REMI-AI Rapid Detection Module (REMI-AI RDM)

K240408 · Epitel, Inc. · OMB · Oct 17, 2024 · Neurology

Device Facts

• Record ID: K240408
• Device Name: REMI-AI Rapid Detection Module (REMI-AI RDM)
• Applicant: Epitel, Inc.
• Product Code: OMB · Neurology
• Decision Date: Oct 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device, PCCP, Pediatric

Intended Use

The REMI-AI Rapid Detection Module (REMI-AI RDM) is a seizure detection module which is integrated into the REMI Remote EEG Monitoring System and is only indicated for use within non-ICU (Intensive Care Unit) healthcare settings. REMI-AI RDM has not been validated for and is not indicated for detection of electrographic status epilepticus. REMI-AI RDM conducts automated analysis of REMI EEG data in near real-time and provides notifications of potential electrographic seizures (events) through the REMI System when seizure prevalence of 10% or greater (indicating seizure activity of at least 30 seconds within a 5-minute rolling window) is detected. When seizure prevalence is displayed, the notification also displays the corresponding event detection confidence. Notifications are intended to be used by qualified clinicians who will exercise professional judgment in their application. Detected events are also annotated in the associated REMI EEG record as an aide to the qualified physician's REMI EEG review. Delays of up to several minutes may occur between the detection of an event and the generation of an event notification, and are thus not a substitute for real-time monitoring. REMI-AI RDM does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. REMI-AI RDM is indicated for use with adult and pediatric patients (6+ years).

Device Story

REMI-AI RDM is a seizure detection software module integrated into the REMI Remote EEG Monitoring System. It processes EEG signals acquired from scalp sensors in near real-time. The device analyzes the last 5 minutes of EEG data using a rolling window; it identifies potential electrographic seizures when prevalence reaches ≥10% (≥30 seconds of activity). Outputs include notifications of potential seizures, prevalence percentages, and confidence levels (Low, Moderate, High, Very High) displayed via the REMI Mobile application; events are also annotated in the EEG record. Used in non-ICU healthcare settings by qualified clinicians to assist in EEG review and clinical assessment. It does not provide diagnostic conclusions or treatment recommendations. Delays of several minutes between event occurrence and notification mean it is not a substitute for real-time monitoring. Benefits include automated identification of seizure events to support clinician decision-making.

Clinical Evidence

Clinical validation used 44 patient records (22 with seizures, 22 without). Primary endpoints: Event-level sensitivity >70% and False Alarm Rate (FAR) <0.446 FP/hr. Results: Event-level sensitivity >70% (95% CI lower bound 78.9%); FAR <0.35 FP/hr (95% CI upper bound 0.164). Subject-level sensitivity was 92.5%. Study included focal, focal-to-generalized, and generalized seizures.

Technological Characteristics

Software-based automatic event detection for EEG. Analyzes 5-minute rolling windows of EEG data. Provides prevalence and confidence metrics. Interoperable with REMI Remote EEG Monitoring System via wireless data transfer. Software includes a Predetermined Change Control Plan (PCCP) for algorithm updates.

Indications for Use

Indicated for adult and pediatric patients (6+ years) in non-ICU healthcare settings for automated analysis of EEG data to detect potential electrographic seizures. Not indicated for electrographic status epilepticus.

Regulatory Classification

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.

Predicate Devices

• Ceribell Pocket EEG Device (Seizure Detection Module) (K191301)
• REMI-AI Discrete Detection Module (RDM) (K231779)

Submission Summary (Full Text)

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October 17, 2024

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

Re: K240408

Trade/Device Name: REMI-AI Rapid Detection Module (REMI-AI RDM) Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB Dated: September 16, 2024 Received: September 17, 2024

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.

FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not

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required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.

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 (QS) 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.

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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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Submission Number (if known)

K240408

Device Name

REMI-AI Rapid Detection Module (REMI-AI RDM)

#### Indications for Use (Describe)

The REMI-AI Rapid Detection Module (REMI-AI RDM) is a seizure detection module which is integrated into the REMI Remote EEG Monitoring System and is only indicated for use within non-ICU (Intensive Care Unit) healthcare settings. REMI-AI RDM has not been validated for and is not indicated for detection of electrographic status epilepticus.

