(218 days)
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.
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.
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.
§ 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).