Who is the manufacturer of NEBA® Compact EEG2R Mobile Headset?

Neba Health, LLC filed the 510(k) submission for NEBA® Compact EEG2R Mobile Headset (K223628).

What is the FDA product code for NEBA® Compact EEG2R Mobile Headset?

OMC. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for NEBA® Compact EEG2R Mobile Headset?

510(k) clearance (submission type: Traditional).

What are the predicate devices for NEBA® Compact EEG2R Mobile Headset?

REMI (K203827); AE-120A EEG Headset (K183529).

Who can help prepare an FDA 510(k) submission like NEBA® Compact EEG2R Mobile Headset?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NEBA® Compact EEG2R Mobile Headset

K223628 · Neba Health, LLC · OMC · Mar 2, 2023 · Neurology

Device Facts

Record ID	K223628
Device Name	NEBA® Compact EEG2R Mobile Headset
Applicant	Neba Health, LLC
Product Code	OMC · Neurology
Decision Date	Mar 2, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2
Attributes	Pediatric

Indications for 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 (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).

Device Story

Battery-powered wireless EEG headset; captures electrical brain activity via 6 disposable Ag/AgCl electrodes; uses Bluetooth LE to transmit signals to a computer running CEEG2R recording software. Headset features flexible platform and adjustable arms for 10-20 International Electrode Placement System positioning. Used in clinical settings by trained medical professionals; provides raw EEG data for review. No diagnostic or automated alert capabilities. Benefits include simplified electrode placement and wireless signal transmission for professional monitoring. Device is reusable; electrodes are single-use.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), EEG-specific safety (IEC 60601-2-26), wireless emissions/exposure (47 CFR Part 15), and biocompatibility (ISO 10993-5).

Technological Characteristics

Battery-powered (3.7V Li-ion) wireless EEG headset; Qi-compliant wireless charging. Materials: polyurethane and polyester. Sensing: 6 passive Ag/AgCl electrodes (ANSI/AAMI EC12). Connectivity: Bluetooth LE. Software: Integrated firmware for signal transmission; CEEG2R recording software for monitoring. Biocompatibility per ISO 10993-1/5/10.

Indications for Use

Indicated for individuals 6 years of age and older in clinical settings to capture, amplify, and wirelessly transmit electrical brain activity for review by a trained medical professional. Not indicated for diagnostic conclusions or automated clinical alerts.

Regulatory Classification

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.

