(94 days)
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.
| Parameter | Acceptance Criteria (Implicit - Identical to Predicate) | Reported Device Performance (MEGA-IOM) | Comment |
|---|---|---|---|
| Device Name and Model | Neuro-IOM 16S, 32S, 32B with Neuro-IOM.NET software | MEGA-IOM 16S, 32S, 32B with Neuro-IOM.NET software | New trade name for the subject device. Functionally identical. |
| Classification Name | Stimulator, Electrical, Evoked Response | Stimulator, Electrical, Evoked Response | Identical |
| Product Codes | GWF (primary), GWE, GWJ, OLT, PDQ | GWF (primary), GWE, GWJ, OLT, PDQ | Identical |
| Regulatory Class | Class II | Class II | Identical |
| Classification Number | 21 CFR 882.1870 | 21 CFR 882.1870 | Identical |
| Indications for Use (IFU) | Matches predicate (detailed in document) | Matches predicate (detailed in document) | Similar; new IFU includes new device name. All other wording identical. |
| Intended User | Trained personnel only | Trained personnel only | Identical |
| Device Hardware Setup | Connected to PC, not standalone | Connected to PC, not standalone | Identical (hardware is unchanged) |
| Electrical Safety Standards | Conforms to specified standards (older versions acceptable for predicate) | Conforms to updated versions of same standards | Subject device conforms to updated versions of standards. |
| Workflow, Menu | PC-controlled | PC-controlled | Identical |
| Interface to Computer | USB | USB | Identical |
| Channels | 16/32 | 16/32 | Identical |
| 1.5 mm touch-proof input jacks | Same | Same | Identical |
| Cable Length | 5m | 5m | Identical |
| Input Impedance | >1000 MOhm | >1000 MOhm | Identical |
| Common Mode Rejection (CMRR) | >90 dB | >90 dB | Identical |
| Low Frequency Filters | 0.2 Hz - 2000 Hz | 0.2 Hz - 2000 Hz | Identical |
| High Frequency Filters | 10 Hz - 4 kHz | 10 Hz - 4 kHz | Identical |
| Notch Filter | 50/60 Hz | 50/60 Hz | Identical |
| Sample Rate | 50 kHz | 50 kHz | Identical |
| Sensitivity | 0.05 µV/division to 20 mV/division | 0.05 µV/division to 20 mV/division | Identical |
| Noise Level | <0.6 µV (<9.5 nV/√Hz) | <0.6 µV (<9.5 nV/√Hz) | Identical |
| Artifact Rejection | Independent for each channel | Independent for each channel | Identical |
| Number of Channels | 16/12/4/4 | 16/12/4/4 | Identical |
| Max Intensity (Stimulator) | 200 mA | 200 mA | Identical |
| Duration (Stimulator) | 0.02 - 5 ms | 0.02 - 5 ms | Identical |
| Stimulus Type | Mono-/biphasic | Mono-/biphasic | Identical |
| Electrical Modes | Single, repetitive, trains | Single, repetitive, trains | Identical |
| TcMEP (Transcranial Electrical stimulator) | 4 channels, 1000V, 0.04-0.2ms duration | 4 channels, 1000V, 0.04-0.2ms duration | Identical |
| Low Current Stimulator | 3/2/1 channels, 20mA, 0.05-0.5ms duration | 3/2/1 channels, 20mA, 0.05-0.5ms duration | Identical |
| Stimulation Type (Auditory) | Click, tone, noise | Click, tone, noise | Identical |
| Rate (Auditory) | 0.01 - 100 Hz | 0.01 - 100 Hz | Identical |
| Intensity (Auditory) | 120 dB nHL | 120 dB nHL | Identical |
| Polarity (Auditory) | Condensation, rarefaction, alternating | Condensation, rarefaction, alternating | Identical |
| Transducers (Auditory) | Insert earphone EAR-3A-10 Ohms | Insert earphone EAR-3A-10 Ohms | Identical |
| Waveform Visualization (Examples) | Freerun, SSEP, AEP, VER, MEP, EEG, CSA, DSA, Trending, Log Book, History, Report Template | Identical visual representations | Identical |
| SSEP, MEP, TcMEP, BAEP, VEP, EMG, EEG, Multimodality support | Yes | Yes | Identical |
| Predefined test templates | Yes | Yes | Identical |
| Creation/editing of templates | Yes | Yes | Identical |
| Generation of neuromonitoring report | Yes | Yes | Identical |
| Image review from microscope/other sources | Yes | Yes | Identical |
| Trending | Yes | Yes | Identical |
| ESU Detection | Yes | Yes | Identical |
| Power Supply | 220/230 V AC, 50/60 Hz | 220/230 V AC, 50/60 Hz | Identical |
