The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures.

SafeOp 3 Accessories: The SafeOp Accessories are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

Device Description

The SafeOp™ 3: Neural Informatix System (SafeOp 3 System), consists of the SafeOp patient interface with power supply and IV pole mount, the Alpha Informatix Tablet with docking station and power supply and a data transfer USB cable. Associated disposable accessories consists of an electrode harness, surface and/or subdermal needle electrodes, MEP Activator, Cranial Hub, PMAP Dilators and stimulating probe or clip contained in various kits.

The subject device is intended for use by trained healthcare professionals, clinical neurophysiologists/technologists and appropriately trained non-clinical personnel. The subject device is intended for use in operating room environments of hospitals and surgical centers. System setup may be performed by both clinical and trained non-clinical personnel.

The subject device records the following modalities:

Somatosensory evoked potentials (SSEP)
Motor evoked potentials (MEP),
. Train-of-four neuromuscular junction (TO4),
Triggered electromyography (tEMG) and ●
. Free run electromyography (sEMG)

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria for the device's performance, nor does it describe a study that rigorously proves the device meets such criteria through a clinical validation or similar performance evaluation.

The document is a 510(k) premarket notification summary for the "SafeOp 3: Neural Informatix System." Its primary purpose is to demonstrate substantial equivalence to a previously cleared predicate device (SafeOp2: Neural Informatix System, K213849, and reference device Cascade IOMAX Intraoperative Monitor, K162199), rather than to present a full clinical performance study with defined acceptance criteria and detailed results.

Here's a breakdown of what the document does say, and what it lacks in relation to your request:

What the document provides:

Device Name: SafeOp 3: Neural Informatix System
Intended Use/Indications for Use: Monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ) during various surgical procedures.
Technological Comparison: A table comparing the SafeOp 3 System to predicate and reference devices, focusing on technical specifications like monitoring modalities, amplifier channels, stimulation parameters (voltage, current, pulse duration, repetition rate), and filter ranges. This comparison primarily aims to establish that the differences in technology do not raise new questions of safety or effectiveness.
Performance Data (Non-clinical): Mentions that "Nonclinical performance testing demonstrates that the subject SafeOp 3 System meets the functional, system, and software requirements." It also states "EMC and Electrical Safety Testing... was performed to ensure all functions... are electrically safe, and comply with recognized electrical safety standards." Usability testing was also performed.
Clinical Information Disclaimer: Explicitly states, "Determination of substantial equivalence is not based on an assessment of clinical performance data."

What the document lacks significantly for your request:

A table of acceptance criteria and reported device performance: This is the most significant omission for your request. The document details technical specifications and comparisons but does not provide quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific error rates) against pre-defined acceptance thresholds for any of its functionalities (MEP, SSEP, EMG, NMJ). The performance data mentioned are non-clinical (functional, system, software, EMC, electrical safety, usability), not clinical performance metrics.
Sample size used for the test set and data provenance: Since specific clinical performance studies are not detailed, this information is not provided.
Number of experts used to establish ground truth and qualifications: Not applicable as a clinical ground truth establishment process for performance evaluation is not described.
Adjudication method for the test set: Not applicable.
MRMC comparative effectiveness study: No such study is mentioned or detailed.
Standalone (algorithm only) performance: While the device is an "algorithm only" in a sense (it processes physiological signals), its performance isn't quantified in a standalone clinical evaluation or comparative study.
Type of ground truth used: No clinical ground truth is described for performance evaluation.
Sample size for the training set: Not applicable, as this is related to AI/ML development and training, which is not described. The device is a neuromonitoring system, not explicitly stated to be an AI/ML device in the context of this submission.
How the ground truth for the training set was established: Not applicable.

Why this information is missing:

The FDA 510(k) pathway for "substantial equivalence" often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate, without necessarily requiring new clinical trials or detailed performance studies if the technological differences are minor and well-understood. The focus is on showing that any differences do not introduce new safety or effectiveness concerns.

In summary, based solely on the provided text, I cannot complete the table of acceptance criteria or describe a study that proves the device meets these criteria in a clinical performance context. The document focuses on demonstrating substantial equivalence through technical comparison and non-clinical testing, rather than presenting clinical performance metrics.

