# K240408: REMI-AI Rapid Detection Module (REMI-AI RDM)

- Pathway: 510(k) (Traditional)
- Applicant: Epitel, Inc.
- Decided: Oct 17, 2024 after 251 days
- Product code: OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K830295 (1983). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191301: Ceribell Pocket EEG Device, Ceribell, Inc. (2019) Summary page 5.
- K231779: REMI AI Discrete Detection Module, Epitel, Inc. (2024) Summary page 5.

## Indications for use
The REMI-AI Rapid Detection Module (REMI-AI ROM) 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 ROM has not been validated for and is not indicated for detection of electrographic status epilepticus. REMI-AI ROM 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 ROM does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. REMI-AI ROM is indicated for use with adult and pediatric patients (6+ years).

Source page: https://510kreport.com/device/K240408
Methodology: https://510kreport.com/methodology