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).

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.

AI/ML Overview

The firm Epitel, Inc. did not conduct a clinical study to prove the device meets acceptance criteria. Instead, they performed non-clinical performance testing and biocompatibility testing. The device is a physiological signal monitor and does not make diagnoses or recommendations. Therefore, the information provided below is a summary of the non-clinical and biocompatibility tests performed.

1. A table of acceptance criteria and the reported device performance

Test Category	Acceptance Criteria	Reported Device Performance
Non-Clinical Testing
Electrical Safety	Compliance with IEC 60601-1 (General requirements for safety of medical electrical equipment)	Compliance was demonstrated.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 (EMC - Requirements and Tests)	Compliance was demonstrated for both emissions and immunity.
Electroencephalograph Specific Safety	Compliance with IEC 60601-2-26 (Particular requirements for the safety of electroencephalographs)	Compliance was demonstrated.
FCC/IC Intentional Radiator	Compliance with FCC Part 15 Radiated Emissions and Class B Conducted Emissions	Compliance was demonstrated.
Biocompatibility Testing
Irritation	Verified through testing per ISO 10993-10:2010	Testing was performed per ISO 10993-10:2010, verifying biocompatibility. The Epilog Sticker was tested for prolonged (>24 hour but <30 days) use.
Sensitization	Verified through testing per ISO 10993-10:2010	Testing was performed per ISO 10993-10:2010, verifying biocompatibility. The Epilog Sticker was tested for prolonged (>24 hour but <30 days) use.
Cytotoxicity	Verified through testing per ISO 10993-5:2009	Testing was performed per ISO 10993-5:2009, verifying biocompatibility. The Epilog Sticker was tested for prolonged (>24 hour but <30 days) use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This section is not applicable as no clinical study was conducted. The performance data is based on non-clinical and biocompatibility testing. The document does not specify general sample sizes (e.g., number of devices tested) for the non-clinical or biocompatibility tests, nor does it specify data provenance in terms applicable to clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as no clinical study was conducted that required ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable as no clinical study was conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable as no clinical study, particularly an MRMC study, was conducted. The device is a physiological signal monitor and does not include AI for interpretation or diagnosis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable as the device is a physiological signal monitor and does not involve a standalone algorithm for diagnostic performance. The submission explicitly states, "REMI does not make any diagnosis or recommendations and is intended only as a physiological signal monitor."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This section is not applicable as no clinical study requiring a ground truth was performed. The non-clinical and biocompatibility testing rely on established standards and laboratory results.

8. The sample size for the training set

This section is not applicable, as no machine learning algorithm requiring a training set for diagnostic or interpretative purposes was mentioned or evaluated in the context of device performance.

9. How the ground truth for the training set was established

This section is not applicable, as no machine learning algorithm requiring a training set was mentioned or evaluated.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

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

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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

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Indications for Use

510(k) Number (if known) K203827

Device Name REMI

Indications for Use (Describe)

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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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
Email	: lehmkuhle@epitel.com

5.3 Correspondent Information

Full Name	: John Pappan
Job Title	: RA Consultant / Project Management
Phone	: 718-964-3406
Email	: 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)

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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 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

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through user centric design and a risk management based approach to design controls.

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Table - 5.3 Comparison Summary

