(260 days)
Not Found
No
The summary describes standard neurophysiological monitoring techniques and a software function for locating instrumentation, with no mention of AI or ML algorithms for data analysis, interpretation, or guidance.
No.
Explanation: The device is described as a monitoring device that provides information to the surgeon to assess neurophysiologic status and aid in surgical procedures, rather than directly treating a disease or condition.
Yes
The device "provides information directly to the surgeon, to help assess a patient's neurophysiologic status" by monitoring various neurophysiologic responses like EMG, MEP, and SSEP, and also helps locate and evaluate spinal nerves, all of which are diagnostic functions.
No
The device description explicitly states that the NVM5 System hardware consists of a Patient Module (PM) and computer, as well as accompanying accessory components which consist of an assortment of disposable conductive probes, electrodes, and electrode leads. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the NVM5® System is not an In Vitro Diagnostic (IVD) 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.
- NVM5 System Function: The NVM5 System operates intraoperatively (during surgery) and directly interacts with the patient's nervous system through electrical stimulation and monitoring of physiological responses (EMG, MEP, SSEP). It provides real-time information about the patient's neurophysiologic status in vivo.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the patient.
Therefore, the NVM5 System falls under the category of a medical device used for intraoperative monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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. NVMS provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial or lumbar motor evoked potential (MEP), or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods.
- 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.
- MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP 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.
- 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 NVMS System for a monitoring physician outside of the operating room.
- Guidance - The Guidance function is intended as an aid for use in either open or percutaneous pedicle cannulation procedures in the lumbar and sacral spine (L1-S1) 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.
- Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.
Product codes (comma separated list FDA assigned to the subject device)
PDQ, ETN, GWF, HAW, IKN, OLO
Device Description
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), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. Moreover, a Twitch Test 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 NVM5 System includes an integrated stereotactic guidance system (NVM5 Guidance) to support the delivery of pedicle screws during EMG monitoring. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods. Lastly, the system also offers an optional screen sharing application to allow a secondary physician to remotely view the events represented on the NVM5 user interface. In summary, the NVM5 System includes the following six (6) software functionalities / modalities:
-
- Electromyography (EMG)
-
- Motor Evoked Potential (MEP)
-
- Somatosensory Evoked Potential (SSEP)
-
- Remote Reader
-
- Guidance
-
- Bendini
The NVM5 System hardware consists of a Patient Module (PM) and computer, 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
Radiographic imaging (for Guidance function), CT, MRI, or radiographic images (for Clinical Use of Guidance)
Anatomical Site
Spinal, lumbar and sacral spine (L1-S1), thoracolumbar and sacral spine (S 1)
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Surgeon, monitoring physician (outside of the operating room) / Intraoperative, 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 NVM5 System is substantially equivalent to other predicate devices and to verify that the NVM5 System meets design specifications and performance characteristics, based upon the intended use. The NVM5 System was subjected to verification and validation testing, as follows:
- NVM5 System Verification and Validation Testing according to the Software Requirements Specifications defined for the system, to include the modifications made as part of the subject device
- NVM5 System software Regression Testing
- Bendini System Integration Testing
- Dual Surface Electrode Functional Testing
- ISO 10993 Biocompatibility Testing cytotoxicity, sensitization, and irritation/intracutaneous
The results of these studies showed that the subject NVM5® 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.
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized letter "N" on the left and the word "NUVASIVE" on the right. Below the word "NUVASIVE" is the tagline "The Power of Innovation" in a smaller font. The logo is black and white.
11.132694
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:
A. Submitted by:
Sheila Bruschi Manager. Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800 Date Prepared: May 13, 2014
Device Name B.
| Trade or Proprietary Name: | NuVasive ® NVM5 ® System |
|---|---|
| Common or Usual Name: | Neurological surgical monitor; |
| Stereotaxic Instrument. | |
| Classification Name: | Neuro Surgical Nerve Stimulator/Locator;. |
| Evoked response electrical stimulator; | |
| Neurological stereotaxic instrument; | |
| Electromyography (EMG) monitor/stimulator | |
| Device Class: | Class II |
| Classification: | §874.1820, §882.1870, §882.4560, §890.1375 |
| Product Code: | PDQ, ETN, GWF, HAW, IKN, OLO |
C. Predicate Devices
The subject NuVasive NVM5 System is substantially equivalent to the predicates:
- . 510(k) K123307, NuVasive NVM5 System
- 510(k) K991054, Nicolet Biomedical, Inc. Bravo Multi-Modality System .
- 510(k) K092744, R&D Medical Products, Inc. Neonatal ECG Electrodes .
Device Description D.
