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The VEEGix EEG System, is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the forehead and wirelessly transmitting the electroencephalographic (EEG) signals for storage and display. The VEEGix EEG System, is intended for use in the acquisition of EEG signals, displaying them in real time and storing them for later review and analysis. The VEEGix EEG System, is intended for use in a hospital Operating Room. Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings. The VEEGix EEG System is indicated for use on patients 18 years of age or older and is to be used by licensed medical professionals who have been adequately trained in the use and interpretation of EEG data for determination of brain state. The VEEGix EEG System does not provide any diagnostic conclusion about the patient's condition. The VEEGix EEG System is not to be used as a stand-alone in the evaluation or diagnosis of a disease or other condition. The VEEGix EEG System is not intended for use in life support systems.

The VEEGix™ EEG system (subject device) is a Electrocochleographic (EEG) device to allow healthcare practitioners, nurses, neurologists and qualified technicians working in hospital Operating Room, Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings to observe a patient's EEG signals and its derivatives. The use of the subject device is a straight-forward procedure of applying the VEEGix Electrode, which is a lightweight band, onto the patient's scalp in which the electrodes acquire the patient's EEG signals. Those signals are transmitted via the VEEGix EEG module) to the VEEGix iOS app (application) which display the patient's EEG measurements in real-time to allow healthcare practitioners, nurses, neurologists and qualified technicians to monitor and record those EEG measurements.

The Neuron-Spectrum-AM system with Neuron-Spectrum.NET software is intended for use as a digital neurophysiological system for recording, processing, and displaying biopotential signals such as Electroencephalography (EEG) and Polysomnography (PSG) derived from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes. The device is portable and can register up to 21 EEG channels, 4 polygraphic channels, and 1 direct current channel. The device does not provide alarms, does not provide automated event marking and does not provide to the user any diagnostic conclusion about the patient's condition. They are in patient care institutions, diagnostics centers, neurosurgical hospitals, experimental laboratories. The device can also be used as a home use device under supervision of qualified personnel. The patient group includes all ages and sexes.

The Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (Subject device) is an ambulatory wireless digital neurophysiological device capable of recording, processing, and displaying electroencephalography (EEG), video EEG, long-term monitoring (LTM), and polysomnography (PSG) biopotential signals. As listed in Table 1, The NS-AM device comprises an Electronic Unit, a Battery Adaptor, an External Rechargeable Battery Bank, a Carrying Pouch and the Neuron-Spectrum.NET desktop application software. The Neuron-Spectrum.NET Software application was cleared in the Predicate's 510(k) submission (K133995). The Subject device supports up to 21 EEG channels, 4 wide-band polygraphic channels, 1 breath channel, and 1 direct current channel for a total of 27 analog input channels. The Electronic Unit acquires, records and transmits biopotential signals such electroencephalography (EEG) and polysomnography (PSG). The built-in 2.4GHz Wi-Fi radio allows real-time transfer of the collected biopotential signals to the computer running the Neuron-Spectrum.NET software. The biopotential signals are also recorded onto a removable SD memory card as back up for later post analysis. The Electronic Unit includes a front panel ON/OFF power button, a light sensor and a User Interface (UI). The UI consist of a liquid crystal display and three menu navigation buttons. Figure 4 shows the UI main functions. The Electronic Unit can be powered by replaceable internal AA batteries or by the External Rechargeable Battery Bank. The Electronic Unit and the External Rechargeable Battery Bank reside side-by-side inside the Carrying Pouch. The pouch is strapped and worn over the patient clothing while in use. The Neuron-Spectrum.NET software is a computer application that receives, records, processes, and displays the biopotential signals collected by the electronic unit on the PC display. The main operations provided by the Neuron-Spectrum.NET software are: - EEG Acquisition - · EEG Review, Editing, Storing, Exporting. - EEG Analysis - Creation of Exam Reports - · Program Setup The electronic unit measures (141 H x 96 W x 36 D) mm and weighs about 270 grams. The External Rechargeable Battery Bank unit measures (165 H x 106 W x 25 D) mm and weighs about 570 grams. The combined weight for the electronic unit, the battery adaptor and the External Rechargeable Battery Bank is approximately 880 grams.

