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The Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG). Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300. Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Nicolet EDX with Natus Elite Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The Nicolet EDX with Natus Elite Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System. The Nicolet EDX with Natus Elite Software is intended to be used by a qualified healthcare provider.

The Nicolet EDX system is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform Nerve Conduction (NCS), Electromyoaraphy (EMG), Evoked Potentials (EP), and Autonomic Responses. Nicolet EDX system provides a variety of tests spanning the various modalities. The Nicolet EDX system consists of the following major components: - Base unit - Amplifier (2- or 8-channel) - Control panels - Computer- laptop or desktop (with display, keyboard and mouse) - Display Monitor (for desktop system) - Application Software (Natus Elite) The Nicolet EDX optional accessories/ components consist of the following: - Audio stimulators (Headphones or other auditory transducers) - Visual stimulators (Natus Visual Stimulator, LED goggles or stimulus monitor) - Electrical stimulators (RS10 comfort probe, WR50 comfort probe plus) - Cart and associated accessories (such as arms, mounts and isolation transformer - Miscellaneous options and accessories such as Patient Response button. Single/Triple footswitch, Tendon (Reflex) hammer, Natus photic stimulator, temperature probe, ultrasound device, bone conductor, printer, etc. The electrodiagnostics system is powered by a connection to mains. The entire user interface of Nicolet EDX system consists of two major elements: - The primary means to interact with the system is via a personal computer (PC) running Natus Elite. - The second means of interaction is the user interface elements on the hardware. The Nicolet EDX is intended to be used by a qualified healthcare provider. This device does not provide any diagnostic conclusion about the patient's condition to the user. The intended use environment is in a professional healthcare facility environment.

The UltraPro is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG). Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300. Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The UltraPro with Natus Elite Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The UltraPro with Natus Elite Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System. The UltraPro with Natus Elite Software is intended to be used by a qualified healthcare provider.

The UltraPro S100 system is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform Nerve Conduction (NCS). Electromyography (EMG), Evoked Potentials (EP), and Autonomic Responses. UltraPro S100 system provides a variety of tests spanning the various modalities. The UltraPro S100 system consists of the following major components: - Main unit (also known as base unit or main base unit) with integrated control panel; ● - Amplifier (3- or 4-channel); - . Computer- laptop or desktop (with keyboard and mouse) - Display Monitor (for desktop system) - . Application Software (Natus Elite) The UltraPro S100 has the following optional accessories/ components: - Audio stimulators (Headphones or other auditory transducers) - Visual stimulators (LED goggles or stimulus monitor) - . Electrical stimulators (RS10 probes, stimulus probe with controls) - Cart and associated accessories when using cart such as isolation transformer - Miscellaneous accessories such as Patient Response button, Triple footswitch, Reflex hammer, temperature probe and adapter, ultrasound device, printer, etc. The electrodiagnostics system is powered by a connection to mains. The entire user interface of UltraPro S100 system consists of two major elements: - The primary means to interact with the system is via a personal computer (PC) running ● Natus Elite. - The second means of interaction is the user interface elements on the hardware. The UltraPro S100 is intended to be used by a qualified healthcare provider. This device does not provide any diagnostic conclusion about the patient's condition to the user. The intended use environment is in a professional healthcare facility environment.

The Delphi Stimulator is intended to be used for stimulation of peripheral nerves for diagnostic purposes.

Delphi stimulator is a Magnetic stimulator used for Magnetic stimulation of peripheral nerves for diagnostic purposes. Magnetic stimulation is a non-invasive technique for stimulating neural tissue. Application areas of magnetic stimulation are a sub-set of the application areas for current stimulation. The Delphi stimulator is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The stimulator consists of power electronics to generate the magnetic field in the Magnetic Coil. It is controlled via a user interface installed on a PC workstation connected to the stimulator. enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The magnetic pulse is Biphasic waveform and the stimulator can stimulate with a frequency of up to 3 pulses per second (pps).

