(90 days)
No
The summary explicitly states that the device and its software "do not provide any diagnostic conclusion or automated alerts of an adverse clinical event about a patient's condition." The device's function is described as amplifying, capturing, and transmitting raw EEG data for review by a trained professional, which does not indicate AI/ML processing.
No.
The device is intended to amplify, capture, and wirelessly transmit electrical activity of the brain for review by a trained medical professional to assist in the diagnosis of neurological disorders. It does not provide any therapy or treatment.
No
The device is intended to amplify, capture, and wirelessly transmit electrical activity of the brain for review by a trained medical professional using previously cleared and validated systems to assist in the diagnosis of neurological disorders. However, the text explicitly states, "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." This indicates it is not a diagnostic device itself, but rather a data acquisition component for a larger diagnostic system.
No
The device description clearly states it is a "battery powered (2 AA, LR6 alkaline disposable) wireless EEG head set" which acquires and transmits electrical activity. This indicates a significant hardware component beyond just software.
Based on the provided information, the AE-120A EEG Head Set is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- AE-120A Function: The AE-120A EEG Head Set directly measures electrical activity from the patient's scalp (in vivo), not from a specimen taken from the patient. It amplifies, captures, and transmits these signals for review by a medical professional.
- Intended Use: The intended use clearly states it's for amplifying, capturing, and wirelessly transmitting electrical activity of the brain for review by a trained medical professional to assist in the diagnosis of neurological disorders. This is a direct measurement of physiological activity, not an analysis of a biological specimen.
Therefore, the AE-120A EEG Head Set falls under the category of a medical device that performs in vivo measurements, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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)
Product codes (comma separated list FDA assigned to the subject device)
OMC, GXY
Device Description
The Nihon Kohden AE-120A EEG Head Set is a battery powered (2 AA, LR6 alkaline disposable) wireless EEG head set which facilitates the placement of disposable EEG electrodes on the patient's scalp. The AE-120A EEG Head Set with the electrodes is then attached to the patient's head using the head set's chin, top, and rear straps.
With the head set turned on and secured in place, the head set acquires and amplifies electrical activity via EEG electrodes placed in contact with the patient's scalp. The captured waveforms from these signals are transmitted wirelessly via Bluetooth to a Nihon Kohden specified electroencephalograph through the AE-120A EEG Head Set and receiver.
The head set outputs the collected brain electrical activity to the computer component of the electroencephalograph system where a medical professional can review and interpret the information.
The AE-120A EEG Head Set has 8 channels for measurement along with one reference and one Z electrode. The electrodes are fixed into position with the head set to approximate the 10-20 electrode positions.
The AE-120A EEG Head Set is designed to work with the Nihon Kohden EEG-1200A series and EEG-9100, cleared in K080546 and K011204, respectively. The associated system software is used to facilitate the communication and display of the information from the head set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's scalp (brain electrical activity)
Indicated Patient Age Range
adults (ages 18 and above)
Intended User / Care Setting
trained medical professionals in a medical facility such as a physician's office, laboratory, or clinic.
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)
Electrode Performance Testing:
This study verified the performance of the NE-091S7 electrodes using the standard ANSI/AAMI EC12:2000.
Sample size: Twelve (12) electrode pairs.
Key Results: The NE-091S7 met all pre-specified acceptance criteria demonstrating the acceptable performance of the electrodes related to electrode pair impedance characteristics (164.72-188.2Ω), electrode pair voltage (-0.7 mV to 0.1 mV), and offset variation and internal noise (13.1μV to 43.6μV).
BIOCOMPATIBILITY:
The evaluation of each patient-contacting accessory and component involved the testing of the finished device testing and where applicable, use in previously cleared devices.
Key Results: This biocompatibility evaluation established the biological safety for all patient contacting device components and accessories of the AE-120A EEG Head Set System by applying the pre-specified acceptance criteria to each test article.
SOFTWARE:
The software in the AE-120A EEG Head Set System including both the firmware on the physical headset device and the associated application to be used on the EEG computer monitor, separate from the headset, has been verified and validated.
ELECTRICAL SAFETY & EMC:
The AE-120A EEG Head Set was tested and demonstrated to conform to several electrical safety and electromagnetic compatibility standards (listed individually in the document). The sponsor also performed wireless coexistence testing on the headset.