Predicate Devices

REMI (K203827)
AE-120A EEG Headset (K183529)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | | |----------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K223628 – Traditional 510(k) Summary | Submitter: | NEBA Health, LLC 2052B Gordon Highway Augusta, GA 30909 NEBA Health, LLC. Phone: (706) 736-5864 Fax: (706) 650-2160 | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person: | E. Howard Merry, President NEBA Health hmerry@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 montage electroencephalograph 21 CFR 882.1400; Electroencephalograph, Class II. GXY (Secondary); Cutaneous Electrode 21 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 | {4}------------------------------------------------ #### 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 {5}------------------------------------------------ (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. {6}------------------------------------------------ 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 2R mobile Headset | Discussion | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | classification regulation | K203827 | K183529 | K223628 | Same. | | | Class II per 21 CFR 882.1400 Electroencephalograph (Head Set) | Class II per 21 CFR 882.1400 Electroencephalograph (Head Set) Class II per 21 CFR 882.1320 (for electrodes within headset) | Class II per 21 CFR 882.1400 Electroencephalograph (Head Set) Class II per 21 CFR 882.1320 (for electrodes within headset) | | | Product code | OMC / GXY | OMC/GXY | OMC/GXY | Same. | | IFU | the REMI Platform is intended to be used in healthcare settings where near real-time and/or remote EEG is warranted. REMI consists of epilog disposable Sensors a single use, single patient, disposable, wearable sensor intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for up to 48 hours. The REMI-Mobile software and REMI- Tablet are intended to receive and transmit data from four Epilog Sensors to secure cloud storage for subsequent viewing and reviewing of EEG on third-party software. REMI does not make any | The AE-120A EEG Head Set is intended to amplify, capture, and wirelessly transmit electrical activity of the brain for review by a trained medical professional using the previously cleared and validated Nihon Kohden electroencephalograph systems (EEG-1200A series and EEG-9100) to assist in the diagnosis of neurological disorders. The AE- 120A EEG Head Set and its associated EEG Software do not provide any diagnostic conclusion or automated alerts of an adverse clinical event about a patient's condition. The device is intended for use by trained medical professionals | The NEBA® Compact EEG 2R Mobile Headset (NEBA 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 | The NEBA Headset and the predicate devices are all reduced montage EEGs with the intended use to amplify, record and wirelessly transmit EEG data to accessories running software for monitoring and reviewing EEG data. All 3 devices are for prescription use only by professionals. All devices have similar intended use environments. The primary predicate, the REMI device and the NEBA Headset have the same population age range. The Nihon Kohden device and the NEBA headset have in common an EEG positioning system. | | Attribute | REMI | NKC | NEBA CEEG 2R mobile Headset | Discussion | | | | | | | | | K203827 | K183529 | K223628 | | | | diagnosis or recommendations and is intended only as a physiological signal monitor. Epilog Sensors are intended for use by trained medical professionals in a professional healthcare facility environment. Epilog Sensors are intended for use with adult and pediatric patients (6+). (Rx only). | in a medical facility such as a physician's office, laboratory, or clinic. The device is intended for use on adults (ages 18 and above). (Rx Only). | conclusion or automated alerts of a 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). | | | Physiological signal acquired | EEG | EEG | EEG | Same. | | Type of patient contact | Contacts patient scalp | contacts patient scalp | Contacts patient scalp | Same. | | electrodes | 2 passive gold electrodes using a conductive hydrogel | 10 passive Ag/AgCl electrodes | 6 passive Ag/AgCl electrodes | The electrodes for the Nihon Kohden device and the NEBA Headset are the same. The disposable electrode for the NEBA Headset is 510(k) approved and ANSI/AAMI EC12 compliant and is manufactured by a | | Attribute | REMI | NKC | NEBA CEEG 2R mobile Headset | Discussion | | | K203827 | K183529 | K223628 | NEBA approved vendor. | | type of use | Epilog Disposable is single use, non-sterile, disposable | Electrodes: Single use, non-sterile, disposable. EEG Device: AE-120A EEG Head set is reusable and nonpatient contacting. Belts are patient contacting and reusable. | Electrodes: Single use, non-sterile, disposable. The NEBA Headset is reusable and comprises both patient and non- patient contacting parts. The headset is reusable and designed for cleaning between uses. | The intended use of the Nihon Kohden device and the NEBA device are similar and differences do not raise questions of safety and effectiveness. | | Channel # | 0-10 | 8 | 1 | Same. The NEBA Headset total EEG channel number is within the range established by the predicates. | | Montage | 10/20 system - Epilog- Disposable can be placed anywhere in the 10/20 system where each channel represents a bipolar derivation approximation of the 10/20 system | 10/20 System - AE- 120A EEG Head Set approximates the 10/20 montage but may deviate slightly depending on the patient's head shape. | 10/20 System - the NEBA Headset is intended to facilitate the placement of electrodes per the 10/20 montage | Same. | | Electrical safety and EMC | 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 difference between the predicate devices and the CEEG2R device for the Input Dynamic Range is negligible when compared to EEG signals in the low micro-volt range and does not affect safety and effectiveness. | | Attribute | REMI | NKC | NEBA CEEG 2R mobile Headset | Discussion | | | K203827 | K183529 | K223628 | | | input noise | 5 µVp-p | 5 µVp-p or less (0.53 to 60 Hz) | ± 4 µV maximum peak-peak 0.5 Hz through 50 Hz a noise limit | Same. | | data transfer | Bluetooth 2.4 GHz | Bluetooth 2.4 GHz | Bluetooth LE 2.4 GHz | Same. | | power source | CR2016 primary lithium (not rechar…

NEBA® Compact EEG2R Mobile Headset

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Identification

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Submission Summary (Full Text)

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NEBA® Compact EEG2R Mobile Headset

Device Facts

Indications for Use

Device Story

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Indications for Use

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Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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