The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures. SafeOp 3 Accessories: The SafeOp Accessories are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

The SafeOp™ 3: Neural Informatix System (SafeOp 3 System), consists of the SafeOp patient interface with power supply and IV pole mount, the Alpha Informatix Tablet with docking station and power supply and a data transfer USB cable. Associated disposable accessories consists of an electrode harness, surface and/or subdermal needle electrodes, MEP Activator, Cranial Hub, PMAP Dilators and stimulating probe or clip contained in various kits. The subject device is intended for use by trained healthcare professionals, clinical neurophysiologists/technologists and appropriately trained non-clinical personnel. The subject device is intended for use in operating room environments of hospitals and surgical centers. System setup may be performed by both clinical and trained non-clinical personnel. The subject device records the following modalities: - Somatosensory evoked potentials (SSEP) - Motor evoked potentials (MEP), - . Train-of-four neuromuscular junction (TO4), - Triggered electromyography (tEMG) and ● - . Free run electromyography (sEMG)

MEGA-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient's neurophysiological status. The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. It is provided in three different configurations: I. 32/B II. 32/S III. 16/S The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potential), MEP (motor evoked potential), EEG (electroencephalography), AEP (auditory evoked potential), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed. The system is not intended to measure vital signs. It records the data to be interpreted by the neuromonitoring specialist. MEGA-IOM system is intended for use in adults age 18 years and older.

The MEGA-IOM system with Neuro-IOM.NET software is intended for intraoperative neurophysiological monitoring (IOM). The system is intended for monitoring the functional integrity and/ or mapping of central and peripheral nervous system including motor and sensory pathways. Soterix Medical is assuming manufacturing of the predicate product cleared in K190703. This 510(k) submission includes the same hardware cleared with the predicate device system (no changes) and an updated version of the software compared to the predicate device. Below, a high-level summary of the changes from the predicate are provided: Software: The primary changes in this 510(k) submission are related to the software. The changes are troubleshooting updates for greater usability such as user interfaces and bug fixes. Detailed descriptions of these software changes per version are provided below: Version 1.1.52.7: Fixes related to the stimulation stop after a few hours, adding a stimuli limit for double train stimulation, allowing pulse duration (200 microseconds) entry, masking noise limitation per IEC 60601-2-40 (Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment), reporting correct status of multichannel operation, prevent skipping of traces, and check for incompatible stimulation parameter entry. Version 1.1.52.8: Fixes related to facilitating quick turning off stimulation, real-time stimulus change control, scrolling in spectral setup window, constraining window within pattern printout to screen, ensuring modality window description is unchanged, incorrect Ch 17 display in emulation mode, video filters error during installation, ensuring all text is displayed within visibility area, incorrect auditory evoked potentials (EPs) average calculation in emulation mode. Version 1.1.52.9: Fixes related to exam saved message, flexibility to change test template sequence, sleep mode prevention, rendering speed, interpulse interval display correction, allowing comments in the event window, automatic creation of user template, template list update, impedance measurement window rendering, parameter display correction in EMG trigger window and Group mode, ensuring non-disappearance of red line around patient's birth date, enabling stimulation via local menu in Scoliosis test template, frame switching error during video recording, displaying correct device status. Version 1.1.53.7: Fixes related to addition of video clip creation button, accidental stimulation activation protection, display of preliminary train in double train mode, voltage and charge value display in stimulation panel, allowing repetitive stimulation in Double Train and Train+Pulse modes, option to view amplitude values up to 10 microA, option to select scales in X axis, option to delay auto saving if stimulation in progress, option to titrate stimulation amplitude using mouse wheel, option to select grid type, confirmation on layout uninstallation, addition of the Pause button in Stimulation programs, option to select motor response search interval and displaying the motor response search interval, addition of measured impedance visualization, offering first the windows already available when adding a new window, preventing closure of window if input row is active in derivation test, enable display of additional TOF parameters, option to playback trace fragments, addition of Take a screenshot command, parameter trend export, pulse duration interval display in TES train, option to enter multiple-line comments, option to re-name layout, option to hide command list, ability to save only responses beyond a certain level, stimulator list scrolling, RMS noise value display, test template cloning, motor response onset marker, previous recorded traces display, layouts during new test reset, stimulator reminder mod, video file duration based on frame rate, saving of the number of traces, test template rewriting, group trace visualization display, layout switching, stimulation resumption post coagulator off, video playback if another program is run. Version 1.1.53.8: Fixes related to allowing multiple image view within the image window, allowing EEG artifact recording, showing baseline in the Overlay mode, option to disable program, option to save screen shots to a specific folder, stimulation program panel addition, correction of autoincrement window bug, correction of DSA rendering. Version 1.1.53.9: Fixes related to custom scale adjustment in Freerun window, randomly changing pulse intervals in multichannel mode, event trace copy to report, layout panel updating post deletion, sound, threshold, and color parameter display during new site addition, EMG channels in template during long-term monitoring, site visibility during stimulation in presence of temporary markers, auto sweep resets, temporary markers display, trace export to EDF, layout non-save post video window opening, type conversion in trace window. Version 1.53.10: Fixes related to video window copying over to report, trace scale reset, appearance of average trace display in case of no averages due to artifacts, site name display in TOF window, saving of initial study state in autosave mode, incomplete installation of video components, volume increment of auditory stimulator signal volume. Version 1.1.53.11: Fixes related to active probe switch-off during monitoring, limiting maximum increment adjustment of electrical stimulation amplitude to 1 mA and 5V, stimulus duration set-up when stimulation amplitude is increased, stimulation disablement after power supply resume, stimulus sound notification, text visualization in dialogue box, non-active stimulator panel, maximum stimulus artifact width display, minimum and maximum MEP trace markers. Version 1.1.53.12: Fixes related to pulse width change during stimulation in multichannel mode, MS Office word report, TeamViewer, logo, and translation corrections. Version 1.1.53.13: Fixes related to removal of sites containing TOF and logo change. Version 1.1.53.14: Fixes related to start monitoring during video camera switch off, video recording in some interface languages, sound disablement during impedance measurement, printing test template, USB driver-related Windows 10 OS bugs. In summary, the aforementioned software changes are related to resolving software bugs and increasing user convenience, but the changes do not impact the intended use, indications for use statement, contraindications, or warnings. They also don't increase the likelihood that the device will be used by a broader or different group of users and do not raise any new risks. Labeling: Modifications have been made to labeling and these changes are related to the new device trade name and change in manufacturer. Instances of "Neuro-IOM" were changed to "MEGA-IOM" in the user manual and on the device labels. Soterix Medical is named the manufacturer and point of contact in the labeling including for all complaints and service requests. Waveforms: The MEGA-IOM system has the same waveforms as the predicate device. No change to the waveforms.

