(179 days)
Not Found
No
The document describes standard neurophysiological monitoring techniques and a guidance system based on electrical stimulation, monitoring of responses, and accelerometer data. There is no mention of AI or ML algorithms being used for analysis, interpretation, or decision-making.
No
The device is strictly for monitoring purposes, providing information to the surgeon to assess neurophysiologic status and aid in surgical procedures, rather than directly treating a condition.
Yes
The device is described as providing "information directly to the surgeon, to help assess a patient's neurophysiologic status" and functions like "XLIF (Detection)" and "Free Run EMG" are used to "locate and evaluate spinal nerves" and "identifies spontaneous EMG activity", which are all diagnostic activities aimed at assessing a patient's condition.
No
The device description explicitly states that the NVM5 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.
Based on the provided information, the NVM5® System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The NVM5® System directly interacts with the patient's body through electrical stimulation and monitoring of physiological responses (EMG, TcMEP, SSEP).
- The intended use and device description clearly state that the NVM5® System is for intraoperative neurophysiologic monitoring during spinal surgery. It provides real-time information about the patient's neurophysiologic status during the procedure, not by analyzing samples outside the body.
- The device description details hardware that directly interfaces with the patient (Patient Module, electrodes, probes). This is characteristic of in vivo devices, not in vitro diagnostics.
The NVM5® System is a medical device used for in vivo monitoring and guidance during surgery.
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. 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 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 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.
- . Guidance - 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.
Product codes (comma separated list FDA assigned to the subject device)
ETN, GWF, HAW, IKN
Device Description
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 the muscle groups imnervated 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 NVM5 System includes an integrated stereotactic guidance system (NVM5 Guidance) to support the delivery of pedicle screws during EMG monitoring. Lastly, the system also offers an optional screen sharing application (Remote Monitoring) to allow a secondary physician to remotely view the events represented on the NVM5 user interface. In summary, the NVMS System includes the following five (5) software functionalities / modalities:
-
- Electromyography (EMG)
-
- Transcranial Motor Evoked Potential (TcMEP), or simply MEP
-
- Somatosensory Evoked Potential (SSEP)
-
- Remote Monitoring
-
- Guidance
The NVM5® 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
radiographic imaging
Anatomical Site
Spinal, Lumbar spine (for guidance function)
Indicated Patient Age Range
adult patients (for guidance function)
Intended User / Care Setting
surgeon, monitoring physician, clinical environment
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 Sustem is substantially equivalent to other predicate devices and to verify that the NVM5 Sustem meets design specifications and performance characteristics, based upon the intended use. The NVM5® 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
- . Guidance performance testing - Accuracy testing for the creation of a cannulation trajectory for bone screw placement that demonstrated equivalent degrees of variance and that the accelerometer-based NVM5 Guidance function and the infrared tracking from the StealthStation are equivalent in their performance (supplemented with the following published clinical literature: Accuracy of percutaneous lumbar pedicle screw placement using the oblique or "owl's-eve" view and novel guidance technology (J Neurosurg Spine. 2010), and Improving accuracy and reducing radiation exposure in minimally invasive lumbar interbody fusion (J Neurosurg Spine, 2010))
Accessories to the NVM50 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 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.)
Angular tolerance of ±2°
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.
K962455, K051357, K061113, K050438, K061148, K022914
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, abstract shape on the left, followed by the word "NUVASIVE" in capital letters. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font size.
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: February 1, 2012
B. Device Name
| Trade or Proprietary Name: | NuVasive® NVM5 System |
|---|---|
| Common or Usual Name: | Neurological surgical monitor |
| Classification Name: | 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: | ETN, GWF, HAW, IKN |
C. Predicate Devices
The subject NuVasive® NVMS 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 |
|---|---|---|
| K962455 | Cadwell Cascade | Cadwell Laboratories, Inc. |
| K051357 | DS7A Constant Current High Voltage Stimulator | Digitimer LTD |
| K061113 | NIM Eclipse and probes (formerly Axon Systems | |
| OrthoMon System) | Medtronic Xomed, Inc. | |
| K050438 | StealthStation® System | Medtronic Inc. |
| K061148 | Disc Electrodes | Rhythmlink International, LLC |
| K022914 | Subdermal Needle Electrodes | Rhythmlink International, LLC |
D. Device Description
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
1
Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized, incomplete square shape on the left, followed by the word "NUVASIVE" in all caps. Below the word "NUVASIVE" is the tagline ":Speed of Innovation".
