Neuro-IOM system with Neuro-IOM.NET software

K190703 · Neurosoft , Ltd. · GWF · May 22, 2021 · Neurology

Device Facts

• Record ID: K190703
• Device Name: Neuro-IOM system with Neuro-IOM.NET software
• Applicant: Neurosoft , Ltd.
• Product Code: GWF · Neurology
• Decision Date: May 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

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.

Device Story

Neuro-IOM system is an intraoperative neurophysiologic monitoring (IOM) device; records electrical signals from central/peripheral nervous systems; provides electrical stimulation (SSEP, MEP, TOF, direct nerve/cortical stimulation) to elicit responses. Inputs: physiological signals via electrodes; outputs: waveforms, spectral arrays (CSA/DSA), and trend plots displayed on a PC. Used in operating rooms/ICUs by trained neuromonitoring specialists. Device transforms raw signals into visual data for real-time assessment of neural integrity during surgery. Clinicians use output to monitor for acute dysfunction (e.g., mechanical trauma, vascular insufficiency) and adjust surgical approach. Benefits include real-time feedback to prevent permanent neurological damage.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993), electrical safety (AAMI/ANSI ES 60601-1), EMC (IEC 60601-1-2), usability (IEC 60601-1-6), and performance testing per IEC 60601-2-40 and IEC 80601-2-26. Software verification and validation conducted per FDA guidance for moderate level of concern.

Technological Characteristics

PC-based IOM system; 16/32 channel configurations; USB connectivity. Stimulators: electrical (monophasic/biphasic, 0-200mA, 1-1000V), auditory, visual. Filters: 0.2-2000Hz (low freq), 10Hz-4kHz (high freq). Input impedance >1000 MOhm. CMRR >90 dB. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40, ISO 10993, ISO 14971.

Indications for Use

Indicated for intraoperative neurophysiologic monitoring to assess neurophysiological status and monitor functional integrity/mapping of central and peripheral nervous systems (motor and sensory pathways) in patients undergoing surgery. Modalities include free-run EMG, direct nerve stimulation, SSEP, MEP, EEG, AEP, VEP, direct cortical stimulation, and TOF. Not for vital signs measurement. For use by trained personnel.

Regulatory Classification

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.

Predicate Devices

• Xltek Protektor 32 (K093304)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 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 [phone] [phone] [e-mail] Mr. Barry Ashar (Consultant) 603.674.9074 [e-mail] Mr. Eugene Polezhaev [phone] [e-mail]

