(796 days)
Not Found
No
The document explicitly states that the system records data to be interpreted by a neuromonitoring specialist and does not mention any AI/ML capabilities or algorithms for data interpretation or analysis.
No
The device is described as "intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient's neurophysiological status." This indicates a diagnostic or monitoring function, not a therapeutic one. The description explicitly states, "It records the data to be interpreted by the neuromonitoring specialist," further supporting its role in information gathering rather than direct treatment.
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 indicates it gathers information about the patient's condition to aid in diagnosis or assessment by a specialist.
No
The device description explicitly states "Neuro-IOM system with Neuro-IOM.NET software," indicating a system that includes both hardware (the "Neuro-IOM system") and software ("Neuro-IOM.NET software"). The performance studies also include biocompatibility, electrical safety, and EMC testing, which are typically associated with hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Neuro-IOM system is described as a medical device for intraoperative neurophysiologic monitoring. It works by recording electrical signals from the nervous system (EMG, SSEP, MEP, EEG, AEP, VEP) and applying electrical stimulation. This is done directly on the patient during surgery or in other clinical settings.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the body to measure physiological responses.
Therefore, the Neuro-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
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 pathways.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
GWF, GWE, GWJ, OLT, PDQ
Device Description
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 pathways. 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 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.
The systems can be used in operating rooms, intensive care units of different health care facilities (including clinics, hospitals, health centers, ambulance centers, etc.), specialized medical facilities (including prevention centers, medicine centers for emergency, military and medical expertise centers), research and educational medical and biological facilities where the neuromonitoring is required, only by qualified operators who have received training on these devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The systems can be used in operating rooms, intensive care units of different health care facilities (including clinics, hospitals, health centers, ambulance centers, etc.), specialized medical facilities (including prevention centers, medicine centers for emergency, military and medical expertise centers), research and educational medical and biological facilities where the neuromonitoring is required, only by qualified operators who have received training on these devices.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests were conducted to demonstrate substantial equivalence to the predicate device.
Biocompatibility testing:
- Evaluation of the principles governing the biological assessment of medical devices in the risk management process.
- Classification of the medical device according to the nature and duration of contact with the body.
- Cytotoxicity of live cells was studied on the calculation of toxicity index.
- Systemic acute toxicological experiments were performed in rabbits.
Electrical safety and electromagnetic compatibility (EMC) testing:
- Electrical safety testing conducted in accordance with AAMI/ANSI ES 60601-1:2005/(R2012) and A1:2012. System complies with this standard.
- EMC testing conducted in accordance with IEC 60601-1-2:2014. System complies with this standard.
Performance tests:
- System usability check carried out in accordance with IEC 60601-1-6. System complies with this standard.
- System check in accordance with IEC 60601-2-40. System complies with this standard.
- System check for environmental tests in accordance with IEC 60068-2-31 and IEC 60068-2-80. System complies with these standards.
- System performance check based on standard requirements for IEC 80601-2-26:2019. System complies with this standard.
Software Verification and Validation Testing:
- Software verification and validation testing were conducted and documentation was provided as recommended by the Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Safety Level of the Software Device is Moderate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
May 22, 2021
Neurosoft Ltd % Barry Ashar Official Correspondent Makromed, Inc. 88 Stiles Road Salem, NH 03079 USA
Re: K190703
Trade/Device Name: Neuro-IOM system with Neuro-IOM.NET software, models - 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: April 9, 2021 Received: April 20, 2021
Dear Barry Ashar:
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 (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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, 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
2
Indications for Use
510(k) Number (if known) K190703
Device Name
Neuro-IOM system with Neuro-IOM.NET software, models - 32/B - 32/S - 16/S
Indications for Use (Describe)
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 pathways.
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 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.
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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3
510(k) Summary
Company Name: Neurosoft Ltd Company Address: 5, Voronin str. 153032 Ivanovo Company Phone: Company Fax: Company e-mail: Official Contact for Correspondence: Phone: E-mail: secondary contact: Phone: Email: Date Summary Prepared:
Russian Federation +7 4932 59-33-44 +7 4932 24-04-80 info@neurosoft.com Mr. Barry Ashar (Consultant) 603.674.9074 bashar@makromed.com Mr. Eugene Polezhaev +7 4932 58-45-84 polezhaev@neurosoft.ru
April 9, 2021
DEVICE IDENTIFICATION Trade name:
Generic/ Common Name: Regulation number:
Regulation name: Product Code: Subsequent Product Codes: Panel:
Neuro-IOM system with Neuro-IOM.NET software, models - 32/B - 32/S - 16/S
intraoperative neurophysiologic system 21 CFR § 882.1870 Class II Evoked response electrical stimulator GWF GWE, GWJ, OLT Neurology
PREDICATE DEVICES:
Neurosoft identified the following legally marketed devices as substantially equivalent: - Xltek Protektor 32, NATUS MEDICAL, INC., K093304
DEVICE DESCRIPTION:
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 pathways. It is provided in III different configurations:
I.32/B 32/8 II. III. ાર્ભદ્ર
4
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 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.
