The REMI Remote EEG Monitoring System is indicated for use in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings where remote EEG is warranted. REMI uses single patient, disposable, wearable sensors intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration up to 30 days.

The REMI System uses the REMI-Mobile software application that runs on qualified portable general purpose computing platforms. REMI-Mobile displays user setup information to trained medical professionals and provides notifications to medical professionals and ambulatory users. REMI-Mobile receives and transmits data from connected REMI Sensors to the secure REMI-Cloud where it is stored and prepared for review on qualified EEG viewing software.

REMI does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. The REMI System is indicated for use with adult and pediatric patients (6+ years).

Device Description

The REMI System has three major components:

REMI Sensor A disposable EEG sensor which is placed on the patient's scalp using a conductive REMI Sticker
REMI Mobile A mobile medical application that is designed to run on a qualified commercial-off-the-shelf mobile computing platform (an Android tablet for use in healthcare settings, and a portable/wearable Android smartwatch for use in ambulatory settings), acquire EEG data transmitted from REMI Sensors and then transmit the EEG data and associated patient information via wireless encrypted transmission to,
REMI Cloud A HIPAA-compliant secure cloud storage and data processing platform where data is processed into a qualified EEG reviewing software format for neurological review.

This 510(k) submission includes the addition of the Android smartwatch for ambulatory use and increases the duration of monitoring to up to 30 days.

AI/ML Overview

The provided text describes the REMI Remote EEG Monitoring System and its substantial equivalence to a predicate device. However, it does not include specific quantitative acceptance criteria or detailed study results that would typically be associated with performance metrics like sensitivity, specificity, accuracy, or effect sizes for AI assistance. The document focuses on demonstrating substantial equivalence through testing of electrical safety, wireless technology, software, and human factors.

Here's an attempt to answer your questions based on the available information, with acknowledgements where information is missing.

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

Based on the provided text, the acceptance criteria are generally framed around meeting regulatory standards and functional requirements rather than quantitative performance metrics for diagnostic accuracy.

Acceptance Criteria Category	Reported Device Performance
Electrical Safety / EMC / Ingress Protection	Met all relevant standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, IEC 60601-1-11:2015 /A1:2021.
Wireless Technology Functionality	- Wireless connections can be initiated, are stable, and accurately transfer EEG signals. - Wireless connection maintained for a minimum of 48 continuous hours.
Environmental/Shelf life	Accelerated aging and subsequent functional verification testing conducted. (No specific performance metrics are given, but implies successful completion).
Packaging Performance	Ship testing and subsequent functional verification testing conducted. (No specific performance metrics are given, but implies successful completion).
Biocompatibility	Patient-contacting components verified with Irritation, Sensitization, and Cytotoxicity testing per ISO 10993-5:2009 and ISO 10993-10:2010 for a prolonged time period. (Identical to predicate device).
Usability/ Human Factors	Evaluated tasks associated with use of the device. (Implies successful evaluation, no specific outcomes provided).
Software Functionality	Updated REMI Mobile software successfully supports portable/wearable ambulatory use by initiating sessions from a primary computing platform (Android tablet) to a portable/wearable computing platform (Wear OS smartwatch).
Bench Testing (End-to-End System Performance)	- Able to acquire EEG signals using REMI Sensors and transmit to REMI Mobile software. - REMI Mobile able to transfer EEG data to REMI Cloud. - Final EEG file format within REMI Cloud is viewable in qualified EEG viewing software. - System meets its Essential Performance (record digitized EEG data with patient-applied sensors, transfer wirelessly to cloud-based archive) and fulfills system requirements.

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

The document does not specify sample sizes for any of the described tests. It mentions "testing conducted," "accelerated aging," "ship testing," and "human factors/usability testing," but provides no details on the number of units, subjects, or data points involved. Similarly, data provenance (country of origin, retrospective/prospective) is not mentioned.

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)

The document does not describe any study establishing ground truth with expert review for a diagnostic purpose. The device is explicitly stated to "not make any diagnostic conclusion" and is "intended as a physiological signal monitor." Therefore, this question is not applicable in the context of the provided information.