monitoring electromyography (EMG), transcranial motor evoked potential (TcMEP) or somatosensory evoked potential (SSEP) responses of the muscle groups imnervated 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 NVM5 System includes an integrated stereotactic guidance system (NVM5 Guidance) to support the delivery of pedicle screws during EMG monitoring. Lastly, the system also offers an optional screen sharing application (Remote Monitoring) to allow a secondary physician to remotely view the events represented on the NVM5 user interface. In summary, the NVMS System includes the following five (5) software functionalities / modalities:
-
- Electromyography (EMG)
-
- Transcranial Motor Evoked Potential (TcMEP), or simply MEP
-
- Somatosensory Evoked Potential (SSEP)
-
- Remote Monitoring
-
- Guidance
The NVM5® 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 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 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.
2
Image /page/2/Picture/1 description: The image shows the logo for "NUVASIVE". The logo consists of a stylized, curved shape on the left, followed by the company name in capital letters. Below the company name, there is a tagline that reads "Speed of Innovation".
- 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 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.
- . Guidance - 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.
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 the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and functions.
3
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510(k) Premarket Notification K112718
NuVasive® NuVasive® NVM5 System
| P | echnical | |
|---|---|---|
| = | ||
| 1 | ||
| 6 | ||
| € | 01 | |
| 011 | ||
| . | ||
| I | omnariso |
| Specification/ Property | Subject Device
NuVasive NVM5 System (K112718) | Cadwell Cascade (K962458) | Predicate Devices
Medtronic NIM Eclipse (K061113) | MEPS, LLC. Digitimer (K051357) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. 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. 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 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 Cadwell Cascade system
is intended to perform the
measurements needed for
Electromyography (EMG),
Nerve Conduction Velocity
(NCV, F wave, H wave),
Evoked Potentials (Brain
Stem, Visual,
Somatosensory) and
Repetitive Nerve Stimulation. | 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. |
Page 4 of 12
4
| | | | 510(k) Premarket Notification K112718
NuVasive® NVM5 System | | | |
|------------------------------------|--------------------------------------------------|--|----------------------------------------------------------------|------------------------------------|----------------------------------------------|--|
| | | | Predicate Devices | | | |
| | | | Cadwell Cascade
(K962458) | Medtronic NIM Eclipse
(K061113) | MEPS, LLC. Digitimer
(K051357) | |
| Specification/
Property | Subject Device
NuVasive NVM5 System (K112718) | | | | | |
| Total Available Channels | 32 | | 32 | 32 | 2 Stimulation | |
| Headbox/
Patient Module | Yes | | Yes | Yes | None | |
| IEC 60601-1
Compliant | Yes | | Yes | Yes | Yes | |
| Full Scale View
Range | $\pm$ 0.5 $\mu$ V to $\pm$ 8mV | | 10 $\mu$ V to 10mV | $\pm$ 10 $\mu$ V to $\pm$ 25mV | N/A-Stimulation Only | |
| Frequency
Response | 3 Hz to 4.8 kHz | | 0.5 Hz to 10kHz | 1Hz to 4 kHz | N/A-Stimulation Only | |
| User Interface | Touch screen and [optional] keyboard/mouse | | Laptop with optional 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 | Yes | | Yes | Yes | 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 | EMG, MEP, and SSEP | | EMG, MEP, and SSEP | EMG, MEP, and SSEP | No | |
| Number of
Recording
Channels | 10 | | N/A | 32 | N/A | |
| Response
Threshold | 10-300 $\mu$ V | | N/A | 10 $\mu$ V to 10 mV | N/A | |
| High Filter | 1.5 kHz | | N/A | 10 kHz | N/A | |
| Low Filter | 0.030 kHz | | N/A | 0.5 kHz | N/A | |
| Notch Filter | None | | N/A | 50 or 60 Hz | N/A | |
) Premarket Notification K112
N.V.L. Inc. ® NVL55
: 上一篇: ........... 1 4 : 2 Print Page 5 of 12
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| ﻣﺎﻧﺘﺨﺎﺑﻬﺎ
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20 |
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| œ |
510(k) Premarket Notification K112718
NuVasive® NuVasive® NVM5 System
| Specification/
Property | Subject Device
