The NVJJB ™ System is a medical device that is intended for intraoperative neurophysiological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiological status. NVJJB provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG) or transcranial motor evoked potential (TcMEP) responses of nerves.
MaXcess Detection - The MaXcess Detection function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool. Difference Screw Test (DST) - The DST function allows the surgeon to locate and evaluate spinal nerves before, during, or after placement of bone screws by verifying nerve integrity and factoring it into the alarm criteria. Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws. Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions. Twitch Test (Train of Four) - The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses. TcMEP - Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The TCMEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury. Remote Reader - The Remote Reader function provides real time remote access to the NVJJB System for a monitoring physician outside of the operating room. Nerve Retractor - The Nerve Retractor function allows the surgeon to locate and identify spinal nerves by directly stimulating exposed nerves to assist in identifying neurophysiological changes during retraction.

Device Description

The NVJJB® System is a medical device that is intended for intraoperative neurophysiological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiological status. NVJJB provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG) or transcranial motor evoked potential (TceMEP) responses of the muscle groups innervated by the nerves. Moreover, a Twitch Test ("Train of Four") function is utilized to test the ability of the nerve to respond, or contract, following four stimulation pulses to determine the presence of neuromuscular block.
Additionally, the NVJJB System also offers an optional screen sharing application (Remote Monitoring) to allow a secondary physician to remotely view the events represented on the NVJJB user interface. In summary, the NVJJB System includes the following three (3) software functionalities / modalities:

Electromyography (EMG)
Transcranial Motor Evoked Potential (TceMEP), or simply MEP
Remote Monitoring
The NVJJB® System hardware consists of a Patient Module (PM) and a Control Unit (CU) comprised of an embedded computer with touch screen controls and an interface card, as well as accompanying accessory components which consist of an assortment of disposable conductive probes, electrodes, and electrode leads

AI/ML Overview

Here's an analysis of the provided text regarding the NuVasive® NVJJB System, focusing on acceptance criteria and the study proving it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific quantitative performance metrics against predefined acceptance criteria for clinical outcomes. The "acceptance criteria" here are implicitly the performance standards of the predicate devices and general electrical safety and compatibility standards.

Specification/Property	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (NuVasive NVJJB System)
Intended Use / Indications	Medtronic NIM Eclipse (K061113): Record, monitor, stimulate/record biopotential signals (EMG, evoked response, nerve/muscle potentials); intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction; feedback for localization/assessment of spinal nerves and verification of instrumentation placement to avoid injury. NuVasive NVM5 System (K112718): Intraoperative neurophysiologic monitoring during spinal surgery; assess patient's neurophysiologic status by electrically stimulating nerves and monitoring EMG, TcMEP, or SSEP responses. Functions include XLIF (detection) for nerve avoidance, Basic & Dynamic Screw Test, Free Run EMG, Twitch Test (Train of Four), TcMEP, SSEP, Remote Reader, and Guidance function for pedicle cannulation.	Intraoperative neurophysiological monitoring and status assessment during spinal surgery, providing information by electrically stimulating nerves and monitoring EMG or TcMEP responses. Functions include MaXcess Detection, Difference Screw Test (DST), Basic & Dynamic Screw Test, Free Run EMG, Twitch Test (Train of Four), TcMEP, Remote Reader, and Nerve Retractor. (Broadly aligns with predicate uses, without SSEP or guidance function explicitly stated).
Electrical Safety Standards	IEC 60601-1 (1988), A1 (1991), A2 (1995); IEC 60601-2-40 (1988); IEC 60601-1-2 (2001), A1 (2004)	Certified to IEC 60601-1 (1988), A1 (1991), A2 (1995); IEC 60601-2-40 (1988); IEC 60601-1-2 (2001), A1 (2004)
Total Available Channels	NuVasive NVM5 System: 32; Medtronic NIM Eclipse: 32	8
Frequency Response	NuVasive NVM5 System: 3 Hz to 4.8 kHz; Medtronic NIM Eclipse: 1Hz to 4 kHz	30 Hz to 4.8 kHz
User Interface	NuVasive NVM5 System: Touch screen and [optional] keyboard/mouse; Medtronic NIM Eclipse: Touch screen and keyboard/mouse	Touch screen and [optional] keyboard/mouse
Remote Monitoring	NuVasive NVM5 System: Yes; Medtronic NIM Eclipse: Yes	Yes
CMRR	NuVasive NVM5 System: > 100 dB @ 60 Hz; Medtronic NIM Eclipse: > 100 dB @ 60 Hz	> 100 dB
A/D Sampling Rate	NuVasive NVM5 System: 9.6 kHz	9.6 kHz
Max Current	NuVasive NVM5 System: 0.09 A; Medtronic NIM Eclipse: 0.1 A	0.05 A
Max Pulse Width	NuVasive NVM5 System: 0.0002 sec; Medtronic NIM Eclipse: 0.0005 sec	0.0002 sec
Max Number of Pulses per second	NuVasive NVM5 System: 5; Medtronic NIM Eclipse: 100	5
Max Charge Density	NuVasive NVM5 System: 107 µC/cm²; Medtronic NIM Eclipse: 25,000 µC/cm²	59 µC/cm²
Biocompatibility	ISO 10993-1	Biocompatibility testing per ISO 10993-1 performed. (Result implicitly meets standard)
Sterilization Validation	ISO 11135-1	Sterilization validation per ISO 11135-1 performed. (Result implicitly meets standard)

