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EpiMonitor is a prescription only medical device system composed of a wearable device "EmbracePlus" and paired mobile software application "EpiMonitor" intended as an adjunct to seizure monitoring in adults and children aged 6 and up in a home environment or healthcare facilities. The device is worn on the wrist and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with either primary or secondary generalized tonic clonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, the wearable device component of EpiMonitor sends a command to a paired mobile device where the EpiMonitor App is programmed to initiate an alert to a designated caregiver. The EpiMonitor app incorporates additional detection sensitivity modes, "high" for use during periods of rest or sleeping or "low" for use during periods of low-intensity activity, in order to reduce false alarm incidents. EpiMonitor records, stores and transmits accelerometer, EDA, peripheral skin temperature and activity data for subsequent retrospective review by a trained healthcare professional via a cloud-based software.

The EpiMonitor system consists of a wearable device and mobile application: - A wearable medical device called EmbracePlus, - A mobile application running on smartphones called "EpiMonitor" The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors, these data are continuously analyzed by an on-board algorithm (EpiAlgo 2.1), which assesses the physiological data and determines if the user may be undergoing a generalized tonic-clonic seizure (GTCS). The EpiAlgo has been validated through testing, using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center, from epilepsy patients experiencing GTCSs in hospital Epilepsy Monitoring Units. When a likely GTCS is detected, EmbracePlus sends, via Bluetooth Low Energy, a message to the EpiMonitor app. The EpiMonitor app communicates to the Empatica Cloud which initiates, through the external provider a voice call and SMS text message is sent to summon the attention of user-designated caregiver(s). In addition to initiating alerts, the EpiMonitor app also continuously receives all the raw sensor data collected by the EmbracePlus. These data are analyzed by one of the EpiMonitor app software modules, EmpaDSP (paragraph 2.3.2), which computes the additional physiological parameters, such as activity during sleep and peripheral skin temperature. The EpiMonitor App is also responsible for transmitting, over a cellular data plan or Wi-Fi connection the sensors' raw data, device information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, and made available to healthcare providers via a specific cloud-based software called Care Monitoring Portal.

The EpiWatch Monitoring System is a prescription, software-only mobile medical application intended for use with a compatible wrist-worn device as an adjunct to seizure monitoring of adults and children ages 5 and up in home or healthcare settings during periods of rest. The EpiWatch Monitoring System continuously records, stores, displays, and transfers data from the compatible wristworn device's built-in physiological-based sensors to support review by healthcare professionals, and people with epilepsy (PWE) or at risk of epilepsy. When the EpiWatch Monitoring System detects and logs physiological patterns associated with generalized tonic-clonic seizures (TCS), the EpiWatch Monitoring System application alerts the identified caregiver(s) to notify of detected possible seizure events.

The EpiWatch Monitoring System is a non-electroencephalogram (non-EEG) physiological signalbased seizure monitoring system. It is similar to other legally-marketated non-electroencephalogram (non-EEG) physiological signal-based seizure monitoring systems. The EpiWatch Monitoring System consists of a software-only mobile medical application intended for use with a compatible wrist-worn device as an adjunct to seizure monitoring of adults and children ages 5 and up. EpiWatch Monitoring System is a software platform composed of: - A compatible wrist-worn device, (e.g. an Apple Watch) - A mobile application running on smartphones called the "EpiWatch Monitoring System . App". The wrist-worn device continuously collects raw data via specific sensors, and feeds consolidated physiological data to the EpiWatch app via APIs. Utilizing a proprietary algorithm, EpiWatch analyzes and assesses the physiological data and determines if there is suspected generalized tonicclonic seizure activity (TCS). The EpiWatch algorithm has been validated through testing, using the gold-standard video electroencephalogram (vEEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center, of epilepsy patients experiencing TCSs in hospital Epilepsy Monitoring Units. When a likely TCS is detected, the EpiWatch Monitoring System App communicates to the EpiWatch Cloud which initiates, through an external provider, a voice call, email and an SMS text message (notification parameters are set by the user at contact setup) to summon the attention of caregiver(s). In addition to initiating alerts, the EpiWatch app also continuously receives all the sensor data collected by the wrist worn device. The EpiWatch App is also responsible for transmitting-over a cellular data plan or Wi-Fi connection-the API data, device information, and computed physiological parameters to the EpiWatch Cloud for further review and storage, which allows seizure reports and other features added to alerting. It also provides necessary information about the state of the system.