| Visual Stimulation | LED goggles | LED goggles | Identical |
| Type of electrodes | Any legally marketed (in the U.S.) probes and surface or needle electrodes with standard lead wire. | Any legally marketed (in the U.S.) probes and surface or needle electrodes with standard lead wire. | Identical |
2. Sample size used for the test set and the data provenance:
The document states that the changes are primarily software-related (bug fixes, usability improvements) and do not impact the device's fundamental performance characteristic or intended use. Therefore, instead of a clinical "test set" with patient data in the typical sense for AI/diagnostic devices, the "testing" described is focused on software verification and validation.
- Sample size for test set: Not applicable in the sense of clinical cases or patient samples. The "test set" consists of software functionalities and user interface elements.
- Data provenance: Not directly applicable to patient data. The provenance relates to the software development process and testing environment. It is internal software validation data.
- Retrospective or prospective: Not applicable to patient data. Software verification and validation are typically performed prospectively during development and after changes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the "ground truth" for this submission is the established, cleared performance of the predicate device. The changes are bug fixes and usability enhancements, not a new diagnostic algorithm requiring expert-established ground truth. The "experts" would be the software developers and quality assurance personnel performing the verification and validation, ensuring the software performs as designed and intended, consistently with the predicate's established functions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Software verification and validation follow structured testing protocols (e.g., unit testing, integration testing, system testing, regression testing) and risk management processes. There is no "adjudication" in the sense of reconciling clinical interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This submission is not for a new AI/CAD device requiring an MRMC study. It is for an established device platform with software updates. The device itself is an "Evoked Response Electrical Stimulator" and "Intraoperative Neurophysiologic System" that records data for interpretation by a neuromonitoring specialist; it does not explicitly feature AI assistance for interpretation that would necessitate an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an instrumentation system for intraoperative neuromonitoring, where the data is recorded to be interpreted by the neuromonitoring specialist. It is inherently a human-in-the-loop system. The software updates are "troubleshooting updates for greater usability such as user interfaces and bug fixes."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this submission is the documented and previously cleared performance of the predicate device. The new device demonstrates substantial equivalence by showing that its software updates do not alter the fundamental safety or effectiveness of the system, which is achieved by confirming that hardware specifications remain identical, and software functions operate as expected (i.e., fixing bugs, improving usability) without introducing new risks or changing the device's core output.
8. The sample size for the training set:
Not applicable. This device is not an AI/machine learning device that requires a "training set" in the context of learned algorithms. The "software updates" are bug fixes and usability improvements to a traditional software application, not a learning algorithm.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the context of machine learning. The "ground truth" for the software's correct operation is defined by its functional requirements and the established performance of the predicate device.