The product is used for intraoperative monitoring and testing during surgical procedures · to examine neuronal tissue (central and peripheral nervous system) by recording and stimulation The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations: - · Measurement: - o Auditory evoked potentials (AEP) - o Electroencephalography (EEG) - o Electrocorticography (ECoG) - o Electromyography (EMG) - o Somatosensory evoked potentials (SSEP) - o Motor evoked potentials (MEP) - o Train of Four (TOF) - · Stimulation: - o Transcranial electrical stimulation (TES) - o Direct cortical and subcortical stimulation (DCS) - o Direct nerve stimulation (DNS) - o Transcutaneous intraoperative nerve stimulation (TINS) - o Direct muscle stimulation (DMS)

The ISIS Headboxes and the ISIS Neurostimulator constitute multimodal intraoperative neuromonitoring systems called ISIS IOM Systems. These systems consist of custom stimulation and recording hardware, a standard laptop or desktop personal computer running an off-the-shelf operating system, and operating software called NeuroExplorer. As an option, these systems mount on device carriers or housings tailored for intraoperative use. The ISIS IOM Systems support the following measurement modalities: - -Auditory Evoked Potentials - -Transcranial and cortical Motor Evoked Potentials - Somatosensory Evoked Potentials - - Free-running and triggered Electromyography - - Electroencephalography - - Train of Four -

The Guardian with Cascade Surgical Studio software is an electroneurodiagnostic device that acquires, displays, and stores physiologic data from peripheral sensory and motor nerves, muscles, and the central nervous system, generated either spontaneously or elicited by stimuli. Guardian can perform somatosensory, auditory, and visual evoked potentials (EPs), electroencephalography (EEG), electrocorticography (ECoG), spontaneous and triggered electromyography (EMG), transcranial motor evoked potentials (TcMEP), direct cortical stimulation (DCS), direct nerve stimulation (TEMG, DNS), nerve conduction studies (NCS), and Train of Four (TOF) analysis. Guardian can provide remote review outside of the operating room. Guardian is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing. The following functions are specifically supported individually or in combination: Evoked Potentials (EPs): Guardian can provide electrical, auditory, and visual stimulation and measure, display, record, and store the electrical activity of the nervous system in response to the stimulations delivered. Electroencephalography (EEG): Guardian can measure, display, record, and store electrical activity of the brain from two or more electrodes on the scalp. Electrocorticography (ECoG): Guardian can measure, display, record, and store electrical activity directly from the brain using two or more electrodes. Free Run Electromyography (EMG): Guardian can acquire, display, record, and store EMG activity of motor nerves. Triggered Electromyography (TEMG): Guardian can electrically stimulate motor nerves, and display, record, and store the results. Transcranial Motor Evoked Potentials (TcMEP): Guardian can deliver electrical transcranial stimulation, and display, record, and store the results. Direct Cortical Stimulation (DCS): Guardian can deliver electrical stimulation to various areas of the cerebral cortex, and display, record, and store the results. Direct Nerve Stimulation (DNS): Guardian can electrically stimulate cranial and peripheral nerves, and display, record, and store the results. Nerve Conduction Study (NCS): Guardian can measure, display, record, and store sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system. Train of Four (TOF): Guardian can deliver a train of four pulses, and measure, display, record, and store the results.

