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 Description

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

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.

AI/ML Overview

The provided text is an FDA 510(k) summary for the Neuro-IOM system. It details the device's technical specifications and compares them to a predicate device (Xltek Protektor 32) to demonstrate substantial equivalence, rather than providing the results of a specific clinical study with defined acceptance criteria and human reader performance.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert ground truth, and MRMC studies are not present in this document because they are not typically required for a 510(k) clearance based on substantial equivalence for this type of device. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate through non-clinical testing and comparison of specifications.

However, I can extract the information that is available and note what is not provided.

Acceptance Criteria and Device Performance:

The document does not present specific "acceptance criteria" for a clinical performance study in the typical sense of metrics like sensitivity, specificity, accuracy, or AUC. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, primarily through comparison of technical specifications and non-clinical performance testing (biocompatibility, electrical safety, EMC, performance tests, and software verification/validation).

The "reported device performance" is demonstrated by showing that the Neuro-IOM system's technical attributes are either identical or sufficiently similar to the predicate device, or where differences exist, they do not adversely affect safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there isn't a direct table of clinical acceptance criteria and performance metrics. Instead, the document provides detailed comparison tables between the subject device (Neuro-IOM system) and the predicate device (Xltek Protektor 32) across various attributes. The acceptance is implied if the differences are found to not adversely affect safety and effectiveness.

Here's a summary of the technical performance comparison, which serves as the basis for the "acceptance" of substantial equivalence:

Attribute / Characteristic	Neuro-IOM 16S, 32S, 32B (Submitted Product)	Xltek Protektor 32 (Predicate Product)	Why the differences do not adversely affect the safety and effectiveness
Intended Use	Intraoperative neurophysiologic monitoring to assess patient's neurophysiological status; monitors functional integrity/mapping of central and peripheral nervous system (motor and sensory pathways). Modalities: free-run EMG, direct nerve stimulation (pedicle screw test), SSEP, MEP, EEG, AEP, VEP, direct cortical stimulation, TOF. Not for vital signs. Records data for neuromonitoring specialist interpretation.	Intraoperative neurological monitoring using EEG, EP, EMG, and TcMEP stimulation techniques to help assess a patient's neurological status during surgery. EPWorks software allows manual configuration of parameters and creation of protocols for EEG, EP, EMG, and TcMEP waveforms.	Same (Similar overall purpose and modalities)
Intended User	Trained personnel only	Trained personnel only	Same
Device Hardware Setup	Connected to PC, not standalone	Connected to PC, not standalone	Same
Amplifiers - Channels	16/32	16/32	Same
Amplifiers - Input Impedance	>1000 MOhm	>100 MOhm	Higher impedance for Neuro-IOM improves signal quality; no adverse impact on safety/effectiveness.
Amplifiers - Common Mode Rejection (CMRR)	>90 dB	>93 dB	Slightly different, but both are high values. No adverse impact on safety/effectiveness (implied).
Amplifiers - Low Frequency Filters	0.2 Hz - 2000 Hz	0.1 - 500 Hz	Neuro-IOM has higher cutoff; effectively cuts off low-frequency oscillations. No adverse impact on safety/effectiveness.
Amplifiers - High Frequency Filters	10 Hz - 4 KHz	30 Hz - 15 KHz	Neuro-IOM range is sufficient for proper signal recording and eliminates high-frequency interference. Difference negligible to impact safety/effectiveness.
Amplifiers - Notch Filter	50/60 Hz	50/60 Hz	Same
Amplifiers - Sample Rate	50 KHz	60 KHz	Difference negligible to impact safety/effectiveness.
Amplifiers - Sensitivity	0.05 µV/division to 20 mV/division	0.1 µV/division to 5 mV/division	Wider range in Neuro-IOM is favorable, allowing display of lower- and higher-amplitude signals. No adverse impact on safety/effectiveness.
Amplifiers - Noise Level	< 0.6 μV (< 9.5 nV/Hz)	< 0.1 µV (< 20 nV/Hz)	Neuro-IOM claims lower noise level compared to predicate's declared value (this statement seems to contradict the actual numbers provided, as 0.6 is higher than 0.1, and 9.5 is lower than 20. The statement probably meant to say it's better in terms of noise density (nV/Hz) despite having a higher total µV, or it's a small difference. Without further clarification from the document, this point is ambiguous and typically the lower the µV, the better. Assuming the submission successfully argued it was acceptable).
Stimulators - Max Intensity (Electrical)	200 mA	100 mA	Larger amplitude in Neuro-IOM allows for transcranial stimulation. No impact on safety/effectiveness.
Stimulators - Duration (Electrical)	0.02 - 5 ms	0.05 - 1 ms	Difference negligible to impact safety/effectiveness.
Stimulators - Number of channels (Transcranial Electrical)	4	4	Same
Stimulators - Max Intensity (Transcranial Electrical)	1000 V	1000 V	Same
Stimulators - Duration (Transcranial Electrical)	0.04 - 0.2 ms	0.05 ms	Increasing duration allows response at lower amplitude. No effect on safety/effectiveness.
Stimulators - Auditory Stimulation Type	Click, tone, noise	Click, pip, tone, noise	Similar (Pip is a type of tone)
Stimulators - Auditory Intensity	120 dB nHL	125 dB nHL	Lower value in Neuro-IOM is better for patient comfort. No adverse impact on safety/effectiveness.
Recording Modalities	SSEP, MEP, TcMEP, BAEP, VEP, EMG, EEG, Multimodality	SSEP, MEP, TcMEP, BAEP, VEP, EMG, EEG, Multimodality	Same
Software Features	Predefined test templates, Creation/editing of test templates, Neuromonitoring report generation, Image review, Trending, ESU Detection	Same functionality. Differences noted as minor graphical appearance.	Same (Processing functions are well known and accepted. Minor graphical differences do not raise new hazards or increase risk of inappropriate signal capture/erroneous interpretation/processing.)
Remote Monitoring	YES (internet browser for acquisition computer screen)	YES (special software for remote access)	Equivalent (User can see acquisition station screen and use chat window for conversation)