The Pascall Systems, Inc. Wireless EEG System, is intended to be used for measuring the electrical activity of a patient's brain, obtained by placing electrodes on the forehead and wirelessly transmitting the electroencephalographic (EEG) signals for storage and display. The Pascall Systems, Inc. Wireless EEG System, is intended for use in the acquisition of EEG signals, displaying them in real time and storing them for later review and analysis. The Pascall Systems, Inc. Wireless EEG System, is intended for use in a hospital Operating Room, Post Anesthesia Care Unit, Intensive Care Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings. The Pascall Systems, Inc. Wireless EEG System is indicated for use on patients 18 years of age or older and is to be used by licensed medical professionals that have been adequately trained in the use and interpretation of raw EEG data for determination of brain state during anesthesia. The Pascall Systems, Inc. Wireless EEG System does not provide any diagnostic conclusion about the patient's condition.

The Pascall Systems Wireless EEG system is a brain monitoring or Electroencephalographic (EEG) device. The system is designed to record and display four channels of electroencephalograms (EEGs) obtained from noninvasive electrodes placed on a patient's head. The acquired EEG waveforms (4 channels) and processed EEG variables which include a Spectrogram, Artifact index, electromyography (EMG) index, burstsuppression probability, and phase-amplitude modulogram are continuously displayed by the system. Licensed medical professionals which include anesthesiologists, nurse anesthetists, etc. combine and interpret the data presented by the Pascall Systems Wireless EEG with information provided by other instruments in the operating room. The primary purpose of the Pascall Systems Wireless EEG is in the acquisition of electroencephalographic (EEG) signals, displaying them along with the processed variables in real time and storing them for later review and analysis. The Wireless EEG system is intended for use in a hospital Operating Room, Post Anesthesia Care Unit, Intensive Unit, Emergency Department, or in other medical facilities such as inpatient and outpatient (ambulatory) surgery settings.

The GE EEG module, E-EEGX, the GE EEG headbox, N-EEGX, and accessories are intended to be used with the compatible CARESCAPE monitors for the monitoring of electroencephalograph (EEG), frontal electromyograph (FEMG), and auditory evoked potentials (AEP) of all hospital patients. The device is intended for use by qualified medical personnel only.

The E-EEGX module is a single-width plug-in interface module to be used with CARESCAPE Bx50 V3 patient monitors. It is used with N-EEGX headbox and accessories for monitoring neurophysiological status of all hospital patients by measuring the electroencephalogram (EEG), frontal electromyogram (FEMG) and auditory evoked potentials (AEP). The E-EEGX module is used with the N-EEGX headbox for monitoring of EEG. FEMG. to stimulate the brain with auditory stimuli, and to measure AEP. The E-EEGX module connects to a N-EEGX headbox which further connects to accessories that connect to the patient. The EEG, FEMG and AEP measurements are performed by the N-EEGX headbox. The N-EEGX headbox measures the raw EEG waveform data from four real-time EEG waveform channels, FEMG from one channel and AEP from two channels. The N-EEGX headbox is connected to the patient with EEG accessories. The E-EEGX module transfers the digitized EEG data received from the N-EEGX headbox to the host monitor. The module also generates the stimuli used in the AEP measurement and performs part of the AEP measurement data processing.

CNS Envision is intended for use by qualified personnel in the review, and analysis of patient data collected using external physiological monitors. These data are: raw and quantitative EEG, recorded video data, generic vital signs, electrocardiography, electromyography, intracranial pressures, transcranial Doppler measurements, and Glasgow Coma Score. CNS Envision includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG waveforms. These include, for example, frequency bands, asymmetry, and burst suppression. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. The aEEG functionality included in CNS Envision is intended to monitor the state of the brain. CNS Envision is intended for use by a physician or other qualified medical personnel who will exercise professional judgement in using the information. It is intended for use on patients of all ages. This device does not provide any diagnostic conclusion about the patient's condition to the user.