2. Sample Size Used for the Test Set and Data Provenance

The document describes nonclinical testing to demonstrate substantial equivalence and verify design specifications. It does not refer to a "test set" in the context of clinical data or patient samples. The testing relies on engineering and laboratory assessments, not a study involving human subjects or retrospective clinical data analysis for performance metrics typical of AI/diagnostic devices.

Sample Size for Test Set: Not applicable in the context of clinical data. The "test set" consists of the device and its accessories undergoing various engineering and safety tests.
Data Provenance: Not applicable as it's not clinical data. The tests are described as "nonclinical testing" performed by NuVasive or certified labs.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth, in the sense of expert consensus on clinical diagnoses or outcomes, is not established for this type of nonclinical engineering and safety testing. The "ground truth" here is adherence to regulatory standards and established engineering principles.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission is for a traditional medical device (neurological surgical monitor), not an AI/diagnostic algorithm that typically undergoes such a study to compare reader performance with and without AI assistance. The focus is on substantial equivalence to existing predicate devices based on technological characteristics and safety.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a way. The "performance data" presented is primarily a standalone assessment of the device's adherence to electrical safety standards and functional specifications in a laboratory setting. This is an "algorithm only" performance (though it's a hardware/software system, not just an algorithm) in the sense that its technical functions (e.g., frequency response, current output, CMRR) are tested intrinsically, not in conjunction with human interpretation of its outputs in a clinical scenario for effectiveness. The "Human-in-the-loop" aspect is an inherent part of its intended use (providing information to a surgeon), but the testing itself is nonclinical and standalone from human interpretation of clinical results.

7. The Type of Ground Truth Used

The "ground truth" in this submission is primarily:

Regulatory Standards: Adherence to international electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-2-40, IEC 60601-1-2).
Biocompatibility and Sterilization Standards: Compliance with ISO 10993-1 and ISO 11135-1.
Engineering Specifications: The device's measured electrical and physical properties (e.g., frequency response, current output, charge density, channel count) are compared against the specifications of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set" of data in the conventional sense. Its functionality is based on established electrophysiological principles and hardware design.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the date April 13, 2012. The month is abbreviated as APR. The day is 13 and the year is 2012. The text is in a simple, sans-serif font.

Image /page/0/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape on the left, followed by the word "NUVASIVE" in all caps. Below the company name is the tagline "Speed of Innovation" in a smaller font.

510(k) Premarket Notification NuVasive® NVJJB System, K112717

510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Submitted by: A.

Elias Ketchum Sr. Associate, Regulatory Affairs NuVasive. Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-4588 Fax: (858) 320-4688

Date Prepared: March 22, 2012

B. Device Name

Trade or Proprietary Name:	NuVasive® NVJJB System
Common or Usual Name:	Neurological surgical monitor
Classification Name:	Surgical Nerve Stimulator/Locator
Device Class:	Class II
Regulation:	§874.1820
Product Code:	ETN, GWF, IKN

Predicate Devices C.