2. Sample size used for the test set and the data provenance:

Sample Size: This document does not describe a clinical study with a "test set" sample size in terms of patient data. The evaluation for 510(k) clearance was based on non-clinical testing (e.g., electrical safety, EMC, performance tests, software verification/validation) and comparison to a predicate device.
Data Provenance: Not applicable as no clinical patient data set was used for performance evaluation described here. The company, Neurosoft Ltd, is based in the Russian Federation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There was no clinical "test set" and thus no ground truth established by experts for that purpose. The ground truth for this submission is implicitly the established safety and effectiveness of the predicate device and the adherence to relevant medical device standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There was no clinical "test set" requiring adjudication.

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 MRMC study was done. This device is an intraoperative neurophysiological monitoring system, not an AI-powered diagnostic imaging tool that would typically undergo such a study. The product description does not indicate AI assistance that would augment human reader performance in interpreting findings beyond displaying physiological data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device functions as a physiological monitoring system that "records the data to be interpreted by the neuromonitoring specialist." It is not a standalone diagnostic algorithm that operates without human interpretation. Its performance is demonstrated through its hardware and software specifications for signal acquisition and display, similar to the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this 510(k) submission is the demonstrated safety and effectiveness of the predicate device (Xltek Protektor 32) and compliance with relevant industry standards (e.g., AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 62366-1, ISO 10993 series). The testing focused on functional equivalence and safety conformance, not diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set:

Not applicable. This document is a 510(k) summary for a physiological monitoring device, not an AI/ML device that requires a training set of data.

9. How the ground truth for the training set was established:

Not applicable, as there was no training set.

Summary

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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 (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

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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)

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 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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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:

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.