Key Results: The device was demonstrated to conform to the listed electrical safety and electromagnetic compatibility standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health and Human Services logo. To the right of that is the FDA U.S. Food & Drug Administration logo.
March 19, 2019
Nihon Kohden Corporation % Natalie Kennel Quality & Regulatory Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, California 92129
Re: K183529
Trade/Device Name: AE-120A EEG Head Set Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC, GXY Dated: December 17, 2018 Received: December 19, 2018
Dear Natalie Kennel:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183529
Device Name AE-120A EEG Head Set
Indications for Use (Describe)
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 facility such as a physician's office, laboratory, or clinic. The device is intended for use on adults (ages 18 and above).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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
K183529 Traditional 510(k) Summary
| Submitter | Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuku-Ku
Tokyo, Japan 161-8560
(949) 680-9048 (Thomas Bento) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Natalie Kennel
Consultant
NJK & Associates, Inc.
13721 Via Tres Vista
San Diego, CA 92129
Phone: (858) 705-0350
Fax: (858) 764-9739
Email: nkennel@njkconsulting.com |
| Date Prepared | March 19, 2019 |
| Subject Device | |
| Device Name | AE-120A EEG Head Set |
| Common Name | Electroencephalograph (EEG) |
| Device Class | Class II |
| Product Code & Regulation | OMC (Primary); Reduced- Montage Standard Electroencephalograph
21 CFR 882.1400; Class II; Electroencephalograph
GXY (Secondary); Cutaneous Electrode
21 CFR 882.1320; Class II; Cutaneous Electrode |
| Review Panel | Neurology: Diagnostic Devices |
Intended Use
The AE-120A EEG Head Set is intended to amplify, capture, and wirelessly transmit electrical activity of the brain for review by a medical professional using the following Nihon Kohden specified electroencephalograph system to assist in the diagnosis of neurological disorders, as the subject device's components, accessories, and software operate as a system with the following devices that have been previously cleared: K011204 -- Neurofax Models EEG-9100 K080546 – EEG-1200A series
4
The above EEG systems are compatible with the subject device they have been updated or can be updated to include newly developed EEG Software needed to operate with the subject device headset.
Device Description for the Subject Device: AE-120A EEG Head Set
The Nihon Kohden AE-120A EEG Head Set is a battery powered (2 AA, LR6 alkaline disposable) wireless EEG head set which facilitates the placement of disposable EEG electrodes on the patient's scalp. The AE-120A EEG Head Set with the electrodes is then attached to the patient's head using the head set's chin, top, and rear straps.
With the head set turned on and secured in place, the head set acquires and amplifies electrical activity via EEG electrodes placed in contact with the patient's scalp. The captured waveforms from these signals are transmitted wirelessly via Bluetooth to a Nihon Kohden specified electroencephalograph through the AE-120A EEG Head Set and receiver.
The head set outputs the collected brain electrical activity to the computer component of the electroencephalograph system where a medical professional can review and interpret the information.
The AE-120A EEG Head Set has 8 channels for measurement along with one reference and one Z electrode. The electrodes are fixed into position with the head set to approximate the 10-20 electrode positions.
The AE-120A EEG Head Set is designed to work with the Nihon Kohden EEG-1200A series and EEG-9100, cleared in K080546 and K011204, respectively. The associated system software is used to facilitate the communication and display of the information from the head set.
Indications for Use
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 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)
Predicate Devices
The AE-120A EEG Head Set is substantially equivalent to the Ceribell Pocket EEG with the Ceribell Instant EEG Headband. Table 1, below, lists the primary predicate device, K170363 (headbox, processing unit, basic software needed to display, store, and archive EEG and allow user-only annotation and marking; does NOT include electrodes, more complex software used to
5
analyze EEG or automatically detect events). The secondary predicate device, K171459, is intended to cover the cutaneous electrode component of system, which is necessary to achieve the intended use and does not change the intended use as compared to the primary predicate EEG device, K170363.
