encevis (2.1)

K240993 · Ait Austrian Institute of Technology GmbH · OMB · Sep 27, 2024 · Neurology

Device Facts

• Record ID: K240993
• Device Name: encevis (2.1)
• Applicant: Ait Austrian Institute of Technology GmbH
• Product Code: OMB · Neurology
• Decision Date: Sep 27, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

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. 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. 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. 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. The aEEG functionality included in encevis is intended to monitor the state of the brain. 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. 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. This device does not provide any diagnostic conclusion about the patient's condition to the user. 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.

Device Story

encevis 2.1 is an integrated software package for EEG review and analysis. It processes EEG data from external systems either offline (stored files) or online (real-time streaming via API). The device includes modules for artifact reduction (PureEEG), seizure detection (NeuroTrend), spike detection (EpiSpike), and pattern detection (rhythmic/periodic patterns, burst suppression, aEEG, spectrogram). It provides on-screen notifications and quantitative measures (seizure burden) to assist neurologists and clinicians in acute-care environments. The software does not provide diagnostic conclusions; clinicians use the output alongside raw EEG review to determine treatment. Benefits include faster detection of electrographic status epilepticus (ESE) prior to manual review, potentially enabling earlier clinical intervention. The device is intended for use by qualified medical practitioners in professional healthcare facilities.

Clinical Evidence

Bench and clinical performance testing conducted. Seizure detection sensitivity (PPA) 93.8% (95% CI 87.0-97.7%) vs 77.3% for Persyst 12. ESE detection PPA 82.6% (95% CI 60.9-95.7%) and NPA 91.4% (95% CI 81.0-96.6%). Spike detection PPA 84.8% vs 8.7% for Persyst. Artifact reduction (PureEEG) demonstrated non-inferiority to Persyst in SNR and clean EEG suppression. Pattern detection sensitivity 81.86% (ANY) and 69.73% (PD). Burst suppression sensitivity 87%, specificity 92%.

Technological Characteristics

Software-based EEG analysis platform. Inputs: scalp EEG data from external systems (offline files or online streaming). Algorithms: rule-based and AI-based detection modules. Connectivity: standalone desktop or integrated via API (AITInterfaceDLL, SeizureICUInterface). No hardware components; no calibration required. Software verification/validation per IEC 62366-1.

Indications for Use

Indicated for review, monitoring, and analysis of scalp EEG recordings in adult patients (>=18 years) to aid neurologists in assessment. Includes detection of electrographic seizures, spikes, and electrographic status epilepticus (ESE) in acute-care environments for patients at risk of seizures. Provides quantitative EEG measures (frequency bands, rhythmic/periodic patterns, burst suppression, spectrogram, aEEG) and artifact reduction (PureEEG). Not for use in Epilepsy Monitoring Units for ESE detection.

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

• encevis 1.12 Review and Analysis Software (K211452)
• Persyst 12 EEG Review and Analysis Software (K132306)
• Ceribell Status Epilepticus Monitor (K223504)
• Ceribell Pocket EEG Device (K191301)

Submission Summary (Full Text)

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September 27, 2024

AIT Austrian Institute of Technology GmbH Tilmann Kluge Official Correspondent Giefinggasse 4 Vienna, Vienna 1210 Austria

Re: K240993

Trade/Device Name: encevis (2.1) Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OMA, OLT Dated: April 11, 2024 Received: April 11, 2024

Dear Tilmann Kluge:

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.

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"

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(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 OS 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 Rue"). 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-devices/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 mediation-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).

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Sincerely,

Image /page/2/Picture/3 description: The image shows the text "Patrick Antkowiak -S" to the right of the letters "FDA". The letters "FDA" are in a light blue color, while the name is in black. The letters "FDA" are much larger than the name.

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

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# Indications for Use

Submission Number (if known)

K240993

Device Name

encevis (2.1)

#### Indications for Use (Describe)

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.

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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.

