(218 days)
Not Found
No
The description focuses on standard EMG monitoring, signal processing, and user interface features. There is no mention of AI, ML, or any learning algorithms used for analysis or decision-making. The performance studies compare the device to a predicate device based on equivalence, not on the performance of an AI/ML model.
No.
The device is used for monitoring and locating nerves, and for registering EMG responses. It provides information to assist surgeons during procedures, but it does not directly treat or provide therapy to the patient.
Yes
Explanation: The device is described as an "electromyography (EMG) monitor" that "records EMG activity" and "assists in early nerve identification by providing the surgeon with tools to help locate and identify the particular nerve at risk." It "monitors EMG activity" and "nerve monitoring involves measuring and displaying amplitudes of EMG responses as well as the latency (delay) between the stimulus and the EMG response." This information is used to "determine and/or change surgical strategy" and "verify the integrity of the nerve." These functions clearly classify it as a diagnostic device, as it provides information about the physiological state of nerves and muscles to aid in medical decision-making.
No
The device description explicitly lists and describes multiple hardware components, including a console, patient interface, cables, and a cart, in addition to software.
Based on the provided information, the NIM Vital™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- NIM Vital™ System Function: The NIM Vital™ System is an intraoperative electromyography (EMG) monitor. It directly interacts with the patient's nerves and muscles during surgery to measure electrical activity. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "locating and monitoring... nerves and registering EMG responses during surgery." This is a real-time, in-vivo (within the body) monitoring function.
Therefore, the NIM Vital™ System falls under the category of a medical device used for physiological monitoring during surgical procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NIM Vital™ System is intended for locating and monitoring, including stimulation, of cranial, spinal, peripheral motor and mixed motor-sensory nerves and registering EMG responses during surgery.
The NIM Vital™ System may be used for EMG monitoring in surgical procedures including: Intracranial, Extracranial, Intratemporal and surgeries associated with the Neck, Spine, Thorax, and Upper and Lower Extremities.
The NIM Vital™ is contraindicated for use with paralyzing anesthetic agents that will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation.
Product codes
GWF, ETN
Device Description
The NIM Vital™ system is an electromyography (EMG) monitor for intraoperative use during surgeries in which a motor or motor-sensory nerve is at risk. The NIM Vital™ records EMG activity from the muscles innervated by the affected nerve. The system assists in early nerve identification by providing the surgeon with tools to help locate and identify the particular nerve at risk within the surgical field. The system monitors EMG activity from the muscles innervated by the nerve at risk, alerting the surgeon when a particular nerve has been activated. Nerve monitoring involves measuring and displaying amplitudes of EMG responses as well as the latency (delay) between the stimulus and the EMG response. The system also allows an option for Automatic Periodic Stimulation (APS), allowing for EMG monitoring, nerve activity trending and alerts.
This information is used throughout the procedure to determine and/or change surgical strategy in order to promote the best outcome for the patient by preserving nerve function. In addition, intraoperative monitoring can help verify the integrity of the nerve throughout the procedure.
NIM Vital™ system provides detailed intraoperative nerve condition information to inspire surgical strategy and help improve patient outcomes.
Proprietary technology notifies user in real time of nerve condition - visually and audibly. NIM Nervassure™ continuous monitoring technology provides real-time feedback on nerve function so surgeons can adjust course, if necessary, during thyroid surgery and other procedures affecting head and neck nerves.
NIM NerveTrend™ EMG reporting enables nerve condition tracking throughout a procedure, even when using intermittent nerve monitoring.
During both continuous and intermittent trending, green, yellow and status bars provide visual information and their associated tones provide audible cues to users of current nerve function and EMG trends.
NIM Vital™ nerve condition information can be captured in a single, meaningful snapshot.
The following components of the NIM Vital™ Nerve Integrity Monitoring System including mechanical, electrical and software design are subject of this 510(k) submission:
NIM Vital™ Console .
NIM Vital™ Console controls the functions of the system:
- Interacting with users via touch screen graphic user interface .
- . Setting parameters for nerve stimulations
- Executing stimulation procedures
- . Processing and displaying EMG responses
- . Notifying users about events by issuing audio signals
- Interfacing with Patient Interface unit .
