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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic NIM Vital Nerve Integrity Monitoring System. This document focuses on demonstrating substantial equivalence to a predicate device (NIM 3.0), rather than proving stand-alone performance or clinical effectiveness through a comparative effectiveness study. Therefore, specific details about acceptance criteria for a new clinical claim, or the methodologies of studies designed to prove such claims, are not present.

However, based on the provided document, we can interpret acceptance criteria and "proof" in the context of a 510(k) for device modifications. The "proof" here is that the modified device, NIM Vital, performs equivalently to the predicate device, NIM 3.0, and adheres to relevant safety and performance standards.

Here's an attempt to answer your questions based solely on the information available in the provided document, acknowledging the limitations for a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this 510(k) are implicitly tied to demonstrating substantial equivalence to the predicate device (NIM 3.0) and compliance with relevant safety and performance standards. The "reported device performance" is framed as the NIM Vital meeting or exceeding the predicate's capabilities and all specified standards.

Since explicit quantifiable acceptance criteria for clinical performance (e.g., sensitivity, specificity for a diagnostic claim) are not provided for a new functionality, the table below reflects the criteria regarding technical and safety performance equivalence as presented in the 510(k) summary.

Acceptance Criterion (Implicit for 510(k) Equivalence)	Reported Device Performance (NIM Vital)
Functional Equivalence to Predicate (NIM 3.0):
- Electrode impedance checking	Satisfied (demonstrated equivalency)
- Monitoring active during bipolar electrocautery	Satisfied (demonstrated equivalency)
- Wire-free synchronized Muting during Monopolar electrocautery	Satisfied (NIM Vital has new software detection without Mute Detector, also deemed equivalent to predicate's wired Mute Detector)
- Recording Mechanical Elicited Responses	Satisfied (demonstrated equivalency)
- Recording Electrical Evoked Responses	Satisfied (demonstrated equivalency)
- APS monitoring trending and alarms	Satisfied (demonstrated equivalency)
- EMG parameters display	Yes (Equivalent to predicate)
- Artifact detection software	Yes (Equivalent to predicate)
- External screen data display	Yes (Equivalent to predicate)
- Continuous Intraoperative Nerve Monitoring	Yes (Equivalent to predicate)
- Event Threshold	Yes (Equivalent to predicate)
- Touch screen control	Yes (Equivalent to predicate)
- Surgeon/Procedure Setting/Customized Quick Set-up	Yes (Equivalent to predicate)
- Surgeon Incrementing Probe control	Yes (Equivalent to predicate)
- Monitoring Reports	Yes (Equivalent to predicate)
- Capable of connecting various styles of patient monitoring electrodes	Yes (Equivalent to predicate)
- Capable of supplying electrical stimulus for evoked responses	Yes (Equivalent to predicate)
Electrical Safety Compliance:
- IEC 60601-1:2005/I2012 and A1:2012, C1:2009/I2012 and A2:2010/I2012 (Consolidated Text)	Test results indicate NIM Vital System complies.
Electromagnetic Compatibility Compliance:
- IEC 60601-1-2 Edition 4.0 2014-02	Test results indicated NIM Vital System complies.
Software Compliance:
- FDA Guidance: Premarket submissions for software, General principles of software validation, Off-The-Shelf Software Use	Compliance demonstrated implicitly through successful software testing.
- IEC 60601-1-4 (for PEMS) and ANSI AAMI IEC 62304:2006/A1:2016	Test results indicated NIM Vital System complies.
Bench Performance (Usability, Battery, RF Coexistence, Specific Device Performance):
- IEC 60601-1-6, IEC 62366-1 (Usability)	Compliance demonstrated implicitly through successful bench testing.
- IEC 62133 (Secondary cells and batteries)	Compliance demonstrated implicitly through successful bench testing (NIM Vital has battery backup, predicate does not).
- AIM 7351731 Rev. 2.00, ANSI IEEE C63.27-2017 (RF Identification, Wireless Coexistence)	Compliance demonstrated implicitly through successful bench testing (NIM Vital has wireless connectivity, predicate does not).
- IEC 60601-2-40:2016 (Electromyographs and evoked response equipment)	Compliance demonstrated implicitly through successful bench testing.
Safety of Stimulation Parameters:	Supported by reference to published scientific articles on electrical stimulation of excitable tissue and clinical guidelines for intraoperative nerve monitoring. NIM Vital has higher Max Stim Current/Pulse Duration and Absolute maximum stimulation current/energy compared to predicate, implying additional safety consideration for these new parameters.