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

Since no expert-based ground truth establishment or diagnostic performance evaluation is detailed, there is no mention of an adjudication method.

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

No MRMC study is mentioned. The device is a physiological signal monitor and does not involve AI assistance for human readers in a diagnostic context.

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

The device itself is a system for acquiring and transmitting EEG data for review by medical professionals on qualified EEG viewing software. It does not perform standalone diagnostic algorithms. Its "Essential Performance" is to record digitized EEG data and transfer it.

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

Given that the device is a physiological signal monitor and "does not make any diagnostic conclusion," the concept of "ground truth" as typically used for diagnostic or screening devices (e.g., pathology, expert consensus on a disease state) is not applicable here. The ground truth for its performance would be the accuracy of EEG signal acquisition and transmission, which is assessed through bench testing and compliance with electrical standards.

8. The sample size for the training set

The document does not describe any machine learning or AI-based component that would require a "training set." The software updates mentioned are for supporting new hardware (smartwatch) and extending monitoring duration, not for developing new diagnostic algorithms.

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

Not applicable, as no training set for an AI/ML algorithm is described.

Summary

{0}------------------------------------------------

June 30, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Epitel, Inc. Randy Parry Staff Regulatory Affairs Specialist 465 South 400 East. Suite 250 Salt Lake City, Utah 84111

Re: K230933

Trade/Device Name: REMI Remote EEG Monitoring System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC, GXY Dated: March 31, 2023 Received: April 3, 2023

Dear Randy Parry:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Patrick Antkowiak -S

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K230933

Device Name REMI Remote EEG Monitoring System

Indications for Use (Describe)

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)
-----------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------

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}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for "epitel". The logo is in a dark blue color. There is a graphic in the middle of the word that looks like a heartbeat.

REMI Remote EEG Monitoring System Traditional 510(k) Summary K230933

1. Applicant Information

Epitel, Inc. 465 S 400 E Suite 250, Salt Lake City, UT 84111

Primary Contact Information

Randy Parry Staff Regulatory Affairs Specialist Mobile: 801-497-6297 Email: r.parry@epitel.com

Secondary Contact Information

Christopher M. Phillips VP, Regulatory Affairs and Quality Mobile: 801-497-6297 Email: c.phillips@epitel.com

Date Prepared

June 30, 2023

1. Subject Device Information Name of Device: REMI Remote EEG Monitoring System Common or Usual Name: EEG System Classification Name: Electroencephalograph, Regulatory Class: Class II Product Code and Regulation Number: OMC - Sec. 882.1400, GXY Sec. 882.1320
1. Predicate Device Name of Device: REMI 510(k) Number: K203827 Manufacturer: Epitel, Inc

4. Device Description

REMI Sensors amplify electroencephalographic activity acquired from a patient's scalp. After amplification, the EEG data is sent to the REMI Mobile medical application running on a qualified commercial-off-the-shelf mobile computing platform. REMI Mobile combines the EEG from the REMI Sensors with corresponding patient information and relays the REMI Cloud server. REMI Cloud processes the data into a format compatible for viewing using qualified EEG viewing software (initially qualified for viewing on Persyst 14 EEG Review and Analysis Software, K182181).

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the word "epitel" in a sans-serif font. The word is in a dark blue color. There is a graphic of a waveform in the middle of the word, replacing the vertical line of the "p".

The REMI System has three major components:

1. REMI Sensor A disposable EEG sensor which is placed on the patient's scalp using a conductive REMI Sticker
1. REMI Mobile A mobile medical application that is designed to run on a qualified commercial-off-the-shelf mobile computing platform (an Android tablet for use in healthcare settings, and a portable/wearable Android smartwatch for use in ambulatory settings), acquire EEG data transmitted from REMI Sensors and then transmit the EEG data and associated patient information via wireless encrypted transmission to,
1. REMI Cloud A HIPAA-compliant secure cloud storage and data processing platform where data is processed into a qualified EEG reviewing software format for neurological review.