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

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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<br>Electronic Unit | Single pulse monophasic normal<br>Image: [Single pulse monophasic normal waveform with labels A and D]<br>A – amplitude (0 – 200 mA, 0 – 400 V)<br>D – duration (50 – 5000 μs) | SSEP, TOF |
| | Single pulse monophasic inverse<br>Image: [Single pulse monophasic inverse waveform with labels A and D]<br>A – amplitude (0 – 200 mA, 0 – 400 V)<br>D – duration (50 – 5000 μs) | SSEP, TOF |
| | Single pulse biphasic<br>Image: [Single pulse biphasic waveform with labels A and D] | SSEP, TOF |
| | A - amplitude (0 - 200 mA, 0 – 400 V)<br>D - duration (50 – 5000 μs) | |
| | Train of pulses<br>Image: Train of pulses | MEP |
| | A - amplitude (0 – 200 mA, 0 – 400 V)<br>D - duration (50 – 5000 μs)<br>ISI - interstimulus interval (3 – 10 ms)<br>N - number of pulses (2 - 200) | |
| Low Current Stimulator Built-in<br>Electronic Unit | Single pulse monophasic normal<br>Image: Single pulse monophasic normal<br>A - amplitude (0-20 mA, 0 – 30 V)<br>D - duration (50 – 500 μs) | Direct nerve<br>stimulation |
| | Single pulse monophasic inverse<br>Image: Single pulse monophasic inverse<br>A - amplitude (0-20 mA, 0-30 V)<br>D-duration (50 – 500 μs) | Direct nerve<br>stimulation |
| | Single pulse biphasic | Direct nerve<br>stimulation |
| Image: Pulse diagram with amplitude A and duration D<br><br>A – amplitude (0 – 20 mA, 0 – 30 V)<br><br>D – duration (50 – 500 μs) | | |
| Image: Train of pulses diagram with amplitude A, duration D, and interstimulus interval ISI<br><br>Train of pulses<br><br>A – amplitude (0 – 20 mA, 0 – 30 V)<br><br>D – duration (50 – 500 μs)<br><br>ISI – interstimulus interval (2 - 10 ms)<br><br>N – number of pulses (1 - 200) | Direct nerve<br>stimulation | |
| Electrical Stimulator Built-in<br>Amplifier Unit | Image: Single pulse normal diagram with amplitude A and duration D<br><br>Single pulse normal<br><br>A – amplitude (0 – 200 mA)<br><br>D – duration (50 – 5000 μs) | SSEP, TOF |
| | Image: Single pulse inverse diagram with amplitude A and duration D<br><br>Single pulse inverse<br><br>A – amplitude (0 – 200 mA) | SSEP, TOF |
| | D - duration (50 – 5000 μs) | |
| | Train of pulses<br>Image: Train of pulses diagram with A, ISI, and D labels<br>ISI<br>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<br>Amplifier Unit | Single pulse normal<br>Image: Single pulse normal diagram with A and D labels<br>A – amplitude (0 - 20 mA)<br>D - duration (50 – 500 μs) | Direct nerve<br>stimulation |
| | Single pulse inverse<br>Image: Single pulse inverse diagram with A and D labels<br>A – amplitude (0 - 20 mA)<br>D - duration (50 – 500 μs) | Direct nerve<br>stimulation |
| | Train of pulses | Direct nerve<br>stimulation |
| | | |
| | Image: waveform with ISI and D labels<br>A - amplitude (0 - 20 mA)<br>D - duration (50 – 500 μs)<br>ISI - interstimulus interval (2 - 10 ms)<br>N - number of pulses (1 - 255) | |
| Transcranial Electrical<br>Stimulator | Single pulse monophasic normal<br>Image: waveform with A and D labels<br>A - amplitude (1 – 1000 V)<br>D - duration (40 – 200 μs) | MEP |
| | Single pulse monophasic inverse<br>Image: waveform with A and D labels<br>A - amplitude (1 – 1000 V)<br>D - duration (40 – 200 μs) | MEP |
| | Single pulse biphasic<br>Image: waveform with A and D labels | MEP |

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| A – amplitude (1 – 1000 V) | | MEP |
|------------------------------------------------------------------------------------------------------------------------------------|--|-----|
| D – duration (40 – 200 μs) | | |
| Train of pulses | | |
| <img alt="Train of pulses diagram" src="pulse_train_1.png"/> | | |
| A - amplitude (1 - 1000 V)<br>D - duration (40 – 200 μs)<br>ISI - interstimulus interval (1 - 10 ms)<br>N - number of pulses (1-9) | | |
| Double train | | MEP |
| <img alt="Double train diagram" src="pulse_train_2.png"/> | | |
| A - amplitude (1 – 1000 V) | | |
| D - duration (40 – 200 μs) | | |
| ISI - interstimulus interval (1 - 10 ms)<br>ITI - intertrain interval (10 – 100 ms) | | |
| Train + Pulse | | MEP |
| <img alt="Train + Pulse diagram" src="pulse_train_3.png"/> | | |
| A - amplitude (1 - 1000 V) | | |
| D - duration (40 – 200 μs) | | |
| ISI - interstimulus interval (1 – 10 ms) | | |

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| ITI – interval between train and pulse (10 – 100 ms) | | |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----|
| Auditory Stimulator | Click<br>Image: Click waveform<br>A<br>D<br>A – amplitude (0 – 120 dB)<br>D – duration (100 – 5000 μs) | AEP |
| | Tone<br>Image: Tone waveform<br>A<br>D<br>A – amplitude (0 – 120 dB)<br>D – duration (0.1 – 90 ms)<br>Tone frequency – 100 – 5000 Hz | AEP |
| Visual Stimulator | Image: Visual Stimulator waveform<br>A<br>D<br>D – duration (2 - 1500 ms)<br>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.

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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.

