(90 days)
Not Found
No
The description focuses on signal amplification and display, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as a monitor intended for locating and identifying nerves, and for detecting and displaying EMG signals. Its use is limited to providing information to the surgeon during procedures, rather than directly treating a condition.
Yes
The device is intended for "locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery," which is a diagnostic purpose. It "detects electromyographic (EMG) signals" and displays them, allowing for the assessment of nerve function.
No
The device description explicitly states that the Neurosign® V4 is an "integrated system consisting of a combination of hardware, software, and accessories." It also describes hardware components like the Pre-amplifier and Stimulator pod cables, and mentions non-clinical testing for electrical and mechanical safety, which are relevant to hardware.
Based on the provided information, the Neurosign® V4 Intraoperative Nerve Monitor 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) outside of the body. The Neurosign® V4, as described, is used during surgery to monitor nerve activity within the patient's body.
- The device description clearly states it detects electromyographic (EMG) signals within muscles caused by nerve activity. This is a physiological measurement taken directly from the patient, not an analysis of a biological sample.
- The intended use is for locating and identifying nerves during surgery. This is an in-vivo application, not an in-vitro one.
Therefore, the Neurosign® V4 falls under the category of a medical device used for physiological monitoring and nerve localization during surgical procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Neurosign® V4 Intraoperative Nerve Monitor is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal nerve roots.
Indications for Neurosign® V4 EMG Monitoring Procedures include: Intracranial, Extracranial, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities.
Indications for spinal procedures which may use Neurosign® V4 EMG monitoring include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery and Open and Percutaneous Lumbar Procedures.
Product codes
PDQ
Device Description
The Neurosign® V4 Intraoperative Nerve Monitor (IONM) is a multi-channel nerve monitor designed for use in Ear, Nose and Throat (ENT) surgery and neurosurgery. The subject device differs from its primary predicate due to the introduction of improved Pre-amplifier and Stimulator pod cables, as well the addition of an 8-channel Pre-amplifier variant.
Using needle or surface electrodes 1 connected to the Pre-amplifier, the nerve monitor detects electromyographic (EMG) signals within muscles caused by the contraction of the muscle due to mechanical manipulation or electrical stimulation of the nerve controlling it. The Neurosign® V4 then amplifies the EMG data into an audible signal and displays the data as a waveform on the active monitoring screen.
The Neurosign® V4 Intraoperative Nerve Monitor is used for patient treatment by prescription only under the supervision of a licensed physician.
The Neurosign® V4 is an integrated system consisting of a combination of hardware, software, and accessories. Its technological characteristics are described in further detail below.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial, peripheral, spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed physician, during surgery
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
Non-Clinical Testing:
Electrical Safety & Mechanical Safety: Tested and found compliant to ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 by independent test laboratory Element Materials Technology. Also, non-clinical bench testing by Magstim confirmed no discerning difference in isolation parameters of new cable design compared to old.
Electromagnetic Compatibility: Tested and found compliant to IEC 60601-1-2: 2014 by independent test laboratory Eurofins Hursley. Non-clinical bench testing by Magstim concluded no discerning difference in EMC performance of new cable design compared to old.
Alarm Systems: Tested and found compliant to IEC 60601-1-8 by independent test laboratory Element Materials Technology.
Biocompatibility: Stimulator Pod, Pre-amplifier, and connecting leads materials were tested and found compliant to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010 by an independent test laboratory.
Human Factors Testing: Usability testing was performed to analyze the user experience of the 8-Channel Neurosign® V4. The Human Factors Engineering report verifies the Neurosign V4, using the 8-channel pre-amplifier, to be safe and effective for the intended users, uses, and use environments. Compliance with IEC 62366-1 was also mentioned.
Software verification and validation testing demonstrated that the software performs as intended. Risks associated with the device were identified, assessed, and mitigated in accordance with ISO14971.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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April 1, 2021
Magstim Company Ltd. Tom Campbell Chief Quality & Regulatory Affairs Officer Spring Gardens Whitland, Carmarthenshire SA34 0HR United Kingdom
Re: K203684
Trade/Device Name: Neurosign V4 Intraoperative Nerve Monitor Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: PDQ
Dear Tom Campbell:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 17, 2021. Specifically, FDA is updating this SE Letter due to typographical errors in the Indications for Use Statement as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jay Gupta, OHT5: Office of Neurological and Physical Medicine Devices, Jay Gupta, 301-796-2795, jay.gupta@fda.hhs.gov.