The systems can be used in operating rooms, intensive care units of different health care facilities (including clinics, hospitals, health centers, ambulance centers, etc.), specialized medical facilities (including prevention centers, medicine centers for emergency, military and medical expertise centers), research and educational medical and biological facilities where the neuromonitoring is required, only by qualified operators who have received training on these devices.
Description of stimuli
| Stimulator | Picture | Modalities |
|---|---|---|
| Electrical Stimulator Built-in | ||
| Electronic Unit | Single pulse monophasic normal | |
| Image: [Single pulse monophasic normal waveform with labels A and D] | ||
| A – amplitude (0 – 200 mA, 0 – 400 V) | ||
| D – duration (50 – 5000 μs) | SSEP, TOF | |
| Single pulse monophasic inverse | ||
| Image: [Single pulse monophasic inverse waveform with labels A and D] | ||
| A – amplitude (0 – 200 mA, 0 – 400 V) | ||
| D – duration (50 – 5000 μs) | SSEP, TOF | |
| Single pulse biphasic | ||
| Image: [Single pulse biphasic waveform with labels A and D] | SSEP, TOF | |
| A - amplitude (0 - 200 mA, 0 – 400 V) | ||
| D - duration (50 – 5000 μs) | ||
| Train of pulses | ||
| Image: Train of pulses | MEP | |
| A - amplitude (0 – 200 mA, 0 – 400 V) | ||
| D - duration (50 – 5000 μs) | ||
| ISI - interstimulus interval (3 – 10 ms) | ||
| N - number of pulses (2 - 200) | ||
| Low Current Stimulator Built-in | ||
| Electronic Unit | Single pulse monophasic normal | |
| Image: Single pulse monophasic normal | ||
| A - amplitude (0-20 mA, 0 – 30 V) | ||
| D - duration (50 – 500 μs) | Direct nerve | |
| stimulation | ||
| Single pulse monophasic inverse | ||
| Image: Single pulse monophasic inverse | ||
| A - amplitude (0-20 mA, 0-30 V) | ||
| D-duration (50 – 500 μs) | Direct nerve | |
| stimulation | ||
| Single pulse biphasic | Direct nerve | |
| stimulation | ||
| Image: Pulse diagram with amplitude A and duration D |
A – amplitude (0 – 20 mA, 0 – 30 V)
D – duration (50 – 500 μs) | | |
| Image: Train of pulses diagram with amplitude A, duration D, and interstimulus interval ISI
Train of pulses
A – amplitude (0 – 20 mA, 0 – 30 V)
D – duration (50 – 500 μs)
ISI – interstimulus interval (2 - 10 ms)
N – number of pulses (1 - 200) | Direct nerve
stimulation | |
| Electrical Stimulator Built-in
Amplifier Unit | Image: Single pulse normal diagram with amplitude A and duration D
Single pulse normal
A – amplitude (0 – 200 mA)
D – duration (50 – 5000 μs) | SSEP, TOF |
| | Image: Single pulse inverse diagram with amplitude A and duration D
Single pulse inverse
A – amplitude (0 – 200 mA) | SSEP, TOF |
| | D - duration (50 – 5000 μs) | |
| | Train of pulses
Image: Train of pulses diagram with A, ISI, and D labels
ISI
D | MEP |
| | A – amplitude (0 - 200 mA) | |
| | D - duration (50 – 5000 μs) | |
| | ISI – interstimulus interval (2 - 10 ms) | |
| | N - number of pulses (1 - 255) | |
| | | |
| Low Current Stimulator Built-in
Amplifier Unit | Single pulse normal
Image: Single pulse normal diagram with A and D labels
A – amplitude (0 - 20 mA)
D - duration (50 – 500 μs) | Direct nerve
stimulation |
| | Single pulse inverse
Image: Single pulse inverse diagram with A and D labels
A – amplitude (0 - 20 mA)
D - duration (50 – 500 μs) | Direct nerve
stimulation |
| | Train of pulses | Direct nerve
stimulation |
| | | |
| | Image: waveform with ISI and D labels
A - amplitude (0 - 20 mA)
D - duration (50 – 500 μs)
ISI - interstimulus interval (2 - 10 ms)
N - number of pulses (1 - 255) | |
| Transcranial Electrical
Stimulator | Single pulse monophasic normal
Image: waveform with A and D labels
A - amplitude (1 – 1000 V)
D - duration (40 – 200 μs) | MEP |
| | Single pulse monophasic inverse
Image: waveform with A and D labels