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March 25, 2024
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Soterix Medical, Inc. Danielle Dadona Regulatory Affairs Specialist 1480 U.S. Highway 9 North Suite 204 Woodbridge, New Jersey 07095
Re: K234080
Trade/Device Name: MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, GWE, GWJ, OLT, PDQ Dated: December 22, 2023 Received: December 22, 2023
Dear Danielle Dadona:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Patrick Antkowiak -S
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical,
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Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K234080
Device Name
MEGA-IOM system with Neuro-IOM.NET software, models - 32/B - 32/S - 16/S
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K234080 Traditional 510(k) SUMMARY MEGA-IOM System
| Date Prepared: | February 29, 2024 |
|---|---|
| Submitter Information | |
| Company andManufacturer Name: | Soterix Medical, Inc.1480 US Highway 9 NorthSuite 204Woodbridge, NJ 07095 |
| Contact Person: | Danielle DadonaPhone: 888-990-8327Fax: 212-315-3232 |
| Device Information | |
| Trade Name: | MEGA-IOM system with Neuro-IOM.NET softwaremodels -32/B -32/S -16/S |
| Common Name: | Intraoperative Neurophysiologic System |
| Classification andProduct Code: | 21 CFR 882.1870, Class IIGWF - Evoked response electrical stimulator |
| Device Class: | Class II |
| Predicate Device: | K190703Neuro-IOM system with Neuro-IOM.NET softwaremodels -32/B -32/S -16/SNeurosoft Ltd21 CFR 882.1870, GWF, Class II |
| Device Description | The MEGA-IOM system with Neuro-IOM.NET software is intended forintraoperative neurophysiological monitoring (IOM). |
| The system is intended for monitoring the functional integrity and/ ormapping of central and peripheral nervous system including motor andsensory pathways. | |
| Soterix Medical is assuming manufacturing of the predicate product clearedin K190703. This 510(k) submission includes the same hardware clearedwith the predicate device system (no changes) and an updated version ofthe software compared to the predicate device. | |
| Below, a high-level summary of the changes from the predicate areprovided: | |
| Software: The primary changes in this 510(k) submission are related to thesoftware. The changes are troubleshooting updates for greater usability suchas user interfaces and bug fixes. Detailed descriptions of these softwarechanges 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 $\mu$ s) entry, masking noise limitation per IEC 60601-2-40 (Particularrequirements for the basic safety and essential performance ofelectromyographs and evoked response equipment), reporting correct statusof multichannel operation, prevent skipping of traces, and check forincompatible 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 modalitywindow description is unchanged, incorrect Ch 17 display in emulationmode, video filters error during installation, ensuring all text is displayedwithin visibility area, incorrect auditory evoked potentials (EPs) averagecalculation in emulation mode. | |
| Version 1.1.52.9: Fixes related to exam saved message, flexibility tochange test template sequence, sleep mode prevention, rendering speed,interpulse interval display correction, allowing comments in the eventwindow, automatic creation of user template, template list update,impedance measurement window rendering, parameter display correctionin EMG trigger window and Group mode, ensuring non-disappearance ofred line around patient's birth date, enabling stimulation via local menu in |
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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 µA, 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,