Sincerely,
Jay R. Gupta -S
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services USA logo, which features a stylized caduceus. To the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name in blue text.
March 17, 2021
Magstim Company Ltd. Tom Campbell Chief Quality & Regulatory Affairs Officer Spring Gardens Whitland, Carmarthenshire SA34 0HR United Kingdom
Re: K203684
Trade/Device Name: Neurosign V4 Intraoperative Nerve Monitor Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDQ Dated: December 17, 2020 Received: December 17, 2020
Dear Tom Campbell:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
2
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay R. Gupta -S
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K203684
Device Name Neurosign® V4 Intraoperative Nerve Monitor
Indications for Use (Describe)
The Neurosign® V4 Intraoperative Nerve Monitor is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal nerve roots.
Indications for Neurosign® V4 EMG Monitoring Procedures include: Intracranial, Extracranial, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities.
Indications for spinal procedures which may use Neurosign® V4 EMG monitoring include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery and Open and Percutaneous Lumbar Procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K203684 Traditional 510(k) SUMMARY Magstim's Neurosign® V4 Intraoperative Nerve Monitor
Prepared according to the requirements outlined in 21 CFR 807.92
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Magstim Company Limited Spring Gardens, Whitland, Carmarthenshire SA34 OHR, United Kingdom
Phone: +44 (0) 1994 240798 Facsimile: +44 (0) 1994 240061
Contact Person: Tom Campbell, Chief Quality & Regulatory Affairs Officer requlatory@magstim.com
Date Prepared: March 17, 2021
Trade Name of Device
Neurosign® V4 Intraoperative Nerve Monitor
Common or Usual Name
Neurosurgical Nerve Locator
Classification
Neurosurgical Nerve Locator
21 CFR 874.1820, Class II, product code PDQ
Predicate Devices
K181559 Neurosign® V4 Intraoperative Nerve Monitor. The Magstim Company Limited (Primary Predicate Device), 21 CFR 874.1820, PDQ, ETN
K053141 Neurosign® Nerve Monitor, Model Neurosign® 400 and Neurosign® 800, The Magstim Company Limited (Secondary Predicate), 21 CFR 874.1820, ETN
Device Description
The Neurosign® V4 Intraoperative Nerve Monitor (IONM) is a multi-channel nerve monitor designed for use in Ear, Nose and Throat (ENT) surgery and neurosurgery. The subject device differs from its primary predicate due to the introduction of improved Pre-amplifier and Stimulator pod cables, as well the addition of an 8-channel Pre-amplifier variant.
5
Using needle or surface electrodes 1 connected to the Pre-amplifier, the nerve monitor detects electromyographic (EMG) signals within muscles caused by the contraction of the muscle due to mechanical manipulation or electrical stimulation of the nerve controlling it. The Neurosign® V4 then amplifies the EMG data into an audible signal and displays the data as a waveform on the active monitoring screen.
The Neurosign® V4 Intraoperative Nerve Monitor is used for patient treatment by prescription only under the supervision of a licensed physician.
The Neurosign® V4 is an integrated system consisting of a combination of hardware, software, and accessories. Its technological characteristics are described in further detail below.
Intended Use
The Neurosign® V4 Intraoperative Nerve Monitor is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal nerve roots.
Technological Characteristics
The Neurosign® V4 is comprised of following components:
-
- Neurosign® V4 Intraoperative Nerve Monitor
-
- Neurosign® V4 Pre-amplifier:
- a. Neurosign® V4 Pre-amplifier 4-Channel
- b. Neurosign® V4 Pre-amplifier 8-Channel
-
- Neurosign® V4 Stimulator Pod
-
- Neurosign® V4 Mute Sensor
The Neurosign® V4 Intraoperative Nerve Monitor (IONM) includes a user interface comprised of an audio output, a color graphics display with a touch screen and dedicated rotary controls for frequently adjusted parameters.
EMG signals are collected from the patient using needle and surface electrodes [1] connected to the Neurosian® V4 Pre-amplifier. The pre-amplifier is available in a 4-channel or 8-channel variant, allowing the user to monitor up to eight separate neural pathways depending on the pre-amplifier used. The Neurosign® V4 Pre-amplifier collects, processes and transmits the EMG signals to the IONM for display and for an audio output.