EpiMonitor is a prescription only medical device system composed of a wearable device "EmbracePlus" and paired mobile software application "EpiMonitor" intended as an adjunct to seizure monitoring in adults and children aged 6 and up in a home environment or healthcare facilities. The device is worn on the wrist and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with either primary or secondary generalized tonic clonic clonic clonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, the wearable device component of EpiMonitor sends a command to a paired mobile device where the EpiMonitor App is programmed to initiate an alert to a designated caregiver. The EpiMonitor app incorporates additional detection sensitivity modes, "high" for use during periods of rest or sleeping or "low" for use during periods of low-intensity activity, in order to reduce false alarm incidents. EpiMonitor records, stores and transmits accelerometer. EDA, peripheral skin temperature and activity data for subsequent retrospective review by a trained healthcare professional via a cloud-based software.

The EpiMonitor system consists of a wearable device and mobile application: - A wearable medical device called EmbracePlus, - A mobile application running on smartphones called "EpiMonitor" The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors, these data are continuously analyzed by an on-board algorithm (EpiAlgo 2.1), which assesses the physiological data and determines if the user may be undergoing a generalized tonic-clonic seizure (GTCS). The EpiAlgo has been validated through testing, using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center, from epilepsy patients experiencing GTCSs in hospital Epilepsy Monitoring Units. When a likely GTCS is detected, EmbracePlus sends, via Bluetooth Low Energy, a message to the EpiMonitor app. The EpiMonitor app communicates to the Empatica Cloud which initiates, through the external provider a voice call and SMS text message is sent to summon the attention of userdesignated caregiver(s). In addition to initiating alerts, the EpiMonitor app also continuously receives all the raw sensor data collected by the EmbracePlus. These data are analyzed by one of the EpiMonitor app software modules, EmpaDSP (paragraph 2.3.2), which computes the additional physiological parameters, such as activity during sleep and peripheral skin temperature. The EpiMonitor App is also responsible for transmitting, over a cellular data plan or Wi-Fi connection the sensors' raw data, device information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, and made available to healthcare providers via a specific cloud-based software called Care Monitoring Portal.

The SPEAC® System is intended for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The non-EEG Physiological Signal Based Seizure Monitoring System continuously records and stores surface electromyographic (sEMG) data for subsequent review. Trained healthcare professionals may use the electrophysiological sEMG data during a post-hoc review, with other contextual data, to characterize upper-extremity motor activity (UEMA) ipsilateral to the activity. Audio data recorded during seizure monitoring may be available for review by a trained healthcare professional. The device is to be used on the belly of the biceps muscle to analyze sEMG signals. When sEMG signal patterns associated with a unilateral, appendicular, tonic extension that could be associated with a GTC seizure are detected, the SPEAC System sends adjunctive alarms to alert caregivers. Adjunctive alarms may be disabled by a physician order while continuing to record sEMG data for subsequent review.

The SPEAC System is a wireless, non-invasive, physiological, surface electromyography (sEMG) recording, monitoring, and alerting system to be used as an adjunct to seizure monitoring during periods of rest. The System continuously records and stores surface electromyographic (sEMG) data for subsequent review by a physician. Trained healthcare professionals may use the electrophysiological sEMG data, with other contextual data, to characterize seizures with upper-extremity motor activity ipsilateral to the device from other activity. SPEAC data gives healthcare professionals another diagnostic tool to characterize seizure events in a home or hospital setting. The System continuously records and distributes sEMG data at 1,000 Hz (and audio around detected events) for post-hoc review by physicians (or other trained healthcare professionals) for the characterization of seizure events. A physician may perform post-hoc review of the SPEAC System data to characterize motor events that may be associated with seizures. The seizure monitoring algorithm is able to send alarms to notify patients and caregivers when a pattern that may be associated with a generalized tonic-clonic (GTC) seizure is measured. Physicians may order the System with or without alarms and may order threshold adjustments to customize the level at which the System alarms. Data collected by the System is uploaded to Brain Sentinel's secure remote storage, the Data Distribution System (DDS), and is remotely accessible for physician review. All patient data is cyber-secured within Microsoft Azure which is FedRAMP certified. The SPEAC System remains the same with no alterations of any kind. The sEMG-based seizure monitoring algorithm is identical to the predicate SPEAC System. The purpose of this submission is to expand the indications for use based on clinical performance testing that was submitted to support a determination of substantial equivalence. When trained appropriately, clinicians may use the subject device to perform post-hoc analysis of the sEMG data from the device, with other contextual patient data, to characterize seizures with upper-extremity motor activity ipsilateral to the device from other activity.