Summary

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April 19, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Alphatec Spine, Inc. Unnati Bhuptani Sr. Regulatory Affairs Specialist 1950 Camino Vida Roble Carlsbad, California 92008

Re: K234092

Trade/Device Name: SafeOp 3: Neural Informatix Systeem Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, GXY, GXZ, IKN, PDQ, ETN Dated: March 21, 2024 Received: March 21, 2024

Dear Unnati Bhuptani:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Patrick
Antkowiak -S

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional

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Enclosure

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Indications for Use

Submission Number (if known)

K234092

Device Name

SafeOp 3: Neural Informatix System

Indications for Use (Describe)

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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Image /page/4/Picture/0 description: The image shows the logo for "atec". The "a" is green and the "tec" is black. There is a trademark symbol in the upper right corner of the logo.

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

I.	SUBMITTER:	Alphatec Spine, Inc.1950 Camino Vida RobleCarlsbad, CA 92008Phone: (760) 432-9286Fax: (760) 431-0289
	Contact Person:	Unnati Bhuptani

Sr. Regulatory Affairs Specialist Alphatec Spine, Inc. Contact Phone: (760) 356-6711

March 20, 2024 Date Summary Prepared:

II. DEVICE

Trade Name:	SafeOp™ 3: Neural Informatix System
Common or Usual Name:	Intraoperative Neuromonitoring
Classification Name:	Stimulator, Electrical, Evoked Response(21 CFR 882.1870)
Regulatory Class:	Class II
Product Code:	GWF
Subsequent Codes:	GXY, GXZ, IKN, PDQ, ETN

III. LEGALLY MARKETED PREDICATE DEVICES

Primary Predicate:

510(k)	Product Name	Clearance Date
K213849	SafeOp2: Neural Informatix System	March 9, 2022

IV. DEVICE DESCRIPTION

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centers. System setup may be performed by both clinical and trained non-clinical personnel.

The subject device records the following modalities:

Somatosensory evoked potentials (SSEP)
Motor evoked potentials (MEP),
. Train-of-four neuromuscular junction (TO4),
Triggered electromyography (tEMG) and ●
. Free run electromyography (sEMG)

INTENDED USE AND INDICATIONS FOR USE V.

Intended Use

The SafeOp 3: Neural Informatix System is intended for use by trained healthcare professionals as a diagnostic device that provides intraoperative neuromonitoring during various surgical procedures.

Indications for Use

The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, extracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures.

TECHNOLOGICAL COMPARISON TO PREDICATES VI.

The subject device was compared to the predicate device in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent. Any technological differences within this 510(k), between the subject device and the predicate device, does not impact substantially equivalence, or safety and effectiveness.

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Table 1: Comparison for Substantial Equivalence

