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 System 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.

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.

REMI System does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. REMI System is indicated for use with adult and pediatric patients (1+ years).

Device Description

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 device (phone or 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.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification Summary for the REMI Remote EEG Monitoring System (K243185). This document details the device's characteristics, indications for use, and the studies conducted to demonstrate its substantial equivalence to a predicate device (REMI Remote EEG Monitoring System, K230933).

Based on the provided information, here's a description of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily relies on comparisons to its own predicate device (K230933) and general performance testing against recognized standards. Specific quantitative acceptance criteria are not explicitly detailed in a table format within this summary, but the general assertion is that the device met all predetermined acceptance criteria derived from the listed tests.

Test Type	Acceptance Criteria (Implicit)	Reported Device Performance
General Electrical Safety, EMC, and Ingress Protection	Compliance with relevant IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, IEC 60601-1-11).	Testing conducted to and met the requirements of the specified IEC standards.
Wireless Technology Testing	Wireless connectivity can be initiated, is stable, and accurately transfers EEG signals. Connection maintained for a minimum of 48 continuous hours.	Wireless connectivity was tested (in accordance with IEC 60601-1-2 and IEC 60601-1-11 requirements) and demonstrated to initiate, maintain stability, and accurately transfer EEG signals. A wireless connection was confirmed to be maintained for a minimum of 48 continuous hours.
Environmental/Shelf life	Device functions as intended after accelerated aging.	Accelerated aging and subsequent functional verification testing were performed. (Outcome states "met all predetermined acceptance criteria").
Packaging Performance	Device maintains integrity and function after ship testing.	Ship testing and subsequent functional verification testing were performed. (Outcome states "met all predetermined acceptance criteria").
Biocompatibility	Long-term contact with intact skin is safe (non-cytotoxic, non-sensitizing, non-irritating).	Biocompatibility testing for long-term contact with intact skin was performed per ISO-10993-1, ISO 10993-10, and ISO 10993-23 for all patient-contacting components. (Outcome states "safe and effective for its intended use" and "met all predetermined acceptance criteria").
Usability/Human Factors	Tasks associated with device use are safe and effective.	Human factors/usability testing was conducted to evaluate tasks associated with use of the device. (Outcome states "met all predetermined acceptance criteria").
Software Verification Testing	End-to-end functionality: Acquire EEG, transmit to mobile, transmit to cloud, viewable in qualified software. Essential performance met.	End-to-end testing confirmed: (1) REMI System acquires EEG signals from REMI Sensors and transmits to REMI Mobile software, (2) REMI Mobile transfers EEG data to REMI Cloud, and (3) final EEG file format within REMI Cloud is viewable in qualified EEG viewing software. This demonstrated that the REMI System meets its Essential Performance and fulfills system requirements.
Clinical Performance (Extension to 1-6 years pediatric patients)	REMI System (including new hydrocolloid REMI Sticker) is safe and effective for monitoring EEG in pediatric patients aged 1 to <6 years.	Retrospective review of REMI EEG records from 13 younger pediatric patients (1 to <6 years) by an independent pediatric epileptologist. Review affirmed potential clinical value and identified captured seizure events. Supports conclusion of safety and effectiveness for this age group.

2. Sample Size Used for the Test Set and Data Provenance

Clinical Performance Test Set (Pediatric Extension):
- Sample Size: 13 younger pediatric patients (ages 1 to <6 years)
- Data Provenance: Retrospective review of existing REMI EEG records gathered from NIH-funded studies conducted by Epitel in support of REMI development efforts. Data collected under IRB oversight and registered under NCT03583957. The document states a single pediatric-focused site was involved.
- Geographic Origin: Not explicitly stated, but NIH funding implies a U.S. origin.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: One
Qualifications: An "experienced pediatric epileptologist independent of wired EEG and generally separated in time from the actual time of collection by over a year - to ensure appropriate experience, consistency, and minimization of bias."

4. Adjudication Method for the Test Set

Adjudication Method: None explicitly described beyond a single expert's retrospective review. The expert's review was the ground truth.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

MRMC Study Done? No. The document describes a retrospective review by a single expert to affirm the clinical value of the EEG records, not a comparative effectiveness study pitting human readers with vs. without AI assistance. The device is a physiological signal monitor, not an AI diagnostic tool in this context.

6. Standalone (Algorithm Only) Performance

Standalone Performance Done? The "Software Verification Testing" section describes end-to-end testing of the system (acquiring, transmitting, and making data viewable), which is essentially testing the algorithm's ability to process and present the data. It verifies the functionality of the system components and data integrity. However, it's not a standalone diagnostic performance study (e.g., sensitivity/specificity for a given condition), as the device "does not make any diagnostic conclusion about the subject's condition." Its essential performance is to record and transfer EEG data.

