(87 days)
Not Found
No
The summary describes a device for capturing and transmitting EEG signals for review by a medical professional. It explicitly states that the device and software "do not provide any diagnostic conclusion or automated alerts of any clinical event." There is no mention of AI, ML, or any form of automated analysis of the EEG data.
No.
The device is intended to capture, amplify, and transmit electrical brain activity for review, which is a diagnostic function, not a therapeutic one. It explicitly states that it "do[es] not provide any diagnostic conclusion or automated alerts of any clinical event about a patient's condition," which further clarifies its role as a data collection tool rather than an intervention.
No.
The "Intended Use / Indications for Use" explicitly states, "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."
No
The device description explicitly states that the NEBA® Compact EEG2R Mobile Headset has both hardware and software components, including an EEG electrode system, a built-in wireless EEG amplifier, a battery, a wireless battery charger, a wireless communication transmitter, and an amplifier printed circuit board (PCB).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for capturing, amplifying, and wirelessly transmitting electrical brain activity (EEG) for review by a trained medical professional. It explicitly states that the device "do not provide any diagnostic conclusion or automated alerts of any clinical event about a patient's condition."
- Device Description: The description focuses on the hardware and software for acquiring and transmitting electrophysiological signals from the scalp. It describes the electrode placement system, amplifier, and wireless communication.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device interacts directly with the patient's scalp to measure electrical activity in vivo (within the body).
The device is an EEG (Electroencephalography) system, which is a type of medical device used to measure electrical activity in the brain. While the information gathered from an EEG can be used by a medical professional to aid in diagnosis, the device itself is not performing an in vitro diagnostic test.
N/A
Intended Use / 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, 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.
Product codes
OMC, GXY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
electrical brain activity, head, scalp
Indicated Patient Age Range
individuals six years of age and older.
Intended User / Care Setting
trained medical professional, clinical settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Clinical testing was not performed to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
rechargeable) | 2 AA (LR6) alkaline
batteries (not
rechargeable) | The NEBA CEEG 2R
mobile Headset has a
built-in 3.7v Lithium
ion battery which is
charged using a Qi-
compliant wireless
power receiver. | The NEBA Headset
use a lithium battery
like the REMI device.
Like both devices the
NEBA Headset does
not connect to mains
power for charging.
The NEBA Headset
has no user accessible
charging port or
interface and charges
wirelessly. The
differences do not
raise issues of safety
and effectiveness. |
| data format | Lay-Dat (Persyst) | Nihon Kohden original
format | European Data
Format (EDF) NEBA
file format 2.4 | The data format does
not raise questions of
safety and
effectiveness. |
| compatibility | Epilog Disposable
works only with REMI
App software and
tablet | Works only with
Nihon Kohden
specified EEG's: EEG-
1200A series
(KO80546) EEG-9100
(KO 11204) | The NEBA CEEG 2R
mobile Headset works
only with NEBA
software | Same. |
| software | Epilog Disposable uses
integrated firmware
only for transmitting
EEC to REMI App
software and tablet | AE-120A EEG Head Set
comes with EEG
software to be placed
on the compatible
EEG for interaction
with and viewing of
EEG data | The NEBA headset
uses integrated
firmware only for
transmitting EEG to
NEBA software and
computer accessory | Same. |
| connector | Epilog Disposable uses
a USB protocol on a
non-standard
connector for
programming only | Single connector of
electrodes to AE-120A
Head Set | The CEEG 2R mobile
Headset is wireless.
There is no patient or
operator accessible
connector for the
NEBA CEEG 2R mobile
headset. | Improved. The NEBA
Headset presents no
external connector
and no user accessible
connectors. |
| Attribute | REMI | NKC | NEBA CEEG 2R | Discussion |
| | | | mobile Headset | |
| | K203827 | K183529 | K223628 | |
| sizes and dimensions | Epilog comes in one
size:
27 mm x 27 mm x 7
mm | AE-120A EEG Head Set
has flexible arms that
are adjusted to fit
different adult patient
head sizes along with
adjustments from the
belts/ straps (chin). | Width, height, and
anatomically
conforming curvature
of The CEEG2 Headset
were selected for
compatibility over a
head size range that
spans two standard
deviations below an
age six mean head
size to two standard
deviations above an
adult mean head size.