Specification/Property	Reference Device	Primary Predicate Device	Subject Device	SE Rationale(if not identical)
510(k)	Cascade IOMAX Intraoperative Monitor(K162199)	ATECIOM AccessoryInstruments (K221821)	SafeOp 2: Neural Informatix System(K213849)	SafeOp 3: Neural Informatix System
Intended Use/Indications forUse	The Cascade IOMAX™ Intraoperative Monitorwith Surgical Studio software (IOMAX) is anelectroneurodiagnostic device that acquires,displays and stores physiologic data fromperipheral sensory and motor nerves, muscles andthe central nervous system, generated eitherspontaneously or elicited by well-defined stimuli.The acquired data are necessary to performsomatosensory, auditory and visual evokedpotentials (EPs), electroencephalography (EEG).electromyography (EMG), transcranial motorevoked potentials (TcMEPs), direct corticalstimulation, nerve conduction studies and Trainof Four (TOF) analysis. SpO2 measures anddisplays oxygen saturation and heart rateinformation. The system also delivers directnerve stimulation required for specific surgicalprocedures.Evoked Potentials (EPs): IOMAX provideselectrical, auditory or visual stimulation andmeasures, displays, records, and stores theelectrical activity of the nervous system inresponse to the stimulation.EEG: IOMAX measures, displays, records, andstores electrical activity of the brain from two ormore electrodes on the head.Free Run EMG: IOMAX acquires, displays,records, and stores spontaneous EMG activity ofmotor nerves by continually displaying a live	The ATEC IOM AccessoryInstruments are utilized inspine surgical procedures toassist in location of thenerves during or afterpreparation and placementof implants (intervertebralfusion cages and pediclescrew fixation devices) inopen and percutaneousminimally invasiveapproaches.	Intended use The SafeOp 2: Neural InformatixSystem is intended for use by trained healthcareprofessionals as a diagnostic device thatprovides intraoperative neuromonitoring duringvarious surgical procedures.Indications for UseThe SafeOp 2: Neural Informatix System isintended for use in monitoring neurologicalstatus by recording somatosensory evokedpotentials (SSEP), electromyography (EMG), orassessing the neuromuscular junction (NMJ).Neuromonitoring procedures includeintracranial, extracranial, intratemporal,extratemporal, neck dissections, upper and lowerextremities, spinal degenerative treatments,pedicle screw fixation, intervertebral fusioncages, rhizotomy, orthopedic surgery,open/percutaneous, lumbar, thoracic, andcervical surgical procedures.	Intended use The SafeOp 3: Neural InformatixSystem is intended for use by trained healthcareprofessionals as a diagnostic device that providesintraoperative neuromonitoring during varioussurgical procedures.Indications for UseThe SafeOp 3: Neural Informatix System is intendedfor use in monitoring neurological status byrecording transcranial motor evoked potentials(MEP), somatosensory evoked potentials (SSEP),electromyography (EMG), or assessing theneuromuscular junction (NMJ). Neuromonitoringprocedures include intracranial, extracranial,intratemporal, extratemporal, neck dissections, upperand lower extremities, spinal degenerativetreatments, pedicle screw fixation, intervertebralfusion cages, rhizotomy, orthopedic surgery,open/percutaneous, lumbar, thoracic, and cervicalsurgical procedures.SafeOp 3 Accessories: The SafeOp Accessories areutilized in spine surgical procedures to assist inlocation of the nerves during or after preparation andplacement of implants (intervertebral fusion cagesand pedicle screw fixation devices) in open andpercutaneous minimally invasive approaches.	Same as predicatesand referencedevices
Specification/Property	Reference Device	Primary Predicate Device	Subject Device	SE Rationale(if not identical)
510(k)	Cascade IOMAX Intraoperative Monitor(K162199)	ATECIOM AccessoryInstruments (K221821)	SafeOp 2: Neural Informatix System(K213849)	SafeOp 3: Neural Informatix System
