No
The summary describes a system for acquiring, transmitting, and storing EEG data for subsequent review by trained professionals using separate software. There is no mention of the device itself performing any analysis, interpretation, or decision-making based on the EEG data using AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is described as a "physiological signal monitor" that "does not make any diagnosis or recommendations." It is intended to capture and transmit EEG data for viewing and reviewing on third-party software, not to provide therapy.
No
The “Intended Use / Indications for Use” section explicitly states, "REMI does not make any diagnosis or recommendations and is intended only as a physiological signal monitor."
No
The device description explicitly lists "Epilog-D disposable EEG sensors" as a major component, which are hardware devices intended to amplify, capture, and wirelessly transmit electrical activity. The summary also mentions the REMI-Tablet, which is a hardware device running the software.
Based on the provided information, the REMI Platform is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- REMI's Function: The REMI Platform is described as a physiological signal monitor that amplifies, captures, and transmits electrical activity of the brain (EEG) from the patient's scalp. It does not analyze or test specimens from the body.
- Intended Use: The intended use explicitly states that REMI "does not make any diagnosis or recommendations and is intended only as a physiological signal monitor."
- Anatomical Site: The device is applied to the patient's scalp, which is an external application for measuring electrical signals, not for analyzing bodily fluids or tissues.
Therefore, the REMI Platform falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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 REM-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 diagnosis or recommendations and is intended only as a physiological signal monitor. Epilog Sensors are intended for use by trained medical professional healthcare facility environment.
Epilog Sensors are intended for use with adult and pediatric patients (6+). (Rx only).
Product codes
OMC, GXY
Device Description
REMI amplifies the electroencephalogram (EEG) from a patient's scalp. After amplification, the EEG are sent to the REMI-Tablet running the REMI-Mobile Application. REMI-Mobile combines the EEG from four Epilog Sensors and patient information and relays the data to a cloud server running Persyst software. The EEG data is accessible through the Persyst Mobile interface. REMI is designed for use with adult and pediatric patients (6+). The user interface for the REMI-Tablet is an 10" LCD touchscreen display.
The user interface for Epilog Sensors is a single button kevpad overmolded in each Sensor, REMI-Tablet power is through A/C adapter as well as limited onboard rechargeable battery. Epilog Sensor power is through a single-use primary coin cell. Using its wireless link, the Epilog Sensors can exchange EEG data and commands with the REMI-Mobile application running on the REMI-Tablet.
REMI has three major components:
- Epilog-D disposable EEG sensors,
- REMI-Mobile - mobile OS application designed to run on a medical-grade tablet, acquire EEG data transmitted from Epilog devices along with user-entered patient and device information, and then transmit the EEG data and patient/device information via wireless encrypted WiFi to.
- REMI-Cloud – A HIPAA-compliant cloud storage and data processing platform where data is processed into a format that a FDA-cleared (K171184) EEG reviewing software called Persyst can use, which will allow remote neurological review.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's scalp
Indicated Patient Age Range
adult and pediatric patients (6+)
Intended User / Care Setting
trained medical professional healthcare facility environment.
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 submission does not contain clinical data. REMI was evaluated for electrical safety in accordance with IEC 60601 Medical Electrical Equipment - Part 1: General requirements for safety. The Epilog sensors were also evaluated for electromagnetic compatibility (EMC), including both emissions and immunity. The Epilog sensors were tested according to IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety; Electromagnetic Compatibility - Requirements and Tests to demonstrate the EMC characteristics of the devices. The Epilog sensors were also tested to IEC 60601-2-26 - Particular requirements for the safety of electroencephalographs. The Epilog sensors were also tested to FCC/IC Intentional Radiator per FCC Part 15 Radiated Emissions and Class B Conducted Emissions. Compliance was demonstrated for all tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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March 29, 2021
Epitel, Inc. % John Pappan RA Consultant / Project Management LeanRAQA 12602 North Summerwind Drive Marana, Arizona 85658
Re: K203827
Trade/Device Name: REMI Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC, GXY Dated: December 24, 2020 Received: December 29, 2020
Dear John Pappan:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (08) 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,
Jay R. Gupta -S
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203827
Device Name REMI
Indications for Use (Describe)
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 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 REM-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 diagnosis or recommendations and is intended only as a physiological signal monitor. Epilog Sensors are intended for use by trained medical professional healthcare facility environment.
Epilog Sensors are intended for use with adult and pediatric patients (6+). (Rx only).