The Neurosign® V4 Stimulator Pod allows the simultaneous connection of two stimulating probes for the mapping and locating of nerves within tissue, and to test the nerve activity at various stages during surgery.
Software documentation for a "major" level of concern has been provided.
1 Single use electrodes and probes not subject to this submission
2 Single use electrodes and probes not subject to this submission
6
Non-Clinical Testing Table 1: Summary of Non-Clinical Testing
| Test | Method | Results/ Comment |
|---|---|---|
| Electrical Safety | ||
| Mechanical Safety | ANSI/AAMI ES60601-1:2005/(R)2012 and | |
| A1:2012- | ||
| Medical electrical equipment - Part 1: | ||
| General requirements for | ||
| basic safety and essential performance; | ||
| FDA Recognition Number: 19-4 | A sample Neurosign® V4 (4-Channel | |
| and 8-Channel Variants) has been | ||
| tested and found to be compliant to the | ||
| requirements of IEC 60601-1 by | ||
| independent test laboratory Element | ||
| Materials Technology, to demonstrate | ||
| safety and effectiveness of the system | ||
| following incorporation of new/different | ||
| characteristics as compared to the | ||
| predicate device. |
Following the design changes to the Pre
amplifier and Stimulator Pod cables,
non-clinical bench testing was performed
by Magstim confirming that there is no
discernable difference in the isolation
parameters of the new cable design in
comparison to the old. |
| Electromagnetic
Compatibility | IEC 60601-1-2: 2014 -
Medical electrical equipment - Part 1-2:
General requirements for basic safety and
essential performance -
Collateral standard: Electromagnetic
compatibility -Requirements and tests;
FDA recognition number: 19-8 | A sample Neurosign® V4 (4-Channel)
has been tested and found to be
compliant to the requirements of EN
60601-1-2 by independent test
laboratory Eurofins Hursley, to
demonstrate safety and effectiveness o
the system following incorporation of
new/different characteristics as
compared to the predicate device.
Following the design change to the Pre-
amplifier and Stimulator Pod cables,
non-clinical bench testing was performed
by Magstim concluding there is no
discernable difference in the EMC
performance of the new cable design in
comparison to the old. |
| Alarm Systems | IEC 60601-1-8 -
Medical electrical equipment - Part 1-8:
General requirements for basic safety and
essential performance - Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems; FDA Recognition Number: 5-76 | A sample Neurosign® V4 has been
tested and found to be compliant to the
requirements of IEC 60601-1-8 by
independent test laboratory Element
Materials Technology, thus
demonstrating the Neurosign® V4 is
substantially equivalent to the legally
marketed predicate device. |
| Biocompatibility | ISO 10993-1:2009 - Biological Evaluation
of Medical Devices - Part 1: Evaluation and
testing within a risk management process | The Neurosign®V4 Nerve Monitor is no
intended to come into contact with the
patient, as patient contact is achieved |
| Human Factors Testing | ISO 10993-5:2009 - Biological evaluation
of medical devices -- Part 5: Tests for in
vitro cytotoxicity; FDA Recognition
Number: 2-245 | via use of single use electrodes and
probes.
However, the Stimulator Pod, Pre-
amplifier and connecting leads may
come into contact with the patient. |
| | ISO 10993-10:2010 - Biological evaluation
of medical devices - Part 10: Tests for
irritation and skin sensitization; FDA
Recognition Number: 2-174 | Samples of these materials have been
tested and found to be compliant to the
requirements of ISO 10993-1, ISO
10993-5 and ISO 10993-10 by an
independent test laboratory, thus
demonstrating the Neurosign® V4 is
substantially equivalent to the legally
marketed predicate device. |
| | AAMI/ANSI HE75 - Human Factors
Engineering - Design of Medical Devices;
FDA Recognition Number: 5-57 | Usability testing was performed to
analyze the user experience of the 8-
Channel Neurosign® V4.
The Human Factors Engineering report
verifies the Neurosign V4, using the 8-
channel pre-amplifier, to be safe and
effective for the intended users, uses,
and use environments thus
demonstrating the Neurosign® V4 is
substantially equivalent to the legally
marketed predicate device. |
| | IEC 62366-1 - Medical Devices - Part 1:
Application of Usability Engineering To
Medical Devices; FDA Recognition
Number: 5-114 | |
7
The software verification and validation testing further demonstrated that the software performs as intended and in accordance with specifications. In accordance with ISO14971, risks associated with the Neurosign® V4 have been identified, assessed and, where necessary, mitigated with risk control measures to an acceptable level.