Note on "Proof": For a 510(k) submission, "proof" of meeting acceptance criteria is primarily demonstrated through verification and validation (V&V) testing, compliance with recognized standards, and a comparison to a legally marketed predicate device to show substantial equivalence. The document repeatedly states that "All testing passed" and "Test results indicated that NIM Vital System complies with the applicable standards."

2. Sample Size Used for the Test Set and Data Provenance

The document describes bench testing and comparative design verification testing to demonstrate equivalence, but it does not specify "sample sizes" in the context of clinical patient data. The tests performed are primarily engineering and system-level tests:

Test Set (for comparative design verification): Not applicable in terms of patient sample size. The "test set" would be the NIM Vital system components compared against the NIM 3.0 system. The comparison involved specific functionalities (e.g., electrode impedance checking, monitoring during cautery, recording responses, APS monitoring).
Data Provenance: Not applicable. This is not a study based on human patient data. The "data" comes from the results of various engineering and functional performance tests conducted on the device itself. The document explicitly states:
- "Animal testing data were not submitted with this 510(k)."
- "Clinical testing was not submitted in this 510(k)."

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Since no clinical testing or human data review was performed for this 510(k) submission, there were no experts used to establish ground truth in the traditional sense of medical image interpretation or clinical diagnosis.
The "ground truth" for the engineering and performance tests is defined by the technical specifications, design requirements, and recognized industry standards (e.g., IEC standards for electrical safety, EMC, software). Compliance is assessed against these predefined technical benchmarks, not clinical expert consensus.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication by medical experts. The V&V testing involved engineering and quality control procedures to verify that the device performed according to its specifications and compared equivalently to the predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The document explicitly states: "Clinical testing was not submitted in this 510(k)." Therefore, no MRMC study was conducted to assess improvement in human reader performance with AI assistance (as the device is not an AI-based diagnostic tool) or other clinical outcomes.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. The NIM Vital is a medical device for nerve monitoring, not a standalone algorithm. Its performance is inherent in its hardware, software, and functional operation. The "performance testing" described (Electrical Safety, EMC, Software, Bench Performance, Comparative Design Verification) can be considered "standalone" in the sense that they evaluate the device's technical capabilities in isolation.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is primarily technical specifications, engineering design requirements, and recognized industry standards (e.g., IEC 60601 family of standards for medical electrical equipment).
For the comparative design verification, the predicate device (NIM 3.0) and its established performance served as a "gold standard" for functional equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set of data. The device's functionality is based on established electrophysiological principles and hardware/software design.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

{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™ 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary K200759

• 510(k) owner	Medtronic Xomed, Inc.6743 Southpoint Drive NorthJacksonville, Florida 32216-0980 USAPhone:904-296-9600Fax: 904-296-2386
• Contact Information	Marek Pawlowski (Primary)Senior Regulatory Affairs SpecialistPhone: 904-279-7587, Fax: 904-296-2386marek.pawlowski@medtronic.comEd Chin (Alternate)Regulatory Affairs DirectorPhone: 904-279-7550, Fax: 904-296-2386ed.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

NIM Vital™ system provides detailed intraoperative nerve condition information to inspire surgical strategy and help improve patient outcomes.

NIM NerveTrend™ EMG reporting enables nerve condition tracking throughout a procedure, even when using intermittent nerve monitoring.

