(94 days)
No
The device description and software changes are focused on bug fixes, usability improvements, and maintaining equivalence to the predicate device. There is no mention of AI or ML capabilities.
No.
The device is described as a medical device intended for intraoperative neurophysiologic monitoring to assess a patient's neurophysiological status, specifically monitoring the functional integrity and/or mapping of the central and peripheral nervous system. It records data to be interpreted by a neuromonitoring specialist. It does not actively treat or restore function, but rather acts as a diagnostic and monitoring tool.
Yes
The device is intended for intraoperative neurophysiologic monitoring to "assess a patient's neurophysiological status" and "monitor the functional integrity and/or mapping of central and peripheral nervous system." This involves recording data from various neurophysiological modalities (e.g., EMG, SSEP, MEP, EEG) for interpretation by a specialist, which directly aligns with the definition of a diagnostic device (assessing or detecting medical conditions).
No
The device description explicitly states that the submission includes the "same hardware cleared with the predicate device system (no changes)" and an updated version of the software. This indicates the device is a system comprising both hardware and software, not software-only.
Based on the provided text, the MEGA-IOM system with Neuro-IOM.NET software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "intraoperative neurophysiologic monitoring" to "assess a patient's neurophysiological status." This involves monitoring the functional integrity and/or mapping of the nervous system.
- Device Description: The description reinforces the intended use for intraoperative neurophysiological monitoring and lists various neurophysiological modalities (EMG, SSEP, MEP, EEG, AEP, VEP, etc.).
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The MEGA-IOM system does not perform these functions. It directly monitors the patient's nervous system activity.
Therefore, the MEGA-IOM system falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GWF, GWE, GWJ, OLT, PDQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central and peripheral nervous system including motor and sensory pathways
Indicated Patient Age Range
adults age 18 years and older.
Intended User / Care Setting
The device is to be used by trained personnel only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Non-clinical performance testing was submitted in the form of software verification and validation and related risk management updates demonstrate that the performance parameters of the MEGA-IOM device are substantially equivalent to that of the predicate device. The software verification and validation testing documentation in accordance with a Moderate level of concern device was provided as recommended by the FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To account for the proposed software changes in this 510(k) submission, non-clinical performance testing was submitted in the form of software verification and validation and related risk management updates demonstrate that the performance parameters of the MEGA-IOM device are substantially equivalent to that of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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"
1
(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,
2
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
3
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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4
K234080 Traditional 510(k) SUMMARY MEGA-IOM System
| Date Prepared: | February 29, 2024 |
|---|---|
| Submitter Information | |
| Company and | |
| Manufacturer Name: | Soterix Medical, Inc. |
| 1480 US Highway 9 North | |
| Suite 204 | |
| Woodbridge, NJ 07095 | |
| Contact Person: | Danielle Dadona |
| Phone: 888-990-8327 | |
| Fax: 212-315-3232 | |
| Device Information | |
| Trade Name: | MEGA-IOM system with Neuro-IOM.NET software |
| models -32/B -32/S -16/S | |
| Common Name: | Intraoperative Neurophysiologic System |
| Classification and | |
| Product Code: | 21 CFR 882.1870, Class II |
| GWF - Evoked response electrical stimulator | |
| Device Class: | Class II |
| Predicate Device: | K190703 |
| Neuro-IOM system with Neuro-IOM.NET software | |
| models -32/B -32/S -16/S | |
| Neurosoft Ltd | |
| 21 CFR 882.1870, GWF, Class II | |
| Device Description | 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 $\mu$ s) 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 |
5
6
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,
7
| | 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. |
| Intended Use: | MEGA-IOM system with Neuro-IOM.NET software is intended for
intraoperative neurophysiologic monitoring. The device provides
information 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 of
central and peripheral nervous system including motor and sensory
pathways. |
| | The system is not intended to measure vital signs. It records the data to be
interpreted by the neuromonitoring specialist. |
| Technological
Comparison | The MEGA-IOM uses the same technological principle as the predicate
device to accomplish the same intended use, namely intraoperative
neurophysiological monitoring. All device components, accessories, and
output 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 software
verification and validation and related risk management updates
demonstrate that the performance parameters of the MEGA-IOM device
are substantially equivalent to that of the predicate device.
The software verification and validation testing documentation in
accordance with a Moderate level of concern device was provided as
recommended by the FDA's Guidance for Industry and FDA Staff
"Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices." |
8
Table: Comparison of Technological Characteristics
| Parameter | MEGA-IOM
Subject Device | Neuro-IOM
Predicate Device | Comment |
|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K234080 | K190703 | -- |
| Device Name and
Model | MEGA-IOM 16S, 32S, 32B
with Neuro-IOM.NET
software | Neuro-IOM 16S, 32S, 32B
with Neuro-IOM.NET
software | -- |
| Manufacturer | Soterix Medical Inc. | Neurosoft Ltd | -- |
| Parameter | MEGA-IOM
Subject Device | Neuro-IOM
Predicate Device | Comment |
| 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) statement | 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 | Neuro-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. It
is provided in III 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
potentials), MEP (motor
evoked potentials), EEG
(electroencephalography), AEP
(auditory evoked potentials),
VEP (visual evoked
potentials), direct cortical | Similar; The
new IFU
includes the
new device
name. All
other
wording is
identical to
the predicate
IFU
statement |
| Parameter | MEGA-IOM
Subject Device | Neuro-IOM
Predicate Device | Comment |
| | 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. | stimulation. Also, the train-of-
four (TOF) stimulation is
performed. The system is not
intended to measure the vital
signs. It records the data to be
interpreted by the
neuromonitoring specialist. | |
| Intended User | The device is to be used by
trained personnel only. | The device is to be used by
trained personnel only. | Identical |
| Device Hardware
Setup | Connected to PC, not
standalone. | Connected to PC, not
standalone. | Identical |
| Electrical Safety
Standards | AAMI/ANSI ES 60601-
1:2005/(R)2012
IEC 60601-1-2:2014
IEC 60601-1-6:2013
IEC 60601-2-40:2016
IEC 62366-1:2015
AAMI/ANSI 62304:2006
ISO series 10993
IEC 60068-2-31:2008
IEC 60068-2-80:2005
ISO 14971:2019
ISO 13485:2016 | AAMI/ANSI ES 60601-
1:2005/(R)2012
IEC 60601-1-2:2014
IEC 60601-1-6:2013
IEC 60601-2-40:2016
IEC 62366-1:2015
AAMI/ANSI 62304:2006
ISO series 10993
IEC 60068-2-31:2008
IEC 60068-2-80:2005
ISO 14971:2007
ISO 13485:2012 | Subject
device
conforms to
updated
versions of
standards. |
| Workflow, Menu | PC-controlled | PC-controlled | Identical |
| Parameter | MEGA-IOM
Subject Device | Neuro-IOM
Predicate Device | Comment |
| Interface to
Computer | USB | USB | Identical |
| Channels | 16/32 | 16/32 | Identical |
| 1.5 mm touch-proof
input jacks on pods | Same | Same | Identical |
| Cable Length | 5 m | 5 m | 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 |