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), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. Moreover, a Twitch Test 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 NVM5 System includes an integrated stereotactic guidance system (NVM5 Guidance) to support the delivery of pedicle screws during EMG monitoring. The System also
1
Image /page/1/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized eye-like shape on the left and the word "NUVASIVE" in bold, sans-serif font on the right. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font.
integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods. Lastly, the system also offers an optional screen sharing application to allow a secondary physician to remotely view the events represented on the NVM5 user interface. In summary, the NVM5 System includes the following six (6) software functionalities / modalities:
-
- Electromyography (EMG)
-
- Motor Evoked Potential (MEP)
-
- Somatosensory Evoked Potential (SSEP)
-
- Remote Reader
-
- Guidance
-
- Bendini
The NVM5 System hardware consists of a Patient Module (PM) and computer, as well as accompanying accessory components which consist of an assortment of disposable conductive probes, electrodes, and electrode leads.
E. Intended Use
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 or lumbar motor evoked potential (MEP), or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods.
- 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.
- MEP Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for . motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP 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.
- SSEP The SSEP function allows the surgeon to assess sensory spinal cord function in . surgical procedures during which the spinal cord is at risk.
2
Image /page/2/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized letter "N" on the left and the word "NUVASIVE" on the right. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font.
- Remote Reader The Remote Reader function provides real time remote access to the . NVM5 System for a monitoring physician outside of the operating room.
- . Guidance - The Guidance function is intended as an aid for use in either open or percutaneous pedicle cannulation procedures in the lumbar and sacral spine (L1-S1) 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.
- . Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.
F. Technological Characteristics
As was established in this submission, the subject NVM5 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 equivalent technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and functions. The technological differences within this 510(k) that were shown to be substantially equivalent to the predicates include:
- . Additional Dual Surface Electrodes
- · . Modified MEP Indications for Use
- Modified SSEP specifications .
3
| NUVASIVE | VuVasive® NVM5® System | |
|---|---|---|
| Specification/ | Table 1 - Comparison of Technical Characteristics | |
| Predicate Device -------- | ||
| ು ಅವರು ಮಾಡು ಮಾಡಿ ಮಾರ್ಗ್ ಪ್ರದಾಖೆಗಳು ಒ | . | |
| Property | - 1 | |
| Nu Vasive NVM5 System (K123307) | ||
| : " | Subject Device " ( 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | |
| Nu Vasive NVM5 System NVM5 System | ||
| म् एक्स्कृतिक्तिः | ||
| : | ||
| neurophysiologic monitoring during spinal surgery. The device provides information | ||
| provides this information by electrically stimulating nerves via electrodes located on | ||
| evoked potential (TceMEP) or somatosensory evoked potential (SSEP) responses nerves. The System also integrates Bendini" software used to locate spinal impla | ||
| surgical accessories and monitoring electromyography (EMG), transcranial motor | ||
| directly to the surgeon, to help assess a patient's neurophysiologic status. NVM2 | ||
| he NVM5 System is a medical device that is intended for intraoperative | ||
| instrumentation for the placement of spinal rods. | lirectly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides | |
| ked potential (MEP), or somatosensory evoked potential (SSEP) responses of nerves. | ||
| europhysiologic monitoring during spinal surgery. The device provides information | ||
| is information by electrically stimulating nerves via electrodes located on surgical | ||
| ssories and monitoring electromyography (EMG), transcranial or lumbar moto | ||
| The System also integrates Bendini® software used to locate spinal implan instrumentation for the placement of spinal rods. | ||
| The NVM5* System is a medical device that is intended for intraoperative | ||
| XLIF (Detection) - The XLIF (Detection) function allows the surgeon to locate and | ||
| evaluate spinal nerves, and is used as a nerve avoidance tool. | XLIF (Detection) - The XLIF (Detection) function allows the surgeon to locate and | |
| valuate spinal nerves, and is used as a nerve avoidance tool | ||
| and evaluate spinal nerves by providing proximity information before, during or after | ||
| Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate | ||
| bone preparation and placement of bone screws. | sic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate | |
| d evaluate spinal nerves by providing proximity information before, during or after | ||
| one preparation and placement of bone screws. | ||
