(90 days)
The REMI Platform is intended to be used in healthcare settings where near real-time and/or remote EEG is warranted. REMI consists of Epilog disposable Sensors - a single patient, disposable, wearable sensor intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for up to 48 hours. The REM-Mobile software and REMI-Tablet are intended to receive and transmit data from four Epilog Sensors to secure cloud storage for subsequent viewing and reviewing of EEG on third-party software.
REMI does not make any diagnosis or recommendations and is intended only as a physiological signal monitor. Epilog Sensors are intended for use by trained medical professional healthcare facility environment.
Epilog Sensors are intended for use with adult and pediatric patients (6+). (Rx only).
REMI amplifies the electroencephalogram (EEG) from a patient's scalp. After amplification, the EEG are sent to the REMI-Tablet running the REMI-Mobile Application. REMI-Mobile combines the EEG from four Epilog Sensors and patient information and relays the data to a cloud server running Persyst software. The EEG data is accessible through the Persyst Mobile interface. REMI is designed for use with adult and pediatric patients (6+). The user interface for the REMI-Tablet is an 10" LCD touchscreen display.
The user interface for Epilog Sensors is a single button kevpad overmolded in each Sensor, REMI-Tablet power is through A/C adapter as well as limited onboard rechargeable battery. Epilog Sensor power is through a single-use primary coin cell. Using its wireless link, the Epilog Sensors can exchange EEG data and commands with the REMI-Mobile application running on the REMI-Tablet.
REMI has three major components:
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Epilog-D disposable EEG sensors,
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REMI-Mobile - mobile OS application designed to run on a medical-grade tablet, acquire EEG data transmitted from Epilog devices along with user-entered patient and device information, and then transmit the EEG data and patient/device information via wireless encrypted WiFi to.
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REMI-Cloud – A HIPAA-compliant cloud storage and data processing platform where data is processed into a format that a FDA-cleared (K171184) EEG reviewing software called Persyst can use, which will allow remote neurological review.
The firm Epitel, Inc. did not conduct a clinical study to prove the device meets acceptance criteria. Instead, they performed non-clinical performance testing and biocompatibility testing. The device is a physiological signal monitor and does not make diagnoses or recommendations. Therefore, the information provided below is a summary of the non-clinical and biocompatibility tests performed.
1. A table of acceptance criteria and the reported device performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Testing | ||
| Electrical Safety | Compliance with IEC 60601-1 (General requirements for safety of medical electrical equipment) | Compliance was demonstrated. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (EMC - Requirements and Tests) | Compliance was demonstrated for both emissions and immunity. |
| Electroencephalograph Specific Safety | Compliance with IEC 60601-2-26 (Particular requirements for the safety of electroencephalographs) | Compliance was demonstrated. |
| FCC/IC Intentional Radiator | Compliance with FCC Part 15 Radiated Emissions and Class B Conducted Emissions | Compliance was demonstrated. |
| Biocompatibility Testing | ||
| Irritation | Verified through testing per ISO 10993-10:2010 | Testing was performed per ISO 10993-10:2010, verifying biocompatibility. The Epilog Sticker was tested for prolonged (>24 hour but 24 hour but 24 hour but |
§ 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).