- NIM Vital™ Patient Interface ●
Under control of NIM Vital™ Console
- Generating stimulation signals
- Receiving and processing EMG responses ●
- . Connecting with Console wirelessly or via cable
NIM Vital™ Accessories: ●
- · Cables allow connection between components of the system
- · Cart provides housing for the component of the system and allows easy movement of the Console within the Operating Room
- · Adaptors allow use of predicate NIM 3.0 System disposables with subject NIM Vital System
The NIM Vital™ System uses sterile disposables that were developed and cleared for use with the predicate device NIM™ 3.0 and are not subject of this 510(k) submission:
- . Disposables:
- · Electrodes stimulation electrodes, return electrodes, Automatic Periodic Stimulation (APS) electrodes
- · Incrementing Probes
In addition, NIM Vital™ System is using a Mute Probe - a non-sterile component of NIM™ 3.0 System to detect activation of electrocautery devices during surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial, spinal, peripheral motor and mixed motor-sensory nerves.
Intracranial, Extracranial, Intratemporal, Extratemporal and surgeries associated with the Neck, Spine, Thorax, and Upper and Lower Extremities.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance testing was performed due to the changes introduced to the device to verify that all characteristics of the predicate device are preserved in the subject device. All testing passed.
Electrical Safety compliance is demonstrated through testing in accordance with AAMI ANSI ES 60601-1: 2005/I2012 and A1:2012, C1:2009/I2012 and A2:2010/I2012 (Consolidated Text) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
Test results indicate that NIM Vital System complies with the applicable standards.
Electromagnetic Compatibility compliance is demonstrated through testing in accordance with IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
Test results indicated that NIM Vital System complies with the applicable standards.
Software testing was performed in compliance with the following guidance and standards:
- FDA Guidance: The content of premarket submissions for software contained in medical devices, May 11, 2005
- FDA Guidance: General principles of software validation: Final guidance for industry and FDA staff, January 11, 2002
- FDA Guidance: Off-The-Shelf Software Use in Medical Devices, Guidance for Industry and FDA Staff, September 26, 2019
- IEC 60601-1-4 Medical Electrical Equipment, Part 1-4: Collateral Standard: Programmable Electrical Medical Systems; IEC 60601-1-4:1996 (First Ed.) + Am. 1:1999 (Consolidated 1.1 Ed.) for use with IEC 60601-1 (1988), Amts. 1 (1991) and 2 (1995)
- ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
Test results indicated that NIM Vital System complies with the applicable standards.
Performance Testing - Bench was performed in compliance with the following standards:
- IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- AAMI ANSI IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
- IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)]
- AIM 7351731 Rev. 2.00 2017-02-23 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
- ANSI IEEE C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
- IEC 60601-2-40: 2016 for use in conjunction with IEC 60601-1: 2005, CORR1:2006, CORR2:2007 Medical Electrical Equipment, Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment.
Test results indicated that NIM Vital System complies with the applicable standards.
General performance verification and validation testing of the subject NIM Vital System was also performed to verify the performance and output characteristics.
The following articles were used to support safety and effectiveness of the stimulation:
- D.R. Merrill et al. / Electrical stimulation of excitable tissue: design of efficacious and safe protocols, Journal of Neuroscience Methods 141 (2005) 171-198
- Mark A. Castoroa, Paul B. Yooa, Juan G. Hincapied, Jason J. Hamanna, Stephen B. Rublea, Patrick D. Wolfa, Warren M. Grill, Excitation properties of the right cervical vagus nerve in adult dogs, Experimental Neurology 227 (2011) 62-68
- Rick Schneider, MD; Gregory W. Randolph, MD, FACS, FACE, Gianlorenzo Dionigi, MD, FACS; et. al., International Neural Monitoring Study Group Guideline 2018 Part I: Staging Bilateral Thyroid Surgery With Monitoring Loss of Signal, Laryngoscope 128: October 2018, S1 - S17
- Gregory W. Randolph, MD; Henning Dralle, MD, et. Al. with the International Intraoperative Monitoring Study Group*: Electrophysiologic Recurrent Laryngeal Nerve Monitoring During Thyroid and Parathyroid Surgery: International Standards Guideline Statement 2010, Laryngoscope 121: January 2011, S1 - S16
In addition to testing listed above a Comparative Design Verification Test Protocol was executed to compare subject NIM Vital nerve monitoring system (wired/wireless) to the currently marketed NIM 3.0 monitoring system as evidence of monitoring equivalence of both systems.