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)

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# 510(k) summary encevis 2.1

# Table of contents

| 1 | Submission Sponsor and Application Correspondent | 2 |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----|
| 2 | Date Prepared | 2 |
| 3 | Device Identification | 2 |
| 4 | Legally Marketed Predicate Devices | 3 |
| 5 | Device description | 3 |
| 5.1 | encevis EEG-viewer | 3 |
| 5.2 | Artefact reduction encevis PureEEG | 3 |
| 5.3 | Seizure detection of encevis NeuroTrend | 3 |
| 5.4 | Detection of seizures and status epilepticus of encevis acute care | 4 |
| 5.5 | Spike detection encevis EpiSpike | 4 |
| 5.6 | Pattern detection and aEEG | 4 |
| 5.7 | Spectrogram | 4 |
| 5.8 | External Interface „encevis AITInterface“ | 4 |
| 5.9 | External Interface „encevis SeizureICUInterface“ | 5 |
| 6 | Indication for Use Statement | 5 |
| 7 | Substantial Equivalence Discussion | 6 |
| 7.1 | Comparison to Primary and Secondary Predicate Device | 6 |
| 7.2 | Comparison to Tertiary and Quaternary Predicate Devices | 11 |
| 7.3 | Comparison of Intended Use and Technological Characteristics with the Predicate Devices | 16 |
| 7.3.1 | Indications for Use Comparison | 16 |
| 7.3.1.1 | General Use | 16 |
| 7.3.1.2 | Seizure detection component | 16 |
| 7.3.1.3 | Spike detection component | 17 |
| 7.3.1.4 | Calculation of quantitative measures | 17 |
| 7.3.1.5 | Calculation of aEEG | 17 |
| 7.3.1.6 | Notifications on an on-screen display | 17 |
| 7.3.1.7 | Artifact Reduction | 18 |
| 7.3.1.8 | Diagnostic output | 18 |
| 7.3.1.9 | Component for Detection of Seizures and Electrographic Status Epilepticus | 18 |
| 7.3.2 | Technological Characteristics Comparison | 19 |
| 7.3.2.1 | User | 19 |
| 7.3.2.2 | Use enivronment | 19 |
| 7.3.2.3 Input Data | 19 | |
| 7.3.2.4 Patient registration method | 20 | |
| 7.3.2.5 Output | 20 | |
| 7.3.2.6 Mode of operation | 20 | |
| 8 Non-Clinical performance Data | 20 | |
| 9 Clinical Performance Data | 21 | |
| 9.1 Seizure detection performance testing | 21 | |
| 9.2 Detection of seizure and status epilepticus for acute care performance testing | 22 | |
| 9.3 encevis spike detection performance testing | 27 | |
| 9.4 encevis artifact reduction performance testing | 28 | |
| 9.5 encevis rhythmic and periodic patterns performance testing | 32 | |
| 9.6 encevis aEEG performance testing | 34 | |
| 9.7 encevis frequency bands performance testing | 35 | |
| 9.8 encevis burst suppression performance testing | 35 | |
| 10 encevis spectrogram performance testing | 36 | |
| 11 Statement of Substantial Equivalence | 37 | |

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# 1 Submission Sponsor and Application Correspondent

AIT Austrian Institute of Technology GmbH Giefinggasse 4 1210 Vienna – Austria Phone: [phone] [phone] Fax: eMail: [e-mail]

# 2 Date Prepared

August 26, 2024

# 3 Device Identification

| Trade/Proprietary Name: | encevis |
|----------------------------|-----------------------|
| Common Name: | Electroencephalograph |
| Classification Regulation: | 21CFR882.1400 |
| Product Code: | OMB, OLT, OMA |
| Class: | II |
| Panel: | Neurology |

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| Primary Predicate: | K211452 | encevis 1.12 Review and Analysis Software |
|--------------------------|---------|---------------------------------------------|
| Additional<br>Predicate: | K132306 | Persyst 12 EEG Review and Analysis Software |
| Additional<br>Predicate: | K223504 | Ceribell Status Epilepticus Monitor |
| Additional<br>Predicate: | K191301 | Ceribell Pocket EEG Device |

# 4 Legally Marketed Predicate Devices

# 5 Device description

encevis combines several modalities for viewing and analyzing EEG data in one integrated software package. The software package can be used both as a standalone desktop application for opening and analyzing stored EEG files (offline mode) and as a module for integration into external EEG systems via the provided API interfaces, enabling the processing of real-time streaming data in online mode. encevis consists of the following modalities:

### 5.1 encevis EEG-viewer

The encevis EEG-viewer is intended for the review and the analysis of EEG-recordings that were recorded with an electroencephalography device using scalp electrodes. It shall aid the user in the examination of EEG-recordings. This includes the frequency filtering of the data, the scaling of the data in x and y direction, display of video together with the EEG data, and the visualization in different montages. In addition, the encevis EEG-viewer can also start modules that automatically analyze the EEG and present the results in form of notifications or in the form of modified EEG-curves. All included modules are intended for the user in the examination and monitoring of EEGrecordings.