Description of stimuli

Stimulator	Picture	Modalities
Electrical Stimulator Built-inElectronic Unit	Single pulse monophasic normalImage: [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 inverseImage: [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 biphasicImage: [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 pulsesImage: 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-inElectronic Unit	Single pulse monophasic normalImage: Single pulse monophasic normalA - amplitude (0-20 mA, 0 – 30 V)D - duration (50 – 500 μs)	Direct nervestimulation
	Single pulse monophasic inverseImage: Single pulse monophasic inverseA - amplitude (0-20 mA, 0-30 V)D-duration (50 – 500 μs)	Direct nervestimulation
	Single pulse biphasic	Direct nervestimulation
Image: Pulse diagram with amplitude A and duration DA – 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 ISITrain of pulsesA – 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 nervestimulation
Electrical Stimulator Built-inAmplifier Unit	Image: Single pulse normal diagram with amplitude A and duration DSingle pulse normalA – amplitude (0 – 200 mA)D – duration (50 – 5000 μs)	SSEP, TOF
	Image: Single pulse inverse diagram with amplitude A and duration DSingle pulse inverseA – amplitude (0 – 200 mA)	SSEP, TOF
	D - duration (50 – 5000 μs)
	Train of pulsesImage: Train of pulses diagram with A, ISI, and D labelsISID	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-inAmplifier Unit	Single pulse normalImage: Single pulse normal diagram with A and D labelsA – amplitude (0 - 20 mA)D - duration (50 – 500 μs)	Direct nervestimulation
	Single pulse inverseImage: Single pulse inverse diagram with A and D labelsA – amplitude (0 - 20 mA)D - duration (50 – 500 μs)	Direct nervestimulation
	Train of pulses	Direct nervestimulation

	Image: waveform with ISI and D labelsA - amplitude (0 - 20 mA)D - duration (50 – 500 μs)ISI - interstimulus interval (2 - 10 ms)N - number of pulses (1 - 255)
Transcranial ElectricalStimulator	Single pulse monophasic normalImage: waveform with A and D labelsA - amplitude (1 – 1000 V)D - duration (40 – 200 μs)	MEP
	Single pulse monophasic inverseImage: waveform with A and D labelsA - amplitude (1 – 1000 V)D - duration (40 – 200 μs)	MEP
	Single pulse biphasicImage: 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

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)

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ITI – interval between train and pulse (10 – 100 ms)
Auditory Stimulator	ClickImage: Click waveformADA – amplitude (0 – 120 dB)D – duration (100 – 5000 μs)	AEP
	ToneImage: Tone waveformADA – amplitude (0 – 120 dB)D – duration (0.1 – 90 ms)Tone frequency – 100 – 5000 Hz	AEP
Visual Stimulator	Image: Visual Stimulator waveformADD – duration (2 - 1500 ms)Max. luminance - 1500 cd/m²	VEP

INDICATIONS FOR USE:

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 is not intended to measure the vital signs. It records the data to be interpreted by the neuromonitoring specialist.

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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, 32BNeurosoft Ltd(Submitted Product)	Xltek Protektor 32NATUS MEDICAL, INC	Why the differences do not adverselyaffect the safety and effectiveness
"K" numbers	NA	K093304
Proprietary / TradeName	Neurosoft Ltd/Neuro-IOM 16S, 32S, 32Bwith 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.NETsoftware is a medical device intended forintraoperative neurophysiologic monitoring: thedevice provides information to assess a patient'sneurophysiological status.The system allows to monitor the functionalintegrity and/or mapping of central andperipheral nervous system including motor andsensory.It is provided in III different configurations:I. 32/BII. 32/SIII. 16/SThe system ensures the following IOMmodalities: free-run EMG (electromyography),direct nerve stimulation including pedicle screwtest, SSEP (somatosensory evoked potentials),MEP (motor evoked potentials), EEG(electroencephalography), AEP (auditory evokedpotentials), VEP (visual evoked potentials),direct cortical stimulation. Also, the train-of-four(TOF) stimulation is performed.The system is not intended to measure the vitalsigns. It records the data to be interpreted by theneuromonitoring specialist.	The Protektor32 channel system, composedof both hardware and software, is intended tobe used for intraoperative neurologicalmonitoring. The instrument usesElectroencephalography (EEG), EvokedPotentials (EP), Electromyography (EMG)and Transcranial Motor Evoked Potential(TcMEP) stimulation techniques to providethe healthcare professionals with informationto help assess a patient's neurological statusduring surgery.The TcMEP mode is intended forintraoperative diagnosis of acute dysfunctionin corticospinal axonal conduction broughtabout by mechanical trauma (traction,shearing, laceration, or compression) orvascular insufficiency.The EPWorks software, an integral part ofthe system, is intended to allow a medicalprofessional to manually configurestimulation and acquisition parameters andto manually create EEG, EP, EMG andTcMEP protocols according to their ownrequirements. The intended use, for each ofthe software's output, is as follows:● The EEG, EP, and EMG waveforms are