Table 1 – List of Predicate Devices to which AE-120A EEG Head Set K183529 Claims Substantial Equivalence; Lower 2 Rows Include Reference Devices for Wireless EEG Data Transmission Characteristics of the Subject Device
| Purpose | 510(k)
Number | Regulation Name | Device Name | Submitter |
|-----------------------------------------------------------------|------------------|----------------------------------------------------------------------|----------------------------------|------------------------------|
| Reduced
Montage
Standard
EEG
(Primary
Predicate) | K170363 | Reduced- Montage
Standard
Electroencephalograph | Ceribell Pocket EEG
Device | Ceribell, Inc |
| Electrode
Component
(Secondary
Predicate) | K171459 | Cutaneous Electrode | Ceribell Instant EEG
Headband | Ceribell, Inc |
| Reference
Devices (Not
Intended as
Predicates) | K131944 | Reduced- Montage
Standard
Electroencephalograph | iEEG | Jordan
NeuroScience, Inc. |
| Devices (Not
Intended as
Predicates) | K082886 | Non-Normalizing
Quantitative
Electroencephalograph
Software | BrainScope Z-100 | BrainScope
Company Inc. |
6
Technological Characteristics as Compared to Predicate Devices
Table 2, belov, includes a comparison of the AE-120A EEG Head Set and its predicates K170363 Ceribell Pocket EEG & K171459 Ceribell Instant EEG Headband. Where is also a comparison to two legally marketed reference devices to support the scientific methodology of wireless transmission of EEG data transfer at decision point 5a of the 510(k) flowchart ("Are the methods acceptable?") to help determine substantial equivalence for the subject device.
| Characteristic | AE-120A EEG Head Set
K183529 | Ceribell Pocket EEG Device
K170363 and Ceribell Instant
EEG Headband K171459 | Comment |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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 Nihon Kohden
electroencephalograph systems cleared
in K080546 and K011204 to assist in the
diagnosis of neurological disorders. | K171459: A single-use disposable
headpiece with an integrated array of 10
passive cutaneous electrodes, that are
applied to the patient's head to record EEG
signals when connected to an EEG
recording device.
K170363: Device intended to record and
store EEG signals, and to present EEG
signals to medical staff. | Similar intended use. The combination of
the 2 Ceribell devices together provide the
same intended use. The combination of
the subject device and a Nihon Kohden
specific EEG system provides the same
intended use: assisting in the diagnosis of
neurological disorders by amplifying,
capturing, and sending electrical activity
of the brain and patient data for review by
a medical professional. |
| | AE-120A EEG Head Set
K183529 | Ceribell Pocket EEG Device
K170363 and Ceribell Instant
EEG Headband K171459 | Comment |
| Characteristic | | | |
| Indications for Use | 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 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) | The Ceribell Pocket EEG
Device is intended to
record and store EEG
signals, and to present the
EEG signals in visual and
audible formats in real
time. The visual and
audible signals assist
trained medical staff to
make neurological
diagnoses.
The Pocket EEG Device
does not provide any
diagnostic conclusion
about the subject's
condition and does not
provide
any automated alerts of
an adverse clinical event.
The Pocket EEG Device
is intended to be used in a
professional
healthcare facility
environment. (Rx only)
The Ceribell Instant EEG
Headband is an
electroencephalogram
| Similar; The combination of the 2 Ceribell
devices provides the same intended use. The
combination of the subject device and a Nihon
Kohden specific EEG system provides the
same intended use: assisting in the diagnosis of
neurological disorders by amplifying,
capturing, and sending electrical activity of the
brain and patient data for review by a medical
professional. (Rx only) |
| Device Class &
Regulation | 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 (EEG Device)
Class II per 21 CFR 882.1320 (Instant EEG
Headband - cutaneous electrodes) | Same |
| Product Code(s) | Primary Proposed: OMC
Secondary Proposed: GXY | K170363 cleared under: OMC
K171459 cleared under: GXY | Same |
| Modalities | EEG | EEG | Same |
| Type of patient
contact | Electrodes and gel contact patient's scalp | Electrodes and gel contact patient's scalp | Same |
| Characteristic | AE-120A EEG Head Set
K183529 | Ceribell Pocket EEG Device
K170363 and Ceribell Instant
EEG Headband K171459 | Comment |
| Electrodes | 10 passive Ag/AgCl electrodes | 10 passive Ag/AgCl electrodes | Same
Subject device EEG disk electrode of Ag
cleared in K171124 but with different
length of lead. |
| Type of use -
Electrodes | Single use, non-sterile, disposable | Single use, non-sterile, disposable | Same |
| Type of use - EEG
device | AE-120A EEG Head set is reusable and
non-patient contacting.
Belts are patient contacting and reusable
(they can be cleaned & disinfected but
are recommended for single patient use) | Ceribell Pocket EEG Device is reusable and
non-patient contacting.