Attributes	Subject DeviceREMI	Predicate Device(s)Ceribell Pocket EEG Device(K170363)Ceribell Instant EEG Headband(K171459)Both K170363 and K171459together is substantially equivalentto REMI	Predicate DeviceNihon KohdenAE-120A EEG Head Set(K183529)	Reference DeviceBraveHeart WirelessLife Sensor Cardiac Monitor(K191331)	Comments
ClassificationRegulation	Class II per 21 CFR 882.1400Electroencephalograph (Head Set)Class II per 21 CFR 882.1320 (forelectrodes within headset)	Class II per 21 CFR 882.1400Electroencephalograph (EEGDevice) Class II per 21 CFR882.1320 (Instant EEG Headband -cutaneous electrodes)	Class II per 21 CFR 882.1400Electroencephalograph (HeadSet) Class II per 21 CFR882.1320 (for electrodes withinheadset)	Class II per 21 CFR 870.2910Radiofrequency physiological signaltransmitter and receiver	Same ClassificationRegulation toCeribellPocket EEG DeviceandNihon Kohden AE-120AEEG Head Set
Product Code(s)	OMC and GXY	OMC and GXY	OMC	DRG, DRT, DRX	Same Product CodestoCeribell PocketEEGDevice and NihonKohdenAE-120A EEGHead Set
Attributes	Subject DeviceREMI	Predicate Device(s)Ceribell Pocket EEG Device(K170363)Ceribell Instant EEG Headband(K171459)Both K170363 and K171459together is substantially equivalentto REMI	Predicate DeviceNihon KohdenAE-120A EEG Head Set(K183529)	Reference DeviceBraveHeart WirelessLife Sensor Cardiac Monitor(K191331)	Comments
Indications for Use	The REMI Platform is intended to beused in healthcare settings wherenear real-time and/or remote EEG iswarranted. REMI consists of Epilogdisposable Sensors - a single use.single patient, disposable, wearablesensor intended to amplify, capture.and wirelessly transmit a singlechannel of electrical activity of thebrain for up to 48 hours. The REMI-Mobile software and REMI-Tabletare intended to receive and transmitdata from four Epilog Sensors tosecure cloud storage for subsequentviewing and reviewing of EEG onthird-party software.REMI does not make any diagnosisor recommendations and is intendedonly as a physiological signalmonitor. Epilog Sensors are intendedmedicalfor use by bytrainedprofessionals in a professionalhealthcare facility environment.Epilog Sensors are intended for usewith adult and pediatric patients(6+). (Rx only).	The Ceribell Pocket EEG(K170363) Device is intended torecord and store EEG signals, and topresent the EEG signals in visual andaudible formats in real time. Thevisual and audible signals assisttrained medical staff to makeneurological diagnoses. The PocketEEG Device does not provide anydiagnostic conclusion about thesubject's condition and does notprovide any automated alerts of anadverse clinical event. The PocketEEG Device is intended to be used ina professional healthcare facilityenvironment. (Rx only)The Ceribell Instant EEG Headband(K171459) is anelectroencephalogram (EEG)electrode array intended forsingle patient use in the recording ofEEGs in patients of 6 years andolder. The Instant EEG Headband isintended for prescription use in thehome, healthcare facility or clinicalresearch environment. (Rx Only).	The AE-120A EEG HeadSet is intended to amplify,capture, and wirelessly transmitelectrical activity of the brain forreview by a trained medicalprofessional using the previouslycleared and validated NihonKohden electroencephalographsystems (EEG-1200A series andEEG-9100) to assist in thediagnosis of neurologicaldisorders. The AE-120A EEGHead Set and its associated EEGSoftware do not provide anydiagnostic conclusion orautomated alerts of an adverseclinical event about a patient'scondition. The device is intendedfor use by trained medicalprofessionals in a medical facilitysuch as a physician's office,laboratory, or clinic. The deviceis intended for use on adults (ages18 and above). (Rx Only).	The Life Sensor Cardiac Monitor(CM) is a wireless monitoring systemintended for use by healthcareprofessionals for monitoring ofphysiological data within healthcaresettings. This includes heart rate andelectrocardiography (ECG).Data is transmitted wirelesslyfrom Life Sensor Electrodeto an application on iOS device whereit is displayed for review byhealthcare professionals. The deviceis intended for use on general carepatients 18 years or older and byprescription only. The device iscontraindicated for use on criticalcare patients, patients with activeimplantable medical devices such aspacemakers, implanted cardioverterdefibrillator (ICD), and leftventricularassist devices (LVAD); for use inmagnetic resonance (MR)environments; for use during surgicalprocedures when electro-surgicalequipment is optional. TheLife Sensor Cardiac Monitor doesnot detect or diagnose medicalconditions.	No significantdifference inIndications for UsetoCeribell PocketEEGDevice and NihonKohdenAE-120A EEGHead Set