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| trace scale reset, appearance of average trace display in case of no averagesdue to artifacts, site name display in TOF window, saving of initial studystate 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 duringmonitoring, limiting maximum increment adjustment of electricalstimulation amplitude to 1 mA and 5V, stimulus duration set-up whenstimulation amplitude is increased, stimulation disablement after powersupply resume, stimulus sound notification, text visualization in dialoguebox, 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 stimulationin multichannel mode, MS Office word report, TeamViewer, logo, andtranslation corrections. | |
| Version 1.1.53.13: Fixes related to removal of sites containing TOF andlogo change. | |
| Version 1.1.53.14: Fixes related to start monitoring during video cameraswitch off, video recording in some interface languages, sound disablementduring impedance measurement, printing test template, USB driver-relatedWindows 10 OS bugs. | |
| In summary, the aforementioned software changes are related to resolvingsoftware bugs and increasing user convenience, but the changes do notimpact the intended use, indications for use statement, contraindications, orwarnings. They also don't increase the likelihood that the device will beused 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 arerelated to the new device trade name and change in manufacturer. Instancesof "Neuro-IOM" were changed to "MEGA-IOM" in the user manual andon the device labels. Soterix Medical is named the manufacturer and pointof contact in the labeling including for all complaints and service requests. | |
| Waveforms: The MEGA-IOM system has the same waveforms as thepredicate device. No change to the waveforms. | |
| Intended Use: | MEGA-IOM system with Neuro-IOM.NET software is intended forintraoperative neurophysiologic monitoring. The device providesinformation to assess a patient's neurophysiological status by evoking a |
| response to electrical stimulation by means of skin electrodes. | |
| The system allows to monitor the functional integrity and/or mapping ofcentral and peripheral nervous system including motor and sensorypathways. | |
| The system is not intended to measure vital signs. It records the data to beinterpreted by the neuromonitoring specialist. | |
| TechnologicalComparison | The MEGA-IOM uses the same technological principle as the predicatedevice to accomplish the same intended use, namely intraoperativeneurophysiological monitoring. All device components, accessories, andoutput specifications are the same as the predicate device. |
| Basis for Equivalence | |
| Performance Testing | To account for the proposed software changes in this 510(k) submission,non-clinical performance testing was submitted in the form of softwareverification and validation and related risk management updatesdemonstrate that the performance parameters of the MEGA-IOM deviceare substantially equivalent to that of the predicate device.The software verification and validation testing documentation inaccordance with a Moderate level of concern device was provided asrecommended by the FDA's Guidance for Industry and FDA Staff"Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices." |
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Table: Comparison of Technological Characteristics
| Parameter | MEGA-IOMSubject Device | Neuro-IOMPredicate Device | Comment |
|---|---|---|---|
| 510(k) | K234080 | K190703 | -- |
| Device Name andModel | MEGA-IOM 16S, 32S, 32Bwith Neuro-IOM.NETsoftware | Neuro-IOM 16S, 32S, 32Bwith Neuro-IOM.NETsoftware | -- |
| Manufacturer | Soterix Medical Inc. | Neurosoft Ltd | -- |
| Parameter | MEGA-IOMSubject Device | Neuro-IOMPredicate Device | Comment |
| Classification Name | Stimulator, Electrical, EvokedResponse | Stimulator, Electrical, EvokedResponse | Identical |
| Product Codes | GWF (primary), GWE, GWJ,OLT, PDQ | GWF (primary), GWE, GWJ,OLT, PDQ | Identical |
| Regulatory Class | Class II | Class II | Identical |
| ClassificationNumber | 21 CFR 882.1870 | 21 CFR 882.1870 | Identical |