NuVasive NVM5 System (K112718) | Cadwell Cascade
(K962458) | Predicate Devices
Medtronic NIM Eclipse
(K061113) | MEPS, LLC. Digitimer
(K051357) |
|--------------------------------------|--------------------------------------------------|------------------------------|---------------------------------------------------------|-----------------------------------|
| Audible EMG | Yes | N/A | Yes | N/A |
| CMRR | > 100 dB @ 60 Hz | N/A | > 100 dB @ 60 Hz | N/A |
| A/D Sampling
Rate | 9.6 kHz | N/A | Unknown | N/A |
| Automatic Muting
During Artifact | Yes | N/A | Yes | N/A |
| Stimulation
Waveform | Rectangular, Monophasic Pulse | N/A | Rectangular, Monophasic and
Biphasic Pulse | N/A |
| Constant
Current/Voltage | Yes | N/A | Yes | N/A |
| Theoretical Max
Voltage | 300 V | N/A | 400 V | N/A |
| Max Current | 0.09 A | N/A | 0.1 A | N/A |
| Max Pulse Width | 0.0002 sec | N/A | 0.0005 sec | N/A |
| Max Number of
Pulses per second | 5 | N/A | 100 | N/A |
| Min Probe
Surface Area | 0.169 cm² | N/A | 0.002 cm² | N/A |
| Calculated Values per IEC 60601-2-40 | | | | |
| Voltage | 90 V | N/A | 100 V | N/A |
| Max RMS
Current | 2.8 mARMS | N/A | 22.3 mARMS | N/A |
| Max RMS
Current Density | 16.57 mARMS/cm² | N/A | 11,150 mARMS/cm² | N/A |
| Max Charge
Density | 107 µC/cm² | N/A | 25,000 µC/cm² | N/A |
| Max Power
Density | 48 W/cm² | N/A | 5000 W/cm² | N/A |
Page 6 of 12
6
| معرب الانج
1000000
Sportunity
| 1 |
|---|
| of Innovatio |
| September |
| Speed |
| ﻮﻧﻴ |
| 12 |
| 12-12-2 |
| 8 |
|
| |
510(k) Premarket Notification K112718
NuVasive® NuVasive® NVM5 System
| :
| ్ శిశ్ | MEPS, LLC. Digitimer | ្រី ជា ជួរ | 1000 V | 1.0 A | 0.00005 sed | 1 0 | 0.492 cm2 | 50 mJ | 1000 V | 22 mArms | 4.7 mARMS/CI | 102 µC/cm² | 2032 W/cm² | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Predicate Devices | A Medtronic NIM Ecl | ﺍﻟﻤﺮﺍﺟﻊ | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | |
| dwell Cascade (K962458) ------------------------------------------------------------------------------------------------------------------------------------------------------ | 일본 일본 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 1971년 19 | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | ||
| : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : | Subject Device System (K112718) Tasive NYM5 System (K112718) ----------------------------------------------------------------------------------------------------------------- | |||||||||||||
| ਿੱਚ ਹੈ। ਇਸ ਨੇ 2008 ਵਿੱਚ ਇੱਕ ਵਿੱਚ ਸੀ। ਹਵਾਲੇ 2008 ਦੀ ਸੀ। | МЕР - | |||||||||||||
| المواليد الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع ال | 000 V | 1 .0 A | 0.00005 se | 8 | 0.492 cm² | 50 m.J | 000 V | 20 mArm | 0.65 mArms/c | 02 μC/cm | 032 W/cm | |||
| Specification/ Property T | 【 | neoretical Mar Voltage | Max Curren | lax Pulse Widtl | Max Number o ulses per secor | Min Surface Area | ilculated Values per IEC 60601-24 | Max Energy | Voltage | Max RMS Current | Max RMS Current Densit | Max Charg | ||
| Density | Max Powe Density |
Page 7 of 12
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| 中華書出 行
Speed of Innovation
12:44:00
POWER
| માં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા | |
|---|---|
| 4 |
510(k) Premarket Notification K11277
NuVasive® NuVasive® NVM5 Syste
| Specification/
Property | Subject Device
NuVasive NVM5 System (K112718) | SSEP | Cadwell Cascade
(K962458) | Predicate Devices | Medtronic NIM Eclipse
(K061113) | MEPS, LLC. Digitimer
(K051357) |
|--------------------------------------|--------------------------------------------------|---------------------|------------------------------|-------------------|------------------------------------|-----------------------------------|
| Theoretical Max
Voltage | 300 V | 400 V | N/A | N/A | N/A | N/A |
| Max Current | 0.09 A | 0.1 A | N/A | N/A | N/A | N/A |
| Max Pulse Width | 0.0003 sec | 0.001 sec | N/A | N/A | N/A | N/A |
| Max Number of
Pulses per second | 9.7 | 90 | N/A | N/A | N/A | N/A |
| Min Surface Area
Electrode | 0.262 cm² | 0.262 cm² | N/A | N/A | N/A | N/A |
| Calculated Values per IEC 60601-2-40 | | | | | | |
| Voltage | 90 V | 100 V | N/A | N/A | N/A | N/A |
| Max RMS
Current | 4.8 mARMS | 30 mARMS | N/A | N/A | N/A | N/A |
| Max RMS
Current Density | 18.32 mARMS/cm² | 114.5 mARMS/cm² | N/A | N/A | N/A | N/A |
| Max Charge
Density | 10 $ µC/cm² $ | 381 $ µC/cm² $ | N/A | N/A | N/A | N/A |
| Max Power
Density | 36.8 W/cm² | 38 W/cm² | N/A | N/A | N/A | N/A |
Page 8 of 12