		intended to help the user assess apatient's neurological status duringsurgery.- Simple waveform parameters (e.g.,amplitude. latency), and user-definedFast Fourier transform (FFT) displays(compressed spectral array or CSA,density spectral array or OSA) areintended to help the user analyse theEEG and EP waveforms.This device is intended to be used byqualified medical practitioners, trained inEEG, EP and EMG who will exerciseprofessional judgment when using theinformation.
Intended User	The device is to be used by trainedpersonnel only	The device is to be used by trainedpersonnel only	Same
Device HardwareSetup	Connected to PC, not standalone	Connected to PC, not standalone	Same
Standards	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	IEC 60601-1:2000IEC 60601-1-1:2000IEC 60601-1-2:2005IEC 60601-2-40:1998IEC 61000-4-2:2001IEC 61000-4-3:2002IEC 61000-4-4:2004IEC 61000-4-5:2005IEC 61000-4-6:2006IEC 61000-4-8:2001IEC 61000-4-11:200461000-3-3:2002ISO 15223:2000
Workflow, Menu	PC-controlled	PC-controlled	Same
Interface toComputer	USB	USB	Same
Amplifiers
Channels	16/32	16/32	Same
1.5 mm touch-proofinput 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 ourdevice improves the quality of signal
Common ModeRejection (CMRR)	>90 dB	>93 dB	registration, there is no adverse impacton the safety and effectiveness.
Low FrequencyFilters	0.2 Hz -2000 Hz	0.1 - 500 Hz	Higher cutoff frequency in our devicemeans that it will effectively cut off low-frequency oscillations cut off by thepredicate device.
High FrequencyFilters	10 Hz - 4 KHz	30Hz - 15KHz	The range covered by our device issufficient for recording signals properlyand will effectively eliminate the high-frequency interference encountered inoperating rooms. The difference isnegligible to impact the safety andeffectiveness.
Notch FilterSample Rate	50/60 Hz50 KHz	50/60 Hz60 KHz	sameThe difference is negligible to impactsafety 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 favorableas it would allow displaying lower- andhigher-amplitude signals.
Noise Level	< 0,6 μV (< 9,5 nV/ $$ Hz)	< 0.1 µV (< 20nV/ $$ Hz)	Our device has a lower noise levelparameter compared to the declaredvalue of the parameter in the technicalmanual of the predicate.
Artifact Rejection	Independent for each channel	Independent for each channel	Same
StimulatorsElectrical
Number ofchannels	16/12/4/4	16
Max Intensity	200 mA	100 mA	Larger amplitude of the stimulus allowsuse of the stimulator for transcranialstimulation. No impact on the safety oreffectiveness.
Duration	0.02 - 5 ms	0.05 - 1 ms	The difference is negligible to impact
			safety and effectiveness.
Stimulus Type	Mono-/biphasic	Mono-/biphasic	Same
Electrical Modes	Single, repetitive, trains	Single, repetitive, trains	Same
TranscranialElectrical stimulatorNumber ofChannelsMax IntensityDuration	41000 V0.04 - 0.2 ms	41000 V0.05 ms	Increasing the duration of the stimulusallows obtaining a response at loweramplitude of the stimulus. No effect onsafety or effectiveness.
Low currentstimulatorNumber ofChannels MaxIntensity Duration	3/2/120 mA0.05 - 0.5 ms	220 mA0.05 - 1 ms	Similar