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 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 forlocating and monitoring, includingstimulation, of cranial, spinal, peripheralmotor and mixed motor-sensory nerves andregistering electromyography (EMG)responses during surgery.	The NIM 3.0 is intended for locatingand identifying cranial and peripheralmotor and mixed motor-sensorynerves during surgery, includingspinal cord and spinal nerve roots. TheAPS electrode is an accessoryintended for providing automaticperiodic stimulation to nerves.
Indications for Use	The NIM VitalTM System is intended forlocating and monitoring, including stimulation,of cranial, spinal, peripheral motor and mixedmotor-sensory nerves and registering EMGresponses during surgery.The NIM VitalTM System may be used for EMGmonitoring in support of surgical proceduresincluding:Intracranial, Extracranial, Intratemporal,Extratemporal and surgeries associated with theNeck, Spine, Thorax, and Upper and LowerExtremities.The NIM VitalTM System is contraindicated foruse with paralyzing anesthetic agents that willsignificantly reduce, if not completely eliminate,EMG responses to direct or passive nervestimulation.	Indications for NIM EMG MonitoringProcedures include: Intracranial,Extracranial, Intratemporal,Extratemporal, Neck Dissections,Thoracic Surgeries, and Upper andLower Extremities.Indications for Spinal Procedureswhich may use NIM 3.0 EMGmonitoring include: DegenerativeTreatments, Pedicle ScrewProcedures, Fusion Cages, Rhizotomy,Orthopedic Surgery, Open andPercutaneous Lumbar and CervicalSurgical Procedures, and ThoracicSurgical Procedures.
Complies with IEC 60601-1 electrical safetystandards	Yes	Yes
Console - Power supply	100V-240V +/-10% 50/60 Hz +/-5%Battery backup	100V-240V +/-10% 50/60Hz +/-5%No battery
Patient Interface powersupply	DC power from Console during wiredconnection, battery power in PI duringwireless connection	DC power from Console
Multi-channelintra operativeneurophysiologicalmonitor	Yes	Yes
Patient Interface	Wired / Wireless	Wired
Monitoring channels	4	4, 8
EMG parameters display	Yes	Yes
Monitoring throughbipolar cautery	Yes	Yes
Device Name	NIM Vital(K200759)	NIM 3.0(K083124)
Artifact detection software	Yes	Yes
External screen datadisplay	Yes	Yes
Speakers	Multiple audio speakers	Single audio speaker
Continuous IntraoperativeNerve Monitoring	Yes	Yes
Event Threshold	Yes	Yes
Touch screen control	Yes	Yes
Surgeon / ProcedureSetting/ CustomizedQuick Set-up	Yes	Yes
Surgeon IncrementingProbe control	Yes	Yes
Monitoring Reports	Yes	Yes
Synchronized ElectroSurgical Unit (ESU)muting	Wired using Mute Detector/ Softwaredetection without using Mute Detector	Wired using Mute Detector
Capable of connectingvarious styles of patientmonitoring electrodes	Yes	Yes
Capable of supplyingelectrical stimulus forevoked responses	Yes	Yes
Max Stim 1 Current MaxPulse Duration	50mA1000 µS	30mA250 µS
Max Stim 2 Current MaxPulse Duration	3mA1000 µS	30mA250 µS
Absolute maximumstimulation currentcapability	50mA	30mA
Maximum Current Densitywith Standard Prass ProbeContact Area = 0.204(mm²)	980 mA/cm² RMS	36.8 mA/cm² RMS
Actual current applied topatient at maximumstimulator setting	50mA@1000Ohms 50mA@500Ohms50mA@250Ohms 50mA@200Ohms	30mA@1000Ohms 30mA@500Ohms30mA@250Ohms 30mA@200Ohms
Absolute maximum energy/ pulse applied to patient atmaximum stimulatorsetting	2.5mJ@1000Ohms 1.25mJ@500Ohms0.6mJ@250Ohms 0.5mJ@200Ohms	0.23mJ@1000Ohms0.13mJ@500Ohms0.06mJ@250Ohms0.05mJ@200Ohms
Device Name	NIM Vital(K200759)	NIM 3.0(K083124)
Lumbar, thoracic, andcervical 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 nervemonitoring	(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 nervestimulation	Yes	Yes
Automatic Stimulation	Yes	Yes
Intended for nervemonitoring	Yes	Yes
System with Custom Cart	Yes	Yes
Use Limited to MedtronicNIM 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:

FDARecognitionNumber	StandardDevelopingOrganization	RecognitionList Number	StandardDesignationNumber andDate	Title of Standard	EffectiveDate	Category
19-4	AAMI ANSI	036	ES 60601-1:2005/I2012and A1:2012,	C1:2009/I2012 andA2:2010/I2012(Consolidated Text)Medical electricalequipment – Part 1:General requirementsfor basic safety andessential 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:

FDARecognitionNumber	StandardDevelopingOrganization	RecognitionList Number	StandardDesignationNumber andDate	Title of Standard	FRPublicationDate	Category
19-8	IEC	037	60601-1-2Edition 4.02014-02	Medical electricalequipment - Part 1-2:Generalrequirementsfor basic safety andessential performance -Collateral standard:Electromagneticcompatibility -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)

FDARecognitionNumber	StandardDevelopingOrganization	RecognitionList Number	StandardDesignationNumber andDate	Title of Standard	FRPublicationDate	Category
13-79	ANSI AAMIIEC	051	62304:2006/A1:2016	Medical device software -Software life cycle processes[Including Amendment 1(2016)]	01/14/2019	(Software/Informaticss)

Test results indicated that NIM Vital System complies with the applicable standards.

{10}------------------------------------------------

Performance Testing - Bench

FDARecognitionNumber	StandardDevelopingOrganization	RecognitionList Number	StandardDesignationNumber andDate	Title of Standard	FRPublicationDate	Category
5-89	IEC	043	60601-1-6Edition 3.1 2013-10	Medical electrical equipment- Part 1-6: Generalrequirements for basic safetyand essential performance –Collateral standard: Usability	06/27/2016	(General I(QS/RM)
5-114	AAMI ANSIIEC	046	62366-1 Edition1.0 2015-02	Medical devices - Part 1:Application of usabilityengineering to medicaldevices [IncludingCORRIGENDUM 1 (2016)]	12/23/2016	(General I(QS/RM)
19-13	IEC	053	62133 Edition 2.02012-12	Secondary cells and batteriescontaining alkaline or othernon-acid electrolytes - Safetyrequirements for portablesealed secondary cells, andfor batteries made from them,for use in portableapplications [Including:Corrigendum 1 (2013)]	12/23/2019	General II(ES/EMC)
19-30	AIM	050	7351731 Rev.2.00 2017-02-23	Medical Electrical Equipmentand System ElectromagneticImmunity Test for Exposureto Radio FrequencyIdentification Readers - AnAIM Standard	09/17/2018	General II(ES/EMC)
19-29	ANSI IEEE	047	C63.27-2017	American National Standard forEvaluation of WirelessCoexistence	08/21/2017	General II(ES/EMC)
N/A	IEC 60601-2-40	N/A	IEC 60601-2-40:2016 for use inconjunction withIEC 60601-1:2005,CORR1:2006,CORR2:2007,	Medical ElectricalEquipment, Part 2-40:Particular requirements forthe basic safety and essentialperformance ofelectromyographs and evokedresponse 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:

1. Electrode impedance checking
1. Monitoring active during bipolar electrocautery.
1. Wire-free synchronized Muting during Monopolar electrocautery
1. Recording Mechanical Elicited Responses
1. Recording Electrical Evoked Responses
1. 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.

Regulation Number and Section

§ 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).