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| Clinical Characteristics for Guidance Function | ||
|---|---|---|
| Device – NVM5 Guidance (K112718) | Predicate Device – StealthStation® (K050438) | Substantially Equivalent |
| This function is intended as an aid for use in percutaneous pedicle cannulation in the lumbar spine of adult patients, and in conjunction with radiographic imaging that allows the surgeon to assess the angulation of accessories relative to patient spinal anatomy for the creation of a cannulation trajectory for bone cement. | The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. |
(Note: For the purposes of this predicate comparison the scope of the indications to be compared are limited to cannulation of a pedicle for pedicle screw placement) | Yes – the Guidance function has limited indications compared to the predicate. |
| Requires input derived from CT, MRI, or radiographic images | Requires input derived from CT, MRI, or radiographic images | |
| Intended to assist the surgeon in cannulating the pedicle based on user predefined trajectory with EMG stimulation | Intended to assist the surgeon in cannulating the pedicle based on user predefined trajectory Integrated with EMG stimulation | Yes |
| References angular sensing technology coupled with associated tracking instruments | References angular and position sensing technology coupled with associated tracking instruments | Yes |
| Utilizes a C-Arm Reticle with radio dense markers | Utilizes a C-Arm Reticle with radio dense markers | Yes |
9
| 510(k) Premarket Notification K112718
| NuVasive® NVM5 System | Substantially Equivalent | ||||
|---|---|---|---|---|---|
| Yes - The reduced degree of data | |||||
| collected by Guidance is still deemed | |||||
| substantially equivalent since it is used | |||||
| in conjunction with fluoroscopic | |||||
| imaging, not indicated for used by the | |||||
| predicate StealthStation. The amount of | |||||
| data collected by Guidance is sufficient | |||||
| to provide angular outputs to compare | |||||
| against the angular inputs identified by | |||||
| the user as the planned trajectory, | |||||
| considering that intraoperative | |||||
| radiographic imaging is used to confirm | |||||
| the starting point and correct trajectory | |||||
| of the cannulation needle. | Yes | Yes | Yes | ||
| Specification/ | |||||
| Property | Subject Device – NVM5 Guidance (K112718) | Predicate Device – StealthStation® (K050438) | |||
| Scientific | |||||
| Principles | |||||
| (continued) | • Uses accelerometers to sense angular measurements | ||||
| based on gravity by collecting 2 degrees of freedom | |||||
| (DOF) (rx, ry) data |
• Displays instrument orientation only (rotational
information in the x and y planes only) with respect
to gravity | • Uses infrared technology to capture positional and
rotational information via 6 DOF (x, y, z, rx, ry, rz)
data
• Displays the location and orientation (positional and
rotational information in the x, y, and z planes) of
instruments in real time merged with pre-
operatively obtained images of patient anatomy | | |
| | 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 | | |
| | Conformance
with Recognized
Standards | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 | Yes | |
| | User Interface | Touch screen, graphical user interface and audio | Touch screen, graphical user interface and audio | Yes | |
| | System
Materials/
Biosafety | Tracking instruments composed of known and
accepted (biocompatible) materials. | Tracking instruments composed of known and
accepted (biocompatible) materials. | Yes | |
| | System
Sterilization | As selected for individual accessories, and validated to
assure an SAL of 10-6. | As selected for individual accessories, and validated to
assure an SAL of 10-6. | Yes | |
Page 10 of 12
10
0(k) Premarket Notification K112718
NuVasive® NVM5 System
1979
| | Subject
NVM5
Dual Surface
(K112718) | Predicate
Sticky-pad™
Electrodes
(K061148) | Subject
NVM5
Dual Needle
(K112718) | Predicate
Subdermal
Needle
Electrodes
(K050194) | Subject
NVM5
Corkscrew
(K112718) | Predicate
Subdermal
Needle
Electrodes
(K050194) | Subject
NVM5
Cranial
Array
(K112718) | Predicate
Subdermal
Needle
Electrodes
(K061148) | Subject
NVM51-
PAS
Needle
(K112718) | Predicate
I-PAK
Needle
(K061113) |