The Cadwell Guardian is a multi-modality intraoperative neurophysiological monitoring system with up to 80 channels of data acquisition. The Guardian system is designed to be flexible and scalable depending on customer and procedural requirements. All systems require a Power Comm and Guardian Base, which contains an electrical Transcranial Stimulator. The user may select up to two Omni Amplifiers, two ES-10 electrical stimulators, one AVX auditory and visual stimulator, and one SMX-32 EEG amplifier that contains a low current electrical stimulator, in order to meet specific requirements. The Guardian requires a (PC) with Windows operating system. The Guardian system uses a new version (4.0) of previously cleared Cadwell Cascade Surgical Studio software. Surgical Studio acquires, stores and reviews a wide range of intraoperative neurophysiological data, such as EMG, EEG, SSEP, BAEP, VEP, MEP and TOF, and includes Report Generation.

The SafeOp 2: Neural Informatix System is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures.

The SafeOp™ 2: Neural Informatix System (SafeOp 2 System), formerly known as EPAD 2 (K182542), consists of the SafeOp head unit with power supply and IV pole mount, the Alpha Informatix Tablet with docking station and power supply and a data transfer USB cable. Associated disposable accessories consists of an electrode harness, surface and/or subdermal needle electrodes, and stimulating probe or clip contained in various kits. The SafeOp 2 System head unit contains a complete data acquisition system that has builtin stimulators, amplifiers, relays, A/D Converters, Digital Signal Processors, CPUs, and storage devices. The head unit interfaces with other equipment through communication ports and serves as the patient-contacting portion of the system where it is close to the surgical field. The head unit hardware contains an eight acquisition (input) channel and six-output channel Evoked Potential Stimulator that is used in the operating room to display nerve and muscle responses. The user can use these responses to diagnose insults to the peripheral or central nerves and to determine relative nerve location, proximity, and integrity data. The SafeOp 2 System application provides the primary graphical user interface and controls for the SafeOp 2 System. The application runs on a touchscreen tablet mobile device which connects to the head unit either via wired USB cable or wireless via Wi-Fi, enabling both user input (e.g., patient and procedure information, adjustment of stimulus and acquisition parameters) and display of output (e.g., display of acquired waveforms, data, messages and alerts to the clinician).

ISIS Headbox 5042xx products: The products are intended for intraoperative neuromonitoring; for recording of electrophysiological signals and stimulating of nerve and muscle tissues. The products are intended for use in the operating room to measure and display the electrical signals generated by muscle, peripheral nerves and the central nervous system. The products support the clinical application of Electroencephalography (EEG), Electromyography (EMG), Somatosensory Evoked Potentials (SEP), Motor Evoked Potentials (MEP), and Auditory Evoked Potentials (AEP). The products are not intended for monitoring life-sustaining functions. ISIS Neurostimulator 504180: The ISIS Neurostimulator is intended for provision of neurophysiological stimulation when used in surgical procedures and for diagnostics. It is suitable for continuous operation and can be used in the following fields: - Transcranial electrical stimulation (TES) - Direct cortical stimulation (DCS) - Direct nerve stimulation (DNS) - Transcutaneous electrical nerve stimulation (TNS) - Direct muscle stimulation (DMS)

The ISIS Headboxes and the ISIS Neurostimulator constitute multimodality intraoperative neuromonitoring systems called ISIS IOM Systems. These systems consist of custom stimulation and recording hardware, a standard laptop or desktop personal computer running an off-the-shelf operating system, and operating software called NeuroExplorer. As an option, these systems mount on device carriers or housings tailored for intraoperative use. The ISIS IOM Systems support the following measurement modalities: - Auditory Evoked Potentials - Transcranial and cortical Motor Evoked Potentials - Somatosensory Evoked Potentials - Freerunning and triggered Electromyography - Electroencephalography - Train of Four

Stimulation of peripheral nerves for diagnostic purposes.

The MEGA-TMS is intended for stimulation of peripheral nerves for diagnostic purposes. The device introduces electrical stimulation to tissue through magnetic induction generated from the coil. The obtained responses of stimulated structures is recorded with an EMG system for further diagnostic evaluation. The MEGA-TMS device is intended to be paired with a Focus EMG device cleared under FDA 510(k): K102610. Magnetic stimulation is used for peripheral nerve conduction studies and to evaluate peripheral nervous system.