7. Type of Ground Truth Used

For Clinical Performance (Pediatric Extension): Expert consensus/review. The "experienced pediatric epileptologist" reviewed the REMI EEG data to assess its quality and presence of EEG features.
For Technical Performance (Software, Electrical, etc.): Predetermined engineering specifications, compliance with recognized standards, and functional verification.

8. Sample Size for the Training Set

The document does not mention a training set or machine learning model being the primary focus of this submission. The device is described as a "physiological signal monitor" that "does not make any diagnostic conclusion." The clinical experience discussed references "318 pediatric patients with a mean REMI Sensor wear of 1.7 days" from NIH-funded studies initially used for "REMI development efforts," which could have implicitly involved some level of data-driven development or refinement, but it's not explicitly framed as a "training set" for a distinct AI algorithm evaluated in this 510(k). The focus of this 510(k) is the extension of the device's indications to a younger pediatric age group and the new hydrocolloid sticker.

9. How the Ground Truth for the Training Set Was Established

As a training set is not explicitly referred to as part of a machine learning model specific to this 510(k)'s purpose, the method for establishing its ground truth is not detailed. The "REMI development efforts" data (n=318) was collected "under Institutional Review Board oversight." However, for the specific aspect of this 510(k) (pediatric extension), the ground truth for the test set (n=13) was established via retrospective review by an experienced pediatric epileptologist.

Summary

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

Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 21, 2025

Epitel. Inc. Christopher Phillips VP, Regulatory Affairs and Quality 465 S 400 E Suite 250 Salt Lake City, Utah 84111

Re: K243185

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: February 21, 2025 Received: February 21, 2025

Dear Christopher Phillips:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory

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

assistance/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,

Image /page/2/Picture/3 description: The image shows the name "Jaime Raben -S" in a large, bold font. The text is black and is set against a white background. The letters are clearly legible, and the name appears to be the main focus of the image.

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

{3}------------------------------------------------

Indications for Use

Submission Number (if known)

K243185

Device Name

REMI Remote EEG Monitoring System

Indications for Use (Describe)

REMI System uses the REMI Mobile software application that runs on qualified commercial off-theshelf 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.

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."

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

Image /page/4/Picture/0 description: The image shows the word "EPITEL" in a stylized, bold, sans-serif font. The letters are a dark blue color. There is a white line drawing of a waveform inside the letter "P". The letters are slightly rounded at the corners. To the right of the letter "L" is the trademark symbol.

REMI Remote EEG Monitoring Svstem Traditional 510(k) Summary

1. Applicant Information

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

Contact Information

Christopher M. Phillips VP, Regulatory Affairs and Quality

Date Prepared

February 21, 2025

2. Subject Device Information

Name of Device: REMI Remote EEG Monitoring System Common or Usual Name: EEG System Classification Name: Electroencephalograph, Electrode, Cutaneous Regulatory Class: Class II Product Code and Regulation Number: OMC - Sec. 882.1400. GXY Sec. 882.1320

3. Predicate Devices

Predicate Type	510(k) Number	Name of Device	Name of Manufacturer
Primary Predicate	K230933	REMI Remote EEGMonitoring System	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).

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 device (phone or 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

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

Image /page/5/Picture/0 description: The image shows the word "EPITEL" in a stylized, sans-serif font. The letters are a dark blue color. The "I" in "EPITEL" has a graphic of a waveform in the middle of the letter. There is a small "TM" symbol in the bottom right corner of the image.

where data is processed into a qualified EEG reviewing software format for neurological review.

This submission provides evidence to demonstrate that:

1. The REMI System is safe and effective for monitoring EEG of pediatric patients ages 1 through <6 years of age in all previously cleared use environments; and
1. A new/hydrocolloid REMI Sticker is safe and effective and is recommended for use with pediatric patients ages 1 through <6 years of aqe along with labeled instructions on daily skin-site checks.

5. Indications for Use

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 System 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 up to 30 days.

6. Predicate Selection

In alignment with FDA Draft Guidance Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission - Draft Guidance for Industry and Food and Drug Administration Staff, appropriate predicate devices have been selected. Potential predicates were reviewed and the REMI Remote EEG Monitoring System (K230933) was selected as it meets or exceeds the expected safety and performance. does not have unmitigated user-related or design related safety issues, and is not associated with any design-related recalls.

