 5-7613-79 | MECA /EvergreenResearch Inc | 10/21/2020 |
| CEEG2RElectromagneticDisturbance | IEC 60601-1-2:2015 | N/A | CCIC SouthernTesting Co.,Ltd. | 11/20/2020 |
| CEEG2R WirelessHeadset Emission andExposure 47 CFFRPart 15 Subpart B | ANSI C63.4:2014 | N/A | CCIC SouthernTesting Co.,Ltd. | 11/20/2020 |
| CEEG2R WirelessCharger RF Exposure | KDB 680106 D01 V03 | N/A | Waltek TestingGroup | 08/19/2021 |
| CEEG2R WirelessCharger 47 CFR Part15 Subpart C | ANSI C63.10-2013 | N/A | Waltek TestingGroup | 08/19/2021 |
| Cytotoxicity | ISO 10993-5:2009 | 2-245 | Nelson Labs | 12/13/2019 |
Table 5b - Performance Testing Summary
The NEBA® Compact EEG2R Mobile Headset was evaluated for basic electrical safety and essential performance to IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
The NEBA® Compact EEG2R Mobile Headset was evaluated for electromagnetic compatibility in accordance with IEC 60601-1-2, Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.
The NEBA® Compact EEG2R Mobile Headset was evaluated for compliance with IEC 60601-1-26, Particular requirements for the safety of electroencephalographs.
The NEBA® Compact EEG2R Mobile also demonstrated compliance with 47 CFR Part 15 Subpart B and Subpart C for emissions and exposure.
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Biocompatibility
NEBA Health used ISO 10993-1:2018 and the FDA guidance "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" to plan biological evaluation and select tests to evaluate the biological response of the CEEG2R device. NEBA Health captured the biological analysis in a document named, "CEEG2 Regulatory (CEEG2R) Mobile Headset -Materials Specification and Biocompatibility Assessment."
NEBA Health used ISO 14971:2007 to determine Risks associated with materials used in the device and their biological hazards. Each material identified as needing a biological review was evaluated. Certain materials required cytotoxicity testing.
Clinical testing
Clinical testing was not performed to demonstrate substantial equivalence.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).