This protocol is documenting equivalence of NIM Vital essential monitoring "User requirement elements" and "System requirement elements" as compared to the NIM 3.0 system.
Points of comparison included:
-
- Electrode impedance checking
-
- Monitoring active during bipolar electrocautery.
-
- Wire-free synchronized Muting during Monopolar electrocautery
-
- Recording Mechanical Elicited Responses
-
- Recording Electrical Evoked Responses
-
- APS monitoring trending and alarms
All comparison Requirements identified in the protocol have been satisfied demonstrating the Equivalency of the new NIM Vital nerve monitoring system (wireless) to the currently marketed NIM 3.0 monitoring system as evidence of NIM Vital monitor equivalency to NIM 3.0 monitor.
Animal testing data were not submitted with this 510(k).
Clinical testing was not submitted in this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).
0
October 28, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medtronic Xomed, Inc. Marek Pawlowski Senior Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216-0980
Re: K200759
Trade/Device Name: NIM Vital, Nerve Integrity Monitor Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF. ETN Dated: September 25, 2020 Received: September 28, 2020
Dear Marek Pawlowski:
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
1
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 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 medical devices and radiation-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,
for
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
2
Indications for Use
510(k) Number (if known) K200769
Device Name NIM Vital™ Nerve Monitoring System
Indications for Use (Describe)
The NIM Vital™ System is intended for locating and monitoring, including stimulation, of cranial, spinal, peripheral motor and mixed motor-sensory nerves and registering EMG responses during surgery.
The NIM Vital™ System may be used for EMG monitoring in surgical procedures including: Intracranial, Extracranial, Intratemporal and surgeries associated with the Neck, Spine, Thorax, and Upper and Lower Extremities.
The NIM Vital™ is contraindicated for use with paralyzing anesthetic agents that will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K200759
| • 510(k) owner | Medtronic Xomed, Inc.
6743 Southpoint Drive North
Jacksonville, Florida 32216-0980 USA
Phone:904-296-9600
Fax: 904-296-2386 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • Contact Information | Marek Pawlowski (Primary)
Senior Regulatory Affairs Specialist
Phone: 904-279-7587, Fax: 904-296-2386
marek.pawlowski@medtronic.com
Ed Chin (Alternate)
Regulatory Affairs Director
Phone: 904-279-7550, Fax: 904-296-2386
ed.chin@medtronic.com |
This Traditional 510(k) submission notifies FDA of modifications to currently marketed product - NIMTM 3.0 Nerve Integrity Monitoring Console and Patient Interface to update mechanical, electrical and software platforms due to the progress of technology.
| • Date Summary Prepared | October 28, 2020 |
|---|---|
| • Proprietary Name; | NIM Vital™ System |
- Device Name ●
●
| Trade name: | NIM Vital™, Nerve Integrity Monitor |
|---|---|
| Common/Usual Name: | Nerve Stimulator |
| Classification Name: | Evoked response electrical stimulator |
| (21 CFR 882.1870, Product Code GWF. Class II) | |
| Surgical nerve stimulator/locator | |
| (21 CFR 874.1820, Product Code ETN, Class II) | |
| Premarket Notification: | K200759 |
| Predicate Device: | |
| Trade Name: | NIM™ 3.0 Nerve Integrity Monitor |
| Common/Usual Name: | Nerve Stimulator |
| Classification Name: | Evoked response electrical stimulator |
| (21 CFR 882.1870, Product Code GWF. Class II) | |
| Surgical nerve stimulator/locator | |
| (21 CFR 874.1820, Product Code ETN, Class II) | |
| Premarket Notification: | K083124 |
4
. Device Description
The NIM Vital™ system is an electromyography (EMG) monitor for intraoperative use during surgeries in which a motor or motor-sensory nerve is at risk. The NIM Vital™ records EMG activity from the muscles innervated by the affected nerve. The system assists in early nerve identification by providing the surgeon with tools to help locate and identify the particular nerve at risk within the surgical field. The system monitors EMG activity from the muscles innervated by the nerve at risk, alerting the surgeon when a particular nerve has been activated. Nerve monitoring involves measuring and displaying amplitudes of EMG responses as well as the latency (delay) between the stimulus and the EMG response. The system also allows an option for Automatic Periodic Stimulation (APS), allowing for EMG monitoring, nerve activity trending and alerts.