7. Substantial Equivalence

The REMI Remote EEG Monitoring System has been developed in compliance with applicable FDA requirements and guidance as well as with recognized standards. This submission includes required documentation and testing data demonstratial equivalence of the REMI Remote EEG Monitoring System to its predicate device. The REMI Remote EEG Monitoring System has undergone Biocompatibility Testing and Clinical Assessment which demonstrate that it is safe and effective for its intended use. Assessment of the technological characteristics, intended use, and conclusions drawn from the verification tests, presented in their respective sections of this submission, demonstrate that the device is as safe and effective as the legally marketed predicate devices.

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

Image /page/6/Picture/0 description: The image shows the word "EPITEL" in a stylized, sans-serif font. The letters are a dark blue color. A white waveform graphic is incorporated into the "P" of the word. The letters are bold and have a rounded appearance. The letters are evenly spaced, and the word is horizontally oriented. The letters "TM" are in the bottom right corner of the image.

7.1. Summary of Technological Characteristics and Substantial Equivalence to Predicate Devices

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

Image /page/7/Picture/0 description: The image shows the word "EPITEL" in a stylized, bold, blue font. The letters are large and blocky, with rounded edges. The "P" has a graphic of a waveform in the middle of it. There is a small "TM" in the bottom right corner of the image.

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

Image /page/8/Picture/0 description: The image shows the word "EPITEL" in a stylized, sans-serif font. The letters are a dark blue color. There is a graphic between the "E" and the "I" that resembles a waveform. The letters are bold and have rounded edges, giving the word a modern and professional look. The letters "TM" are in the bottom right corner.

8. Performance Data

The REMI Remote EEG Monitoring System was tested to verify its design and to validate its safe and effective use for the intended population and use environments. Results of this testing, included in this premarket notification, support a determination of substantial equivalence. Testing included the following:

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the word "EPITEL" in a stylized, sans-serif font. The letters are a dark blue color. There is a graphic of a waveform in the middle of the word, between the "E" and the "I". The letters are bold and have a slightly rounded appearance, and there is a "TM" symbol in the bottom right corner.

Test Type	Summary
General Electrical Safety,Electromagnetic Compatibilityand Ingress Protection	Testing conducted to:IEC 60601-1:2005, including Amendment 2:2021, Medical electrical equipment - Part1: General requirements for basic safety and essential performance,IEC 60601-1-2:2015, Medical electrical equipment – Part 1-2: General requirementsfor basic safety and essential performance - Collateral Standard: Electromagneticdisturbances - Requirements and testsIEC 60601-2-26:2015, Particular Requirements For The Basic Safety And EssentialPerformance Of ElectroencephalographsIEC 60601-1-11:2015 + A1:2021, Medical Electrical Equipment - Part 1-11: Generalrequirements for basic safety and essential performance - Collateral Standard:Requirements for medical electrical equipment and medical electrical equipment andmedical electrical systems used in the home healthcare environment
Wireless Technology Testing	Wireless functionality is needed for the REMI System to achieve its EssentialPerformance. Because of this, comprehensive EMC testing of the REMI System hasbeen conducted, including immunity to electromagnetic disturbance, in accordancewith IEC 60601-1-2 and consistent with the requirements of IEC 60601-1-11.REMI Sensor wireless connectivity was tested with the qualified computing platformoperating REMI Mobile and with REMI Cloud to demonstrate that wirelessconnections can be initiated, are stable, and are able to accurately transfer EEGsignals per FDA Guidance Radio Frequency Wireless Technology in Medical Devices.REMI Sensors were also tested to ensure that a wireless connection is able to bemaintained 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	Biocompatibility testing supporting long-term contact with intact skin was performedper ISO-10993-1 for all patient-contacting components that require premarketsubmission. Specific tests were completed according to ISO 10993-10,and ISO 10993-23.
Usability/ Human Factors	Human factors/usability testing was conducted to evaluate tasks associated with useof the device.
Software Verification Testing	REMI Mobile software end-to-end testing has been conducted to ensure that theREMI System meets its Essential Performance: to record digitized EEG data withpatient-applied sensors, and transfer the data, wirelessly, to a cloud-based archive.End to end testing verified that (1) the REMI System is able to acquire EEG signalsusing REMI Sensors and subsequently transmit that EEG data to REMI Mobilesoftware, (2) that REMI Mobile is able to transfer the EEG data to the REMI Cloud,and (3) the final EEG file format within REMI Cloud is viewable in qualified EEGviewing software. This testing demonstrates that the REMI System meets itsEssential Performance and fulfills system requirements.

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 its predicate device.

Clinical Experience 9.

