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Neuro Omega System: The Neuro Omega System with the incorporated HaGuide Software, including the Drive Headstage unit, is intended to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes. The Neuro Omega System with the incorporated HaGuide Software is also intended: - To monitor, record, and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record, and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). - To measure, record, and display the electrical activity of the patient's brain obtained from two or more electrodes on the head (EEG). - To measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes. - To provide stimulation via electrode pairs or a hand-held bipolar probe for use in functional brain mapping procedures during treatment of patients with a seizure disorder. The Neuro Omega System with the incorporated installed HaGuide Software, is intended for intraoperative use by medical personnel. Within hospitals, laboratories, clinics, or nursing home settings or outside of a medical facility under the direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording. NeuroSmart System: The NeuroSmart System with the incorporated HaGuide Software, is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, to record from and stimulate brain motor and to aid in the placement of depth electrodes

The cleared devices under K220553, the HaGuide Software incorporated in Neuro Omega/NeuroSmart systems, is designed to detect the STN region, it detects the entrance and exit boundaries of STN regions. Furthermore, it presents real-time graphs of power spectrum density and the normalized root mean square (nRMS) of the region. The HaGuide Software consists of the following components: - Patient Dashboard: The Patient Dashboard is comprised of a list of patients/cases that the user added, providing a user-friendly way to manage the surgery cases. - Planning Setup: The Planning Setup is used by the user to setup the surgery planning. - Trajectory Setup: The Trajectory Setup is used by the user to setup trajectory. - MER/HaGuide: MER/HaGuide is comprised of: - Real-time Microelectrode Recording (MER) signal processing, presented as o Normalized Root Mean Square (NRMS) and Power Spectrum Density (PSD) graphs, to assist the user to interpret the signals. - MER notes taking adding notes and tags to specific site location to o document and annotate the signals. - HaGuide Recommendation: Detection of the Subthalamic Nucleus (STN) o borders, including the Intra STN detection of Dorsolateral Oscillatory Region (DLOR) and Ventromedial Non-Oscillatory Region (VMNR) boundary. - Operation Room Report Upload – Cloud: The OR report uploading feature is used to export the case data and HaGuide graphs and HaGuide recommendation securely to the cloud. - Raw Data Upload – Cloud: The raw data uploading feature is used to upload the raw recording data files securely to the cloud for offline processing The HaGuide Software can work in three setups: - 1. The HaGuide Software can be installed on the Neuro Omega/NeuroSmart PC and used on the system. - 2. The HaGuide Software can be installed on an external PC as a standalone software for the purpose of working in off-line mode with no connection to the system. In all setups the safety and effectiveness of the Neuro Omega/NeuroSmart systems isn't compromised, as the HaGuide Software is a non-blocking software (it doesn't affect the system's functionality even in malfunction). The HaGuide Software can run on both modes without affecting the Neuro Omega/NeuroSmart systems safety and effectiveness, nor its functionality.

The Neuro Omega system with the incorporated Navigation Tool software (the improved HaGuide software), including the Drive Headstage unit, is intended to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes. The subject device, the Neuro Omega System with the incorporated Navigation Tool software is also intended: - To monitor, record, and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record, and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG). - To measure, record, and display the electrical activity of the patient's brain obtained from two or more electrodes on the head (EEG). - To measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes. - To provide stimulation via electrode pairs or a hand-held bipolar probe for use in functional brain mapping procedures during treatment of patients with a seizure disorder. The Neuro Omega with the incorporated installed Navigation tool software, is intended for intraoperative use by medical personnel. Within hospitals, laboratories, clinics, or nursing home settings or outside of a medical facility under the direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording. The NeuroSmart System with the incorporated Navigation Tool software, is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes.