This information is used throughout the procedure to determine and/or change surgical strategy in order to promote the best outcome for the patient by preserving nerve function. In addition, intraoperative monitoring can help verify the integrity of the nerve throughout the procedure.
NIM Vital™ system provides detailed intraoperative nerve condition information to inspire surgical strategy and help improve patient outcomes.
Proprietary technology notifies user in real time of nerve condition - visually and audibly. NIM Nervassure™ continuous monitoring technology provides real-time feedback on nerve function so surgeons can adjust course, if necessary, during thyroid surgery and other procedures affecting head and neck nerves.
NIM NerveTrend™ EMG reporting enables nerve condition tracking throughout a procedure, even when using intermittent nerve monitoring.
During both continuous and intermittent trending, green, yellow and status bars provide visual information and their associated tones provide audible cues to users of current nerve function and EMG trends.
NIM Vital™ nerve condition information can be captured in a single, meaningful snapshot.
The following components of the NIM Vital™ Nerve Integrity Monitoring System including mechanical, electrical and software design are subject of this 510(k) submission:
NIM Vital™ Console .
NIM Vital™ Console controls the functions of the system:
- Interacting with users via touch screen graphic user interface .
- . Setting parameters for nerve stimulations
- Executing stimulation procedures
- . Processing and displaying EMG responses
- . Notifying users about events by issuing audio signals
- Interfacing with Patient Interface unit .
- NIM Vital™ Patient Interface ●
5
Under control of NIM Vital™ Console
- Generating stimulation signals
- Receiving and processing EMG responses ●
- . Connecting with Console wirelessly or via cable
NIM Vital™ Accessories: ●
- · Cables allow connection between components of the system
- · Cart provides housing for the component of the system and allows easy movement of the Console within the Operating Room
- · Adaptors allow use of predicate NIM 3.0 System disposables with subject NIM Vital System
The NIM Vital™ System uses sterile disposables that were developed and cleared for use with the predicate device NIM™ 3.0 and are not subject of this 510(k) submission:
- . Disposables:
- · Electrodes stimulation electrodes, return electrodes, Automatic Periodic Stimulation (APS) electrodes
- · Incrementing Probes
In addition, NIM Vital™ System is using a Mute Probe - a non-sterile component of NIM™ 3.0 System to detect activation of electrocautery devices during surgical procedures.
Intended Use .
The NIM Vital™ system is intended for locating and monitoring, including stimulation, of cranial, spinal, peripheral motor and mixed motor-sensory nerves and registering electromyography (EMG) responses during surgery.
● Indications for Use
The NIM Vital™ System is intended for locating and monitoring, including stimulation, of cranial, spinal, peripheral motor and mixed motor-sensory nerves and registering EMG responses during surgery.
The NIM Vital™ System may be used for EMG monitoring in surgical procedures including: Intracranial, Extracranial, Intratemporal, Extratemporal and surgeries associated with the Neck, Spine, Thorax, and Upper and Lower Extremities.
The NIM Vital™ System is contraindicated for use with paralyzing anesthetic agents that will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation.
. Comparison of Technological Characteristics with Predicate Device
The differences between the subject device – NIM Vital System and the predicate device NIM 3.0 System are related to updating mechanical, electrical and software platforms due to the progress of technology. These differences do not change the intended use, indications for use nor functionality of this medical device.
6
A summary of how the technological characteristics of the subject device NIM Vital compare to a legally marketed device NIM 3.0 is presented in Table 5.1.
| Device Name | NIM Vital
(K200759) | NIM 3.0
(K083124) |
|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GWF, ETN | GWF, ETN |
| Intended Use | The NIM VitalTM system is intended for
locating and monitoring, including
stimulation, of cranial, spinal, peripheral
motor and mixed motor-sensory nerves and
registering electromyography (EMG)
responses during surgery. | The NIM 3.0 is intended for locating
and identifying cranial and peripheral
motor and mixed motor-sensory
nerves during surgery, including
spinal cord and spinal nerve roots. The
APS electrode is an accessory
intended for providing automatic
periodic stimulation to nerves. |
| Indications for Use | The NIM VitalTM System is intended for
locating and monitoring, including stimulation,
of cranial, spinal, peripheral motor and mixed
motor-sensory nerves and registering EMG
responses during surgery.