	stream of mechanically induced myotomecontractions.
	TcMEP: IOMAX delivers transcranialstimulation via dedicated outputs forintraoperative assessment.
	Cortical Stimulation: IOMAX delivers LowCurrent Stimulation (LCS) during surgicalprocedures to map various areas of the cortex.
	Triggered EMG (TEMG): IOMAX electricallystimulates the motor nerves, and displays,records, and stores the resulting compoundmuscle action potentials in the innervated muscle.
	Nerve Conduction Study (NCS): IOMAXmeasures, displays, records, and stores sensoryand motor nerve conduction time (latency) byapplying a stimulus to peripheral nerves, thespinal cord, and the central nervous system.
	Train of Four (TOF) or Twitch Test: IOMAXdelivers a train of four pulses and measures,displays, records, and stores the compoundmuscle action potential amplitude fade foranalysis.
	SpO2: IOMAX measures and displays oxygensaturation and heart rate information.
	Remote Reader: IOMAX provides passive, realtime remote review of intraoperative monitoringfor a physician outside of the operating room.
	IOMAX is used by or under the direction of alicensed physician, surgeon, or neurologist in aprofessional healthcare facility environment for
Specification/Property	Reference Device		Primary Predicate Device	Subject Device	SE Rationale(if not identical)
510(k)	Cascade IOMAX Intraoperative Monitor(K162199)	ATECIOM AccessoryInstruments (K221821)	SafeOp 2: Neural Informatix System(K213849)	SafeOp 3: Neural Informatix System
	pre-operative, intraoperative and post-operativetesting.
Device Class	II	II	II	II	Identical topredicate andreference devices
Product Code	GWF, DQA, ETN, GWE, GWJ, GWQ, GZO,IKN, JXE, OLT	PDQ, ETN	GWF, GXY, GXZ, IKN, PDQ, ETN	GWF, GXY, GXZ, IKN, PDQ, ETN	Identical topredicate andreference devices
RegulationNumber (21CFR)	§882.1870, §870.2700, §874.1820, §882.1890,§882.1900, §882.1400, §882.1540, §890.1375,§882.1550	§874.1820	§882.1870, §882.1320, §882.1350, §890.1375,§874.1820, §874.1820	§882.1870, §882.1320, §882.1350, §890.1375,§874.1820, §874.1820	Identical topredicate andreference devices
DeviceClassificationName	Stimulator, Electrical, Evoked Response	Surgical nervestimulator/locator	Stimulator, Electrical, Evoked Response	Stimulator, Electrical, Evoked Response,Surgical nerve stimulator/locator	Identical topredicate andreference devices
MonitoringModalities/Operating Modes	• Electrode Impedance Test• Evoked potential (EP) in the form of:• Brainstem auditory• Visual• Somatosensory• Transcranial electrical motor evokedpotential (TcMEP)• Electromyography (EMG)• Electroencephalogram (EEG)• Nerve conduction studies in the form of:• NCV• F wave• H reflex• Train of four (TOF)• SpO2 and heart rate values	N/A	• Electrode Test• Electromyography (EMG)• Somatosensory Evoked Potentials (SSEP)• Neuromuscular Junction Testing - Train ofFour (TO4)	• Electrode Test• Electromyography (EMG)• Somatosensory Evoked Potentials (SSEP)• Motor Evoked Potential (TCMEP or MEP)• Neuromuscular Junction Testing - Train of Four(TO4)	Identical topredicate andreference devices
Specification/Property	Reference Device		Primary Predicate Device	Subject Device	SE Rationale(if not identical)
510(k)	Cascade IOMAX Intraoperative Monitor(K162199)	ATECIOM AccessoryInstruments (K221821)	SafeOp 2: Neural Informatix System(K213849)	SafeOp 3: Neural Informatix System
	• Threshold mode
60601-1Compliant	Yes	N/A	Yes	Yes	Identical topredicate andreference devices
Total AmplifierChannels	Supports Up to 48	N/A	Up to 8	Up to 16	SubstantiallyEquivalent to thepredicates andreference device
OperatingSystem	Windows 7 Professional (SP1, 64-bit) orWindows 10. Windows 10	N/A	Windows 10 powered tablet	Windows 10 powered tablet	Identical topredicate, SafeOp 2System (K213849)
Remote Access	No	N/A	No	No	Identical topredicate andreference devices