The Neuro Omega system is designed for different neurosurgery and neurophysiologic clinical applications including recording from and stimulating brain motor and sensory neurons to accurate navigation of electrodes for neurosurgery target localization in treatment of movement disorders by and to aid in the placement of depth electrodes. The device is also designed for measuring bioelectric signals produced by muscles and stimulating peripheral nerves to aid in the diagnosis of neuromuscular disease (EMG). The device may also be used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG). The Neuro Omega System may also be used to measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes. The Neuro Omega System may also be used to provide stimulation via electrode pairs or a hand-held bipolar probe for use in functional brain mapping procedures during the treatment of patients with a seizure disorder. The subject device, the Neuro Omega incorporated the installed Navigation Tool software (the improved HaGuide software) is a real-time software incorporated in electrophysiological recording and stimulating systems (like: Neuro Omega and NeuroSmart systems). The tool is designed to detect the STN region (improved HaGuide Tool as was cleared under K171581 for Neuro Omega & K172042 for NeuroSmart), it detects the entrance and exit boundaries of STN regions. The tool gives the user a stimulation location recommendation. Furthermore, the tool presents real-time graphs of power spectrum density and RMS of STN region. The Navigation Tool can aid in the placement of a compatible DBS Lead when the lead is connected to the cleared Alpha Omega Disposable Sterile LeadConfirm (K191739) and to the Neuro Omega System. This feature allows the user to record through the implanted lead and based on the recordings show simple spectral measures (PSD) within the frequency bands of interest. Based on the recordings from the lead, and the NeuroProbe MicroElectrode recordings, this feature shows the correlation in frequency band between both these recordings. When the subject device, the Neuro Omega incorporated the installed Navigation tool is connected to the internet, the relevant intraoperative data collected during DBS surgery can be uploaded to Alpha Omega's cloud by the physician for Neurologist use. This information will assist the Neurologist in programming of the Implantable Pulse Generator (IPG). Alpha Omega's NeuroSmart system physiological navigation system is accurate, aiding the neurosurgeons during functional neurosurgery for placing Deep Brain Stimulation (DBS) electrodes. The NeuroSmart system can record signals from the brain cells or stimulate the brain target zone during the operation procedure. The subject device, the NeuroSmart incorporated the installed Navigation Tool software improved HaGuide software) is a real-time software incorporated in (the electrophysiological recording and stimulating systems (like: Neuro Omega and Neuro Smart systems). The tool is designed to detect the STN, it detects the entrance and exit boundaries of STN regions. The tool gives the user a stimulation location recommendation. Furthermore, the tool presents real-time graphs of power spectrum density and RMS of each region. The Navigation Tool can aid in the placement of a compatible DBS Lead when the lead is connected to the cleared Alpha Omega Disposable Sterile LeadConfirm (K191739) and to the NeuroSmart System. This feature will allow the user to record through the implanted lead and based on the recordings show simple spectral measures (PSD) within the frequency bands of interest. Based on the recordings from the lead and the NeuroProbe MicroElectrode recordings, this feature shows the correlation in frequency band between both these recordings. When the subject device, the NeuroSmart incorporated the installed Navigation tool is connected to the internet, the relevant intraoperative data collected during DBS surgery can be uploaded to Alpha Omega's cloud by the physician for Neurologist use. This information will assist the Neurologist in programming the Implantable Pulse Generator (IPG). The Navigation Tool SW can work in two modes: - 1. The Navigation Tool can be installed on the Neuro Omega/ NeuroSmart Systems. - 2. The Navigation Tool can work as a standalone software, for that purpose it can be installed on external PC to work in off-line mode. In both modes the safety and effectiveness of the Neuro Omega and NeuroSmart systems are not compromised, as the Navigation Tool software is a non-blocking software (it doesn't affect the system's functionality even in malfunction). The Navigation Tool software can run in both modes without affecting the Neuro Omega system safety and effectiveness, nor its functionality. The main use of the Navigation tool SW when it runs as a standalone software, is for visual purpose only, meaning to receive data from the systems and present it in graphs. No changes are made to the retrieved data. Furthermore, the data will be used for verification only for the neurologist prior to fine-tuning the IPG work mode by using the IPG interface (not Alpha Omega's device). The Navigation Tool provides an option to upload raw data and OR reports to the Alpha Omega server. - . The raw data include the MER .mpx files and the workspace files that were saved during the surgery by the Neuro Omega or NeuroSmart system (if enabled by the user). - The OR report includes all the HaGuide parameters, OR notes, stimulation . assessments, and lead recording. The Alpha Omega server adheres to industry cybersecurity standards. The Navigation Tool Software in both its modes, as a standalone software and a software installed on Neuro Omega/NeuroSmart systems, can upload data for storage via secured protocols (FTPS, HTTPS) to Alpha Omega server using the internet connectivity. Neuro Omega/NeuroSmart software does not upload data to any web server. They are able to connect locally to the Navigation Tool, which is the only channel through which data can be uploaded to Alpha Omega server. The Navigation Tool cannot download or retrieve any data from Alpha Omega server.