The NIM VitalTM System may be used for EMG
monitoring in support of surgical procedures
including:
Intracranial, Extracranial, Intratemporal,
Extratemporal and surgeries associated with the
Neck, Spine, Thorax, and Upper and Lower
Extremities.
The NIM VitalTM System is contraindicated for
use with paralyzing anesthetic agents that will
significantly reduce, if not completely eliminate,
EMG responses to direct or passive nerve
stimulation. | Indications for NIM EMG Monitoring
Procedures include: Intracranial,
Extracranial, Intratemporal,
Extratemporal, Neck Dissections,
Thoracic Surgeries, and Upper and
Lower Extremities.
Indications for Spinal Procedures
which may use NIM 3.0 EMG
monitoring include: Degenerative
Treatments, Pedicle Screw
Procedures, Fusion Cages, Rhizotomy,
Orthopedic Surgery, Open and
Percutaneous Lumbar and Cervical
Surgical Procedures, and Thoracic
Surgical Procedures. |
| Complies with IEC 60601-
1 electrical safety
standards | Yes | Yes |
| Console - Power supply | 100V-240V +/-10% 50/60 Hz +/-5%
Battery backup | 100V-240V +/-10% 50/60Hz +/-5%
No battery |
| Patient Interface power
supply | DC power from Console during wired
connection, battery power in PI during
wireless connection | DC power from Console |
| Multi-channel
intra operative
neurophysiological
monitor | Yes | Yes |
| Patient Interface | Wired / Wireless | Wired |
| Monitoring channels | 4 | 4, 8 |
| EMG parameters display | Yes | Yes |
| Monitoring through
bipolar cautery | Yes | Yes |
| Device Name | NIM Vital
(K200759) | NIM 3.0
(K083124) |
| Artifact detection software | Yes | Yes |
| External screen data
display | Yes | Yes |
| Speakers | Multiple audio speakers | Single audio speaker |
| Continuous Intraoperative
Nerve Monitoring | Yes | Yes |
| Event Threshold | Yes | Yes |
| Touch screen control | Yes | Yes |
| Surgeon / Procedure
Setting/ Customized
Quick Set-up | Yes | Yes |
| Surgeon Incrementing
Probe control | Yes | Yes |
| Monitoring Reports | Yes | Yes |
| Synchronized Electro
Surgical Unit (ESU)
muting | Wired using Mute Detector/ Software
detection without using Mute Detector | Wired using Mute Detector |
| Capable of connecting
various styles of patient
monitoring electrodes | Yes | Yes |
| Capable of supplying
electrical stimulus for
evoked responses | Yes | Yes |
| Max Stim 1 Current Max
Pulse Duration | 50mA
1000 µS | 30mA
250 µS |
| Max Stim 2 Current Max
Pulse Duration | 3mA
1000 µS | 30mA
250 µS |
| Absolute maximum
stimulation current
capability | 50mA | 30mA |
| Maximum Current Density
with Standard Prass Probe
Contact Area = 0.204
(mm²) | 980 mA/cm² RMS | 36.8 mA/cm² RMS |
| Actual current applied to
patient at maximum
stimulator setting | 50mA@1000Ohms 50mA@500Ohms
50mA@250Ohms 50mA@200Ohms | 30mA@1000Ohms 30mA@500Ohms
30mA@250Ohms 30mA@200Ohms |
| Absolute maximum energy
/ pulse applied to patient at
maximum stimulator
setting | 2.5mJ@1000Ohms 1.25mJ@500Ohms
0.6mJ@250Ohms 0.5mJ@200Ohms | 0.23mJ@1000Ohms
0.13mJ@500Ohms
0.06mJ@250Ohms
0.05mJ@200Ohms |
| Device Name | NIM Vital
(K200759) | NIM 3.0
(K083124) |
| Lumbar, thoracic, and
cervical procedures | Yes | Yes |
| Degenerative procedures | Yes | Yes |
| Pedicle screw | Yes | Yes |
| Neck Dissections | Yes | Yes |
| Orthopedic Surgery | Yes | Yes |
| Fusion Cages | Yes | Yes |
| Rhizontomy | Yes | Yes |
| Peripheral nerve
monitoring | (Yes) Upper and lower extremities) | (Yes) Upper and lower extremities) |
| Accessories | | |
| Subdermal electrode | Yes | Yes |
| Sterile/Single Use | Yes | Yes |
| Method of Sterilization | ETO | ETO |
| Intended for nerve
stimulation | Yes | Yes |
| Automatic Stimulation | Yes | Yes |
| Intended for nerve
monitoring | Yes | Yes |
| System with Custom Cart | Yes | Yes |
| Use Limited to Medtronic
NIM Systems | Yes | Yes |
Table 5.1. Summary of Characteristics
7
8
Performance Characteristics .