Clinical experience provided in support of the subject device was gathered from NIH-funded

{10}------------------------------------------------

Image /page/10/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 graphic of a waveform in the middle of the word, between the letters "E" and "I". The letters are all capitalized, and there is a small "TM" symbol in the bottom right corner of the image.

studies conducted by Epitel in support of REMI development efforts, conducted under Institutional Review Board oversight (and registered under NCT03583957). REMI Sensors experience at a single pediatric-focused site involved 318 pediatric patients with a mean REMI Sensor wear of 1.7 days across both healthcare facility and ambulatory settings (ages 1-21).

Retrospective review of pediatric REMI EEG records gathered from 13 younger pediatric patients (ages 1 to <6 years) enrolled at the site was completed. This review of REMI EEG data was performed by an experienced pediatric epileptologist independent of wired EEG and generally separated in time from the actual time of collection by over a year - to ensure appropriate experience, consistency, and minimization of bias. The review consisted of checks for quality of the resulting EEG records and assessments for EEG features. The review affirmed that each resulting REMI EEG record could potentially bring value to the clinical care of the young pediatric patients. Of note, the pediatric epileptologist identified three REMI EEG records where REMI Sensors had captured a seizure event.

This Clinical Experience with REMI Sensors and resulting REMI EEG records supports a conclusion that use of the REMI System (including wear of REMI Sensors and new/hydrocolloid REMI Stickers) is safe and effective for monitoring EEG of pediatric patients ages 1 through <6 years of age in all previously cleared use environments.

Substantial Equivalence Conclusion 10.