The Support
Subassemblies
measure, inside view,
approximately 107
mm in width and 70 | Same. Like the Nihon
Kohden headset, the
NEBA Headset is
adjustable to
accommodate a range
or head sizes. |
| conductive gel | Conductive electrolyte
is in the form of a
hydrogel converted in
a one-piece adhesive
sticker as an accessory
to Epilog-Disposable.
The sticker is
replaceable and
onetime use | Conductive electrolyte
paste is included in a
packet gel reservoir
integrated into each
electrode. User
inserts electrode into
the electrode
attachment position
in Head Set with paste | mm in height.
Conductive electrolyte
gel is integrated into
each electrode. | Same. The NEBA
Headset uses
electrodes with
integrated conductive
gel like the Nihon
Khoden Device. |
| Biocompatibility | Biocompatibility of
patient contacting
components verified
with Irritation,
Sensitization, and
Cytotoxicity testing
per ISO 10993- 5:2009
and ISO 10993-
10:2010 | Biocompatibility of
patient contacting
components verified
with Cytotoxicity,
Sensitization, and
Irritation per ISO
10993-S and ISO-
10993-10 | Biocompatibility of
patient contacting
components verified
with Cytotoxicity,
Sensitization, and
Irritation per ISO
10993-S and ISO-
10993-10 | ISO 10993-1:2009 was
used to evaluate the
materials. ISO 10993-
5:2009 was used to
test for Cytotoxicity.
Material risk analysis
indicated materials
did not put patient or
operator at risk.
Sensitization, and
Irritation were ruled
out. |
7
8
9
10
Performance data
Table 5b summarizes the efforts to validate and verify the performance of the CEEG2R device.
11
| Description | Industry Standard | FDA
Recognition
Number | Testing Lab | Complete
Date |
|----------------------------------------------------------------------------------|-------------------------------------------------------------------|------------------------------|---------------------------------------|------------------|
| CEEG2 Headset
Assembly Verification | IEC 60601-1-6:2006 | N/A | Evergreen
Research Inc | 02/25/2020 |
| CEEG2 Headset
Assembly Verification | IEC 60601-1:2005/A1:2012
IEC 60601-2-26:2012
ISO 14971:2007 | N/A
N/A
5-40 | MECA /
Evergreen
Research Inc | 10/28/2020 |
| CEEG2 Headset
Assembly Verification | N/A | N/A | Evergreen
Research Inc | 11/03/2021 |
| CEEG2R Mobile
Software Verification | IEC 60601-1-6:2006 | N/A | Evergreen
Research Inc | 03/02/2020 |
| CEEG2R Mobile
Software Verification | N/A | N/A | Evergreen
Research Inc | 05/05/2020 |
| CEEG2R Mobile
Software Verification | IEC 60601-1-
8:2006/A1:2012
IEC 62304:2006/A1:2016 | 5-76
13-79 | MECA /
Evergreen
Research Inc | 10/21/2020 |
| CEEG2R
Electromagnetic
Disturbance | IEC 60601-1-2:2015 | N/A | CCIC Southern
Testing Co.,
Ltd. | 11/20/2020 |
| CEEG2R Wireless
Headset Emission and
Exposure 47 CFFR
Part 15 Subpart B | ANSI C63.4:2014 | N/A | CCIC Southern
Testing Co.,
Ltd. | 11/20/2020 |
| CEEG2R Wireless
Charger RF Exposure | KDB 680106 D01 V03 | N/A | Waltek Testing
Group | 08/19/2021 |
| CEEG2R Wireless
Charger 47 CFR Part
15 Subpart C | ANSI C63.10-2013 | N/A | Waltek Testing
Group | 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.
12
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.