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
510(k) Summary
5.1 Applicant/Submitter
| Company Name | : Epitel, Inc. |
|---|---|
| Phone Number | : 801-497-6297 |
| Company Street Address | : 124 S. 400 E. |
| City | : Salt Lake City |
| State | : UT |
| Country | : USA |
| Zip Code | : 84111 |
5.2 Contact Person
| Full Name | : Mark Lehmkuhle |
|---|---|
| Job Title | : CEO/CTO |
| Phone | : 801-497-6297 |
| : lehmkuhle@epitel.com |
5.3 Correspondent Information
| Full Name | : John Pappan |
|---|---|
| Job Title | : RA Consultant / Project Management |
| Phone | : 718-964-3406 |
| : johnp@leanraqa.com |
5.4 Date of Preparation
Date of Preparation
: 02/23/2021
5.5 Device Information
Table - 5.1 Device information
| Trade Name | REMI |
|---|---|
| Common or Usual Name | Electroencephalograph. |
| Classfication Name | 21 CFR 882.1400 |
| Regulatory Class | 2 |
| Product Code | OMC, GXY |
5.6 Predicate Device(s)
Table - 5.2 Predicate Device(s)
4
| Predicate Type | 510(k) Number | Name Of Device | Name Of Manufacturer |
|---|---|---|---|
| Predicate Device | K171459 | Ceribell Instant EEG Headband | Ceribell, Inc. |
| Predicate Device | K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. |
| Predicate Device | K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation |
| Reference Device | K191331 | Life Sensor Cardiac Monitor | BraveHeart Wireless, Inc. |
5.7 Device Description
REMI amplifies the electroencephalogram (EEG) from a patient's scalp. After amplification, the EEG are sent to the REMI-Tablet running the REMI-Mobile Application. REMI-Mobile combines the EEG from four Epilog Sensors and patient information and relays the data to a cloud server running Persyst software. The EEG data is accessible through the Persyst Mobile interface. REMI is designed for use with adult and pediatric patients (6+). The user interface for the REMI-Tablet is an 10" LCD touchscreen display.
The user interface for Epilog Sensors is a single button kevpad overmolded in each Sensor, REMI-Tablet power is through A/C adapter as well as limited onboard rechargeable battery. Epilog Sensor power is through a single-use primary coin cell. Using its wireless link, the Epilog Sensors can exchange EEG data and commands with the REMI-Mobile application running on the REMI-Tablet.
REMI has three major components:
-
Epilog-D disposable EEG sensors,
-
REMI-Mobile - mobile OS application designed to run on a medical-grade tablet, acquire EEG data transmitted from Epilog devices along with user-entered patient and device information, and then transmit the EEG data and patient/device information via wireless encrypted WiFi to.
-
REMI-Cloud – A HIPAA-compliant cloud storage and data processing platform where data is processed into a format that a FDA-cleared (K171184) EEG reviewing software called Persyst can use, which will allow remote neurological review.
5.8 Intended Use/Indications for Use
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 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 of EEG on third-party software.
REMI does not make any 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).
5.9 Comparison of Technological Characteristics with Predicate
REMI is substantially equivalent to the Ceribell Pocket EEG device combined with Ceribell Instant EEG Headband and Nihon Kohden AE-120A EEG headset based on the Comparison Summary in the substantial equivalence discussion.
Epilog Sensors use a one-piece conductive "sticker" that includes a conductive hydrogel converted with an adhesive similar to the BraveHeart Wireless Life Sensor Cardiac Monitor. While the BraveHeart sensor amplifies the electrocardiogram from the chest and REMI amplifies the electroencephalogram from the scalp, both devices are wearable sensors intended to record biopotentials that are similar in frequency and amplitude to justify comparison.
Epitel is of the opinion that the individual and combined system differences do not change the safety and effectiveness of this device with respect to the proposed pathway. Nor do the risks vary significantly from the predicate devices, and similar reference devices on the market; what risks do exist are similar and mitigated
5
through user centric design and a risk management based approach to design controls.