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B. Discussion of the MEP modality

Moor Evised Potentials (MEP) is a rearmonity used in suggaal procedures to periodically assess the integrity of more news for the suger. The ME modity has been aded to the subject Sale of 3 System o provincity of essere ingrity of decembry of tecs and support the standed prociee of mille mailing which provides assessment of both ascending (sensory) and descending (motor) spinal pathways.

Comparison to MEP functionality in the reference device, Cascade IOMAX Intraoperative System (K162199):

The effection a with mage of nearmations while sunal sual vised putatials (ER), electronials (ER), electronially (EX), becamily group) (EXG), tection yearly (ENG), teascanial evalentials (1) MEP) direct cortual studies and Train of Four (TOP) and Jour (TOP) and Joses on similified and Doced or spinal neuromnitioning aplications portually, the capitiines of the subject of the MEP modaliy are a subset of the reference cover Control (K1219). The Inited stimulation and aquisition paraments of the subject Sate of 3 System eist as subset of the reference Montors (K162.99) specification rage to best serve the intended use of spinsh newmanning Title 2 below povies a dealed compunism of technologial cheven the subject Sale of 3 System and relieve, Casade IOMAX Intragreative Morine (KM2199) specific on the MEP modility The ormprisen novided in Ta demonstrates that the MEP modiet Safel p 3 System on be considered substantially quivalent to the reference device, Cassade OMAX Intraoperative Monion (K162.99)