| ● | ||
| Free Run EMG - The Free Run EMG function identifies spontancous EMG activity | ||
| of spinal nerves by continually displaying a live stream waveform of any | ||
| mechanically induced myotome contractions. | spinal nerves by continually displaying a live stream waveform of any | |
| Free Run EMG – The Free Run EMG function identifies spontancous EMG activity | ||
| mechanically induced myotome contractions. | ||
| Intended Use / | 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. | witch Test (Train of Four) - The Twitch Test Function allows the surgeon to assess | |
| oderate degrees of neuromuscular block in effect by evaluating muscle contraction | ||
| llowing a train of four stimulation pulses | ||
| Indications for | ||
| Use | TceMEP - Transcranial stimulation techniques for motor evoked potentials are used | |
| TceMEP function provides an adjunctive method to allow the surgeon to monitor | ||
| during procedures with a risk of surgicall | ||
| conduction of the corticospinal tract | ||
| to assess for acute dysfunction in axonal | ||
| spinal cord and motor pathway integrity | ||
| induced motor injury. | MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques | |
| for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function | ||
| 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 | ||
| n surgical procedures during which the spinal cord is at risk | SSEP – The SSEP function allows the surgeon to assess sensory spinal cord function | |
| 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 | cmote Reader - The Remote Reader function provides real time remote access to | |
| the NVM5 System for a monitoring physician outside of the operating room | ||
| spinal anatomy for the creation of a cannulation trajectory for bone screw placement | ||
| percutaneous pedicle cannulation procedures in the lumbar and sacral spine (LI-S1) | ||
| allows the surgeon to assess the angulation of system accessories relative to patie | ||
| of adult patients, and when used in conjunction with radiographic imaging and E | ||
| Guidance ~ The Guidance function is intended as an aid for use in either open on | 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 | ||
| rcutaneous pedicle cannulation procedures in the thoracolumbar and sacral spinc | ||
| S I) of adult patients, and when used in conjunction with radiographic imaging | ||
| uidance - The Guidance function is intended as an aid for use in either open | ||
| those instructions and bend a rod using the Bendini Bender, a mechanical rod bender | ||
| Bendini ~ The Bendini Spinal Rod Bending function is used to locate spinal implar | ||
| system instrumentation (screws, hooks) to determine their relative location to or | ||
| mother to generate bend instructions to shape a spinal rod. A surgeon is able to | hose instructions and bend a rod using the Bendini Bender, a mechanical rod bender | |
| ndini – The Bendini Spinal Rod Bending function is used to locate spinal implan | ||
| nother to generate bend instructions to shape a spinal rod. A surgeon is able to use | ||
| stem instrumentation (screws, hooks) to determine their relative location to on | ||
| placement. | ||
| Specification/ | ||
| Property | Predicate Device | |
| NuVasive NVM5 System (K123307) | Subject Device | |
| NuVasive NVM5 System | ||
| Software | ||
| Modalities / | ||
| Functionalities | XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test TceMEP SSEP Remote Monitoring Guidance Bendini | XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test MEP SSEP Remote Monitoring Guidance Bendini |
| Algorithms | XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test TceMEP SSEP Guidance Bendini | Identical algorithms as predicate. |
| Total Available | ||
| Channels | 32 | 32 |
| Headbox/ | ||
| Patient Module | Yes | Yes |
| IEC 60601-1 | ||
| Compliant | Yes | Yes |
| Full Scale View | ||
| Range | $\pm 0.5\mu V$ to $\pm 8mV$ | $\pm 0.5\mu V$ to $\pm 8mV$ |
| Frequency | ||
| Response | 3 Hz to 4.8 kHz | 3 Hz to 4.8 kHz |
| User Interface | NuVasive-supplied computer or | |
| NuVasive provided touch screen and [optional] keyboard/mouse | NuVasive-supplied computer or | |
| NuVasive provided touch screen and [optional] keyboard/mouse | ||
| Remote | ||
| Monitoring | Yes | Yes |
| Train of Four | ||
| Testing | Yes | Yes |
| Needle Electrodes | Various | Various |
| Surface | ||
| Electrodes | Various | Various |
| Specification/ | ||
| Property | Predicate Device | |
| NuVasive NVM5 System (K123307) | 510(k) Premarket Notification | |
| NuVasive® NVM5® System | ||
| Electrode Leads | ||
| Stimulating | ||
| Probes | Various | Subject Device |
| NuVasive NVM5 System | ||
| Recording | ||
| Channels | Various | Various |
| EMG, MEP, and SSEP | EMG, MEP, and SSEP | |
| EMG Modalities | XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test | XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test |
| Types of Modes | ||
| Threshold Values | ||
| for Color Alerts | ||
| Audio feedback | Automatic Stimulation | Automatic Stimulation |
| Yes | Yes (Identical to predicate) | |
| Yes | Yes | |
| Types of Modes | ||
| Threshold Values | ||
| for Color Alerts | ||
| Audio feedback | Basic & Dynamic Screw Test | Automatic Stimulation |