6
Table - 5.3 Comparison Summary
| Attributes | Subject Device
REMI | Predicate Device(s)*
Ceribell Pocket EEG Device
(K170363)
Ceribell Instant EEG Headband
(K171459)
Both K170363 and K171459
together is substantially equivalent
to REMI | Predicate Device
Nihon Kohden
AE-120A EEG Head Set
(K183529) | Reference Device
BraveHeart Wireless
Life Sensor Cardiac Monitor
(K191331) | Comments |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
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) | 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 870.2910
Radiofrequency physiological signal
transmitter and receiver | Same Classification
Regulation to
Ceribell
Pocket EEG Device
and
Nihon Kohden AE-
120A
EEG Head Set |
| Product Code(s) | OMC and GXY | OMC and GXY | OMC | DRG, DRT, DRX | Same Product Codes
to
Ceribell Pocket
EEG
Device and Nihon
Kohden
AE-120A EEG
Head Set |
| Attributes | Subject Device
REMI | Predicate Device(s)
Ceribell Pocket EEG Device
(K170363)
Ceribell Instant EEG Headband
(K171459)
Both K170363 and K171459
together is substantially equivalent
to REMI | Predicate Device
Nihon Kohden
AE-120A EEG Head Set
(K183529) | Reference Device
BraveHeart Wireless
Life Sensor Cardiac Monitor
(K191331) | Comments |
| Indications for Use | 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 diagnosis
or recommendations and is intended
only as a physiological signal
monitor. Epilog Sensors are intended
medical
for use by by
trained
professionals in a professional
healthcare facility environment.
Epilog Sensors are intended for use
with adult and pediatric patients
(6+). (Rx only). | The Ceribell Pocket EEG
(K170363) 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
(K171459) is an
electroencephalogram (EEG)
electrode array intended for
single patient use in the recording of
EEGs in patients of 6 years and
older. The Instant EEG Headband is
intended for prescription use in the
home, healthcare facility or clinical
research environment. (Rx Only). | 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 Life Sensor Cardiac Monitor
(CM) is a wireless monitoring system
intended for use by healthcare
professionals for monitoring of
physiological data within healthcare
settings. This includes heart rate and
electrocardiography (ECG).
Data is transmitted wirelessly
from Life Sensor Electrode
to an application on iOS device where
it is displayed for review by
healthcare professionals. The device
is intended for use on general care
patients 18 years or older and by
prescription only. The device is
contraindicated for use on critical
care patients, patients with active
implantable medical devices such as
pacemakers, implanted cardioverter
defibrillator (ICD), and left
ventricular
assist devices (LVAD); for use in
magnetic resonance (MR)
environments; for use during surgical
procedures when electro-surgical
equipment is optional. The
Life Sensor Cardiac Monitor does
not detect or diagnose medical
conditions. | No significant
difference in
Indications for Use
to
Ceribell Pocket
EEG
Device and Nihon
Kohden
AE-120A EEG
Head Set |
| Attributes | Subject Device
REMI | Predicate Device(s)
Ceribell Pocket EEG Device
(K170363)
Ceribell Instant EEG Headband
(K171459)
Both K170363 and K171459
together is substantially equivalent
to REMI | Predicate Device
Nihon Kohden
AE-120A EEG Head Set
(K183529) | Reference Device
BraveHeart Wireless
Life Sensor Cardiac Monitor
(K191331) | Comments |
| Physiological Signal
Acquired | EEG | EEG | EEG | ECG | Same Physiological
Signal Acquired
to Ceribell Pocket
EEG Device and
Nihon Kohden
AE-120A EEG
Head Set |
| Type of patient
contact | Contacts patient scalp | Contacts patient scalp | Contacts patient scalp | Contacts patient chest over the heart | Same type of patient
contact to
Ceribell Pocket EEG
and
Nihon Kohden AE-
120A EEG
Head Set |
| Electrodes | 2 passive gold electrodes
using a conductive hydrogel
sticker | 10 passive Ag/AgCl
electrodes | 10 passive Ag/AgCl
electrodes | 2 passive electrodes using a
conductive hydrogel sticker | No significant
difference in
Electrodes to
BraveHeart
Wireless Life
Sensor Cardiac
Monitor |
| Attributes | Subject Device
REMI | Predicate Device(s)
Ceribell Pocket EEG Device
(K170363)
Ceribell Instant EEG Headband
(K171459)
Both K170363 and K171459
together is substantially equivalent
to REMI | Predicate Device
Nihon Kohden
AE-120A EEG Head Set
(K183529) | Reference Device
BraveHeart Wireless
Life Sensor Cardiac Monitor
(K191331) | Comments |
| Type of Use | Epilog Disposable is single
use,
non-sterile, disposable | Electrodes: Single use, nonsterile,
disposable.
EEG Device:
Ceribell Pocket EEG Device
is
reusable and non-patient
contacting.