Performance testing was performed due to the changes introduced to the device to verify that all characteristics of the predicate device are preserved in the subject device. All testing passed.
Electrical Safety Testing
Electrical Safety compliance is demonstrated through testing in accordance with:
| FDA
Recognition
Number | Standard
Developing
Organization | Recognition
List Number | Standard
Designation
Number and
Date | Title of Standard | Effective
Date | Category |
|------------------------------|----------------------------------------|----------------------------|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------------------|
| 19-4 | AAMI ANSI | 036 | ES 60601-1:
2005/I2012
and A1:2012, | C1:2009/I2012 and
A2:2010/I2012
(Consolidated Text)
Medical electrical
equipment – Part 1:
General requirements
for basic safety and
essential performance
(IEC 60601-1:2005,
MOD) | 07/09/2014 | General II
(ES/EMC) |
Test results indicate that NIM Vital System complies with the applicable standards.
9
Electromagnetic Compatibility Testing
Electromagnetic Compatibility compliance is demonstrated through testing in accordance with:
| FDA
Recognition
Number | Standard
Developing
Organization | Recognition
List Number | Standard
Designation
Number and
Date | Title of Standard | FR
Publication
Date | Category |
|------------------------------|----------------------------------------|----------------------------|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------|
| 19-8 | IEC | 037 | 60601-1-2
Edition 4.02014-
02 | Medical electrical
equipment - Part 1-2:
Generalrequirements
for basic safety and
essential performance -
Collateral standard:
Electromagnetic
compatibility -
Requirements and tests | 09/17/2018 | General II
(ES/EMC) |
Test results indicated that NIM Vital System complies with the applicable standards.
Software Testing
Software testing was performed in compliance with the following guidance and standards:
- FDA Guidance: The content of premarket submissions for software contained in ● medical devices, May 11, 2005
- FDA Guidance: General principles of software validation: Final guidance for industy . and FDA staff, January 11, 2002
- . FDA Guidance: Off-The-Shelf Software Use in Medical Devices, Guidance for Industry and FDA Staff, September 26, 2019
- . IEC 60601-1-4 Medical Electrical Equipment, Part 1-4: Collateral Standard: Programmable Electrical Medical Systems; IEC 60601-1-4:1996 (First Ed.) + Am. 1:1999 (Consolidated 1.1 Ed.) for use with IEC 60601-1 (1988), Amts. 1 (1991) and 2 (1995)
| FDA
Recognition
Number | Standard
Developing
Organization | Recognition
List Number | Standard
Designation
Number and
Date | Title of Standard | FR
Publication
Date | Category |
|------------------------------|----------------------------------------|----------------------------|-----------------------------------------------|-------------------------------------------------------------------------------------------------|---------------------------|---------------------------------|
| 13-79 | ANSI AAMI
IEC | 051 | 62304:2006/A1:2
016 | Medical device software -
Software life cycle processes
[Including Amendment 1
(2016)] | 01/14/2019 | (Software/
Informatics
s) |
Test results indicated that NIM Vital System complies with the applicable standards.
10
Performance Testing - Bench
| FDA
Recognition
Number | Standard
Developing
Organization | Recognition
List Number | Standard
Designation
Number and
Date | Title of Standard | FR
Publication
Date | Category |
|------------------------------|----------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|----------------------------|
| 5-89 | IEC | 043 | 60601-1-6
Edition 3.1 2013-
10 | Medical electrical equipment
- Part 1-6: General
requirements for basic safety
and essential performance –
Collateral standard: Usability | 06/27/2016 | (General I
(QS/RM) |
| 5-114 | AAMI ANSI
IEC | 046 | 62366-1 Edition
1.0 2015-02 | Medical devices - Part 1:
Application of usability
engineering to medical
devices [Including
CORRIGENDUM 1 (2016)] | 12/23/2016 | (General I
(QS/RM) |
| 19-13 | IEC | 053 | 62133 Edition 2.0
2012-12 | Secondary cells and batteries
containing alkaline or other
non-acid electrolytes - Safety
requirements for portable
sealed secondary cells, and
for batteries made from them,
for use in portable
applications [Including:
Corrigendum 1 (2013)] | 12/23/2019 | General II
(ES/
EMC) |
| 19-30 | AIM | 050 | 7351731 Rev.