Auditory
Stimulation Type	Click, tone, noise	Click, pip, tone, noise	Similar
Rate	0.01 - 100 Hz	0.2 - 100 Hz	Similar
Intensity	120 dB nHL	125 dB nHL	For patient comfort, lower value isbetter.
Polarity	Condensation, rarefaction, alternating	Condensation, rarefaction, alternating	Same
Transducers	Insert earphone EAR-3A-10 Ohms	TDH - 39 headphones, TIP inserts	Similar
Visual
Rate	0.01 - 100 Hz	0.1 - 100 Hz	Same
Color	red	Black, red, green, blue	Similar
Recording modalities
SSEP	Yes	Yes	Same
MEP	Yes	Yes	Same
TcMEP	Yes	Yes	Same
BAEP	Yes	Yes	Same
VEP	Yes	Yes	Same
EMG	Yes	Yes	Same
EEG	Yes	Yes	Same
Multimodality	Yes	Yes	Same
Software features
Predefined testtemplates	Yes	Yes	Same
Creation andediting of testtemplates	Yes	Yes	Same
Generation ofneuromonitoringreport	Yes	Yes	Same
Image review frommicroscope orother sources	Yes	Yes	Same
Trending	Yes	Yes	Same
ESU Detection	Yes	Yes	Same
Power supply	220/230 V AC50/60 Hz	100 - 240 V AC50/60 Hz	Similar
Accessories
Visual	LED goggles	LED goggles	Same
Type of electrodes	Any legally marketed (in the U.S.) probesand surface or needle electrodes withstandard lead wire.	Any legally marketed (in the U.S.)probes and surface or needle electrodeswith standard lead wire.	Equivalent – no significant difference incharge density or current densityexpected
ATTRIBUTE /CHARACTERISTICS	NEURO-IOM.NET SOFTWARENEUROSOFT (Submitted Product)	Xltek Protektor 32 Natus	Why the differences do not adverselyaffect the safety and effectiveness
'K"numbers		K093304
IndicationsFor Use	Neuro-IOM system with Neuro-IOM.NETsoftware is a medical device intended forintraoperative neurophysiologic monitoring:the device provides information to assess apatient's neurophysiological status.The system allows to monitor the functionalintegrity and/or mapping of central andperipheral nervous system including motorand sensory pathways.It is provided in III different configurations:I. 32/BII. 32/SIII. 16/SThe system ensures the following IOMmodalities: free-run EMG(electromyography), direct nerve stimulationincluding pedicle screw test, SSEP(somatosensory evoked potentials), MEP(motor evoked potentials), EEG(electroencephalography), AEP (auditoryevoked potentials), VEP (visual evokedpotentials), direct cortical stimulation. Also,the train-of-four (TOF) stimulation isperformed.The system is not intended to measure thevital signs. It records the data to beinterpreted by the neuromonitoring specialist.	The EPWorks software, an integral part ofthe system, is intended to allow a medicalprofessional to manually configurestimulation and acquisition parameters andto manually create EEG, EP, EMG andTcMEP protocols according to their ownrequirements. The intended use for each ofthe software's outputs is as follows:1.The EEG, EP, and EMG waveforms areintended to help the user assess a patient'sneurological status during surgery.2.Simple waveform parameters (e.g.,amplitude. latency), and user-defined FastFourier transform (FFT) displays(compressed spectral array or CSA,density spectral array or OSA) are intendedto help the user analyze the EEG and EPwaveforms.
Functions