The Alpha Omega Disposable Sterile LeadConfirm for MER is intended to be used in neurosurgery for connecting a compatible DBS Lead to a compatible recording and stimulation device. The Alpha Omega Disposable Sterile LeadConfirm for MER is indicated for assisting Neurosurgeons, in the operating room during functional neurosurgery, to aid in the placement of a compatible DBS Lead. The Alpha Omega Disposable Sterile LeadConfirm should only be used to connect a compatible DBS Lead to a compatible recording and stimulation device.

Alpha Omega's Sterile LeadConfirm cable and adaptor connects the DBS lead to Alpha Omega's approved physiological navigation systems for recording and stimulation system: Neuro Omega (K171581) and NeuroSmart (K172042). The purpose of the submission is to introduce the Sterile LeadConfirm Cable and Adaptor, the subject devices are sterile Hardware only. There are three types of the subject device, Alpha Omega's Sterile LeadConfirm Cables: - 1) Sterile LeadConfirm M Cable that connects to Medtronic Lead P960009 (3389, 3387) - 2) Sterile LeadConfirm B Cable that connects to Boston Scientific Lead P150031 (BSC-DB-2201, BSC-DB-2202) - 3) Sterile LeadConfirm A Cable that connects to Abbott Lead P140009 (6170/ 6171/ 6172/ 6173/ 6178/ 6170/ 6180/ 6181) In addition, there are two types of Sterile LeadConfirm Adaptors: - 1) Sterile LeadConfirm M Adaptor - 2) Sterile LeadConfirm A Adaptor AOE (Alpha Omega Engineering) stimulation with LeadConfirm cable and adaptor is identical to IPG/ test stimulator, with the following parameters: - a) Pulse shape: Square wave, Lili pulse - b) Amplitude up to 12mA - c) Duration up to 500uSec

The NeuroNav System / NeuroSmart System, incorporated the installed HaGuide software, is intended to be used in assisting neurosurgeons, in the operating functional neurosurgery, and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrode. The NeuroNav Drive is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, to aid in the placement of depth electrodes.

Alpha Omega's NeuroNav System is an accurate electrodes navigation system to aid the neurosurgeon in placement of DBS electrodes. The system is designed to be used in the operating room during neurosurgery. The NeuroNav Drive system is designed for compatibility with Alpha Omega's Microprobes (NeuroProbes K120098) or with other manufacturers' compatible electrodes, and is compatible with all the existing Stereotactic Frames and Frameless procedures. NeuroNav system can record signals from the brain cells (Micro-Electrode Recording -MER) or stimulate the brain target zone during movement disorders neurosurgery procedure. In addition, the NeuroNav system is planned to include additional sub model, will be traded as "NeuroSmart", this sub model is identical to the NeuroNav system, the subject device, and incorporated the installed HaGuide software, will be elaborated hereunder. The installed HaGuide software is a user option tool, which is a real-time software solution designed to accurately detects the Sub Thalamic Nucleus region, its entrance and exit boundaries as well gives the user a stimulation location recommendation. The HaGuide software robustly detects intra STN detection of Dorso lateral Oscillatory Region (DLOR) and Ventro Medical Non-Oscillatory Region (VMNR) boundary.

The Neuro Omega System, including the NeuroDrive unit, is intended to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes. The Neuro Omega System is also intended to monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (EMG).The device may also be used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG). The device is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.

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