This 510(k) submission includes the addition of the Android smartwatch for ambulatory use and increases the duration of monitoring to up to 30 days.

5. Intended Use

Acquisition and presentation of electroencephalographic (EEG) data.

6. Indications for Use

The REMI Remote EEG Monitoring System (REMI System) is indicated for use in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings where remote EEG is warranted. REMI uses single use, single patient, disposable, wearable sensors intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration of up to 30 days.

The REMI System uses the REMI Mobile software application that runs on qualified commercial off-the-shelf mobile computing platforms. REMI Mobile displays user setup information to trained medical professionals and provides notifications to medical professionals and ambulatory users. REMI Mobile receives and transmits data from connected REMI Sensors to the secure REMI Cloud where it is stored and prepared for review on qualified EEG viewing software.

7. Substantial Equivalence

The REMI System has been developed in compliance with applicable FDA requirements and quidance as well as with recognized standards. This submission includes required documentation and testing data demonstrating substantial equivalence of the REMI System to its predicate device. The device has undergone software testing, human factors/usability testing, electromagnetic compatibility and electrical safety testing, and biocompatibility testing, which demonstrate that it is safe and effective for its intended use. The subject REM System presents no new significant risks or safety concerns, and any potential risks have been mitigated as low as reasonably possible.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for "epitel". The logo is in a dark blue color. The "e" and "p" are connected with a line that looks like an EKG reading.

7.1. Summary of Technological Characteristics and Substantial Equivalence

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the word "epitel" in a bold, sans-serif font. The letters are a dark blue color. There is a stylized graphic of a waveform inside of a blue square that is placed above the "i" in "epitel". The waveform is white.

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for "epitel". The logo is in a dark blue color. The "e" and "p" are connected to a square with a white line going through it. The rest of the letters are not connected.

Performance Testing 8.

Testing verifying the performance requirements of the subject device was conducted and is included in this premarket notification, the results of which support substantial equivalence. A summary of the testing is included below:

The REMI System was tested to verify its safe and effective use for the intended population and use environments. Testing included the following:

Test Type	Summary
General Electrical Safety,Electromagnetic Compatibility andIngress Protection	Testing conducted to:IEC 60601-1:2005, including Amendment 2:2021, Medical electricalequipment - Part 1: General requirements for basic safety and essentialperformance,IEC 60601-1-2:2015, Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance - CollateralStandard: Electromagnetic disturbances - Requirements and testsIEC 60601-2-26:2015, Particular Requirements For The Basic Safety AndEssential Performance Of ElectroencephalographsIEC 60601-1-11:2015 + A1:2021, Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipment andmedical electrical equipment and medical electrical systems used in thehome healthcare environment
Test Type	Summary
Wireless Technology Testing	Wireless functionality is needed for the REMI System to achieve itsEssential Performance. Because of this, comprehensive EMC testing ofthe REMI System has been conducted, including immunity toelectromagnetic disturbance, in accordance with IEC 60601-1-2 andconsistent with the requirements of IEC 60601-1-11.REMI Sensor wireless connectivity was tested with the qualifiedcomputing platform to demonstrate that wireless connections can beinitiated, are stable, and are able to accurately transfer EEG signals.REMI Sensors were also tested to ensure that a wireless connection isable to be maintained for a minimum of 48 continuous hours.
Environmental/Shelf life	Accelerated aging and subsequent functional verification testing
Packaging Performance	Ship testing and subsequent functional verification testing
Biocompatibility	There are no new patient contacting components as part of thissubmission and no new biocompatibility testing was required. The patientcontacting materials are identical to those presented in the predicatedevice submission (K203827). There have not been any changes to thematerial or tested contact type/duration.
Usability/ Human Factors	Human factors/usability testing was conducted to evaluate tasksassociated with use of the device.
Software Testing	REMI Mobile software has been updated compared to the predicatesoftware hand-off an initialized session from a primary computing platform(Android tablet) to a portable/wearable computing platform (Wear OSsmartwatch) in order to support portable/wearable ambulatory use.
Bench Testing	End to end testing was conducted to ensure that the REMI System meetsits Essential Performance: to record digitized EEG data with patient-applied sensors, and transfer the data, wirelessly, to a cloud-basedarchive.End to end testing verified that (1) the REMI System is able to acquireEEG signals using REMI Sensors and subsequently transmit that EEGdata to REMI Mobile software, (2) that REMI Mobile is able to transfer theEEG data to the REMI Cloud, and (3) the final EEG file format withinREMI Cloud is viewable in qualified EEG viewing software. This testingdemonstrates that the REMI System meets its Essential Performance andfulfills system requirements.