The subject NuVasive® NVJJB System is substantially equivalent to one or more of the following predicate devices listed in Table 1 below.

510(k)	Trade or proprietary or model name	Manufacturer
K112718	NVM5® System	NuVasive, Inc.
K061113	NIM Eclipse and probes (formerly AxonSystems OrthoMon System)	Medtronic Xomed, Inc.
K051357	DS7A Constant Current High Voltage Stimulator	Digitimer LTD
K061148	Disc Electrodes	Rhythmlink International, LLC
K022914	Subdermal Needle Electrodes	Rhythmlink International, LLC
K112709	Stimulation/Dissection Instruments	NuVasive, Inc.

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Image /page/1/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized graphic to the left of the word "NUVASIVE". Below the word "NUVASIVE" is the tagline "Speed of Innovation".

D. Device Description

Additionally, the NVJJB System also offers an optional screen sharing application (Remote Monitoring) to allow a secondary physician to remotely view the events represented on the NVJJB user interface. In summary, the NVJJB System includes the following three (3) software functionalities / modalities:

1. Electromyography (EMG)
1. Transcranial Motor Evoked Potential (TceMEP), or simply MEP
1. Remote Monitoring

The NVJJB® System hardware consists of a Patient Module (PM) and a Control Unit (CU) comprised of an embedded computer with touch screen controls and an interface card, as well as accompanying accessory components which consist of an assortment of disposable conductive probes, electrodes, and electrode leads

E. Intended Use

· MaXcess Detection The MaXcess Detection function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool.
· Difference Screw Test (DST) The DST function allows the surgeon to locate and evaluate spinal nerves before, during, or after placement of bone screws by verifying nerve integrity and factoring it into the alarm criteria.
· Basic & Dynamic Screw Test The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.
· Free Run EMG The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.

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Image /page/2/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a circular graphic on the left and the word "NUVASIVE" on the right. Below the word "NUVASIVE" is the phrase "Speed of Innovation".

Twitch Test (Train of Four) The Twitch Test Function allows the surgeon to assess . moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.
· TcMEP Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The TcMEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.
· Remote Reader The Remote Reader function provides real time remote access to the NVJJB System for a monitoring physician outside of the operating room.
· Nerve Retractor The Nerve Retractor function allows the surgeon to locate and identify spinal nerves by directly stimulating exposed nerves to assist in identifying neurophysiological changes during retraction.

F. Technological Characteristics

As was established in this submission, the subject NV.JJB® System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and functions.