Attributes	Subject DeviceREMI	Predicate Device(s)Ceribell Pocket EEG Device(K170363)Ceribell Instant EEG Headband(K171459)Both K170363 and K171459together is substantially equivalentto REMI	Predicate DeviceNihon KohdenAE-120A EEG Head Set(K183529)	Reference DeviceBraveHeart WirelessLife Sensor Cardiac Monitor(K191331)	Comments
Physiological SignalAcquired	EEG	EEG	EEG	ECG	Same PhysiologicalSignal Acquiredto Ceribell PocketEEG Device andNihon KohdenAE-120A EEGHead Set
Type of patientcontact	Contacts patient scalp	Contacts patient scalp	Contacts patient scalp	Contacts patient chest over the heart	Same type of patientcontact toCeribell Pocket EEGandNihon Kohden AE-120A EEGHead Set
Electrodes	2 passive gold electrodesusing a conductive hydrogelsticker	10 passive Ag/AgClelectrodes	10 passive Ag/AgClelectrodes	2 passive electrodes using aconductive hydrogel sticker	No significantdifference inElectrodes toBraveHeartWireless LifeSensor CardiacMonitor
Attributes	Subject DeviceREMI	Predicate Device(s)Ceribell Pocket EEG Device(K170363)Ceribell Instant EEG Headband(K171459)Both K170363 and K171459together is substantially equivalentto REMI	Predicate DeviceNihon KohdenAE-120A EEG Head Set(K183529)	Reference DeviceBraveHeart WirelessLife Sensor Cardiac Monitor(K191331)	Comments
Type of Use	Epilog Disposable is singleuse,non-sterile, disposable	Electrodes: Single use, nonsterile,disposable.EEG Device:Ceribell Pocket EEG Deviceisreusable and non-patientcontacting.Ceribell Instant EEGheadband issingle use, patient contactinganddisposable.	Electrodes: Single use, non-sterile.disposableEEG Device: AE-120A EEGHead set is reusable andnonpatientcontacting. Belts are patientcontacting and reusable (they canbe cleaned & disinfected butare recommended for singlepatient use)	Electrodes: Single use, non-sterile,disposable. The Life Sensor Moduleautomatically performs all theprocessing functions relatedto capturing the requiredphysiological data from the body andperforms encrypted, bi-directionalcommunication to the Life SensorApplication, using Bluetooth LowEnergy (BLE), when in range of theLife Sensor Application installed on apaired iOS device.	No significantdifference inType of Use to allpredicates
Channel	Up to 10	8	8	1	No significantdifference inEEG Channels toCeribellPocket EEG DeviceandNihon Kohden AE-120AEEG Head Set
Montage	10/20 system - Epilog-Disposablecan be placed anywhere in the 10/20system where each channelrepresents a bipolar derivationapproximation of the 10/20 system	10/20 System - Ceribell Pocket EEGDevice and Ceribell Instant EEGHeadband approximates a 10/20montage	10/20 System - AE-120AEEG Head Set approximates the10/20 montage but maydeviate slightly dependingon the patient's head shape	Not Applicable	No significantdifference inMontage to CeribellPocketEEG Device andNihon Kohden AE-120A EEGHead Set
Attributes	Subject DeviceREMI	Predicate Device(s)Ceribell Pocket EEG Device(K170363)Ceribell Instant EEG Headband(K171459)Both K170363 and K171459together is substantially equivalentto REMI	Predicate DeviceNihon KohdenAE-120A EEG Head Set(K183529)	Reference DeviceBraveHeart WirelessLife 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 60601-2-26IEC 62133	IEC 60601-1,IEC 60601-1-2,IEC 60601-2-26	IEC 60601-1,IEC 60601-1-2,IEC 60601-2-27	No significantdifference inElectrical Safety &EMC to predicates
Input DynamicRange	1 mVp-p	Unknown	1 mVp-p	Unknown	No significantdifference inDynamic Range toNihon Kohden AE-120A EEG Head Set
Input Noise	5 μVp-p	Unknown (presumed to besame asit meetsIEC 60601-2-26)	5 μVp-p or less (0.53 to 60Hz)	Unknown	No significantdifference inInput Noise toNihonKohden AE-120AEEG Head Set
Transfer of data	Bluetooth 2.4 GHz	Micro-USB cable	Bluetooth 2.4 GHz	Bluetooth 2.4 GHz	Same Transfer ofdata to EEG asCeribell PocketEEG Device andNihon Kohden AE-120A EEG Head Set
Power Source	CR2016 primary lithium (notrechargeable)	Lithium ion batteries –rechargeable with 100-240 V ACpower adapter (Device doesnot work when connected to AC torecharge)	2 AA (LR6) alkalinebatteries (not rechargeable)	Lithium Ion (not rechargeable)	No significantdifference inPower Source to allpredicates
Attributes	Subject DeviceREMI	Predicate Device(s)Ceribell Pocket EEG Device(K170363)Ceribell Instant EEG Headband(K171459)Both K170363 and K171459together is substantially equivalentto REMI	Predicate DeviceNihon KohdenAE-120A EEG Head Set(K183529)	Reference DeviceBraveHeart WirelessLife Sensor Cardiac Monitor(K191331)	Comments