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for "epitel". The logo is in blue and features a stylized "e" with a waveform graphic inside the letter. The rest of the word "pitel" is written in a sans-serif font.

The REMI Remote EEG Monitoring System met all predetermined acceptance criteria derived from the above listed tests and demonstrated substantially equivalent performance as compared with the predicate device.

9. Substantial Equivalence Conclusion

The subject device has the same intended use, similar indications for use and incorporates the same fundamental technology as the legally marketed predicate device to which it was compared. Based on intended use, technological characteristics, and performance testing to account for differences in technological characteristics as compared to the predicate, it can be concluded that the subject device, REMI Remote EEG Monitoring System, is substantially equivalent to the identified predicate device.

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).

Attribute	Subject Device K230933REMI Remote EEG Monitoring System	Predicate Device K203827REMI
Intended Use	Acquisition and presentation ofelectroencephalographic (EEG) data.	Acquisition and presentation ofelectroencephalographic (EEG) data.
Indications for Use	The REMI Remote EEG Monitoring System isindicated for use in healthcare settings where nearreal-time and/or remote EEG is warranted and inambulatory settings where remote EEG iswarranted. REMI uses single use, single patient,disposable, wearable sensors intended to amplify,capture, and wirelessly transmit a single channel ofelectrical activity of the brain for a duration up to 30days.The REMI System uses the REMI-Mobile softwareapplication that runs on qualified portable generalpurpose computing platforms. REMI-Mobiledisplays user setup information to trained medicalprofessionals and provides notifications to medicalprofessionals and ambulatory users. REMI-Mobilereceives and transmits data from connected REMISensors to the secure REMI-Cloud where it isstored and prepared for review on qualified EEGviewing software.REMI does not make any diagnostic conclusionabout the subject's condition and is intended as aphysiological signal monitor. The REMI System isindicated for use with adult and pediatric patients(6+ years). (Rx only).	The REMI System is intended to be used inhealthcare settings where near real-time and/orremote EEG is warranted. REMI uses disposableSensors – a single use, single patient, disposable,wearable sensor intended to amplify, capture, andwirelessly transmit a single channel of electricalactivity of the brain for up to 48 hours. The REMIMobile software and REMI Tablet are intended toreceive and transmit data from four REMI Sensors tosecure cloud storage for subsequent viewing andreviewing of EEG on third-party software.REMI does not make any diagnosis orrecommendations and is intended only as aphysiological signal monitor.REMI Sensors are intended for use by trainedmedical professionals in a professional healthcarefacility environment. REMI Sensors are intended foruse with adult and pediatric patients (6+). (Rx only).
Use Environment	The REMI system is intended to be used in healthcare settings for near real time/and or remote EEGsignal collection.The REMI system is intended to be used inambulatory settings for remote EEG signalcollection and includes home-use.	The REMI system is intended to be used in healthcare settings for near real time/and or remote EEGsignal collection.
Software/SystemUser Interface	REMI Mobile medical applicationThe REMI Mobile application is run on qualifiedcommercial off-the-shelf Android computingplatforms.	REMI Mobile medical applicationThe REMI Mobile application is run on qualifiedcommercial off-the-shelf Android computingplatforms.
Qualified ComputingPlatform OperatingSystems	Android 11 or higherWear OS 3.0 or higher	Android 6