Substantial Equivalence Discussion
The Neurosign® V4 (subject of this submission) is substantially equivalent to the primary predicate device, the Neurosign® V4 Intraoperative Nerve Monitor (K181559) and the secondary predicate device, the Neurosign® Nerve Monitor Model Neurosign® 400 and Model Neurosign® 800® (K053141).
The intended use and indications for use are identical between the Neurosign® V4 (subject of this submission) and the primary predicate device, the Neurosign® V4 Intraoperative Nerve Monitor (K181559).
All devices have the same four principal components:
- (1) Intraoperative Nerve Monitor,
- (2) Pre-amplifier,
- (3) Stimulator and
- (4) Mute Sensor.
The notable difference between the subject device Neurosign® V4 and that which was cleared earlier in K181559 includes the redesign of the Pre-amplifier and Stimulator pod
8
cables to improve reliability and malleability during use, as well the addition of an 8-channel Pre-amplifier variant, enabling the user to monitor up to eight separate neural pathways at risk during surgery. The Neurosign® V4 8-Channel Pre-amplifier is substantially equivalent to the Neurosign® V4 4-Channel Pre-amplifier previously cleared under K181559, with the addition of 4 additional electrode channels.
Furthermore, the addition of an 8-channel Pre-amplifier is supported by the clearance of the secondary predicate device (K053141), as the secondary predicate includes the option to monitor up to eight separate neural pathways at risk during surgery.
The Principles of Operation are identical to the primary predicate device, the Neurosign® V4 Intraoperative Nerve Monitor (K181559). Both the subject device and the predicate device systems are all systems that are intended for use in collecting, processing and representing EMG signals from nerves at of choice during surgery.
Both the subject and predicate devices use a stimulator for the mapping and locating of nerves within tissue and testing the nerve activity at various stages during surgery. All offer the option to use a mute sensor to silence the audio output during episodes of RF interference from electrocautery.
A summary of the similarities and minor differences between the Neurosign® V4, the previous Neurosign® V4 (primary predicate device) and the Neurosign® Nerve Monitor Model Neurosign® 400 and Model Neurosign® 800 (Secondary Predicate Device) are described in Table 2.
Conclusions
In summary, the subject and predicate devices are substantially equivalent based on their identical intended use and similar technological characteristics, which have been tested according to the applicable non-clinical performance testing.
Non-clinical test data demonstrates that the Neurosign® V4 is as safe and effective as the predicate devices.
Thus, the Neurosign® V4 Intraoperative Nerve Monitor is substantially equivalent to the primary predicate device, the Neurosign® V4 Intraoperative Nerve Monitor (K181559), and the secondary predicate device, the Neurosign® Nerve Monitor, Model Neurosign® 400.
9
Table 2: Substantial Equivalence Summary
| Criteria of
Comparison | K203684
Neurosign® V4 Intraoperative
Nerve Monitor
(Subject of this submission) | K181559
Neurosign® V4
Intraoperative Nerve
Monitor
(Primary Predicate Device) | K053141
Neurosign® Nerve Monitor,
Model Neurosign® 400 and
Model Neurosign® 800®
(Secondary Predicate
Device) |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Magstim Company Limited | Magstim Company Limited | Magstim Company Limited |
| Device Name | Neurosign® V4 Intraoperative
Nerve Monitor | Neurosign® V4
Intraoperative Nerve
Monitor | Neurosign® Nerve Monitor,
Model Neurosign® 400 |
| Product code(s)
& regulation | PDQ
21 CFR 874.1820 | PDQ, ETN
21 CFR 874.1820 | ETN
21 CFR 874.1820 |
| Intended Use/
Indications for
Use | The Neurosign® V4
Intraoperative Nerve Monitor
is intended for locating and
identifying cranial and
peripheral motor and mixed
motor-sensory nerves during
surgery, including spinal
nerve roots.
Indications for Neurosign®
V4 EMG Monitoring
Procedures include:
Intracranial, Extracranial,
Intratemporal, Extratemporal,
Neck Dissections, Thoracic
Surgeries, and Upper and
Lower Extremities.
Indications for spinal
procedures which may use
Neurosign® V4 EMG
monitoring include:
Degenerative Treatments,
Pedicle Screw Procedures,
Fusion Cages, Rhizotomy,
Orthopedic Surgery and
Open and Percutaneous
Lumbar Procedures. | The Neurosign® V4
Intraoperative Nerve
Monitor is intended for
locating and identifying
cranial and peripheral motor
and mixed motor-sensory
nerves during surgery,
including spinal nerve roots.