Ceribell Instant EEG
headband is
single use, patient contacting
and
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 (they can
be cleaned & disinfected but
are recommended for single
patient use) | Electrodes: Single use, non-sterile,
disposable. The Life Sensor Module
automatically performs all the
processing functions related
to capturing the required
physiological data from the body and
performs encrypted, bi-directional
communication to the Life Sensor
Application, using Bluetooth Low
Energy (BLE), when in range of the
Life Sensor Application installed on a
paired iOS device. | No significant
difference in
Type of Use to all
predicates |
| Channel | Up to 10 | 8 | 8 | 1 | No significant
difference in
EEG Channels to
Ceribell
Pocket EEG Device
and
Nihon Kohden AE-
120A
EEG Head Set |
| 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 - Ceribell Pocket EEG
Device and Ceribell Instant EEG
Headband approximates a 10/20
montage | 10/20 System - AE-120A
EEG Head Set approximates the
10/20 montage but may
deviate slightly depending
on the patient's head shape | Not Applicable | No significant
difference in
Montage to Ceribell
Pocket
EEG Device and
Nihon Kohden AE-
120A EEG
Head Set |
| Attributes | Subject Device
REMI | Predicate Device(s)
Ceribell Pocket EEG Device
(K170363)
Ceribell Instant EEG Headband
(K171459)
Both K170363 and K171459
together is substantially equivalent
to REMI | Predicate Device
Nihon Kohden
AE-120A EEG Head Set
(K183529) | Reference Device
BraveHeart Wireless
Life Sensor Cardiac Monitor
(K191331) | Comments |
| 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 | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-2-26 | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-2-27 | No significant
difference in
Electrical Safety &
EMC to predicates |
| Input Dynamic
Range | 1 mVp-p | Unknown | 1 mVp-p | Unknown | No significant
difference in
Dynamic Range to
Nihon Kohden AE-
120A EEG Head Set |
| Input Noise | 5 μVp-p | Unknown (presumed to be
same as
it meets
IEC 60601-2-26) | 5 μVp-p or less (0.53 to 60
Hz) | Unknown | No significant
difference in
Input Noise to
Nihon
Kohden AE-120A
EEG Head Set |
| Transfer of data | Bluetooth 2.4 GHz | Micro-USB cable | Bluetooth 2.4 GHz | Bluetooth 2.4 GHz | Same Transfer of
data to EEG as
Ceribell Pocket
EEG Device and
Nihon Kohden AE-
120A EEG Head Set |
| Power Source | CR2016 primary lithium (not
rechargeable) | Lithium ion batteries –
rechargeable with 100-240 V AC
power adapter (Device does
not work when connected to AC to
recharge) | 2 AA (LR6) alkaline
batteries (not rechargeable) | Lithium Ion (not rechargeable) | No significant
difference in
Power Source to all
predicates |
| Attributes | Subject Device
REMI | Predicate Device(s)
Ceribell Pocket EEG Device
(K170363)
Ceribell Instant EEG Headband
(K171459)
Both K170363 and K171459
together is substantially equivalent
to REMI | Predicate Device
Nihon Kohden
AE-120A EEG Head Set
(K183529) | Reference Device
BraveHeart Wireless
Life Sensor Cardiac Monitor
(K191331) | Comments |
| Data Format | Lay-Dat (Persyst) | Edf | Nihon Kohden original format | Unknown | No significant
difference in
Data Format to
Ceribell
Pocket EEG Device
and
Nihon Kohden AE-
120A
EEG Head Set.