The SPEAC® System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The System records and stores surface electromyographic (sEMG) data for subsequent review by a trained healthcare professional. The device is to be used on the belly of the biceps muscle to analyze sEMG signals that may be associated with generalized tonic-clonic (GTC) seizures. When sEMG signal patterns associated with a unilateral, appendicular, tonic extension that could be associated with a GTC seizure are detected, the SPEAC System sends adjunctive alarms to alert caregivers. Adjunctive alarms may be disabled by a physician order while continuing to record sEMG data for subsequent review.

The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System (Predicate), is a physiological, surface electromyography (sEMG) monitor with or without alarms that records and stores data for review by a physician for characterization of seizure events. The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with an algorithm using the default threshold or by a modified threshold ordered by the physician. The sEMG monitor is worn unilaterally on the belly of the patient's biceps and it analyzes for sEMG GTC seizures and provide local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that may be associated with such seizures that are detected. The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced with the second sEMG Monitor on the opposite arm of the patient. The sEMG that is removed after 24-hours is then attached to a Base Station. By connecting the sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base Station. The recorded data is then automatically uploaded to Brain Sentinel's cloudbased storage unit, Data Distribution System (DDS), where they await review by a physician. All patient data is cyber-secured within Microsoft Azure which is FedRAMP certified.

The Embrace is a prescription only device that is indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. The device is worn on the wrist and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with generalized tonic clonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired wireless device that is programmed to initiate an alert to a designated caregiver. The System records and stores data from Accelerometer, EDA, and Temperature sensors for subsequent review by a trained healthcare professional.

The Embrace is a wearable biosensor device that can capture, store, and wirelessly transmit sensor data via Bluetooth to a paired remote device. Embrace runs an on-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTCS). The algorithm has been validated on data, labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 6 epilepsy centers, from epilepsy patients experiencing GTCSs in hospital Epilepsy Monitoring Units. When a likely GTCS is detected, the Embrace sends a message to the Alert smartphone application, which initiates calls and texts to summon the attention of designated caregivers. The device also enables patients to manually record seizure events, and provides contextual information related to activity and sleep.

The Embrace is a prescription only device that is indicated for use as an adjunct to seizure monitoring of adults in home or healthcare facilities during periods of rest. The device is worn on the wrist, and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with generalized tonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired wireless device that is programmed to initiate an alert to a designated caregiver. The System records and stores data from Accelerometers, EDA, and Temperature for subsequent review by a trained healthcare professional.

The Embrace is a wearable biosensor device that can capture, store, and wirelessly transmit sensor data via Bluetooth to a paired remote device. Embrace runs an on-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTC). The algorithm has been validated on data, labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center, from epilepsy patients experiencing GTCs in hospital Epilepsy Monitoring Units. When a likely GTC is detected, the Embrace sends a message to the Alert smartphone application, which initiates calls and texts to summon the attention of designated caregivers.

The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic (GTC) seizures and to provide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.

The Brain Sentinel Monitoring and Alerting System is a sEMG-based system for identifying sEMG activity that may be associated with generalized tonic-clonic seizures (GTCS). The device has two main components: the sEMG monitor and the base station. The sEMG monitor is worn on the patient's upper arm and monitors EMG activity in the arm via cutaneous electrodes connected to the sEMG monitor. Upon identification of sEMG activity, the monitor communicates wirelessly to the base station, which alerts a healthcare provider or caregiver in one or more ways (e.g., audible alarm, text message, e-mail, etc.).