|--------------------------|----------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------|-------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Manufacturer | NuVasive, Inc. | Rhythmlink International, LLC | NuVasive, Inc. | Rhythmlink International, LLC | NuVasive, Inc. | Rhythmlink International, LLC | NuVasive, Inc. | Rhythmlink International, LLC | NuVasive, Inc. | Medtronic |
| Length(s) | N/A | N/A | Needle length: 12mm | Needle length: 13mm | N/A | N/A | Needle length: 12mm | Needle length: 13mm | Overall assembly length: 8.75" | Overall assembly length: 7.58" |
| 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 | • Outer sheath diameter: 0.250"
• Inner sheath diameter: 0.179"
• Cannula diameter: 0.118" | • Outer Cannula proximal diameter: 0.187"
• Outer Cannula distal diameter: 0.125"
• Stylette diameter: 0.093" |
| Stim/Record Surface Area | 1.78cm² | 3 - 15.75cm² | 0.262cm² | 0.326cm² | 0.492cm² | 0.584cm² | 0.655cm² | 0.163cm² | 0.645 – 2.987cm² | 0.3cm² |
Page 11 of 12
NUVASIVE
11
Image /page/11/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized letter N on the left, followed by the word "NUVASIVE" in all caps. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font size.
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject NVM5 Sustem is substantially equivalent to other predicate devices and to verify that the NVM5 Sustem meets design specifications and performance characteristics, based upon the intended use. The NVM5® 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
- . Guidance performance testing - Accuracy testing for the creation of a cannulation trajectory for bone screw placement that demonstrated equivalent degrees of variance and that the accelerometer-based NVM5 Guidance function and the infrared tracking from the StealthStation are equivalent in their performance (supplemented with the following published clinical literature: Accuracy of percutaneous lumbar pedicle screw placement using the oblique or "owl's-eve" view and novel guidance technology (J Neurosurg Spine. 2010), and Improving accuracy and reducing radiation exposure in minimally invasive lumbar interbody fusion (J Neurosurg Spine, 2010))
Accessories to the NVM50 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 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, and safe and effective for its intended use.
12
Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Elias Ketchum Sr. Associate, Regulatory Affairs NuVasive, Inc. 7475 Lusk Boulevard San Diego, CA 92121
MAR 1 6 2012
Re: K112718
Trade/Device Name: NuVasive® NVM5® System Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN, GWF, HAW, IKN Dated: February 6, 2012 Received: February 7, 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 for association 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 Tou may, therefore, mans of the Act include requirements for annual registration, listing of general controls provisions of wactice, 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 If your device is classified (boo acore). 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.
13
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 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.
Melvin R. Fields, M.D.
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
14
Indications for Use .
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: NuVasive® NVM5 System
Indications For Use:
The NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring spinal I he NYM - System is a medical Geneven, to the surgeon, to help assess a patient's neurophysiologic status. Surgery. The device provides maron and surves via electrodes located on surgical accessories IV WP > provides this intermation by clectrically secreted potential (TceMEP) 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 . Dasic & Dyllanite Serve Test = The Deter Teachens and many and preparation and placement of bone screws.
- Free Run EMG The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by . I to kun Live dive 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 . I coller = Transcranial stimataton techniquicospinal tract. The TcMEP function provides an adjunctive motor pathway integrity during procedures with a method to allow the surgeon to monitor spinal cord i 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 . The Outdation is thenom is theneve as an the ntsed 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.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kristen Bowsher
Page 1 of 1 Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number_ K 112718