Data Format	Lay-Dat (Persyst)	Edf	Nihon Kohden original format	Unknown	No significantdifference inData Format toCeribellPocket EEG DeviceandNihon Kohden AE-120AEEG Head Set.Persyst iscompatible with EdfandNihon Kohdenformats
Compatibility	Epilog Disposable works only withREMI App software and tablet	Ceribell Instant EEG Headbandworks only with Ceribell PocketEEG Device	Works only with Nihon Kohdenspecified EEG's: EEG-1200Aseries (K080546) EEG-9100(K011204)	The Life Sensor Application,installed on a paired iOS device,interacts with the Life SensorFirmware and manages the upload,processing, and display of thephysiological data transmitted by theLife Sensor Module.	No significantdifference inproprietarycompatibility withall predicates.
Software	Epilog Disposable usesintegrated firmware only fortransmitting EEG to REMI Appsoftware and tablet	Ceribell Pocket EEG Devicecomes with EEG Recording ViewerSoftware	AE-120A EEG Head Set comeswith EEG software to be placedon the compatible EEG forinteraction with and viewing ofEEG data	Unknown	No significantdifference inEEG Softwareformat to CeribellPocket EEG Deviceand Nihon KohdenAE-120A EEGHead Set
Attributes	Subject DeviceREMI	Predicate Device(s)Ceribell Pocket EEG Device(K170363)Ceribell Instant EEG Headband(K171459)Both K170363 and K171459together is substantially equivalentto REMI	Predicate DeviceNihon KohdenAE-120A EEG Head Set(K183529)	Reference DeviceBraveHeart WirelessLife Sensor Cardiac Monitor(K191331)	Comments
Connector	Epilog Disposable uses a USBprotocol on a non-standardconnector for programmingonly	Integrated single cableconnector inCeribell Instant EEG Headband toconnect to EEG recording device	Single connector of electrodesto AE-120A Head Set	Unknown	No significantdifference inConnector interfaceto Ceribell PocketEEG Device andNihon Kohden AE-120A EEG Head Set
Available Sizes andDimension	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 Sethas flexible arms that are adjustedto fit different adult patient headsizes along withadjustments from the belts/ straps(chin)	One Size	Epilog sensor issmaller thanpredicates but do notraise concerns ofsafety oreffectiveness
ConductiveElectrolyte Gel	Conductive electrolyte is inthe form of a hydrogelconverted in aone-piece adhesive stickeras anaccessory to Epilog-Disposable.The sticker is replaceableand onetimeuse.	Conductive electrolyte gel isincluded in a packet gelreservoirintegrated into eachelectrode assembly. User isalsoable to add additionalelectrolyte gel when neededusing asyringe.	Conductive electrolytepaste isincludedin a packet gel reservoirintegrated into eachelectrode.User inserts electrodeinto the electrodeattachmentposition inHead Set with paste.	Conductive electrolyte is intheform of a hydrogelconverted in aone-piece adhesive stickeras anaccessory to the Life SensorModule.The sticker is replaceableand onetimeuse.	Same ConductiveElectrolyte toBraveHeartWireless LifeSensorCardiac Monitor
Attributes	Subject DeviceREMI	Predicate Device(s)Ceribell Pocket EEG Device(K170363)Ceribell Instant EEG Headband(K171459)Both K170363 and K171459together is substantially equivalentto REMI	Predicate DeviceNihon KohdenAE-120A EEG Head Set(K183529)	Reference DeviceBraveHeart WirelessLife Sensor Cardiac Monitor(K191331)	Comments
Biocompatibility	Biocompatibility of patientcontacting componentsverifiedwith Irritation,Sensitization, andCytotoxicitytesting per ISO 10993-5:2009 andISO 10993-10:2010	Biocompatibility of patientcontacting componentsverified withIrritation,Sensitization, andCytotoxicitytesting per ISO 10993-5:2009 andISO 10993-10:2010	Biocompatibility of patientcontactingcomponentsverifiedwith Cytotoxicity,Sensitization, andIrritation per ISO 10993-5andISO-10993-10	Biocompatibility of patientcontacting componentsverifiedwith Irritation,Sensitization, andCytotoxicitytesting per ISO 10993-5:2009 andISO 10993-10:2010	SameBiocompatibility toall 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) use, the Epilog Sticker and BraveHeart sticker were tested for prolonged (>24 hour but <30 days) use. Therefore, the Epilog Sticker biocompatibility performance is substantially equivalent to both the BraveHeart sticker and Ceribell Instant EEG headband.

5.12 Clinical Testing

The submission does not contain clinical data.

5.13 Conclusion

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.

Regulation Number and Section

§ 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).