Feature	Cascade IOMAX IntraoperativeMonitor (K162199)	SafeOp 3 System (subject device)	Comparison	Substantial Equivalence Rationale
MEP Stimoutputs	Nine outputs, each selectable asanode or cathode	Four outputs, arranged in twopairs, polarity selectable	The subject SafeOp 3 System has a defined quadripolar stim montagewhich is accommodated with the four outputs arranged in two pairs. TheMEP Stim Outputs are used to deliver stimulation to the motor cortex viafour transcranial electrodes. Bipolar stim montage has traditionally beenused to induce a response for MEP stimulation but quadripolar stimulationis also commonly used because of less patient movement and increasedlikelihood of evoking motor response at lower stimulation levels¹. TheSafeOp 3 System used a quadripolar stim montage to elicit a response atlower stimulation levels.	• Testing which covers the system leveldelivery of MEP Pulses as set by the user,across the settable range of pulseconfigurations.
TotalAmplifierChannels	Up to 48	Up to 16	The subject SafeOp 3 System is specific for use in spine. The systemutilizes the 16 amplifier channels in the following manner:- 6 bilateral channels for EMG acquisition (12 total, leveraged bythe Train of Four, sEMG, tEMG, and MEP Modalities). Thissupports adequate coverage for the monitoring modalities statedabove and case types supported.- 3 channels for SSEP acquisition. This supports cortical and trans-cortical SSEP acquisition montages, which is adequate coveragefor the monitoring modalities and case types supported.- 1 extra channel for either EMG of SSEP acquisition.	• Testing which covers the acquisitionsensitivity of MEP Responses acrossall available channels
			Since the reference device Cascade IOMAX Intraoperative Monitor(K162199) is used in neuromonitoring applications in addition to spine,the reference device requires additional channels to perform otherneuromonitoring activities such as EEG. As described above, the subjectSafeOp 3 System only requires 16 amplifier channels to performneuromonitoring for all modalities. Therefore, the differences in number	• Testing which covers firmware MEPstimulation energy limits and stimulationdiagnostics
				The above listed system level and firmwarelevel testing demonstrate that the specificationshave been met through V&V Testingindividually and as part of the system, nosignificant failures or deviations were observed.
Feature	Cascade IOMAXIntraoperative Monitor(K162199)	SafeOp 3 System (subject device)(K162199)	Comparison	Substantial Equivalence Rationale
StimWaveform	Positive, Negative, Biphasic	Positive, Negative	The reference device, Cascade IOMAX Intraoperative Monitor(K162199) uses optional biphasic stim waveforms for MEPs to limitstimulus artifact with longer pulse durations. The subject SafeOp 3System has a shorter pulse duration and therefore does not need biphasicwaveforms for the MEP modality of the SafeOp 3 System to function asintended.	Completed V&V testing successfullydemonstrates that the differences in thetechnological characteristics have no impact onthe performance, safety and effectiveness of thesubject SafeOp 3 System when compared to thereference device, Cascade IOMAX IntraoperativeMonitor (K162199).
Voltage Range	50-1000 V	50-1000 V	Same range as the reference device, Cascade IOMAX IntraoperativeMonitor (K162199)	The differences in the technologicalcharacteristics between subject SafeOp 3 Systemand the reference device, Cascade IOMAXIntraoperative Monitor (K162199) do notintroduce any new risks that are not already
Current Range	50-1500 mA	50-1500 mA	Same range as the reference device, Cascade IOMAX IntraoperativeMonitor (K162199)	inherent to clinical use of the MEP Modality. Allrisks related to the addition of the MEPModality have been adequately mitigated.
Output ControlMode	Constant voltage or constant current	Constant voltage	the subject SafeOp 3 can be considered substantially equivalent to thereference device, Cascade IOMAX Intraoperative Monitor (K162199),since both systems provide the constant voltage as an output controlmode. The Constant Voltage output control mode is most commonly usedin intraoperative MEP monitoring according to MacDonald, D.B., et al2,and therefore was chosen as the preferred Output Control Mode for thesubject SafeOp 3 System.	Therefore, these differences in technologicalcharacteristics do not affect device safety oreffectiveness and can be consideredSubstantially Equivalent to the reference deviceCascade IOMAX Intraoperative Monitor(K162199).
Pulse Duration	50 usec - 500 µsec	50 µsec - 150 µsec	The pulse duration required to evoke a motor response is 50µsec. Thesubject SafeOp 3 System has pulse duration range from 50µsec to150µsec to provide the user with flexibility in parameters to optimize thelikelihood of evoking a response. In addition, since the subject SafeOp3System uses a quadripolar montage, a motor response can be evoked atthe range specified for the subject device. The SafeOp 3 System uses asubset of the Cascade IOMAX Intraoperative Monitor that is generallyused in clinical practice. Verification and Validation testing demonstratethat the MEP modality of the SafeOp 3 System functions as intended.
Maximumenergy into 1kohmimpedance	50 mJ/pulse	50 mJ/pulse	Same as the reference Cascade IOMAX Intraoperative Monitor.
Repetition rate	1 Hz max	1 Hz max	Same
LowFrequencyFilter	0.3 Hz-100 Hz	1-30Hz	The low frequency filter range of 1-30 Hz for the subject SafeOp 3System is the same as the predicate SafeOp 2 System. This frequencyrange allows the signal of interest to pass through the filter. Addition ofMEP modality does not affect the frequency range of signal of interest.MacDonald, DB, et al2, found that filter settings of 10-100 Hz to 1500-3000 Hz are appropriate for limb muscles. Stimulus artifact may obscurecranial MEPs with these settings: opening the low frequency filter to 0.2-
Feature	Cascade IOMAXIntraoperative Monitor(K162199)	SafeOp 3 System (subject device)	Comparison	Substantial Equivalence Rationale
HighFrequencyFilter	30Hz - 5kHz	1.5 - 3kHz	2 Hz or constraining it to 150-300 Hz can help. Therefore, although thesubject SafeOp 3 System has a smaller low frequency filter range ascompared to reference Cascade IOMAX Intraoperative Monitor(K162199), the differences in the range do not affect the safety oreffectiveness of the device or its ability to function as intended.The high frequency filter range of 1.5 - 3kHz for the subject SafeOp 3System is the same as the predicate SafeOp 2 System. This frequencyrange allows the signal of interest to pass through the filter. Addition ofMEP modality has does not affect the frequency range of signal ofinterest. MacDonald, DB, et al 2, found that filter settings of 10-100 Hz to1500–3000 Hz are appropriate for limb muscles. Therefore, although thesubject SafeOp 3 System has a smaller high frequency filter range ascompared to reference Cascade IOMAX Intraoperative Monitor(K162199), the differences in the range do not affect the safety oreffectiveness of the device or its ability to function as intended.
ImpedanceMeasurement	All outputs	All outputs	Same

Table 2: Comparison of Technological Characteristics

' Schwartz, SL., et.al, (202). "Quadripolation for Motor Evokel Potentials. J.C.in! Neurophysiology, 39(1), 92-97, doi: 10.1097WNY 20000000000751

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PERFORMANCE DATA VII.

Nonclinical performance testing demonstrates that the subject SafeOp 3 System meets the functional, system, and software requirements.

EMC and Electrical Safety Testing of the SafeOp 3 System was performed to ensure all functions of the system and its accessories are electrically safe, and comply with recognized electrical safety standards.

Usability testing was performed to demonstrate that the subject SafeOp 3 System presents no adverse effect within the intended environment, and the subject device was therefore found to be substantially equivalent to the predicate.

Clinical Information

Determination of substantial equivalence is not based on an assessment of clinical performance data.

VIII. CONCLUSION

Based upon the information provided in this 510(k) submission, it has been determined that the subject device, SafeOp 3 System, is substantially equivalent to the legally marketed primary predicate device in regards to indications for use, intended use, design, technology, and performance.

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).