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Specification/Property	Subject Device	Predicate Devices
	NuVasive NVJJB System (K112717)	NuVasive NVM5 System (K112718)	Medtronic NIM Eclipse(K061113)	MEPS, LLC.Digitimer (K051357)
Intended Use/Indications forUse	The NVJJB ™ System is a medical device that is intended forintraoperative neurophysiological monitoring and status assessmentduring spinal surgery. The device provides information directly to thesurgeon, to help assess a patient's neurophysiological status. NVJJBprovides this information by electrically stimulating nerves viaelectrodes located on surgical accessories and monitoringelectromyography (EMG) or transcranial motor evoked potential(TcMEP) responses of nerves.MaXcess Detection - The MaXcess Detection function allows thesurgeon to locate and evaluate spinal nerves, and is used as a nerveavoidance tool. Difference Screw Test (DST) - The DST function allows the surgeonto locate and evaluate spinal nerves before, during, or after placementof bone screws by verifying nerve integrity and factoring it into thealarm criteria. Basic & Dynamic Screw Test - The Screw Test functions allow thesurgeon to locate and evaluate spinal nerves by providing proximityinformation before, during or after bone preparation and placement ofbone screws. Free Run EMG - The Free Run EMG function identifies spontaneousEMG activity of spinal nerves by continually displaying a live streamwaveform of any mechanically induced myotome contractions. Twitch Test (Train of Four) - The Twitch Test Function allows thesurgeon to assess moderate degrees of neuromuscular block in effectby evaluating muscle contraction following a train of four stimulationpulses. TcMEP - Transcranial stimulation techniques for motor evokedpotentials are used to assess for acute dysfunction in axonalconduction of the corticospinal tract. The TCMEP function providesan adjunctive method to allow the surgeon to monitor spinal cord andmotor pathway integrity during procedures with a risk of surgicallyinduced motor injury. Remote Reader - The Remote Reader function provides real timeremote access to the NVJJB System for a monitoring physicianoutside of the operating room. Nerve Retractor - The Nerve Retractor function allows the surgeonto locate and identify spinal nerves by directly stimulating exposednerves to assist in identifying neurophysiological changes duringretraction.	The NVM5 System is a medical device that is intended forintraoperative neurophysiologic monitoring during spinal surgery.The device provides information directly to the surgeon, to helpassess a patient's neurophysiologic status. NVM5 provides thisinformation by electrically stimulating nerves via electrodeslocated on surgical accessories and monitoring electromyography(EMG), transcranial motor evoked potential (TCMEP) orsomatosensory evoked potential (SSEP) responses of nerves.XLIF (Detection) - The XLIF (Detection) function allows thesurgeon to locate and evaluate spinal nerves, and is used as anerve avoidance tool. Basic & Dynamic Screw Test - The Screw Test functionsallow the surgeon to locate and evaluate spinal nerves byproviding proximity information before, during or after bonepreparation and placement of bone screws. Free Run EMG-The Free Run EMG function identifiesspontaneous EMG activity of spinal nerves by continuallydisplaying a live stream waveform of any mechanicallyinduced myotome contractions. Twitch Test (Train of Four) - The Twitch Test Function allowsthe surgeon to assess moderate degrees of neuromuscular blockin effect by evaluating muscle contraction following a train offour stimulation pulses. TeMEP - Transcranial stimulation techniques for motor evokedpotentials are used to assess for acute dysfunction in axonalconduction of the corticospinal tract. The TeMEP functionprovides an adjunctive method to allow the surgeon to monitorspinal cord motor pathway integrity during procedures with arisk of surgically induced motor injury. SSEP-The SSEP function allows the surgeon to assesssensory spinal cord function in surgical procedures duringwhich the spinal cord is at risk. Remote Reader - The Remote Reader function provides realtime remote access to the NVM5 System for a monitoringphysician outside of the operating room. The Guidance function is intended as an aid for use in eitheropen or percutaneous pedicle cannulation procedures in thelumbar spine of adult patients, and when used in conjunctionwith radiographic imaging and EMG, allows the surgeon toassess the angulation of system accessories relative to patientspinal anatomy for the creation of a cannulation trajectory forbone screw placement.	The OrthoMon system isintended for use torecord, monitor andstimulate/recordbiopotential signalsincludingelectromyography(EMG), evoked responseand nerve/musclepotentials and for theintraoperative diagnosisof acute dysfunction incorticospinal axonalconduction. The systemprovides feedback to thesurgeon and OR team toassist in the localizationand assessment of spinalnerves and verification ofplacement of spinalinstrumentation to avoidinjury to at risk nerveroots	The DS7A andDS7AH arestimulators intendedfor use duringneurologicalmonitoring andassessment in aclinical environment.They are intended foruse by trainedpersonnel eithercompetent to applyappropriate stimuli orunder the supervisionand instruction of onewho is.

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Specification/Property	Subject DeviceNuVasive NVJJB System (K112717)	Predicate DevicesNuVasive NVM5 System (K112718)	Predicate DevicesMedtronic NIM Eclipse(K061113)	MEPS, LLC.Digitimer (K051357)2 Stimulation
Total AvailableChannels	8	32	32	None
Headbox/Patient ModuleIEC 60601-1Compliant	Digital Preamplifier with A/D Converter	Yes	Yes	Yes
Full ScaleView Range	Yes	Yes	Yes	N/A-StimulationOnly
FrequencyResponse	30 Hz to 4.8 kHz	3 Hz to 4.8 kHz	1Hz to 4 kHz	N/A-StimulationOnly
User Interface	Touch screen and [optional] keyboard/mouse	Touch screen and [optional] keyboard/mouse	Touch screen andkeyboard/mouse	Push button, Dials,Switches and LCDnumbers
RemoteMonitoring	Yes	Yes	Yes	N/A-MEP only
Train of FourTesting	Various	Various	Various	N/A-MEP only
NeedleElectrodes	Various	Various	Various	N/A-MEP only
SurfaceElectrodes	Various	Various	Various	N/A-MEP only
ElectrodeLeads	Various	Various	Various	N/A-MEP only
StimulatingProbes	Various	Various	Various	N/A-MEP only
RecordingChannels	8	EMG, MEP, and SSEP	EMG, MEP, and SSEP	No
Number ofRecordingChannels	8	10	32	N/A
ResponseThreshold	10-300µV user settable for free run and stimulated	10-300 μV	10 µV to 10 mV	N/A
High Filter	1.5k Hz	1.5 kHz	10 kHz	N/A
Low Filter	30 Hz	0.030 kHz	0.5 kHz	N/A
Notch Filter	None	None	50 or 60 Hz	N/A
Audible EMG	Yes	Yes	Yes	N/A

