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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 provided text is a 510(k) Premarket Notification from the FDA for the "MEGA-IOM system with Neuro-IOM.NET software". This document primarily focuses on demonstrating substantial equivalence to a predicate device (K190703 Neuro-IOM system with Neuro-IOM.NET software) rather than detailing extensive clinical studies with acceptance criteria for new device performance.

The submission is for a device that has primarily undergone software updates and a change in manufacturer. Therefore, the "study that proves the device meets the acceptance criteria" is in the form of software verification and validation, and comparison to the predicate device's established performance.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide explicit "acceptance criteria" in the traditional sense of a clinical trial (e.g., target sensitivity/specificity for a diagnostic AI). Instead, the acceptance criteria are implicitly demonstrating that the updated software, in conjunction with the unchanged hardware, performs identically or equivalently to the predicate device. The performance is assessed by confirming that all functional and technical specifications remain the same.

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