The REMI Remote EEG Monitoring System 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, performance testing, and clinical experience to account for differences in technological characteristics as compared to the predicate, it can be concluded that the subject device, the 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 DeviceREMI Remote EEG Monitoring System	Predicate DeviceREMI Remote EEG Monitoring System(K230933)
ClassificationandRegulation	Class II per 21 CFR 882.1400Electroencephalograph (Head Set)Class II per 21 CFR 882.1320 (forelectrodes within sensors)	Class II per 21 CFR 882.1400Electroencephalograph (Head Set)Class II per 21 CFR 882.1320 (forelectrodes within sensors)
FDA ProductCode(s)	OMC - SystemGXY - Electrodes	OMC - SystemGXY - Electrodes
Intended Use	Acquisition and presentation of EEG data usingwearable sensors	Acquisition and presentation of EEG data usingwearable sensors
Indications forUse	The REMI Remote EEG Monitoring System isindicated for use in healthcare settings wherenear real-time and/or remote EEG is warrantedand in ambulatory settings where remote EEGis warranted. REMI System uses single use,single patient, disposable, wearable sensorsintended to amplify, capture, and wirelesslytransmit a single channel of electrical activity ofthe brain for a duration of up to 30 days.	The REMI Remote EEG Monitoring System(REMI System) is indicated for use in healthcaresettings where near real-time and/or remote EEGis warranted and in ambulatory settings whereremote EEG is warranted. REMI uses single use,single patient, disposable, wearable sensorsintended to amplify, capture, and wirelesslytransmit a single channel of electrical activity ofthe brain for a duration of up to 30 days.
	REMI System uses the REMI Mobile softwareapplication that runs on qualified commercialoff-the-shelf mobile computing platforms. REMIMobile displays user setup information totrained medical professionals and providesnotifications to medical professionals andambulatory users. REMI Mobile receives andtransmits data from connected REMI Sensorsto the secure REMI Cloud where it is stored andprepared for review on qualified EEG viewingsoftware.	REMI System uses the REMI Mobilesoftware application that runs on qualifiedcommercial off-the-shelf mobile computingplatforms. REMI Mobile displays user setupinformation to trained medical professionals andprovides notifications to medical professionalsand ambulatory users. REMI Mobile receivesand transmits data from connected REMISensors to the secure REMI Cloud where it isstored and prepared for review on qualified EEGviewing software.
	REMI System does not make any diagnosticconclusion about the subject's condition and isintended as a physiological signal monitor.REMI System is indicated for use with adult andpediatric patients (1+ years).	REMI does not make any diagnostic conclusionabout the subject's condition and is intended as aphysiological signal monitor. The REMI Systemis indicated for use with adult and pediatricpatients (6+ years).
UseEnvironment	The REMI System is indicated for use in healthcare settings for near real time and/or remoteEEG signal collection.	The REMI System is indicated for use in healthcare settings for near real time and/or remoteEEG signal collection.
	The REMI System is indicated for use inambulatory settings for remote EEG signalcollection.	The REMI System is indicated for use inambulatory settings for remote EEG signalcollection.
CumulativeWear Time	Up to 30 days. Prolonged contact.	Up to 30 days. Prolonged contact.
Software/SystemUser Interface	REMI Mobile medical application	REMI Mobile medical application
	The REMI Mobile application is run on qualifiedcommercial off-the-shelf computing platforms.	The REMI Mobile application is run on qualifiedcommercial off-the-shelf computing platforms.
Attribute	Subject DeviceREMI Remote EEG Monitoring System	Predicate DeviceREMI Remote EEG Monitoring System(K230933)
Sensor UserInterface	The REMI Sensor has a single push buttonintegrated into the sensor that serves as theuser interface. Some feedback about sensorstatus is given 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.
PhysiologicalSignal Acquired	EEG acquired from a patient's scalp	EEG acquired from a patient's scalp
Patient Contact	REMI Sticker accessory contacts the patient'sskin (scalp).	REMI Sticker accessory contacts the patient'sskin (scalp).
Electrodes	2 passive gold electrodes that interface with thescalp through a conductive hydrogel integratedinto the sticker.	2 passive gold electrodes that interface with thescalp through a conductive hydrogel integratedinto the sticker.
Type of Use	REMI sensor is a non-sterile, single-usedisposable device.	REMI sensor is a non-sterile, single-usedisposable device.
Channels	Up to 10	Up to 10
Montage	10/20 system – REMI Sensor can be placedanywhere in the 10/20 system where eachchannelrepresents a bipolar derivation approximation ofthe 10/20 system	10/20 system - REMI Sensor can be placedanywhere in the 10/20 system where eachchannelrepresents a bipolar derivation approximation ofthe 10/20 system
Electrical Safetyand EMC	IEC 60601-1,IEC 60601-1-2,IEC 60601-2-26,IEC 60601-1-11	IEC 60601-1,IEC 60601-1-2,IEC 60601-2-26,IEC 60601-1-11
Input Range(sensors)	1 mVp-p	1 mVp-p
Input Noise(sensors)	$5 \mu Vp-p$	$5 \mu Vp-p$
Transfer of Datafrom the sensorto REMI Mobile(operating on aqualifiedcomputingplatform)	Low power wireless personal area network(proprietary Bluetooth)	Low power wireless personal area network(proprietary Bluetooth)
Transfer of datafrom REMIMobile 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)
Attribute	Subject DeviceREMI Remote EEG Monitoring System	Predicate DeviceREMI Remote EEG Monitoring System(K230933)
Firmware(sensors)	REMI sensors use integrated firmware to collectand transmit EEG data to the REMI Mobileapplication.	REMI sensors use integrated firmware to collectand transmit EEG data to the REMI Mobileapplication.
Software (REMICloud)	The REMI Cloud receives EEG data from theREMI Mobile app and prepares it into a formatfor viewing in the qualified EEG viewingsoftware.	The REMI Cloud receives EEG data from theREMI Mobile app and prepares it into a formatfor viewing in the qualified EEG viewingsoftware.
	REMI Cloud also facilitates transfer andsubsequent receipt of EEG data for additionalcharacterization by EEG analysis module(s).	REMI Cloud also facilitates transfer andsubsequent receipt of EEG data for additionalcharacterization by EEG analysis module(s).
	REMI Cloud includes an additional functionalitythat makes EEG data available to compatiblemodule(s) for additional EEG datacharacterization.	REMI Cloud includes an additional functionalitythat makes EEG data available to compatiblemodule(s) for additional EEG datacharacterization.
Connector	REMI Sensors are equipped with anon-standard USB pinout/connector that is onlyused for programming during production. Thisinterface is not 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 isnot used by the clinician or patient.
Available Sizes(sensor)	REMI Sensor comes in one size:Width: 27 mmLength: 27 mmDepth: 7 mm	REMI Sensor comes in one size:Width: 27 mmLength: 27 mmDepth: 7 mm
ConductiveElectrolyte Gel(sticker)	Conductive electrolyte is in the form of ahydrogel converted in a one-piece adhesivesticker as an accessory to the REMI Sensor.The sticker is replaceable and single use.	Conductive electrolyte is in the form of ahydrogel converted in a one-piece adhesivesticker as an accessory to the REMI Sensor.The sticker is replaceable and single use.
Biocompatibility(sticker)	Biocompatibility of patient contactingcomponents verified with Cytotoxicity,Sensitization, and Irritation for long-term use.	Biocompatibility of patient contactingcomponents verified with Cytotoxicity,Sensitization, and Irritation for < 30 day use.