Ceribell Instant EEG headband is single use,
patient contacting and disposable. | Subject device is reusable whereas
predicate is single use disposable.
However, this difference does not raise
different questions of safety and
effectiveness. |
| EEG channels | 8 | 8 | Same |
| Montage | 10/20 System1 | 10/202 | Same |
| Electrical Safety &
EMC | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-2-26 | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-2-26
IEC 62133 | Same:
Refer to performance testing section of
this Summary for details on the standards
to which the subject device claims
conformance and other performance
testing. Note: IEC 62133 does not apply
to AE-120A because the subject device is
powered by alkaline batteries. |
| Characteristic | AE-120A EEG Head Set
K183529 | Ceribell Pocket EEG Device
K170363 and Ceribell Instant
EEG Headband K171459 | Comment |
| Input dynamic range | 1 mVp-p | Unknown (presumed to be same as it meets
IEC 60601-2-26) | Similar;
AE-120A complies with the requirement
of the input dynamic range specified in
clause 201.12.1.101.2, IEC 60601-2-26 |
| Input noise | 5 µ Vp-p or less (0.53 to 60 Hz) | Unknown (presumed to be same as it meets
IEC 60601-2-26) | Similar
AE-120A complies with the requirement
of the input noise specified in clause
201.12.1.101.3, IEC 60601-2-26 |
| Transfer of data to
EEG | Bluetooth 2.4 GHz | Micro-USB cable | Whereas the subject device transmits the
data wirelessly in real time via Bluetooth
to the compatible EEG system, the
Ceribell Pocket EEG Device transmits the
data via a cable after collection.
The following two legally marketed
reference devices are cited to support this
scientific methodology of wireless
transmission of EEG data transfer as
acceptable for the intended use. The
reference devices are: iEEG (K131944)
and BrainScope Z-100 (K082886). |
| Power source | Battery powered | Battery powered | Same |
| Type of battery | 2 AA (LR6) alkaline batteries
(not rechargeable) | Lithium ion batteries -rechargeable with
100-240 V AC power adapter (Device does
not work when connected to AC to
recharge) | Similar;
The differences do not raise any different
questions of safety or effectiveness |
| Data format | Nihon Kohden original format | Edf | Similar;
Since the AE-120A EEG Head Set
provides the data to only Nihon Kohden
specified EEG's, this difference does not
raise any different questions of safety or
effectiveness. |
| Characteristic | AE-120A EEG Head Set
K183529 | Ceribell Pocket EEG Device
K170363 and Ceribell Instant
EEG Headband K171459 | Comment |
| Compatibility | Works only with Nihon Kohden
specified EEG's:
EEG-1200A series (K080546)
EEG-9100 (K011204) | Ceribell Instant EEG Headband works only
with Ceribell Pocket EEG Device | Similar;
Both subject and predicate device are
intended to be connected to external EEG
recording devices. The differences in EEG
recording compatibility does not raise any
different questions of safety or
effectiveness |
| EEG Software | AE-120A EEG Head Set comes with
EEG software to be placed on the
compatible EEG for interaction with and
viewing of EEG data | Ceribell Pocket EEG Device comes with
EEG Recording Viewer Software | Similar.
Both devices come with software for
viewing the EEG data collected with the
device. The AE-120A EEG Head Set
software for the associated Nihon Kohden
EEG allows the user to interact with the
head set and review and interpret the data
on the EEG. |
| Connector | Single connector of electrodes to AE-
120A Head Set | Integrated single cable connector in Ceribell
Instant EEG Headband to connect to EEG
recording device | Same |
| Able to accommodate
different patient head
sizes | 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) | Ceribell Instant EEG Headband comes in
three sizes
Small (48.4 - 53.6 cm)
Medium (53.3 -56.5 cm)
Large (55.5 - 62 cm) | Similar;
Both subject and predicate devices can
accommodate different patient sizes. AE-
120A is limited to adults only to be sure
that its flexibility is adequate for the range
of head sets |
| Conductive
Electrolyte Material | 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. | Conductive electrolyte gel is included in a
packet gel reservoir integrated into each
electrode assembly. User is also able to add
additional electrolyte gel when needed using
a syringe | Same |
| Characteristic | AE-120A EEG Head Set
K183529 | Ceribell Pocket EEG Device
K170363 and Ceribell Instant
EEG Headband K171459 | Comment |
| Biocompatibility | Patient contacting components verified
with Cytotoxicity, Sensitization, and
Irritation per ISO 10993-5and ISO
10993-10 (or previous clearance or
previous use of material/processing for
same patient contact and duration).