Hardware Comparison – Chart 1

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Software Comparison – Chart 2

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Neuro-IOM System

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Image /page/18/Figure/3 description: This image compares the features of NEURO-IOM.NET SOFTWARE NEUROSOFT and Xltek Protektor 32 Natus, focusing on their impact on safety and effectiveness. The comparison highlights the "Freerun waveform" and "SSEP, AEP, VER (averaged) waveform" attributes. For the "Freerun waveform", both software allow users to adjust the scale and threshold. For the "SSEP, AEP, VER (averaged) waveform", both software allow users to change the scale, and automatic marker setup and manual correction are available.

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ATTRIBUTE /CHARACTERISTICS	NEURO-IOM.NET SOFTWARENEUROSOFT (Submitted Product)	Xltek Protektor 32 Natus	Why the differences do not adverselyaffect the safety and effectiveness
3- MEP (triggered)waveform	Image: MEP (triggered) waveform from NEUROSOFT	Image: MEP (triggered) waveform from Xltek Protektor 32 Natus	Equivalent - users can change scale.Automatic markers setup and manualcorrection are available.
4- EEG window	Image: EEG window from NEUROSOFT	Image: EEG window from Xltek Protektor 32 Natus	Equivalent - users can change scale.
ATTRIBUTE /CHARACTERISTICS	NEURO-IOM.NET SOFTWARENEUROSOFT (Submitted Product)	Xltek Protektor 32 Natus	Why the differences do not adverselyaffect the safety and effectiveness
5-CSA window		CSA WindowMontage Channel LabelTime AxisSpectral EdgePower AxisFrequency Axis	Equivalent – users can see spectrums andspectrum edge traces.
6-DSA window		DSA WindowMontage Channel LabelTime AxisSpectral EdgePower Axisis shown inthe displayof color.Frequency Axis	Equivalent – users can see densityspectrum array and spectrum edgetrace.
7-Totalpowerwindow	NO	QuadrantTime AxisRight AnteriorPower Axisis shown inthe bars.Frequency Axislight PosteriorEpochLabels	This function presented only inXltek Protektor software and is notfundamental to perform theanalysis of EEG for diagnosticpurposes.
	RO-IOM.NET SOFTWAREFUROSOFT (Submitted Product)	XItek Protektor 32 Natus	Why the differences do not adverselyaffect the safety and effectiveness
		The Total Power Ratio windowshows the ratio of high frequencyto low frequency activity in eachquadrant. Delta, Alpha,Beta bands are defined in theSpectral Settings dialog box
8-Trending window			Equivalent - user can see paramtrend plots and change colors andtime scale.

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Neuro-IOM System

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ATTRIBUTE /CHARACTERISTICS	NEURO-IOM.NET SOFTWARENEUROSOFT (Submitted Product)	Xltek Protektor 32 Natus	Why the differences do not adverseaffect the safety and effectiveness
9 -Log book window	EventsTime Comment 08:29:25 Início de cirurgia 08:34:00 Teste "Facial Neuro-MEP-4 - com alarme de descarga espontânea"iniciado. 08:50:30 Baseline PEM Cz-C4 08:57:29 Teste "Facial + PEM" iniciado. 08:57:40 Acesso cirúrgico 09:02:19 Baseline PEM Cz-C3 09:29:06 Estímulo porção timpânica 10:09:32 Irrigação com soro morno 10:10:25 Estímulo porção proximal timpânica pós cocleostomia																					Image: Log Book windowNote that pertains to whole test.Note that is attached to waveform.Time that the note was applied.For notes linked to waveforms, shows the trace label, set # and acquisition time.Image: Log BookAdd a general note to the test by selecting from the Notes menu or creating a custom note.Delete a note.Open the Edit Notes dialog box to change the title, add comments or add link the note to a waveform.	Equivalent - users can see notesand time associated, and changenote title.
10-Historywindow		Image: History windowRefresh/Stop ButtonStatus Box currently shows Time Scale Start TimeHistory Display Configuration Selection ButtonTime Scale SizeToggle time scale units between minutes and seconds.Adjust All GainsMove display to beginning of time scale.Step start of time scale backStep start of time scale forward.Move display to end of time scale.Waveforms are yellow (by default)Cursor (marker) calculations are green (by default)Reading GapStatus bar messages change according to the position of the mouse pointer.Move the scroll box left or right to view more data	Equivalent - user can change scaleand traces number.

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ATTRIBUTE / CHARACTERISTICS	NEURO-IOM.NET SOFTWARENEUROSOFT (Submitted Product)	Xltek Protektor 32 Natus	Why the differences do not adverselyaffect the safety and effectiveness
11-Reporttemplates	Image: NEUROSOFT Software	Image: Xltek Protektor 32 Natus	Equivalent – user can create reporttemplate, including report header.
12 - Remotemonitoring	YES. User can use internet browser forobserving acquisition computer screen.	YES. User need to use special softwareto access and view monitoring dataremotely.	Equivalent - user can see acquisitionstation screen and use chat windowfor conversation.

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SUBSTANTIAL EQUIVALENCE DISCUSSION:

Based on the analysis of its hardware specifications the subject device Neuro-IOM system manufactured by Neurosoft Ltd is substantially equivalent to the predicate device Xltek Protektor manufactured by Natus Inc.

Both the devices are intended for intraoperative neurophysiologic monitoring. to assess a patient's neurological status during surgery. The subject device incorporates the same fundamental scientific technology and has functional characteristics which are the same or equivalent to those of the predicate device. They have the same principle of operation, main specifications and safety. Stimulation type is the same, the duration and frequency range is quite similar. They have the same recording modalities and software features.