A - amplitude (1 – 1000 V)
D - duration (40 – 200 μs) | MEP |
| | Single pulse biphasic
Image: waveform with A and D labels | MEP |
5
6
7
8
9
| A – amplitude (1 – 1000 V) | MEP | |
|---|---|---|
| D – duration (40 – 200 μs) | ||
| Train of pulses | ||
| A - amplitude (1 - 1000 V) | ||
| D - duration (40 – 200 μs) | ||
| ISI - interstimulus interval (1 - 10 ms) | ||
| N - number of pulses (1-9) | ||
| Double train | MEP | |
| A - amplitude (1 – 1000 V) | ||
| D - duration (40 – 200 μs) | ||
| ISI - interstimulus interval (1 - 10 ms) | ||
| ITI - intertrain interval (10 – 100 ms) | ||
| Train + Pulse | MEP | |
| A - amplitude (1 - 1000 V) | ||
| D - duration (40 – 200 μs) | ||
| ISI - interstimulus interval (1 – 10 ms) |
10
| ITI – interval between train and pulse (10 – 100 ms) | ||
|---|---|---|
| Auditory Stimulator | Click | |
| Image: Click waveform | ||
| A | ||
| D | ||
| A – amplitude (0 – 120 dB) | ||
| D – duration (100 – 5000 μs) | AEP | |
| Tone | ||
| Image: Tone waveform | ||
| A | ||
| D | ||
| A – amplitude (0 – 120 dB) | ||
| D – duration (0.1 – 90 ms) | ||
| Tone frequency – 100 – 5000 Hz | AEP | |
| Visual Stimulator | Image: Visual Stimulator waveform | |
| A | ||
| D | ||
| D – duration (2 - 1500 ms) | ||
| Max. luminance - 1500 cd/m² | VEP |
INDICATIONS FOR USE:
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 pathways.
11
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 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.
12
Page 10
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL E Q U I V A L E N C E:
In support of a substantial equivalence determination, hereunder are comparison charts with the submitted devices.
| ATTRIBUTE /
CHARACTERISTICS | Neuro-IOM 16S, 32S, 32B
Neurosoft Ltd
(Submitted Product) | Xltek Protektor 32
NATUS MEDICAL, INC | Why the differences do not adversely
affect the safety and effectiveness |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| "K" numbers | NA | K093304 | |
| Proprietary / Trade
Name | Neurosoft Ltd/Neuro-IOM 16S, 32S, 32B
with Neuro-IOM.NET software | Xltek Protector 32 | |
| CFR Section | 882.1870 | 882.1870 | Same |
| Pro-code | GWF, GWE, GWJ, OLT | GWF, GWE, GWJ, OLT | Same |
| Classification name | Stimulator, Electrical, Evoked Response | Stimulator, Electrical, Evoked Response | Same |
| Intended Use | 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 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. | The Protektor32 channel system, composed
of both hardware and software, is intended to
be used for intraoperative neurological
monitoring. The instrument uses
Electroencephalography (EEG), Evoked
Potentials (EP), Electromyography (EMG)
and Transcranial Motor Evoked Potential
(TcMEP) stimulation techniques to provide
the healthcare professionals with information
to help assess a patient's neurological status
during surgery.
The TcMEP mode is intended for
intraoperative diagnosis of acute dysfunction
in corticospinal axonal conduction brought
about by mechanical trauma (traction,
shearing, laceration, or compression) or
vascular insufficiency.
The EPWorks software, an integral part of
the system, is intended to allow a medical
professional to manually configure
stimulation and acquisition parameters and
to manually create EEG, EP, EMG and
TcMEP protocols according to their own
requirements. The intended use, for each of
the software's output, is as follows:
● The EEG, EP, and EMG waveforms are | |
| | | | |
| | | intended to help the user assess a
patient's neurological status during
surgery.
- Simple waveform parameters (e.g.,
amplitude. latency), and user-defined
Fast Fourier transform (FFT) displays
(compressed spectral array or CSA,
density spectral array or OSA) are
intended to help the user analyse the
EEG and EP waveforms.