2.00 2017-02-23 | Medical Electrical Equipment
and System Electromagnetic
Immunity Test for Exposure
to Radio Frequency
Identification Readers - An
AIM Standard | 09/17/2018 | General II
(ES/
EMC) |
| 19-29 | ANSI IEEE | 047 | C63.27-2017 | American National Standard for
Evaluation of Wireless
Coexistence | 08/21/2017 | General II
(ES/
EMC) |
| N/A | IEC 60601-2-40 | N/A | IEC 60601-2-40:
2016 for use in
conjunction with
IEC 60601-1:
2005,
CORR1:2006,
CORR2:2007, | Medical Electrical
Equipment, Part 2-40:
Particular requirements for
the basic safety and essential
performance of
electromyographs and evoked
response equipment. | 08/18/2016 | N/A |
Performance testing was performed in compliance with the following standards:
Test results indicated that NIM Vital System complies with the applicable standards.
General performance verification and validation testing of the subject NIM Vital System was also performed to verify the performance and output characteristics.
The following articles were used to support safety and effectiveness of the stimulation:
- D.R. Merrill et al. / Electrical stimulation of excitable tissue: design of efficacious and ● safe protocols, Journal of Neuroscience Methods 141 (2005) 171-198
- Mark A. Castoroa, Paul B. Yooa, Juan G. Hincapied, Jason J. Hamanna, Stephen B. . Rublea,Patrick D. Wolfa, Warren M. Grill, Excitation properties of the right cervical vagus nerve in adult dogs, Experimental Neurology 227 (2011) 62-68
- Rick Schneider, MD; Gregory W. Randolph, MD, FACS, FACE, Gianlorenzo ● Dionigi, MD, FACS; et. al., International Neural Monitoring Study Group Guideline
11
2018 Part I: Staging Bilateral Thyroid Surgery With Monitoring Loss of Signal, Laryngoscope 128: October 2018, S1 - S17
- Gregory W. Randolph, MD; Henning Dralle, MD, et. Al. with the International Intraoperative Monitoring Study Group*: Electrophysiologic Recurrent Laryngeal Nerve Monitoring During Thyroid and Parathyroid Surgery: International Standards Guideline Statement 2010, Laryngoscope 121: January 2011, S1 - S16
In addition to testing listed above a Comparative Design Verification Test Protocol was executed to compare subject NIM Vital nerve monitoring system (wired/wireless) to the currently marketed NIM 3.0 monitoring system as evidence of monitoring equivalence of both systems.
This protocol is documenting equivalence of NIM Vital essential monitoring "User requirement elements" and "System requirement elements" as compared to the NIM 3.0 system.
Points of comparison included:
-
- Electrode impedance checking
-
- Monitoring active during bipolar electrocautery.
-
- Wire-free synchronized Muting during Monopolar electrocautery
-
- Recording Mechanical Elicited Responses
-
- Recording Electrical Evoked Responses
-
- APS monitoring trending and alarms
All comparison Requirements identified in the protocol have been satisfied demonstrating the Equivalency of the new NIM Vital nerve monitoring system (wireless) to the currently marketed NIM 3.0 monitoring system as evidence of NIM Vital monitor equivalency to NIM 3.0 monitor.
Performance Testing - Animal
Animal testing data were not submitted with this 510(k).
Clinical Testing
Clinical testing was not submitted in this 510(k).
Conclusion ●
NIM Vital™ Nerve Integrity Monitoring System is substantially equivalent to the predicate NIM™ 3.0 System. The updates of mechanical, electrical and software platforms have been verified and validated demonstrating that the changes meet product requirements. The changes did not affect intended use, indications for use, functionality nor fundamental technology. Further, the changes do not raise any new questions of safety and effectiveness of the Nerve Integrity Monitoring System.