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# 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 /<br>CHARACTERISTICS | Neuro-IOM 16S, 32S, 32B<br>Neurosoft Ltd<br>(Submitted Product) | Xltek Protektor 32<br>NATUS MEDICAL, INC | Why the differences do not adversely<br>affect the safety and effectiveness |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| "K" numbers | NA | K093304 | |
| Proprietary / Trade<br>Name | Neurosoft Ltd/Neuro-IOM 16S, 32S, 32B<br>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<br>software is a medical device intended for<br>intraoperative neurophysiologic monitoring: the<br>device provides information to assess a patient's<br>neurophysiological status.<br>The system allows to monitor the functional<br>integrity and/or mapping of central and<br>peripheral nervous system including motor and<br>sensory.<br>It is provided in III different configurations:<br>I. 32/B<br>II. 32/S<br>III. 16/S<br>The system ensures the following IOM<br>modalities: free-run EMG (electromyography),<br>direct nerve stimulation including pedicle screw<br>test, SSEP (somatosensory evoked potentials),<br>MEP (motor evoked potentials), EEG<br>(electroencephalography), AEP (auditory evoked<br>potentials), VEP (visual evoked potentials),<br>direct cortical stimulation. Also, the train-of-four<br>(TOF) stimulation is performed.<br>The system is not intended to measure the vital<br>signs. It records the data to be interpreted by the<br>neuromonitoring specialist. | The Protektor32 channel system, composed<br>of both hardware and software, is intended to<br>be used for intraoperative neurological<br>monitoring. The instrument uses<br>Electroencephalography (EEG), Evoked<br>Potentials (EP), Electromyography (EMG)<br>and Transcranial Motor Evoked Potential<br>(TcMEP) stimulation techniques to provide<br>the healthcare professionals with information<br>to help assess a patient's neurological status<br>during surgery.<br>The TcMEP mode is intended for<br>intraoperative diagnosis of acute dysfunction<br>in corticospinal axonal conduction brought<br>about by mechanical trauma (traction,<br>shearing, laceration, or compression) or<br>vascular insufficiency.<br>The EPWorks software, an integral part of<br>the system, is intended to allow a medical<br>professional to manually configure<br>stimulation and acquisition parameters and<br>to manually create EEG, EP, EMG and<br>TcMEP protocols according to their own<br>requirements. The intended use, for each of<br>the software's output, is as follows:<br>● The EEG, EP, and EMG waveforms are | |
| | | | |
| | | intended to help the user assess a<br>patient's neurological status during<br>surgery.<br>- Simple waveform parameters (e.g.,<br>amplitude. latency), and user-defined<br>Fast Fourier transform (FFT) displays<br>(compressed spectral array or CSA,<br>density spectral array or OSA) are<br>intended to help the user analyse the<br>EEG and EP waveforms.<br>This device is intended to be used by<br>qualified medical practitioners, trained in<br>EEG, EP and EMG who will exercise<br>professional judgment when using the<br>information. | |
| Intended User | The device is to be used by trained<br>personnel only | The device is to be used by trained<br>personnel only | Same |
| Device Hardware<br>Setup | Connected to PC, not standalone | Connected to PC, not standalone | Same |
| Standards | AAMI/ANSI ES 60601-1:2005/(R)2012<br>IEC 60601-1-2:2014<br>IEC 60601-1-6:2013<br>IEC 60601-2-40:2016<br>IEC 62366-1:2015<br>AAMI/ANSI 62304:2006<br>ISO series 10993<br>IEC 60068-2-31:2008<br>IEC 60068-2-80:2005<br>ISO 14971:2007<br>ISO 13485:2012 | IEC 60601-1:2000<br>IEC 60601-1-1:2000<br>IEC 60601-1-2:2005<br>IEC 60601-2-40:1998<br>IEC 61000-4-2:2001<br>IEC 61000-4-3:2002<br>IEC 61000-4-4:2004<br>IEC 61000-4-5:2005<br>IEC 61000-4-6:2006<br>IEC 61000-4-8:2001<br>IEC 61000-4-11:2004<br>61000-3-3:2002<br>ISO 15223:2000 | |
| Workflow, Menu | PC-controlled | PC-controlled | Same |
| Interface to<br>Computer | USB | USB | Same |
| Amplifiers | | | |
| Channels | 16/32 | 16/32 | Same |
| 1.5 mm touch-proof<br>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<br>device improves the quality of signal |
| Common Mode<br>Rejection (CMRR) | >90 dB…