REMI-AI RDM conducts automated analysis of REMI EEG data in near real-time and provides notifications of potential electrographic seizures (events) through the REMI System when seizure prevalence of 10% or greater (indicating seizure activity of at least 30 seconds within a 5-minute rolling window) is detected. When seizure prevalence is displayed, the notification also displays the corresponding event detection confidence. Notifications are intended to be used by qualified clinicians who will exercise professional judgment in their application. Detected events are also annotated in the associated REMI EEG record as an aide to the qualified physician's REMI EEG review.

Delays of up to several minutes may occur between the detection of an event and the generation of an event notification, and are thus not a substitute for real-time monitoring. REMI-AI RDM does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. REMI-AI RDM is indicated for use with adult and pediatric patients (6+ years).

Type of Use (select one or both as applicable)

| | <span>☑</span> Prescription Use (21 CFR 801 Subpart D) |
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|--|--------------------------------------------------------|

ver-The-Counter Use (21 CFR 801 Subpart C)

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# REMI-AI Rapid Detection Module (REMI-AI RDM) 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

October 9, 2024

#### 2. Subject Device Information

Name of Device: REMI-AI Rapid Detection Module (REMI-AI RDM) Common or Usual Name: EEG System Classification Name: Automatic Event Detection Software For Full-Montage Electroencephalograph Regulatory Class: Class II Product Code and Regulation Number: OMB - Sec. 882.1400

#### 3. Predicate Devices

| Predicate Type | 510(k) Number | Name of Device | Name of Manufacturer |
|---------------------|---------------|-------------------------------------------------------------|----------------------|
| Primary Predicate | K191301 | Ceribell Pocket EEG<br>Device<br>(Seizure Detection Module) | Ceribell, Inc. |
| Secondary Predicate | K231779 | REMI-AI Discrete Detection<br>Module (RDM) | Epitel, Inc. |

#### 4. Device Description

REMI-AI RDM conducts automated analysis of EEG data collected by the REMI System in near real-time. REMI-AI RDM provides notifications of the prevalence and confidence of potential electrographic seizures, having a combined prevalence of 10% or greater, which correlates with a duration of at least 30 seconds of activity within a rolling 5 minute window of EEG.

REMI-AI RDM notifications are presented through the REMI Mobile software application, and are intended to be used by qualified clinicians who will exercise professional judgment in their interpretation. Notifications include the prevalence and confidence value for the event and are marked in the associated EEG record in order to assist qualified clinicians in their assessment.

REMI-AI RDM notifications identify when a section of EEG is consistent with seizure characteristics it has been trained to recognize. When a notification is presented, clinical context and facility procedures should inform next steps in patient evaluation and management. REMI-AI RDM does not make any treatment or management recommendations.

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Delays of up to several minutes may occur between the start of an event, the detection of an event and the generation of an event notification, and are thus not a substitute for real-time monitoring.

#### 5. Indications for Use

The REMI-AI Rapid Detection Module (REMI-AI RDM) is a seizure detection module which is intecrated into the REMI Remote EEG Monitoring System and is only indicated for use within non-ICU (Intensive Care Unit) healthcare settings. REMI-AI RDM has not been validated for and is not indicated for detection of electrographic status epilepticus.

REMI-AI RDM conducts automated analysis of REMI EEG data in near real-time and provides notifications of potential electrographic seizures (events) through the REMI System when seizure prevalence of 10% or greater (indicating seizure activity of at least 30 seconds within a 5-minute rolling window) is detected. When seizure prevalence is displayed. the notification also displays the corresponding event detection confidence. Notifications are intended to be used by qualified clinicians who will exercise professional judgment in their application. Detected events are also annotated in the associated REMI EEG record as an aide to the qualified physician's REMI EEG review.

Delays of up to several minutes may occur between the detection of an event and the generation of an event notification, and are thus not a substitute for real-time monitoring. REMI-Al RDM does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. REMI-AI RDM is indicated for use with adult and pediatric patients (6+ years).

#### 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 Ceribell Pocket EEG Seizure Detection module primary predicate device 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. A secondary predicate was selected in the REMI-Al Discrete Detection Module as a secondary predicate in order to support some technological characteristics. The secondary predicate also 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

REMI-AI RDM 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 demonstrating substantial equivalence of REMI-AI RDM to its predicate device. REMI-AI RDM has undergone Software Testing, Human Factors/Usability testing, and Clinical Validation 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 leqally marketed predicate devices.