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510(k) Premarket Notification K112717
NuVasive® NVJJB System

Specification/Property	Subject DeviceNuVasive NVJJB System (K112717)	Predicate DevicesNuVasive NVM5 System (K112718)	Medtronic NIM Eclipse(K061113)	MEPS, LLC.Digitimer (K051357)
CMRR	> 100 dB	> 100 dB @ 60 Hz	> 100 dB @ 60 Hz	N/A
A/D SamplingRate	9.6 kHz	9.6 kHz	Unknown	N/A
AutomaticMuting DuringArtifact	Yes	Yes	Yes	N/A
StimulationWaveform	Rectangular, Monophasic Pulse	Rectangular, Monophasic Pulse	Rectangular, Monophasic andBiphasic Pulse	N/A
ConstantCurrent/Voltage	Yes	Yes	Yes	N/A
TheoreticalMax Voltage	240 V	300 V	400 V	N/A
Max Current	0.05 A	0.09 A	0.1 A	N/A
Max PulseWidth	0.0002 sec	0.0002 sec	0.0005 sec	N/A
Max Numberof Pulses persecond	5	5	100	N/A
Min ProbeSurface Area	0.169 cm²	0.169 cm²	0.002 cm²	N/A
Calculated Values per IEC 60601-2-40
Voltage	50 V	90 V	100 V	N/A
Max RMSCurrent	1.6 mARMS	2.8 mARMS	22.3 mARMS	N/A
Max RMSCurrentDensity	6.1 mARMS/cm²	16.57 mARMS/cm²	11,150 mARMS/cm²	N/A
Max ChargeDensity	59 µC/cm²	107 µC/cm²	25,000 µC/cm²	N/A
Max PowerDensity	15 W/cm²	48 W/cm²	5000 W/cm²	N/A
	510(k) Premarket Notification K112717NuVasive® NVJJB System
Subject DeviceNuVasive NVJJB System (K112717)	Predicate DevicesNuVasive NVM5 System (K112718)	Predicate DevicesMedtronic NIM Eclipse(K061113)	Predicate DevicesMEPS, LLC.Digitimer (K051357)
1000 V	1000 V	N/A	1000 V
1.0 A	1.0 A	N/A	1.0 A
0.00005 sec	0.00005 sec	N/A	0.00005 sec
4	8	N/A	10
0.492 cm²	0.492 cm²	N/A	0.492 cm²
50 mJ	50 mJ	N/A	50 mJ
1000 V	1000 V	N/A	1000 V
14 mARMS	20 mARMS	N/A	22 mARMS
28.4 mARMS/cm²	40.65 mARMS/cm²	N/A	44.7 mARMS/cm²
101 µC/cm²	102 µC/cm²	N/A	102 µC/cm²
2032 W/cm²	2032 W/cm²	N/A	2032 W/cm²

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510(k) Premarket Notification K112717
NVJJB System NVJJB System