CNS Envision is a Microsoft Windows-based software application that facilitates the review, annotation and analysis of patient data and physiological measurements. Some of these data, such as ECG, are displayed in raw format whereas other types, such as EEG, are analyzed and quantified by the software. The specific type of input data that are reviewable by CNS Envision software are: Raw electroencephalography (EEG) Quantitative EEG trends; density spectral arrays (DSA) spectral edge frequency (SEF), alpha-delta ratio (ADR), and amplitude EEG (aEEG) Video Generic vital signs which are heart rate (HR), respiration rate (RR), pulse oximetry (SpO2), blood pressure, arterial blood pressure (ABP), mean arterial pressure (MAP), and body temperature Electrocardiography (ECG) Electromyography (EMG) Intracranial pressure (ICP) Transcranial Doppler (TCD) measurements (e.g. spectral envelope, peak velocity, and pulsatility index; TCD measurement is collected by the predicate K080217 device's interface module which interfaces with the Spencer TCD device cleared in K002533, which was a predicate to the predicate K080217 Glasgow Coma Score (GCS); this parameter is manually entered on the CNS Monitor (K080217) with 3 total GCS scores by the user; the CNS software automatically sums the 3 scores and stores the data to provide a trend graph CNS Envision also has several features to enable ease-of-use. For example, users may select customized layouts that provide data displays that can be tailored to their monitoring needs according to data sources. The subject device also offers customizable EEG montages that present raw EEG data to medical personnel for interpretation. Unlike the predicate device, Component Neuromonitoring System™, the subject device does not perform direct data acquisition. Instead, it offers the ability to review data remotely or adjust the review speed.

1. Cadwell Bolt is a software-only device intended for post-hoc analysis of EEG data. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. This device is intended to be used with EEG data from patients of all ages. 2. Cadwell Bolt includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG data. These include the following 10 analyzers: - -Amplitude Integrated EEG (aEEG), - -Peak Envelope, - -Envelope Asymmetry, - -Spectrogram, - -Band Power. - -Power Ratio, - -Spectral Entropy, - -Burst Suppression Ratio, - -Inter-burst Interval, and - -Bursts-per-Minute. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG data. A minimum of one epoch of data is required to perform Bolt analysis. 3. The aEEG functionality included in Cadwell Bolt is intended to monitor the state of the brain. 4. Cadwell Bolt can provide notifications, based on user-defined thresholds, for quantitative EEG measures such as a notification within the application software that can be used when processing a record during acquisition. Delays can occur between the beginning of an event and when the Bolt notification will be shown to a user. Cadwell Bolt notifications cannot be used as a substitute for real-time monitoring of the underlying EEG data by a trained expert. This device does not provide any diagnostic conclusion about the patient's condition to the user as part of its output. The software does not contain automated detection algorithms.

Cadwell Bolt is a software-only device for use with EEG data. The Cadwell Bolt receives EEG data as an input and uses this input to calculate and display the following quantitative measures of electroencephalographic data: (1) amplitude integrated EEG (aEEG), (2) peak envelope, (3) envelope asymmetry, (4) spectrogram, (5) band power, (6) power ratio. (7) spectral entropy, (8) burst suppression ratio. (9) inter-burst interval, and (10) bursts-per-minute. In addition to the 10 analyzers mentioned above, Cadwell Bolt calculates if a value is greater than a user-defined threshold. A horizontal black bar is displayed in the trend window and signifies the current threshold setting. The user may move the bar up/down to adjust the threshold. Thresholding is available for the following trends: . peak envelope, . envelope asymmetry, spectrogram, . band power, and ● power ratio. . The Cadwell Bolt device performs analysis on a userdefined set of EEG channels within the EEG data and displays graphical results to be interpreted by qualified medical practitioners. Additional user-selectable parameters are available depending on the analyzer selected for display. These parameters include frequency ranges or bands for analysis, number of epochs to average, and minimum burst suppression durations. Using the userdefined thresholds, Cadwell Bolt can provide notifications to the user and can optionally highlight the associated EEG data. Notifications and/ or highlights can be accepted or rejected by a qualified medical practitioner. Additional features and user-selectable parameters include: Output display color Output display size ● Output display name Epoch length ● Notch filter ● Selected inputs (bipolar or referential) . Output display time scale (y-axis)