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

| Attribute | Subject Device<br>REMI-AI Rapid Detection Module | Primary Predicate Device<br>Ceribell Pocket EEG Device<br>(K191301) | Secondary Predicate Device<br>REMI-Al Discrete Detection Module<br>(K231779) |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification and<br>Regulation | Class II per 21 CFR 882.1400<br>Electroencephalograph | Class II per 21 CFR 882.1400<br>Electroencephalograph | Class II per 21 CFR 882.1400<br>Electroencephalograph |
| FDA Product<br>Code(s) | OMB - Automatic Event Detection<br>Software | OMB - Automatic Event Detection<br>Software<br>OMC - Reduced Montage System<br>GWQ - Full Montage System<br>GXY - Electrodes | OMB - Automatic Event Detection<br>Software |
| Intended Use | Analysis of EEG signal data for<br>detection of seizure events | Analysis of EEG signal data for<br>detection of seizure events | Analysis of EEG signal data for<br>detection of seizure events |
| Indications for Use | The REMI-AI Rapid Detection<br>Module (REMI-AI RDM) is a seizure<br>detection module which is<br>integrated into the REMI Remote<br>EEG Monitoring System and is only<br>indicated for use within non-ICU<br>(Intensive Care Unit) healthcare<br>settings. REMI-AI RDM has not<br>been validated for and is not<br>indicated for detection of<br>electrographic status epilepticus.<br>REMI-AI RDM conducts automated<br>analysis of REMI EEG data in near<br>real-time and provides notifications<br>of potential electrographic seizures<br>(events) through the REMI System<br>when seizure prevalence of 10% or<br>greater (indicating seizure activity of<br>at least 30 seconds within a 5-<br>minute rolling window) is detected.<br>When seizure prevalence is<br>displayed, the notification also<br>displays the corresponding event<br>detection confidence. Notifications<br>are intended to be used by qualified<br>clinicians who will exercise<br>professional judgment in their<br>application. Detected events are<br>also annotated in the associated<br>REMI EEG record as an aide to the<br>qualified physician's REMI EEG<br>review.Delays of up to several<br>minutes may occur between the<br>detection of an event and the<br>generation of an event notification,<br>and are thus not a substitute for<br>real-time monitoring. REMI-AI RDM<br>does not make any | The Ceribell Pocket EEG Device is<br>intended to record and store EEG<br>signals, and to present the EEG<br>signals in visual and audible<br>formats in real time. The visual and<br>audible signals assist trained<br>medical staff to make neurological<br>diagnoses. The Pocket EEG Device<br>is intended to be used in a<br>professional healthcare facility<br>environment.<br>Additionally, the EEG Recording<br>Viewer Software component of the<br>Pocket EEG Device incorporates a<br>Seizure Detection component that<br>is intended to mark previously<br>acquired sections of EEG<br>recordings in patients greater than<br>or equal to 18 years of age that<br>may correspond to electrographic<br>seizures in order to assist qualified<br>clinical practitioners in the<br>assessment of EEG traces. The<br>Seizure Detection component<br>provides notifications to the user<br>when detected seizure prevalence<br>is "Frequent," "Abundant," or<br>"Continuous," per the definitions of<br>the American Clinical<br>Neurophysiology Society Guideline<br>14. Notifications include an<br>on-screen display on the Pocket<br>EEG Device and the optional<br>sending of an e-mail message to a<br>clinician. Delays of up to several<br>minutes can occur between the<br>beginning of a seizure and when<br>the Seizure Detection notifications | The REMI-AI Discrete Detection<br>Module (REMI-AI DDM) is indicated<br>for the analysis of REMI<br>Remote EEG Monitoring System<br>electroencephalogram (EEG)<br>recordings.<br>REMI-AI DDM is<br>intended to be used by physicians<br>qualified to analyze and interpret<br>EEG who will exercise professional<br>judgment in using the information.<br>As an aide to the qualified<br>physician's REMI EEG review,<br>REMI-AI DDM marks previously<br>acquired sections of REMI EEG<br>that may correspond to neurological<br>events of interest indicative of<br>potential electrographic seizures<br>lasting at least 10 seconds in<br>duration. REMI-AI DDM is indicated<br>for use with adult and pediatric<br>patients (6+ years).<br>REMI-AI DDM does not mark REMI<br>EEG records in real time and does<br>not provide any diagnostic<br>conclusion about the patient's<br>condition to the user. |
