(134 days)
The NeuroVision EMG Endotracheal Tube is intended for use with any compatible monitoring system during surgical procedures for continuous EMG neurological monitoring and status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.
The NuVasive® NeuroVision® EMG Endotracheal (ET) Tube is an endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring during surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The NeuroVision EMG ET Tube is provided as a sterile, single use disposable accessory that connects to a compatible EMG monitor to provide an open airway for patient ventilation during EMG neuromonitoring of the Recurrent Laryngeal Nerve (RLN).
This document describes a 510(k) premarket notification for the NuVasive® NeuroVision® EMG Endotracheal Tube. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria based on a clinical study as would be typical for an AI/ML medical device. Therefore, much of the requested information (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance with AI) is not applicable to this submission.
Here's an attempt to extract and frame the available information in the requested format, acknowledging the limitations due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of 510(k) submission, "acceptance criteria" are implicitly met by demonstrating that the device functions as intended and is safe, and that its technological characteristics are substantially equivalent to legally marketed predicate devices. The "performance" is demonstrated through nonclinical testing to ensure it meets established standards and performs comparably to predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Safety & Biocompatibility: Device materials are safe for patient contact. | Biocompatibility testing per ISO 10993-1 requirements, including: |
- Cytotoxicity testing (per ISO 10993-5)
- Intracutaneous testing (per ISO 10993-10)
- Sensitization testing (per ISO 10993-10)
Results showed the device met specifications and criteria. |
| Functional Performance: The device performs its intended functions (e.g., provides open airway, supports EMG monitoring, cuff inflation, no leaks). | Functional bench testing, including: - Functional testing per ISO 5361
- Inflation valve functionality
- Leak test
- Electrode resistance test
- System integration test
- Bending test
Results showed the device met specifications and criteria. |
| Stability: The device maintains its performance over its shelf life. | Stability Testing performed.
Results showed the device met specifications and criteria. |
| Sterilization & Packaging: The device is sterile and properly packaged to maintain sterility until use. | Sterilization & Packaging Validations performed.
Results showed the device met specifications and criteria. |
| Substantial Equivalence: The device is as safe and effective as its predicate devices, with similar technological characteristics. | Comparisons in design, intended use, material composition, function, packaging, and sterilization to predicate devices (K090298, K032491, K050162) indicated substantial equivalence. For instance: - Laryngeal Surface Electrode: YES (Subject ETT) vs. YES (Predicates)
- Endolaryngeal Location: YES (Subject ETT) vs. YES (Predicates)
- Number of Electrodes: 4 (Subject ETT) vs. 4 (K090298, K050162); unknown for K032491
- Electrode Surface Material: Conductive Silver Ink (Subject ETT, K032491) vs. Stainless Steel Wire (K090298, K050162)
- Tube & Cuff Materials: PVC (Subject ETT, K032491) vs. Silicone (K090298, K050162)
- Reinforcing Material: None (Subject ETT, K032491) vs. Stainless Steel Wire (K090298, K050162)
- Tube Dimensions: Various (Subject ETT) vs. Various (Predicates)
- Sterilization & Packaging: Sterile, single use only (Subject ETT) vs. Sterile, single use only (Predicates)
Overall conclusion: The device was found to be substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission relies on nonclinical bench testing and comparisons to predicate devices, not clinical test sets or patient data.
- Data Provenance: Not applicable. The "data" comes from laboratory and bench testing, not patient data from a specific country or retrospective/prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. There was no clinical test set requiring expert ground truth establishment. The evaluation was based on engineering and biocompatibility standards.
4. Adjudication Method for the Test Set
- Not applicable. There was no test set requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not an AI/ML device, and no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This device is a passive medical device (endotracheal tube with electrodes for monitoring); it does not involve algorithms or AI.
7. The Type of Ground Truth Used
- The "ground truth" for demonstrating device performance and substantial equivalence was based on established engineering standards (e.g., ISO 5361, ISO 10993 series) and direct comparison of functional and material characteristics to legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not applicable. There is no AI/ML component, therefore no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, no ground truth was established for it.
§ 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).