Persyst is
compatible with Edf
and
Nihon Kohden
formats |
| Compatibility | Epilog Disposable works only with
REMI App software and tablet | Ceribell Instant EEG Headband
works only with Ceribell Pocket
EEG Device | Works only with Nihon Kohden
specified EEG's: EEG-1200A
series (K080546) EEG-9100
(K011204) | The Life Sensor Application,
installed on a paired iOS device,
interacts with the Life Sensor
Firmware and manages the upload,
processing, and display of the
physiological data transmitted by the
Life Sensor Module. | No significant
difference in
proprietary
compatibility with
all predicates. |
| Software | Epilog Disposable uses
integrated firmware only for
transmitting EEG to REMI App
software and tablet | Ceribell Pocket EEG Device
comes with EEG Recording Viewer
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 | Unknown | No significant
difference in
EEG Software
format to Ceribell
Pocket EEG Device
and Nihon Kohden
AE-120A EEG
Head Set |
| Attributes | Subject Device
REMI | Predicate Device(s)
Ceribell Pocket EEG Device
(K170363)
Ceribell Instant EEG Headband
(K171459)
Both K170363 and K171459
together is substantially equivalent
to REMI | Predicate Device
Nihon Kohden
AE-120A EEG Head Set
(K183529) | Reference Device
BraveHeart Wireless
Life Sensor Cardiac Monitor
(K191331) | Comments |
| Connector | Epilog Disposable uses a USB
protocol on a non-standard
connector for programming
only | Integrated single cable
connector in
Ceribell Instant EEG Headband to
connect to EEG recording device | Single connector of electrodes
to AE-120A Head Set | Unknown | No significant
difference in
Connector interface
to Ceribell Pocket
EEG Device and
Nihon Kohden AE-
120A EEG Head Set |
| Available Sizes and
Dimension | Epilog comes in one size:
27 mm x 27 mm x 7 mm | Small (48.4 - 53.6 cm)
Medium (53.3 - 56.5 cm)
Large (55.5 - 62 cm) | 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) | One Size | Epilog sensor is
smaller than
predicates but do not
raise concerns of
safety or
effectiveness |
| Conductive
Electrolyte 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 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. | 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 is in
the
form of a hydrogel
converted in a
one-piece adhesive sticker
as an
accessory to the Life Sensor
Module.
The sticker is replaceable
and onetime
use. | Same Conductive
Electrolyte to
BraveHeart
Wireless Life
Sensor
Cardiac Monitor |
| Attributes | Subject Device
REMI | Predicate Device(s)
Ceribell Pocket EEG Device
(K170363)
Ceribell Instant EEG Headband
(K171459)
*Both K170363 and K171459
together is substantially equivalent
to REMI | Predicate Device
Nihon Kohden
AE-120A EEG Head Set
(K183529) | Reference Device
BraveHeart Wireless
Life Sensor Cardiac Monitor
(K191331) | Comments |
| 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
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-
5and
ISO-10993-10 | Biocompatibility of patient
contacting components
verified
with Irritation,
Sensitization, and
Cytotoxicity
testing per ISO 10993-
5:2009 and
ISO 10993-10:2010 | Same
Biocompatibility to
all predicates |
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5.10 Performance Data
Non Clinical 5.10.1
REMI was evaluated for electrical safety in accordance with IEC 60601 Medical Electrical Equipment - Part 1: General requirements for safety. The Epilog sensors were also evaluated for electromagnetic compatibility (EMC), including both emissions and immunity. The Epilog sensors were tested according to IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety; Electromagnetic Compatibility - Requirements and Tests to demonstrate the EMC characteristics of the devices. The Epilog sensors were also tested to IEC 60601-2-26 - Particular requirements for the safety of electroencephalographs. The Epilog sensors were also tested to FCC/IC Intentional Radiator per FCC Part 15 Radiated Emissions and Class B Conducted Emissions. Compliance was demonstrated for all tests.
Further detail is discussed in the Declaration of Conformity and Summary Reports.
5.11 Biocompatibility Testing
In accordance with ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing', the Epilog Sensor is considered to be a surface device that contacts only the skin with prolonged duration. The adhesive sticker accessory (Sticker) is the only component of the Epilog Sensor that comes into direct contact with the patient's scalp.
Both the Epilog Sticker and BraveHeart sticker are directly patient contacting whereas the Ceribell Instant EEG headband and Nihon Kohden AE120 Head Set use electrodes that directly contact the scalp while using a conductive electrolytic gel paste.
The tissue contacting components of the Epilog Sticker include an adhesive and crosslinked conductive hydrogel that is substantially equivalent to the adhesive and crosslinked conductive hydrogel used in the BraveHeart sticker. The crosslinked hydrogel in both the Epilog Sticker and BraveHeart sticker creates an electrically-conductive physical barrier between the scalp and sensor electrodes whereas the low-viscosity of the electrically-conductive gel in both the Ceribell Instant EEG headband and Nihon Kohden AE120 Head Set allow direct contact of the electrodes to the scalp.
Both the Epilog Sensor and BraveHeart Wireless Life Sensor use their respective stickers to mechanically hold their sensors to the scalp and chest, respectively. The Ceribell Instant EEG headband and Nihon Kohden AE120 Head Set use mechanical force to hold the headband and headset to the scalp.
Biocompatibility of patient contacting components for all four devices have been verified with similar Irritation, Sensitization, and Cytotoxicity testing per ISO 10993-5:2009 and ISO 10993-10:2010. Whereas the Ceribell Instant EEG headband was tested for limited (24 hour but