# K240993: encevis (2.1)

- Pathway: 510(k) (Traditional)
- Applicant: Ait Austrian Institute of Technology GmbH
- Decided: Sep 27, 2024 after 169 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: 4 generations back to K830295 (1983). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211452: Encevis, Austrian Institute of Technology GmbH (2021) Summary page 8.
- K132306: Persyst 12 Eeg Review and Analysis Software, Persyst Development Corp. (2013) Summary page 8.
- K223504: Ceribell Status Epilepticus Monitor, Ceribell, Inc. (2023) Summary page 8.
- K191301: Ceribell Pocket EEG Device, Ceribell, Inc. (2019) Summary page 8.

## Most influential descendants
- K261712: Ceribell EEG Analysis Software (2026), 0 descendants of its own
- K260998: Ceribell Neurology Review Software (2026), 0 descendants of its own

## Indications for use
1. encevis is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. 2. The seizure detection component of encevis is intended to mark previously acquired sections of adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the standard 10/20-system. 3. The spike detection component of encevis is intended to mark previously acquired sections of the patient's EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The Spike detection component is intended to be used in adult patients greater than or equal to 18 years. encevis Spike detection performance has not been assessed for intracranial recordings. 4. encevis includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include frequency bands, rhythmic and periodic patterns, burst suppression and spectrogram. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. 5. The aEEG functionality included in encevis is intended to monitor the state of the brain. 6. encevis provides notifications on an on-screen display for seizure detection, electrographic status epilepticus detection, spike detection, quantitative EEG and aEEG that can be used when processing a record during acquisition (online) or based on stored EEG files (offline). Notifications can also be provided to external systems via the external interfaces to make them accessible to the user through the external system in a human-readable format. Delays of up to several minutes can occur between the beginning of a seizure, electrographic status epilepticus, the occurrence of a spike or detection of quantitative EEG features and when the encevis notifications will be shown to a user. encevis notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert. 7. encevis PureEEG (Artifact Reduction) is intended to reduce EMG and electrode artifacts in a standard 10-20 EEG recording. PureEEG does not remove the entire artifact signal and is not effective for other types of artifacts. PureEEG may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifact, and any interpretation or diagnosis must be made with reference to the original waveforms. 8. This device does not provide any diagnostic conclusion about the patient's condition to the user. 9. The encevis Component for Detection of Seizures and Electrographic Status Epilepticus is indicated for the detection of Seizures and Electrographic Status Epilepticus in patients greater than or equal to 18 years of age who are at risk for seizures. The Component for Detection of Seizures and Electrographic Status Epilepticus of encevis analyzes EEG waveforms and identifies patterns that may be consistent with seizures and electrographic status epilepticus as defined in the American Clinical Neurophysiology Society's Guideline 14. EEG recordings should be obtained with a full scalp montage according to the standard 10/20-system. The diagnostic output does also include a measure of seizure prevalence ("seizure burden") within a 10 minute (short-term seizure burden) and a 60 minute (hourly seizure burden) moving window. The output of the Component for Detection of Seizures and Electrographic Status Epilepticus of encevis is intended to be used as a diagnostic output for determining patient treatment in acute-care environments. Detections from the Component for Detection of Seizures and Electrographic Status Epilepticus of encevis provide one input to the clinician that is intended to be used in conjunction with other elements of clinical practice to determine the appropriate treatment course for the patient. The Component for Detection of Seizures and Electrographic Status Epilepticus of encevis is intended for detection of electrographic status epilepticus only. The Component for Detection of Seizures and Electrographic Status Epilepticus of encevis does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns. The Component for Detection of Seizures and Electrographic Status Epilepticus of encevis is not intended for use in Epilepsy Monitoring Units.

Source page: https://510kreport.com/device/K240993
Methodology: https://510kreport.com/methodology