| Yes | Yes (Identical to predicate) | |
| Yes | Yes | |
| Types of Modes | ||
| Threshold Values | ||
| for Color Alerts | ||
| Audio feedback | Free Run EMG | Manual Stimulation |
| Yes | Yes (Identical to predicate) | |
| Yes | Yes | |
| Types of Modes | ||
| Threshold Values | ||
| for Color Alerts | ||
| Audio feedback | Twitch Test | Manual and Automatic Stimulation |
| Yes | Yes (Identical to predicate) | |
| Yes | Yes | |
| Types of Modes | ||
| Threshold Values | ||
| for Color Alerts | ||
| Audio feedback | MEP | Manual and Automatic Stimulation |
| Yes | Yes (Identical to predicate) | |
| Yes | Yes | |
| Types of Modes | ||
| Threshold Values | ||
| for Color Alerts | ||
| Audio feedback | SSEP | Manual Stimulation |
| Yes | Yes | |
| Yes | Yes | |
| 510(k) Premarket Notification | ||
| NuVasive® NVM5® System | ||
| Specification/ | ||
| Property | Predicate Device | |
| NuVasive NVM5 System (K123307) | Subject Device | |
| NuVasive NVM5 System | ||
| Threshold Values | ||
| for Color Alerts | Yes | Yes |
| Audio feedback | Yes | Yes |
| Screen-sharing | ||
| accessibility | Remote Monitoring | Remote Monitoring |
| Guidance | ||
| Clinical Use | Requires input derived from CT, MRI, or radiographic images Intended to assist the surgeon in cannulating the pedicle based on user predefined trajectory Integrated with EMG stimulation | Requires input derived from CT, MRI, or radiographic images Intended to assist the surgeon in cannulating the pedicle based on user predefined trajectory Integrated with EMG stimulation |
| Performance | ||
| Requirements | Angular tolerance of ±2° Confirmation of alignment to pre-planned trajectory Seamlessly integrated with an insulated Jamshidi Needle | Angular tolerance of ±2° Confirmation of alignment to pre-planned trajectory Seamlessly integrated with an insulated Jamshidi Needle |
| IEC 60601 | ||
| Compliant | YES | YES |
| User Interface | Touch screen, graphical user interface and audio | Touch screen, graphical user interface and audio |
| Components | Bendini | |
| Optical (IR) tracking technology system, IR tracking instruments, computer. | Optical (IR) tracking technology system, IR tracking instruments, computer. | |
| User Interface | Touch screen, graphical user interface and audio. | Touch screen, graphical user interface and audio. |
| IEC 60601 | ||
| Compliant | YES | YES |
| Instrumentation | IR Digitizer (with integrated passive spheres) Rod Bender | IR Digitizer (with integrated passive spheres) Rod Bender |
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NUVASIVE
510(k) Premarket Notification
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6
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ে Performance Data
Nonclinical testing was performed to demonstrate that the subject NVM5 System is substantially equivalent to other predicate devices and to verify that the NVM5 System meets design specifications and performance characteristics, based upon the intended use. The NVM5 System was subjected to verification and validation testing, as follows:
- . NVM5 System Verification and Validation Testing according to the Software Requirements Specifications defined for the system, to include the modifications made as part of the subject device
- NVM5 System software Regression Testing .
- Bendini System Integration Testing .
- Dual Surface Electrode Functional Testing ●
- ISO 10993 Biocompatibility Testing cytotoxicity, sensitization, and ● irritation/intracutaneous
The results of these studies showed that the subject NVM5® 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 NVM5 System has been shown to be substantially equivalent to legally marketed predicate devices.
8
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2014
NuVasive, Inc. Ms. Sheila Bruschi Manager, Regulatory Affairs 7475 Lusk Blvd. San Diego, CA 92121
Re: K132694
Trade/Device Name: NuVasive NVM5 System Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical nerve locator Regulatory Class: Class II Product Code: PDQ, ETN, GWF, HAW, IKN, OLO Dated: April 17, 2014 Received: April 18, 2014
Dear Ms. Bruschi:
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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
9
Page 2 - Ms. Sheila Bruschi
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address:
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (if known) K132694
Device Name NuVasive® NVM5 System
Indications for Use (Describe)
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. NVMS provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial or lumbar motor evoked potential (MEP), or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods.
· 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.
· MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to 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 NVMS System for a monitoring physician outside of the operating room.
· Guidance - The Guidance function is intended as an aid for use in either open or percutaneous pedicle cannulation procedures in the lumbar and sacral spine (LI-SI) 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.
· Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos L. Peña -S
FORM FDA 3881 (1/14)
:
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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