| Indications for Use(IFU) statement | MEGA-IOM system withNeuro-IOM.NET software is amedical device intended forintraoperativeneurophysiologic monitoring:the device providesinformation to assess apatient's neurophysiologicalstatus. The system allows tomonitor the functional integrityand/or mapping of central andperipheral nervous systemincluding motor and sensorypathways. It is provided inthree different configurations:I. 32/B, II. 32/S, III. 16/SThe system ensures thefollowing IOM modalities:free-run EMG(electromyography), directnerve stimulation includingpedicle screw test, SSEP(somatosensory evokedpotential), MEP (motor evokedpotential), EEG(electroencephalography),AEP (auditory evokedpotential), VEP (visual evokedpotentials), direct cortical | Neuro-IOM system withNeuro-IOM.NET software is amedical device intended forintraoperativeneurophysiologic monitoring:the device providesinformation to assess apatient's neurophysiologicalstatus. The system allows tomonitor the functional integrityand/or mapping of central andperipheral nervous systemincluding motor and sensory. Itis provided in III differentconfigurations:I. 32/B, II. 32/S, III. 16/SThe system ensures thefollowing IOM modalities:free-run EMG(electromyography), directnerve stimulation includingpedicle screw test, SSEP(somatosensory evokedpotentials), MEP (motorevoked potentials), EEG(electroencephalography), AEP(auditory evoked potentials),VEP (visual evokedpotentials), direct cortical | Similar; Thenew IFUincludes thenew devicename. Allotherwording isidentical tothe predicateIFUstatement |
| Parameter | MEGA-IOMSubject Device | Neuro-IOMPredicate Device | Comment |
| stimulation. Also the train-of-four (TOF) stimulation isperformed. The system is notintended to measure vitalsigns. It records the data to beinterpreted by theneuromonitoring specialist.MEGA-IOM system isintended for use in adults age18 years and older. | stimulation. Also, the train-of-four (TOF) stimulation isperformed. The system is notintended to measure the vitalsigns. It records the data to beinterpreted by theneuromonitoring specialist. | ||
| Intended User | The device is to be used bytrained personnel only. | The device is to be used bytrained personnel only. | Identical |
| Device HardwareSetup | Connected to PC, notstandalone. | Connected to PC, notstandalone. | Identical |
| Electrical SafetyStandards | AAMI/ANSI ES 60601-1:2005/(R)2012IEC 60601-1-2:2014IEC 60601-1-6:2013IEC 60601-2-40:2016IEC 62366-1:2015AAMI/ANSI 62304:2006ISO series 10993IEC 60068-2-31:2008IEC 60068-2-80:2005ISO 14971:2019ISO 13485:2016 | AAMI/ANSI ES 60601-1:2005/(R)2012IEC 60601-1-2:2014IEC 60601-1-6:2013IEC 60601-2-40:2016IEC 62366-1:2015AAMI/ANSI 62304:2006ISO series 10993IEC 60068-2-31:2008IEC 60068-2-80:2005ISO 14971:2007ISO 13485:2012 | Subjectdeviceconforms toupdatedversions ofstandards. |
| Workflow, Menu | PC-controlled | PC-controlled | Identical |
| Parameter | MEGA-IOMSubject Device | Neuro-IOMPredicate Device | Comment |
| Interface toComputer | USB | USB | Identical |
| Channels | 16/32 | 16/32 | Identical |
| 1.5 mm touch-proofinput jacks on pods | Same | Same | Identical |
| Cable Length | 5 m | 5 m | Identical |
| Input Impedance | >1000 MOhm | >1000 MOhm | Identical |
| Common ModeRejection (CMRR) | >90 dB | >90 dB | Identical |
| Low FrequencyFilters | 0.2 Hz - 2000 Hz | 0.2 Hz - 2000 Hz | Identical |
| High FrequencyFilters | 10 Hz - 4 kHz | 10 Hz - 4 kHz | Identical |
| Notch Filter | 50/60 Hz | 50/60 Hz | Identical |
| Sample Rate | 50 kHz | 50 kHz | Identical |
| Sensitivity | 0.05 µV/division to 20mV/division | 0.05 µV/division to 20mV/division | Identical |
| Noise Level | <0.6 µV (<9.5 nV/√Hz) | <0.6 µV (<9.5 nV/√Hz) | Identical |
| Artifact Rejection | Independent for each channel | Independent for each channel | Identical |
| Number of Channels | 16/12/4/4 | 16/12/4/4 | Identical |
| Max Intensity | 200 mA | 200 mA | Identical |
| Duration | 0.02 - 5 ms | 0.02 - 5 ms | Identical |