### 5.2 Artefact reduction encevis PureEEG

The artefact reduction encevis PureEEG is an analysis module that automatically recognizes and reduces in the EEG-data that come from EMG and electrode artefacts. This modality is available within EEG viewer or via external software interface.

#### 5.3 Seizure detection of encevis NeuroTrend

The seizure detection of encevis NeuroTrend is a module for the automatic marking of areas in the EEG that could correspond to epileptic seizures with electrographic correlate. The seizure detection of encevis NeuroTrend makes the results available to the user. This analysis can take place during the recording ("online"), which is recommended due to minimal notifiation delays. Alternatively the analysis can be done post-hoc with previoulsy stored EEG files ("offline"). To minimize notification delay for detected seizures, offline analyses should be done in regular, short time intervals.

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#### 5.4 Detection of seizures and status epilepticus of encevis acute care

Detection of seizures and electrographic status epilepticus of encevis acute care is a module for the automatic marking of areas in the EEG recorded in acute care patients that could correspond to epileptic seizures with electrographic correlate. It also identifies patterns that may be consistent with electrographic status epilepticus. The detection of seizures and status epilepticus of encevis acute care makes the results available to the user in form of seizure notifications and seizure burden over time. encevis recommends to perform this analysis during the recording ("online") to minimize notifiation delays by using an external EEG system that support the external interfaces for online processing. Alternatively the analysis can be done post-hoc with previously stored EEG files ("offline"). To minimize notification delay for detected seizures or detected electrographic status epilepticus, offline analyses should be done in regular, short time intervals.

#### 5.5 Spike detection encevis EpiSpike

The spike detection encevis EpiSpike is a module for the automatic marking of areas in the EEG that could correspond to spikes. A graphical user interface presents the results to the user. This analysis can take place during the recording ("online") or post-hoc with previoulsy stored EEG files ("offline").

#### 5.6 Pattern detection and aEEG

The encevis pattern detection of encevis NeuroTrend and encevis acute care automatically detects EEGpatterns defined in the Standardized Critical Care EEG Terminology of the American Clinical Neurophysiology Society and graphically presents the results to the user. Additionally, it detects and visualizes rhythmic patterns with frequencies of up to 12Hz and Burst-Suppression. It serves as a support during the examination of EEG-recordings in the EMU and acute care. This post-hoc analysis can take place in parallel to the recording or after the recording finished. In addition, encevis NeuroTrend and encevis acute care calculate and visualize continuous measures that describe the EEG. This includes the analysis of the frequency distribution and the aEEG. This analysis can take place during the recording ("online") or post-hoc with previoulsy stored EEG files ("offline").

#### 5.7 Spectrogram

The encevis spectrogram graphically provides the user with a spectrogram for all or a selected number of EEG channels within a defined time range.

#### 5.8 External Interface "encevis AlTInterface"

The external interface "encevis AlTInterface" enables the control of encevis by a software system of an EEG manufacturer. The interface allows to start the modules, to transmit EEG data to the modules, and to receive results at the calling software. This interface allows manufacturers of EEG systems to directly integrate encevis into their recording software. encevis viewer, encevis artifact reduction, and encevis spectrogram can not be controlled by the external AlTInterface. If encevis is used via the "AlTInterfaceDLL" external interface and without encevis graphical user interface, results and notifications are made available via the "AITInterface. In this scenario, the device using the external interface must ensure that the results and notifications are accessible to the user without avoidable delay.

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#### 5.9 External Interface "encevis SeizureICUInterface"

The external interface "encevis SeizurelCUnterface" allows the "encevis detection of seizures " to be integrated into a software system of an EEG manufacturer. The interface allows to start the module "encevis detection of seizures and status epilepticus", to transmit EEG data to the module and to receive results at the calling software. This interfacae allows manufacturers of EEG systems to directly integrate the module "encevis detection of seizures and status epilepticus" into their recording software. If encevis Seizure/CUInterface" external interface and without encevis graphical user interface, results and notifications are made available via the "SeizurelCUnterface" external interface. In this scenario, the external interface must ensure that the results and notifications are accessible to the user without avoidable delay,

# 6 Indication for Use Statement

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 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 EEG by a trained expert.

7. encevis PureEG (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 Epileptious 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

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analyzes EEG waveforms and identifies patterns that may be consistent with seizures and electrographic status epiledicus 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.