| Attribute | Subject Device<br>REMI-AI Rapid Detection Module | Primary Predicate Device<br>Ceribell Pocket EEG Device<br>(K191301) | Secondary Predicate Device<br>REMI-AI Discrete Detection Module<br>(K231779) |
| | diagnostic conclusion about the<br>subject's condition and is intended<br>as a physiological signal monitor.<br>REMI-AI RDM is indicated for use<br>with adult and pediatric patients (6+<br>years). | will be shown to a user.<br>The Pocket EEG Device does not<br>provide any diagnostic conclusion<br>about the subject's condition and<br>Seizure Detection notifications<br>cannot be used as a substitute for<br>real time monitoring of the<br>underlying EEG by a trained expert. | |
| Seizure event<br>detection module | REMI-AI RDM is a seizure<br>detection module that analyzes the<br>last 5 minutes of EEG in a rolling<br>window and identifies seizure<br>events. | The Ceribell Pocket EEG seizure<br>detection module analyzes the last<br>5 minutes of EEG in a rolling<br>window and identifies seizure<br>events. | REMI-AI DDM detects<br>electrographic events in previously<br>acquired EEG data. |
| Seizure event<br>notifications | When a seizure event is detected, a<br>notification is generated. These<br>notifications are provided to the<br>REMI System (K230933) for<br>interoperable display on the REMI<br>Mobile software.<br>Notifications include identifying an<br>event that has been detected and<br>provides the prevalence values and<br>algorithm confidence.<br>Event notifications are also<br>annotated in the EEG record. | When a seizure event is detected, a<br>notification is generated. The<br>Seizure Detection module also<br>provides notifications of detected<br>seizure by displaying an on-screen<br>message on the Ceribell EEG<br>Recorder and the optional sending<br>of an email message | No notifications are generated |
| Seizure<br>prevalence | Seizure prevalence is calculated for<br>the 5-minute rolling window.<br>Notifications and annotations<br>include of:<br>• Prevalence values presented as<br>a percentage which can range<br>from 10% to 100%. | Seizure prevalence (defined as<br>seizure burden, or the percentage<br>of time epochs classified as<br>seizure) is calculated for the<br>5-minute rolling window.<br>Notifications and annotations<br>include of:<br>• Frequent seizure detected if<br>seizure burden is 10% (30<br>seconds or more)<br>• Abundant seizure if greater than<br>or equal to 50%<br>• Continuous if greater than or<br>equal to 90% | Seizure prevalence is not<br>calculated.<br>No seizure prevalence notifications<br>or annotations |
| Event confidence | Confidence is calculated for<br>detected events. Confidence is a<br>measure that the event is not a<br>false positive.<br>Notifications and annotations<br>includes of: | Event confidence is not calculated.<br>No event confidence included in<br>notifications or annotations | Confidence is calculated for<br>detected events. Confidence is a<br>measure that the event is not a<br>false positive.<br>No notifications are presented. |
| | • Event confidence presented as<br>Low, Moderate, High, or Very | | Annotations consist of:<br>• Event confidence presented as |
| Attribute | Subject Device<br>REMI-AI Rapid Detection Module | Primary Predicate Device<br>Ceribell Pocket EEG Device<br>(K191301) | Secondary Predicate Device<br>REMI-AI Discrete Detection Module<br>(K231779) |
| | High (along with corresponding<br>percentage ranges) | | Low, Moderate, High, or Very<br>High (along with corresponding<br>percentage ranges) |
| Time before<br>notifications may<br>be presented | Several minutes | Several minutes | Not applicable |
| Seizure event<br>review | REMI-AI RDM will annotate EEG<br>records to identify the detected<br>seizure event to aid in EEG review.<br>These events are provided to the<br>REMI System. | Ceribell EEG Portal includes a<br>seizure detection module that will<br>mark EEG records to identify the<br>detected seizure event to aid in<br>EEG review. | REMI-AI DDM will annotate EEG<br>records to identify the detected<br>seizure event to aid in EEG review.<br>These events are provided to the<br>REMI System. |
| | The REMI System stores EEG<br>records in a standard EEG format<br>for viewing in a qualified EEG<br>viewing software.…