As for the software, the processing functions for both the subject device and predicate devices are well known and accepted as the conventional tools. The Neuro-IOM.NET software resides on a PC like XItek Protektor 32 and it has indications for use and characteristics that are a subset of the ones of Xltek Protektor 32. The functions of the Neuro-IOM.NET software are a sub-group of the ones of the software of the predicate device. These functions are generic for both devices. The predicate devices substantially perform the same operations and the minor differences consist in graphical appearance of the control icons and graphical appearance on displaying the results. These minor differences do not raise any new hazard, they don't increase the risk of inappropriate signal capture or the risk of an erroneous interpretation of the results by the operator or the risk of an erroneous processing, thus no additional safety and effectiveness issues arise.

DISCUSSION OF NONCLINICAL TESTS

Nonclinical tests were conducted to demonstrate substantial equivalence to the predicate device.

N	Standard/guidanceused for testing	Test method	Summary ofthe results
Biocompatibility testing
1.	ISO 10993-1-2018Biological evaluation ofmedical devices - Part 1:Evaluation and testingwithin a riskmanagementprocess	-	- the principlesgoverning thebiological assessmentof medical devices inthe risk managementprocess wereevaluated;- the medical device isclassified according tothe nature andduration of theircontact with the body;
Cytotoxicity
2.	ISO 10993-5 Medicaldevices. Biologicalevaluation of medical	The methods describedinclause 8 of	The cytotoxicity oflivecells was studied on
	in vitrocytotoxicity	this ISO	the calculation oftoxicity index
Irritation
3.	ISO 10993-10 Medicaldevices. Biologicalevaluation of medicaldevices. Part 10. Testforirritation and delayed-typehypersensitivity	The methods describedinclause 6 ofthis ISO	The systemic acutetoxicologicalexperimentswere performed inrabbits.
Systemic toxicity
4.	ISO 10993-11Biologicalevaluation of medicaldevices - Part 11: Testsfor systemictoxicity	The methods describedinclause 5 ofthis ISO	The systemic acutetoxicologicalexperimentswere performed inrabbits.
Electrical safety and electromagnetic compatibility (EMC)
5.	AAMI/ANSI ES60601-1:2005/(R2012) andA1:2012 Medicalelectrical equipment -Part 1: Generalrequirements for basicsafety and essentialperformance (IEC60601-1:2005, MOD);	Electrical safetytesting was conductedon the Neuro-IOMdevice, in accordancewith the requirementsof the standard	The system complieswith the AAMI/ANSIES 60601-1
6.	IEC 60601-1-2:2014Medical electricalequipment - Part 1-2:General requirementsfor basic safety andessential performance -Collateral standard:Electromagneticcompatibility -Requirements and tests.	EMC testing wasconducted on theNeuro-IOM device,in accordance withthe requirements ofthe standard	The system complieswith the IEC 60601-1-2:2014
Performance tests
7.	IEC 60601-1-6Medical electricalequipment - Part 1-6:General requirementsfor basic safety andessential performance -Collateral standard:Usability	The system usabilitycheck was carried outin accordance with therequirements of thestandard	The system complieswith the IEC 60601-1-6
8.	IEC 60601-2-40Medical electrical	The system check inaccordance with the	The system complieswith the IEC 60601-
	Particular requirementsfor the basic safety andessential performanceof electromyographsand evoked responseequipment	standard
9.	IEC 60068-2-31Environmental testing- Part 2-31: Tests -Test Ec: Roughhandling shocks,primarily forequipment-typespecimens	System check forenvironmental tests	The system complieswith the IEC 60068-2-31
10.	IEC 60068-2-80Environmental testing -Part 2-80: Tests - TestFi: Vibration - Mixedmode		The system complieswith the IEC 60068-2-80
11.	IEC 80601-2-26:2019Medical electricalequipment - Part 2-26:Particularrequirements for thebasic safety andessential performanceofelectroencephalograph	The systemperformance checkbased on standardrequirements	The system complieswith the IEC 80601-2-26:2019
Software Verification and Validation Testing
12.	Guidance for Industryand FDA Staff,"Guidance for theContent of PremarketSubmissions forSoftware Contained in	Software verificationand validation testingwere conducted anddocumentation wasprovided asrecommended by	Safety Level of theSoftware Device isModerate.

The following performance data were provided in support of the substantial equivalence determination.

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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.

Regulation Number and Section

§ 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).