# 7 Substantial Equivalence Discussion

The following table compares the encevis to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

| | Subject Device | Primary Predicate Device | Secondary Predicate Device |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | encevis 2.1 | encevis 1.12 | Persyst 12<br>EEG Review and Analysis Software |
| Device Identification | | | |
| 510k Reference | (subject device) | K211452 | K132306 |
| Product Code | OMB | OMB | OMB |
| Additional Codes | OLT, OMA | OLT, OMA | OLT, OMA |
| Class | II | II | II |
| Regulation<br>Number | 21CFR882.1400 | 21CFR882.1400 | 21CFR882.1400 |
| Regulation Name | Electroencephalograph | Electroencephalograph | Electroencephalograph |
| Manufacturer | AIT Austrian Institute of<br>Technology GmbH | AIT Austrian Institute of Technology<br>GmbH | Persyst Development Corporation |
| Device Description and Identification | | | |
| General Device<br>Description | EEG Review and Analysis<br>Software | EEG Review and Analysis Software | EEG Review and Analysis Software |
| Indication for<br>Use<br>General use | 1. encevis is intended for the<br>review, monitoring and analysis of<br>EEG recordings made by<br>electroencephalogram (EEG)<br>devices using scalp electrodes and<br>to aid neurologists in the<br>assessment of EEG. This device is<br>intended to be used by qualified<br>medical practitioners who will<br>exercise professional judgment in<br>using the information. | 1. encevis is intended for the<br>review, monitoring and analysis of<br>EEG recordings made by<br>electroencephalogram (EEG)<br>devices using scalp electrodes and<br>to aid neurologists in the<br>assessment of EEG. This device is<br>intended to be used by qualified<br>medical practitioners who will<br>exercise professional judgment in<br>using the information. | 1. Persyst 12 EEG Review and<br>Analysis Software is intended for the<br>review, monitoring and analysis of<br>EEG recordings made by<br>electroencephalogram (EEG)<br>devices using scalp electrodes and<br>to aid neurologists in the assessment<br>of EEG. This device is intended to be<br>used by qualified medical<br>practitioners who will exercise<br>professional judgment in using the<br>information. |
| Indication for<br>Use: Seizure<br>detection | 2. The seizure detection<br>component of encevis is intended<br>to mark previously acquired<br>sections of adult (greater than or<br>equal to 18 years) EEG recordings<br>that may correspond to<br>electrographic seizures, in order to<br>assist qualified clinical practitioners<br>in the assessment of EEG traces.<br>EEG recordings should be obtained<br>with a full scalp montage according<br>to the standard 10/20-system. | 2. The seizure detection component<br>of encevis is intended to mark<br>previously acquired sections of adult<br>(greater than or equal to 18 years)<br>EEG recordings that may<br>correspond to electrographic<br>seizures, in order to assist qualified<br>clinical practitioners in the<br>assessment of EEG traces. EEG<br>recordings should be obtained with<br>a full scalp montage according to<br>the standard 10/20-system. | 2. The Seizure Detection component<br>of Persyst 12 is intended to mark<br>previously acquired sections of adult<br>(greater than or equal to 18 years)<br>EEG recordings that may correspond<br>to electrographic seizures, in order to<br>assist qualified clinical practitioners<br>in the assessment of EEG traces.<br>EEG recordings should be obtained<br>with a full scalp montage according<br>to the standard 10/20 system. |
| Indication for<br>Use: Spike<br>detection | 3. The spike detection component<br>of encevis is intended to mark<br>previously acquired sections of the<br>patient's EEG recordings that may<br>correspond to spikes, in order to<br>assist qualified clinical practitioners<br>in the assessment of EEG traces.<br>The Spike detection component is<br>intended to be used in adult<br>patients greater than or equal to 18<br>years. encevis Spike detection<br>performance has not been<br>assessed for intracranial<br>recordings. | 3. The spike detection component of<br>encevis is intended to mark<br>previously acquired sections of the<br>patient's EEG recordings that may<br>correspond to spikes, in order to<br>assist qualified clinical practitioners<br>in the assessment of EEG traces.<br>The Spike Detection component is<br>intended to be used in adult patients<br>greater than or equal to 18 years.<br>encevis Spike Detection<br>performance has not been<br>assessed for intracranial recordings. | 3. The Spike Detection component of<br>Persyst 12 is intended to mark<br>previously acquired sections of the<br>patient's EEG recordings that may<br>correspond to spikes, in order to<br>assist qualified clinical practitioners<br>in the assessment of EEG traces.<br>The Spike Detection component is<br>intended to be used in patients at<br>least one month old. Persyst 12<br>Spike Detection performance has not<br>been assessed for intracranial<br>recordings. |