This device is intended to be used by
qualified medical practitioners, trained in
EEG, EP and EMG who will exercise
professional judgment when using the
information. | |
| Intended User | The device is to be used by trained
personnel only | The device is to be used by trained
personnel only | Same |
| Device Hardware
Setup | Connected to PC, not standalone | Connected to PC, not standalone | Same |
| 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 14971:2007
ISO 13485:2012 | IEC 60601-1:2000
IEC 60601-1-1:2000
IEC 60601-1-2:2005
IEC 60601-2-40:1998
IEC 61000-4-2:2001
IEC 61000-4-3:2002
IEC 61000-4-4:2004
IEC 61000-4-5:2005
IEC 61000-4-6:2006
IEC 61000-4-8:2001
IEC 61000-4-11:2004
61000-3-3:2002
ISO 15223:2000 | |
| Workflow, Menu | PC-controlled | PC-controlled | Same |
| Interface to
Computer | USB | USB | Same |
| Amplifiers | | | |
| Channels | 16/32 | 16/32 | Same |
| 1.5 mm touch-proof
input jacks on pods | Same | Same | Same |
| Cable Length | 5 m | 10 ft., 20 ft. | Same |
| Input impedance | >1000 MOhm | >100 MOhm | Since the higher input impedance in our
device improves the quality of signal |
| Common Mode
Rejection (CMRR) | >90 dB | >93 dB | registration, there is no adverse impact
on the safety and effectiveness. |
| Low Frequency
Filters | 0.2 Hz -2000 Hz | 0.1 - 500 Hz | Higher cutoff frequency in our device
means that it will effectively cut off low-
frequency oscillations cut off by the
predicate device. |
| High Frequency
Filters | 10 Hz - 4 KHz | 30Hz - 15KHz | The range covered by our device is
sufficient for recording signals properly
and will effectively eliminate the high-
frequency interference encountered in
operating rooms. The difference is
negligible to impact the safety and
effectiveness. |
| Notch Filter
Sample Rate | 50/60 Hz
50 KHz | 50/60 Hz
60 KHz | same
The difference is negligible to impact
safety and effectiveness. |
| Sensitivity | 0.05 µV/division to 20 mV/division | 0.1 µV/division to 5 mV/division | Wider range of our device is favorable
as it would allow displaying lower- and
higher-amplitude signals. |
| Noise Level | Irritation | | | |
| 3. | ISO 10993-10 Medical
devices. Biological
evaluation of medical
devices. Part 10. Test
for
irritation and delayed-
type
hypersensitivity | The methods described
in
clause 6 of
this ISO | The systemic acute
toxicological
experiments
were performed in
rabbits. |
| Systemic toxicity | | | |
| 4. | ISO 10993-11
Biological
evaluation of medical
devices - Part 11: Tests
for systemic
toxicity | The methods described
in
clause 5 of
this ISO | The systemic acute
toxicological
experiments
were performed in
rabbits. |
| Electrical safety and electromagnetic compatibility (EMC) | | | |
| 5. | AAMI/ANSI ES
60601-
1:2005/(R2012) and
A1:2012 Medical
electrical equipment -
Part 1: General
requirements for basic
safety and essential
performance (IEC
60601-1:2005, MOD); | Electrical safety
testing was conducted
on the Neuro-IOM
device, in accordance
with the requirements
of the standard | The system complies
with the AAMI/ANSI
ES 60601-1 |
| 6. | IEC 60601-1-2:2014
Medical electrical
equipment - Part 1-2:
General requirements
for basic safety and
essential performance -
Collateral standard:
Electromagnetic
compatibility -
Requirements and tests. | EMC testing was
conducted on the
Neuro-IOM device,
in accordance with
the requirements of
the standard | The system complies
with the IEC 60601-1-
2:2014 |
| Performance tests | | | |
| 7. | IEC 60601-1-6
Medical electrical
equipment - Part 1-6:
General requirements
for basic safety and
essential performance -
Collateral standard:
Usability | The system usability
check was carried out
in accordance with the
requirements of the
standard | The system complies
with the IEC 60601-
1-6 |
| 8. | IEC 60601-2-40
Medical electrical | The system check in
accordance with the | The system complies
with the IEC 60601- |
| | Particular requirements
for the basic safety and
essential performance
of electromyographs
and evoked response
equipment | standard | |
| 9. | IEC 60068-2-31
Environmental testing - Part 2-31: Tests -
Test Ec: Rough
handling shocks,
primarily for
equipment-type
specimens | System check for
environmental tests | The system complies
with the IEC 60068-
2-31 |
| 10. | IEC 60068-2-80
Environmental testing -
Part 2-80: Tests - Test
Fi: Vibration - Mixed
mode | | The system complies
with the IEC 60068-
2-80 |
| 11. | IEC 80601-2-26:2019
Medical electrical
equipment - Part 2-26:
Particular
requirements for the
basic safety and
essential performance
of
electroencephalograph | The system
performance check
based on standard
requirements | The system complies
with the IEC 80601-
2-26:2019 |
| Software Verification and Validation Testing | | | |
| 12. | Guidance for Industry
and FDA Staff,
"Guidance for the
Content of Premarket
Submissions for
Software Contained in | Software verification
and validation testing
were conducted and
documentation was
provided as
recommended by | Safety Level of the
Software Device is
Moderate. |
The following performance data were provided in support of the substantial equivalence determination.
25
26
CONCLUSION:
Neurosoft believes that the submitted Neuro-IOM system with Neuro-IOM software is substantially equivalent in its intended use, technological specifications, principle of operation, and processing functions to the predicate device based on the supported nonclinical testing.