Predicate Devices

K112718, K061113, K051357, K061148, K022914, K112709

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard neurophysiological monitoring techniques (EMG, TcMEP, Twitch Test) and remote viewing capabilities. There is no mention of AI, ML, or any algorithms that learn or adapt from data. The performance studies focus on electrical safety, compatibility, and equivalence to predicate devices, not on the performance of any AI/ML model.

Therapeutic

No.
The device is used for monitoring and assessment during surgery, not for treating any condition or disease.

Diagnostic

Yes

Explanation: The device is intended for "intraoperative neurophysiological monitoring and status assessment" during spinal surgery by assessing a patient's neurophysiological status through electrical stimulation and monitoring responses. This process of assessing status and monitoring for changes is a diagnostic function. The intended use also details specific functions like "MaXcess Detection," "Difference Screw Test," and "Free Run EMG" which are all methods of locating, evaluating, or identifying nerve activity, further confirming its diagnostic nature.

SaMD (Software as a Medical Device)

No

The device description explicitly states that 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. This indicates the presence of significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the NVJJB™ System is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
NVJJB™ System Function: The NVJJB™ System operates in vivo (within the living body) during surgery. It directly stimulates nerves and monitors physiological responses (EMG and TcMEP) in the patient's muscles.
Intended Use: The intended use clearly states it's for "intraoperative neurophysiological monitoring and status assessment during spinal surgery." This is a real-time assessment of the patient's nervous system function during the procedure, not an analysis of a sample taken from the body.

The device is a medical device used for physiological monitoring during surgery, which falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

ETN, GWF, IKN

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:

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Spinal nerves, spinal cord, corticospinal tract

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Surgeon, monitoring physician outside of the operating room

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K112718, K061113, K051357, K061148, K022914, K112709

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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 Axon
Systems 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.

1

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

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:

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

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.

2

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 for
Use	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.	The NVM5 System is a medical device that is intended for
intraoperative neurophysiologic monitoring during spinal surgery.
The device provides information directly to the surgeon, to help
assess a patient's neurophysiologic status. NVM5 provides this
information by electrically stimulating nerves via electrodes
located on surgical accessories and monitoring electromyography
(EMG), transcranial motor evoked potential (TCMEP) or
somatosensory evoked potential (SSEP) responses of nerves.
XLIF (Detection) - The XLIF (Detection) function allows the
surgeon to locate and evaluate spinal nerves, and is used as a
nerve avoidance tool. 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. TeMEP - Transcranial stimulation techniques for motor evoked
potentials are used to assess for acute dysfunction in axonal
conduction of the corticospinal tract. The TeMEP function
provides an adjunctive method to allow the surgeon to monitor
spinal cord motor pathway integrity during procedures with a
risk of surgically induced motor injury. SSEP-The SSEP function allows the surgeon to assess
sensory spinal cord function in surgical procedures during
which the spinal cord is at risk. Remote Reader - The Remote Reader function provides real
time remote access to the NVM5 System for a monitoring
physician outside of the operating room. The Guidance function is intended as an aid for use in either
open or percutaneous pedicle cannulation procedures in the
lumbar spine of adult patients, and when used in conjunction
with radiographic imaging and EMG, allows the surgeon to
assess the angulation of system accessories relative to patient
spinal anatomy for the creation of a cannulation trajectory for
bone screw placement.	The OrthoMon system is
intended for use to
record, monitor and
stimulate/record
biopotential signals
including
electromyography
(EMG), evoked response
and nerve/muscle
potentials and for the
intraoperative diagnosis
of acute dysfunction in
corticospinal axonal
conduction. The system
provides feedback to the
surgeon and OR team to
assist in the localization
and assessment of spinal
nerves and verification of
placement of spinal
instrumentation to avoid
injury to at risk nerve
roots	The DS7A and
DS7AH are
stimulators intended
for use during
neurological
monitoring and
assessment in a
clinical environment.
They are intended for
use by trained
personnel either
competent to apply
appropriate stimuli or
under the supervision
and instruction of one
who is.