NUVASIVE

	Subject NVJJB Dual Surface (K112717)	Predicate Sticky pad™ Electrodes (K061148)	Subject NVJJB Dual Needle (K112718)	Predicate Subdermal Needle Electrodes (K050194)	Subject NVJJB Corkscrew (K112718)	Predicate Subdermal Needle Electrodes (K050194)	Subject NVJJB Cranial Array (K112718)	Predicate Subdermal Needle Electrodes (K061148)
Manufacturer	NuVasive, Inc.	Rhythmlink International, LLC	NuVasive, Inc.	Rhythmlink International, LLC	NuVasive, Inc.	Rhythmlink International, LLC	NuVasive, Inc.	Rhythmlink International, LLC
Length(s)	N/A	N/A	Needle length: 12mm	Needle length: 13mm	N/A	N/A	Needle length: 12mm	Needle length: 13mm
Size(s)	Pad size: 17.81cm²	Pad size: Min: 1.5 x 2.0cm (3.0cm²)Max: 4.5 x 3.5cm (15.75cm²)	Needle diameter: 0.036cm	Needle diameter: 0.04cm	Needle Diameter: 0.058cmNeedle height: 0.302cm	Needle diameter: 0.06cmNeedle height: 0.380cm	Needle diameter: 0.036cm	Needle diameter: 0.04cm
Stim/Record Surface Area	1.78cm²	3 - 15.75cm²	0.262cm²	0.326cm²	0.492cm²	0.584cm²	0.655cm²	0.163cm²

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Image /page/8/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized, abstract shape on the left, followed by the word "NUVASIVE" in capital letters. Below the company name is the tagline "iSpeed of Innovation" in a smaller font. The logo appears to be printed in black ink on a white background.

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject NV.J.B® System is substantially equivalent to other predicate devices and to verify that the NVJJB® System meets design specifications and performance characteristics, based upon the intended use. The NVJJB® System was subjected to electrical safety and compatibility testing and was certified to the following standards, including all applicable normative reference standards:

IEC 60601-1 (1988), A1 (1991), A2 (1995): Medical Electrical Equipment Part 1: . General Requirements for Safety
IEC 60601-2-40 (1988): Medical Electrical Equipment Part 2-40:Particular . requirements for the safety of electromyographs and evoked response equipment
IEC 60601-1-2 (2001), A1 (2004): Medical Electrical Equipment Part 1-2: General . Requirements for Safety Collateral Standard Electromagnetic Compatibility

Accessories to the NVJJB® System also underwent the following performance testing, where applicable:

Impedance and continuity testing .
. Current density testing
Electrical performance and durability . .
. Fluid interference
. Biocompatibility testing per ISO 10993-1
Sterilization validation per ISO 11135-1 .
Penetration and friction testing of needle electrodes .

The results of these studies showed that the subject NVJJB® System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.

H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NV.JB® System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, with three wavy lines representing the body and a head-like shape at the top.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

APR 1 3 2012

NuVasive, Incorporated % Mr. Elias Ketchum Senior Associate, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K112717

Trade/Device Name: NuVasive NVJJB System Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN, GWF, IKN Dated: March 22, 2012 Received: March 26, 2012

Dear Mr. Ketchum:

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. 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 I lease be advised that I Dris beauting that your device complies with other requirements of the Act that I Drinas intatutes and regulations administered by other Federal agencies. You must or any I ederal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2-Mr. Elias Ketchum

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Malvina B. Eydelman, M.D.

Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

{11}------------------------------------------------

Indications for Use

510(k) Number (if known): K112717

Device Name: NuVasive® NVJJB® System

Indications For Use:

MaXcess Detection The MaXcess Detection function allows the surgeon to locate and evaluate . ● spinal nerves, and is used as a nerve avoidance tool.
Difference Screw Test (DST) -- The DST function allows the surgeon to locate and evaluate . spinal nerves before, during, or after placement of bone screws by verifying nerve integrity and factoring it into the alarm criteria.
Basic & Dynamic Screw Test The Screw Test functions allow the surgeon to locate and ● evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.
Free Run EMG The Free Run EMG function identifies spontaneous EMG activity of spinal . nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.
Twitch Test (Train of Four) The Twitch Test Function allows the surgeon to assess moderate . degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.
TcMEP -- Transcranial stimulation techniques for motor evoked potentials are used to assess for . acute dysfunction in axonal conduction of the corticospinal tract. The TcMEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.
Remote Reader The Remote Reader function provides real time remote access to the NVJJB . System for a monitoring physician outside of the operating room.
Nerve Retractor- The Nerve Retractor function allows the surgeon to locate and identify spinal . nerves by directly stimulating exposed nerves to assist in identifying neurophysiological changes during retraction.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

William Goins, Ph.D. Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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510(k) Number K112717

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.