Sensor UserInterface	The REMI Sensor has a single push buttonintegrated into the sensor that serves as the userinterface. Some feedback about sensor status isgiven via an onboard LED.	The REMI Sensor has a single push buttonintegrated into the sensor that serves as the userinterface. Some feedback about sensor status isgiven via an onboard LED.
Physiological SignalAcquired	EEG acquired from a patient's scalp	EEG acquired from a patient's scalp
Attribute	Subject Device K230933REMI Remote EEG Monitoring System	Predicate Device K203827REMI
Patient Contact	REMI-Sticker accessory contacts the patient's skin(scalp).	REMI-Sticker accessory contacts the patient's skin(scalp).
Cumulative WearTime	Up to 30 days. Prolonged contact.	Up to 48 hours. Prolonged contact.
Electrodes	2 passive gold electrodes that interface with thescalp through a conductive hydrogel integrated intothe sticker.	2 passive gold electrodes that interface with thescalp through a conductive hydrogel integrated intothe sticker.
Type of Use	REMI sensor is a non-sterile, single-usedisposable device.	REMI sensor is a non-sterile, single-use disposabledevice.
Channels	Up to 10	Up to 10
Montage	10/20 system – REMI Sensor can be placedanywhere in the 10/20 system where each channelrepresents a bipolar derivation approximation ofthe 10/20 system	10/20 system - REMI Sensor can be placedanywhere in the 10/20 system where each channelrepresents a bipolar derivation approximation of the10/20 system
Electrical Safety andEMC	IEC 60601-1,IEC 60601-1-2,IEC 60601-2-26IEC 60601-1-11:2015 /A1:2020	IEC 60601-1,IEC 60601-1-2,IEC 60601-2-26
Input Range(sensors)	1 mVp-p	1 mVp-p
Input Noise (sensors)	5 µVp-p	5 µVp-p
Transfer of Data fromthe sensor to REMIMobile (operating ona qualified computingplatform)	Low power wireless personal area network	Low power wireless personal area network
Transfer of data fromREMI Mobile to REMICloud	Secured WiFi or Cellular data connection	Secured WiFi or Cellular data connection
Power Source(sensors)	Primary lithium button cell (not rechargeable)	Primary lithium button cell (not rechargeable)
Data Format (Viewersoftware)	Common EEG data formats (e.g., lay-dat)	Common EEG data formats (e.g., lay-dat)
Firmware (sensors)	REMI sensors use integrated firmware to collectand transmit EEG data to the REMI Mobileapplication.	REMI sensors use integrated firmware to collect andtransmit EEG data to the REMI Mobile application.
Software (REMICloud)	The REMI Cloud receives EEG data from theREMI Mobile app and prepares it into a format forviewing in the qualified EEG viewing software.REMI Cloud also facilitates transfer andsubsequent receipt of EEG data for additionalcharacterization by EEG analysis module(s).	The REMI Cloud receives EEG data from the REMIMobile app and prepares it into a format for viewingin the qualified EEG viewing software.
Attribute	Subject Device K230933REMI Remote EEG Monitoring System	Predicate Device K203827REMI
Connector	REMI Sensors are equipped with a non-standardUSB pinout/connector that is only used forprogramming during production. This interface isnot used by the clinician or patient.	REMI Sensors are equipped with a non-standardUSB pinout/connector that is only used forprogramming during production. This interface is notused by the clinician or patient.
	Available Sizes(sensor)	REMI Sensor comes in one size:Width: 27 mmLength: 27 mmDepth: 7 mm
ConductiveElectrolyte Gel(sticker)	Conductive electrolyte is in the form of a hydrogelconverted in a one-piece adhesive sticker as anaccessory to the REMI Sensor.	Conductive electrolyte is in the form of a hydrogelconverted in a one-piece adhesive sticker as anaccessory to the REMI Sensor.
	The sticker is replaceableand single use.	The sticker is replaceableand single use.
Biocompatibility	Biocompatibility of patient contacting componentsverified with Irritation, Sensitization, andCytotoxicity testing per ISO 10993-5:2009 and ISO10993-10:2010 for a prolonged time period.	Biocompatibility of patient contacting componentsverified with Irritation, Sensitization, and Cytotoxicitytesting per ISO 10993-5:2009 and ISO 10993-10:2010 for a prolonged time period.