These components include: electrodes,
electrode gel, paste | Patient contacting components verified with
Cytotoxicity, Sensitization, and Irritation
per ISO 10993-5and ISO 10993-10 | Similar;
All patient contacting components
evaluated according to ISO 10993-1 and
associated FDA guidance |
| Additional electrodes | Two additional optional electrode sets
can be used (NE-090S1 and NE-091S7) | N/A | The subject device includes two
additional electrodes that can be added to
the headset's occipital region; these have
been tested for performance since they
were not previously cleared under 21 CFR
882.1400 like the other electrodes; this
difference does not raise different
questions of safety or effectiveness;
This electrode is the same as NM-317Y3
cleared in K120397 (882.1870 Evoked
response electrical stimulator) but is not
used for the purpose of evoked
stimulation; it is only used for recording. |
Table 2 - Comparison of the AE-120A EEG Head Set to Predicates K170363 & K171459
7
8
1 AE-120A EEG Head Set approximates the 10/20 montage but may deviate slightly depending on the patient's head shape
² Ceribell Pocket EEG Device and Ceribell Instant EEG Headband also approximates a 10/20 montage
9
10
11
Table 3 – Comparison to Reference Devices
| Characteristic | AE-120A EEG Head
Set K183529 | Reference Device #1
iEEG K131944 | Reference Device #2
BrainScope Z-100
K082886 | Comment |
|-----------------|---------------------------------|-------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Modalities | EEG | EEG | EEG | Same |
| EEG Channels | 8 | 8 | 8 | Same |
| Montage | 10/20 system | 10/20 system | 10/20 system | Same |
| Wireless Output | Bluetooth 2.4 GHz | Bluetooth 2.4 GHz | Bluetooth 2.4 GHz | Same |
| Sampling Rate | 200 Hz | 250 Hz | 200 Hz | Subject device same as
second reference device.
Both meet the minimum of
200Hz recommended by
ECRI 2017 |
12
| Characteristic | AE-120A EEG Head
Set K183529 | Reference Device #1
iEEG K131944 | Reference Device #2
BrainScope Z-100
K082886 | Comment |
|------------------------------------------|---------------------------------|-------------------------------------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ADC Resolution | 12 bit | 16 bit | 16 bit | Subject device is lower than
reference devices but 12 bit
still provides more than 4000
levels of resolution & meets
the minimum of 12 bit
according to ECRI 2017
review. |
| ADC Common Mode
Rejection Rate (CMRR) | > 90 dB | > 115 dB | > 100 dB | Substantially equivalent to
the predicates. Subject
device is slightly lower but
complies with the
requirement of the input
noise specified in clause
201.12.1.101.5, IEC
60601-2-26 |
| Input Impedance | 1200 Mohms | 10 Mohms | 10 Mohms | Subject device is improved
compared to the predicates |
| Electrode impedance check | Yes | Yes | Yes | Same |
13
PERFORMANCE TESTING
Electrode Performance Testing
- ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes for NE-091S7 electrodes
This study verified the performance of the NE-091S7 electrodes using the standard ANSI/AAMI EC12:2000 because portions of this test protocol are appropriate and suitable for the subject device since they are also disposable electrodes. Only clauses 5.2.2.1 (electrode impedance), 5.2.2.2 (Electrode DC Offset Voltage), and 5.2.2.3 (Combined Offset Instability and Internal Noise) were applicable as this standard is primarily intended for electrodes for Electro-cardiographs (ECG), not EEG. Thus, some aspects of the standard cannot be applied due to the difference in anatomical region and difference in the intended use of the subject device. Twelve (12) electrode pairs were tested. The NE-091S7 met all pre-specified acceptance criteria demonstrating the acceptable performance of the electrodes related to electrode pair impedance characteristics (164.72-188.2Ω), electrode pair voltage (-0.7 mV to 0.1 mV), and offset variation and internal noise (13.1μV to 43.6μV).
NE-118A EEG disk electrodes were previously cleared in K171124, a 510(k) held by the sponsor of the subject device 510(k) and these electrodes identical materials but are of different length lead.
BIOCOMPATIBILITY
The patient-contacting components of the subject device fall within category A - limited (