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| Specification/
Property | Subject Device
NuVasive NVJJB System (K112717) | Predicate Devices
NuVasive NVM5 System (K112718) | Predicate Devices
Medtronic NIM Eclipse
(K061113) | MEPS, LLC.
Digitimer (K051357)
2 Stimulation |
|--------------------------------------------------------|----------------------------------------------------|-----------------------------------------------------|---------------------------------------------------------|----------------------------------------------------|
| Total Available
Channels | 8 | 32 | 32 | None |
| Headbox/
Patient Module
IEC 60601-1
Compliant | Digital Preamplifier with A/D Converter | Yes | Yes | Yes |
| Full Scale
View Range | Yes | Yes | Yes | N/A-Stimulation
Only |
| Frequency
Response | 30 Hz to 4.8 kHz | 3 Hz to 4.8 kHz | 1Hz to 4 kHz | N/A-Stimulation
Only |
| User Interface | Touch screen and [optional] keyboard/mouse | Touch screen and [optional] keyboard/mouse | Touch screen and
keyboard/mouse | Push button, Dials,
Switches and LCD
numbers |
| Remote
Monitoring | Yes | Yes | Yes | N/A-MEP only |
| Train of Four
Testing | Various | Various | Various | N/A-MEP only |
| Needle
Electrodes | Various | Various | Various | N/A-MEP only |
| Surface
Electrodes | Various | Various | Various | N/A-MEP only |
| Electrode
Leads | Various | Various | Various | N/A-MEP only |
| Stimulating
Probes | Various | Various | Various | N/A-MEP only |
| Recording
Channels | 8 | EMG, MEP, and SSEP | EMG, MEP, and SSEP | No |
| Number of
Recording
Channels | 8 | 10 | 32 | N/A |
| Response
Threshold | 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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4

510(k) Premarket Notification K112717
NuVasive® NVJJB System

| Specification/
Property | Subject Device
NuVasive NVJJB System (K112717) | Predicate Devices
NuVasive 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 Sampling
Rate | 9.6 kHz | 9.6 kHz | Unknown | N/A |
| Automatic
Muting During
Artifact | Yes | Yes | Yes | N/A |
| Stimulation
Waveform | Rectangular, Monophasic Pulse | Rectangular, Monophasic Pulse | Rectangular, Monophasic and
Biphasic Pulse | N/A |
| Constant
Current/
Voltage | Yes | Yes | Yes | N/A |
| Theoretical
Max Voltage | 240 V | 300 V | 400 V | N/A |
| Max Current | 0.05 A | 0.09 A | 0.1 A | N/A |
| Max Pulse
Width | 0.0002 sec | 0.0002 sec | 0.0005 sec | N/A |
| Max Number
of Pulses per
second | 5 | 5 | 100 | N/A |
| Min Probe
Surface 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 RMS
Current | 1.6 mARMS | 2.8 mARMS | 22.3 mARMS | N/A |
| Max RMS
Current
Density | 6.1 mARMS/cm² | 16.57 mARMS/cm² | 11,150 mARMS/cm² | N/A |
| Max Charge
Density | 59 µC/cm² | 107 µC/cm² | 25,000 µC/cm² | N/A |
| Max Power
Density | 15 W/cm² | 48 W/cm² | 5000 W/cm² | N/A |
| | 510(k) Premarket Notification K112717
NuVasive® NVJJB System | | | |
| Subject Device
NuVasive NVJJB System (K112717) | Predicate Devices
NuVasive NVM5 System (K112718) | Predicate Devices
Medtronic NIM Eclipse
(K061113) | Predicate Devices
MEPS, 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 | |

Page 6 of 9

6

Page 7 of 9

7

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: 0.058cm
Needle height: 0.302cm	Needle diameter: 0.06cm
Needle 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

Page 8 of 9

8

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.

9

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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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

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Indications for Use

510(k) Number (if known): K112717

Device Name: NuVasive® NVJJB® System

Indications For Use:

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.

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