(286 days)
The Next Generation EMG Endotracheal Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative monitoring of EMG activity of the laryngeal musculature when connected to an appropriate EMG monitor.
The EMG Tube is indicated for use when continuous monitoring of the integrity of the nerves supplying the laryngeal musculature is required during surgical procedures.
The Next Gen EMG Endotracheal Tube is a standard-size PVC (DEHP-free polyvinyl chloride) endotracheal tube with inflatable high volume, low pressure cuffs. Each tube is imprinted with four (two pairs) conductive silver electrodes. The conductive silver is printed on the PVC of the main shaft of the endotracheal tube and exposed only for a short distance, approximately 40 mm, slightly superior to the cuff, for contacting the vocal cords. The electrodes are designed to make contact with the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device.
The provided document describes the safety and performance testing for the Medtronic Xomed, Inc. Next Gen EMG Endotracheal Tube as part of its 510(k) submission (K112686). This submission focuses on demonstrating substantial equivalence to predicate devices (NuVasive® NeuroVision® EMG Endotracheal Tube K094054 and Xomed EMG Endotracheal Tube K925640) due to a design change from silicone to PVC material for the tube and from stainless steel wire to conductive silver ink for the electrodes.
The device is not an AI/ML device, therefore, many of the questions related to AI/ML will not be applicable.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria or performance metrics in a pass/fail format common for quantitative performance claims. Instead, it describes compliance with standards and functional equivalence.
| Item | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Full compliance with ISO 10993-1 requirements | Testing performed, including cytotoxicity (ISO 10993-5:2009), intracutaneous reactivity (ISO 10993-10:2010), and sensitization (ISO 10993-10:2010). Data determined to be scientifically valid. |
| Mechanical/Physical Compliance | Compliance with ISO 5361:1999 (for endotracheal tubes) | Compliance testing performed. |
| Electrical Functionality (Electrodes) | Proper electrode impedance for EMG monitoring | Electrode impedance test performed. |
| Wire Harness Integrity | Reliable connection and signal transmission through the wire harness | Wire harness test performed. |
| Product Integration | Components function together as intended | Product integration testing performed. |
| Marking Ink Adhesion | Ink applied to the tube remains adherent and functional | Marking ink adhesion test performed. |
| In-vivo EMG Monitoring Performance | Substantially equivalent performance to predicate devices in monitoring nerve integrity during surgery | Functional testing performed using an animal model demonstrated substantial equivalence to predicate devices. |
| Safety and Effectiveness | Device is safe and effective when used as intended, with risks and benefits comparable to predicate devices. | Data supports that the subject device is safe and effective and performs in the same manner as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number. The document mentions "in house laboratories conducted studies" and "functional testing was performed using an animal model." It does not specify the number of animals or trials.
- Data Provenance: The studies were conducted "in house laboratories" by Medtronic Xomed, Inc. The nature of the studies implies prospective testing for the functional and animal model studies, designed specifically to evaluate the new device. The country of origin for the data is implied to be the USA, given the company's location (Jacksonville, Florida) and the 510(k) submission to the FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the device is not an AI/ML diagnostic tool that relies on expert interpretation of output for ground truth establishment. The performance is assessed through objective biophysical measurements and functional equivalence. The "ground truth" for the animal study would be the actual nerve integrity, which is monitored by the device's EMG output and compared to the predicate device's output.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess subjective findings and discrepancies are resolved. This device's testing involves objective measurements (biocompatibility, electrical, mechanical) and functional comparison in an animal model, not subjective human assessment needing adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not applicable as the device is not an AI/ML algorithm designed for interpretation or assistance to human readers in a diagnostic context. Its function is to facilitate EMG monitoring.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a medical instrument (an endotracheal tube with electrodes) that functions to provide EMG signals for monitoring. It is not an algorithm, and therefore the concept of "standalone algorithm performance" is not applicable. Its performance is inherent to its physical and functional properties.
7. The Type of Ground Truth Used
- For biocompatibility: Compliance with ISO standards and specific test outcomes (e.g., absence of cytotoxicity, irritation, sensitization).
- For functional testing (electrode impedance, wire harness, product integration, ink adhesion, compliance): Engineering specifications and established biophysical principles, and adherence to relevant ISO standards (e.g., ISO 5361:1999 for compliance).
- For animal model study: The "ground truth" is the actual nerve integrity and laryngeal muscle activity in the animal model, observed and verified through established physiological methods, with the new device's EMG output compared directly to that of the predicate devices. The goal was to prove substantial equivalence in monitoring capability.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. Its design and manufacturing are based on engineering principles and material science.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.