Indications for Neurosign®
V4 EMG Monitoring
Procedures include:
Intracranial, Extracranial,
Intratemporal,
Extratemporal, Neck
Dissections, Thoracic
Surgeries, and Upper and
Lower Extremities.
Indications for spinal
procedures which may use
Neurosign® V4 EMG
monitoring include:
Degenerative Treatments
Pedicle Screw Procedures,
Fusion Cages, Rhizotomy,
Orthopedic Surgery and
Open and Percutaneous
Lumbar Procedures. | To locate and identify
cranial motor nerves during
ENT and intra-cranial
procedures. |
| Intraoperative Nerve Monitor | | | |
| Type of monitor | EMG | EMG | EMG |
| System
hardware | Digital | Digital | Digital |
| Display | 15" color touchscreen | 15" color touchscreen | 125mm x 95mm
electroluminescent display |
| Criteria of
Comparison | K203684
Neurosign® V4 Intraoperative
Nerve Monitor
(Subject of this submission) | K181559
Neurosign® V4
Intraoperative Nerve
Monitor
(Primary Predicate Device) | K053141
Neurosign® Nerve Monitor,
Model Neurosign® 400 and
Model Neurosign® 800®
(Secondary Predicate
Device) |
| Stimulator
adjust | By control knob | By control knob | By control knob |
| Volume adjust | By control knob; individual
channels by touchscreen | By control knob; individual
channels by touchscreen | By control knob |
| Needle
placement
impedance
checking | Yes | Yes | No |
| | Amplifier | | |
| Number of
channels | 4 (4-Channel Pre-amplifier)
8 (8-Channel Pre-amplifier) | 4 | 4 (Neurosign® 400)
8 (Neurosign® 800) |
| Color coded
electrode
sockets | Yes | Yes | Yes |
| Bandwidth | 10Hz - 1kHz | 10Hz - 1kHz | 10Hz - 5kHz |
| Common mode
rejection ratio | > 90dB @ 50/60Hz | > 90dB @ 50/60Hz | > 95dB @ 50/60Hz |
| | Stimulator | | |
| Stimulator
channels | Channel 1: 2 probes | Channel 1: 2 probes | Channel 1: 2 probes |
| Operational
mode | Constant Current or
Constant Voltage | Constant Current or
Constant Voltage | Constant Current or
Constant Voltage |
| Current ranges | 10μΑ – 10mA | 10μA - 10mA | 50µA - 10mA |
| Voltage ranges | 10mV - 10V | 10mV - 10V | 50mV - 10V |
| Accuracy | Current Stimulating Mode
± 10% (1mA – 10mA), into
1kΩ load
± 25% (10μA - 990 μA), into
1kΩ load
Voltage Stimulating Mode
± 10% (1V - 10V), into 1kΩ
load
± 25% (10mV - 990 mV), into
1kΩ load | Current Stimulating Mode
± 10% (1mA – 10mA), into
1kΩ load
± 25% (10μA - 990 μA), into
1kΩ load
Voltage Stimulating Mode
± 10% (1V - 10V), into 1kΩ
load
± 25% (10mV - 990 mV),
into 1kΩ load | Current Stimulating Mode
± 10% (50µA - 10mA), into
1kΩ load
Voltage Stimulating Mode
± 10% (50mV – 10V), into
1kΩ load |
| | Mute Sensor | | |
| Available | Yes | Yes | Yes |
| | Operational Environment | | |
| Criteria of
Comparison | K203684
Neurosign® V4 Intraoperative
Nerve Monitor
(Subject of this submission) | K181559
Neurosign® V4
Intraoperative Nerve
Monitor
(Primary Predicate Device) | K053141
Neurosign® Nerve Monitor,
Model Neurosign® 400 and
Model Neurosign® 800®
(Secondary Predicate
Device) |
| Operating
temperature | 5°C to 40°C | 5°C to 40°C | 5°C to 30°C |
| Relative
humidity | 10% to 80% (non-
condensing) | 10% to 80% (non-
condensing) | 30% to 70% (non-
condensing) |
| Atmospheric
pressure | 70kPa to 106kPa | 70kPa to 106kPa | 50kPa to 106kPa |
10
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