| Parameter | MEGA-IOMSubject Device | Neuro-IOMPredicate Device | Comment |
| Stimulus Type | Mono-/biphasic | Mono-/biphasic | Identical |
| Electrical Modes | Single, repetitive, trains | Single, repetitive, trains | Identical |
| TranscranialElectrical stimulatorNumber of ChannelsMax IntensityDuration | 41000 V0.04 - 0.2 ms | 41000 V0.04 - 0.2 ms | Identical |
| Low currentstimulatorNumber of ChannelsMax IntensityDuration | 3/2/120 mA0.05 - 0.5 ms | 3/2/120 mA0.05 - 0.5 ms | Identical |
| Stimulation Type | Click, tone, noise | Click, tone, noise | Identical |
| Rate | 0.01 - 100 Hz | 0.01 - 100 Hz | Identical |
| Intensity | 120 dB nHL | 120 dB nHL | Identical |
| Polarity | Condensation, rarefaction,alternating | Condensation, rarefaction,alternating | Identical |
| Transducers | Insert earphone EAR-3A-10Ohms | Insert earphone EAR-3A-10Ohms | Identical |
| Rate | 0.01 - 100 Hz | 0.01 - 100 Hz | Identical |
| Color | red | red | Identical |
| SSEP | Yes | Yes | Identical |
| MEP | Yes | Yes | Identical |
| TcMEP | Yes | Yes | Identical |
| Parameter | MEGA-IOMSubject Device | Neuro-IOMPredicate Device | Comment |
| BAEP | Yes | Yes | Identical |
| VEP | Yes | Yes | Identical |
| EMG | Yes | Yes | Identical |
| EEG | Yes | Yes | Identical |
| Multimodality | Yes | Yes | Identical |
| Predefined testtemplates | Yes | Yes | Identical |
| Creation and editingof test templates | Yes | Yes | Identical |
| Generation ofneuromonitoringreport | Yes | Yes | Identical |
| Image review frommicroscope or othersources | Yes | Yes | Identical |
| Trending | Yes | Yes | Identical |
| ESU Detection | Yes | Yes | Identical |
| Power Supply | 220/230 V AC50/60 Hz | 220/230 V AC50/60 Hz | Identical |
| Visual | LED goggles | LED goggles | Identical |
| Type of electrodes | Any legally marketed (in theU.S.) probes and surface orneedle electrodes with standardlead wire. | Any legally marketed (in theU.S.) probes and surface orneedle electrodes with standardlead wire. | Identical |
| Parameter | MEGA-IOMSubject Device | Neuro-IOMPredicate Device | Comment |
| Freerun waveform | Image: MEGA-IOM Freerun waveform | Image: Neuro-IOM Freerun waveform | Identical |
| SSEP, AEP, VER(Averaged)waveform | Image: MEGA-IOM SSEP, AEP, VER waveform | Image: Neuro-IOM SSEP, AEP, VER waveform | Identical |
| MEP (triggered)waveform | Image: MEGA-IOM MEP waveform | Image: Neuro-IOM MEP waveform | Identical |
| EEG Window | Image: MEGA-IOM EEG Window | Image: Neuro-IOM EEG Window | Identical |
| Parameter | MEGA-IOMSubject Device | Neuro-IOMPredicate Device | Comment |
| CSA Window | Image: Spectral analysis CSA | Image: Spectral analysis CSA | Identical |
| DSA Window | Image: Spectral analysis DSA | Image: Spectral analysis DSA | Identical |
| Trending Window | Image: Trending Window MEGA-IOM | Image: Trending Window Neuro-IOM | Identical |
| Parameter | MEGA-IOMSubject Device | Neuro-IOMPredicate Device | Comment |
| Log Book Window | EventsImage: MEGA-IOM Log Book Window | EventsImage: Neuro-IOM Log Book Window | Identical |
| History Window | Image: MEGA-IOM History Window | Image: Neuro-IOM History Window | Identical |
| Report Template | Image: MEGA-IOM Report Template | Image: Neuro-IOM Report Template | Identical |
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Conclusion
The MEGA-IOM device is technologically similar to the predicate device. The differences in the technological aspects are limited to the software modifications that have been made to improve the usability and bugs associated with the software. The hardware and indications for use (IFU) statement are identical to the predicate and no changes have been made therein.
To account for the software changes, nonclinical tests in the form of software verification and validation have been provided to demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device K190703 Neuro-IOM.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).