The Lifelines iEEG is an EEG system that allows acquisition, display, archive, storage and analysis of physiological signals. The intended user of this product is a qualified medical practitioner trained in electroencephalography who will exercise professional judgment in using the information. The Lifelines iEEG system also includes the display of a quantitative EEG plots, power spectrum, which is intended to help the user to monitor and analyze the EEG. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Lifelines iEEG is medical device used to acquire, display, archive, store and analyze EEG examinations. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of acquiring and presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The system software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions. The components of Lifelines iEEG are: - Lifelines iEEG software: - . iEEG Centrum - . iEEG Review - iEEG Acquisition . - Lifelines Trackit, Lifelines Ltd, 510(k)#K010460 - Lifelines Photic Stimulator, Lifelines Ltd, 510(k)# K101691 ● - Off the shelf PC and medical grade power supply ● - Off the shelf IP Video Camera ●

The DiscoverEEG System, Model DE-401 is intended to be used for measuring and recording the electrical activity of a subject's brain, obtained by placing non-invasive electrodes on the head. The DiscoverEEG, DE-401 is indicated for use in acquiring electroencephalographic (EEG) signals in the OR, ICU, ER, clinical settings and at home and for clinical research. The medical use of data acquired by the DiscoverEEG is to be performed under the direction and interpretation of a licensed medical professional. The DiscoverEEG, Model DE-401 does not provide any diagnostic conclusion about the subject's condition.

The DiscoverEEG System, Model DE-401, is a wearable, medical-grade EEG device that acquires and stores up to four electroencephalograms (EEGs) obtained from noninvasive electrodes placed on a subject's head. The acquired EEG waveforms, as well as, processed EEG spectral variables are continuously stored by the system for later retrieval. The data can be transferred from the DiscoverEEG hardware to a computer for review. The DiscoverEEG System, Model DE-401 has four main components: Acquisition Module, Memory Module, Disposable Electrode Array, and Data Viewer Software.

The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes. The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1 breath channel and 2 direct current channels (Neuron-Spectrum-4/P). Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitative electroencephalography (qEEG) , including specific parameters such as Rhythmicity, FFT power ratio and amplitude metrics. The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories.The patient group includes all ages and sexes.

The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and Neuron-Spectrum- 4/P with Neuron-Spectrum.NET software are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes. The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P) EEG channels, 1 (Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphic channels (Neuron-Spectrum-4/P: ECG, EOG), 1 breath channel and 2 direct current channels (Neuron-Spectrum-4/P). Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitative electroencephalography (qEEG) , including specific parameters such as Rhythmicity, FFT power ratio and amplitude metrics. The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories-The patient group includes all ages and sexes

The COGNISION System is for use by qualified clinical professionals in private practice offices or small clinical settings for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and auditory evoked potentials (AEP) information.

The COGNISION™ EEG/EP System is a combination device for reduced montage recording and display of electroencephalographic (EEG) and evoked potentials (EP) test data. The system uses elastic bands to accurately position 10 electrode pods around the head (7 recording channels, 2 linked mastoids, and 1 common). EEG signal amplification, conditioning, and A/D conversion is performed by electronic circuits closely coupled to the electrode pods through short flexible printed wires. The headset is connected by a cable to a handheld control unit and data acquisition box (HCU). A lithium-ion battery in the HCU is used to power the system. The HCU communicates via a wireless data link to a Windows PC to stream EEG data. HydroDot® Biosensors (from HydroDot Inc., and not included as part of this submission) are inserted into each electrode pod to electrically couple the electrode pods to the subjects scalp. Software on the PC is used to setup the tests and view and evaluate the resultant test data using standard EEG/EP display methods. Calibrated audiometric earphones (from E-A-R Auditory Systems) can be plugged in to the amplifier A/D converter box to deliver various auditory stimuli to produce evoked potential EEG responses.