| Indication for<br>Use: Quantitative<br>measures | 4. encevis includes the calculation<br>and display of a set of quantitative<br>measures intended to monitor and<br>analyze the EEG waveform. These<br>include frequency bands, rhythmic<br>and periodic patterns, burst<br>suppression and spectrogram.<br>These quantitative EEG measures<br>should always be interpreted in<br>conjunction with review of the<br>original EEG waveforms. | 4. Persyst 12 includes the calculation<br>and display of a set of quantitative<br>measures intended to monitor and<br>analyze the EEG waveform. These<br>include FFT, Rhythmicity, Peak<br>Envelope, Artifact Intensity,<br>Amplitude, Relative Symmetry and<br>Suppression Ratio. Automatic event<br>marking is not applicable to the<br>quantitative measures. These<br>quantitative EEG measures should<br>always be interpreted in conjunction<br>with review of the original EEG<br>waveforms. | |
| Indication for<br>Use: aEEG | 5. The aEEG functionality included<br>in encevis is intended to monitor<br>the state of the brain. | 5. The aEEG functionality included in<br>Persyst 12 is intended to monitor the<br>state of the brain. The automated<br>event marking function of Persyst 12<br>is not applicable to aEEG. | |
| Indication for<br>Use: Notifications | 6. encevis provides notifications on<br>an on-screen display for seizure<br>detection, electrographic status<br>epilepticus detection, spike<br>detection, quantitative EEG and<br>aEEG that can be used when<br>processing a record during<br>acquisition (online) or based on<br>stored EEG files (offline).<br>Notifications can also be provided<br>to external systems via the external<br>interfaces to make them accessible<br>to the user through the external<br>system in a human-readable<br>format.<br>Delays of up to several minutes<br>can occur between the beginning of<br>a seizure, electrographic status<br>epilepticus, the occurrence of a<br>spike or detection of quantitative<br>EEG features and when the<br>encevis notifications will be shown<br>to a user. encevis notifications<br>cannot be used as a substitute for<br>real time monitoring of the<br>underlying EEG by a trained<br>expert. | 6. Persyst 12 provides notifications<br>for seizure detection, quantitative<br>EEG and aEEG that can be used<br>when processing a record during<br>acquisition. These include an on<br>screen display and the optional<br>sending of an email message.<br>Delays of up to several minutes can<br>occur between the beginning of a<br>seizure and when the Persyst 12<br>notifications will be shown to a user.<br>Persyst 12 notifications cannot be<br>used as a substitute for real time<br>monitoring of the underlying EEG by<br>a trained expert. | |
| Indication for<br>Use: Artifact<br>reduction | 7. encevis PureEEG (Artifact<br>Reduction) is intended to reduce<br>EMG and electrode artifacts in a<br>standard 10-20 EEG recording.<br>PureEEG does not remove the<br>entire artifact signal and is not<br>effective for other types of artifacts.<br>PureEEG may modify portions of<br>waveforms representing cerebral<br>activity. Waveforms must still be<br>read by a qualified medical<br>practitioner trained in recognizing<br>artifact, and any interpretation or<br>diagnosis must be made with<br>reference to the original<br>waveforms. | 7. encevis PureEEG (Artifact<br>Reduction) is intended to reduce<br>EMG, eye movement, and electrode<br>artifacts in a standard 10-20 EEG<br>recording. PureEEG does not<br>remove the entire artifact signal,<br>and is not effective for other types of<br>artifacts. PureEEG may modify<br>portions of waveforms representing<br>cerebral activity. Waveforms must<br>still be read by a qualified medical<br>practitioner trained in recognizing<br>artifact, and any interpretation or<br>diagnosis must be made with<br>reference to the original waveforms. | 7. Persyst AR (Artifact Reduction) is<br>intended to reduce EMG, eye<br>movement, and electrode artifacts in<br>a standard 10-20 EEG recording. AR<br>does not remove the entire artifact<br>signal, and is not effective for other<br>types of artifacts. AR may modify<br>portions of waveforms representing<br>cerebral activity. Waveforms must<br>still be read by a qualified medical<br>practitioner trained in recognizing<br>artifact, and any interpretation or<br>diagnosis must be made with<br>reference to the original waveforms. |
| Indication for<br>Use: Diagnostic<br>output | 8. This device does not provide any<br>diagnostic conclusion about the<br>patient's condition to the user.…