📋 FDA Reference
Laryngeal Surface Electrode-Endotracheal Tube M-500-Et Lse-Et
Rln Systems
Summary: The Laryngeal Surface Electrode-Endotracheal Tube is a device used to monitor laryngeal nerve function during surgery. It is primarily used by otolaryngologists and anesthesiologists to prevent nerve damage.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K003745 ↗
Decision Date ?
January 16, 2001
Product Code ?
ETN
Device Class ?
Class 2
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on January 16, 2001. Manufactured by RLN Systems, it is classified as a Class 2 medical device under product code ETN.
What It Is
The Laryngeal Surface Electrode-Endotracheal Tube is an endotracheal tube equipped with surface electrodes designed to monitor the function of the recurrent laryngeal nerve (RLN) during surgical procedures. It works by detecting electrical activity in the laryngeal muscles, providing real-time feedback to surgeons. This helps in preventing nerve damage during surgeries involving the neck and throat.
FDA-Cleared Indications
- Endotracheal intubation with intraoperative monitoring of laryngeal muscle electrical activity.
- Monitoring laryngeal or recurrent laryngeal nerve function during surgery involving the neck or larynx.
- Use with compatible monitoring equipment to provide electrical feedback about laryngeal nerve function.
Clinical Applications
- Intraoperative recurrent laryngeal nerve monitoring during thyroid surgery.
- Intraoperative laryngeal nerve monitoring during parathyroid surgery.
- Monitoring laryngeal muscle activity during selected head and neck operations.
- Endotracheal airway management when surface-electrode monitoring of laryngeal function is required.
Practical Considerations
- The tube must be positioned so the surface electrodes contact the appropriate laryngeal anatomy; incorrect positioning can produce unreliable signals.
- Choose the tube size according to the patient's airway anatomy and the requirements of the procedure.
- Use only with compatible nerve-monitoring equipment and verify electrode connections before monitoring begins.
- Secure the tube carefully because movement during surgery can affect electrode contact and monitoring quality.
- MRI compatibility should be confirmed in the current manufacturer labeling before an MRI examination; conductive electrodes and monitoring components may create safety or image-quality concerns.
Related Literature
The linked study investigated the presence of evoked laryngeal electromyography responses in patients with vocal cord paralysis. It found that only 1 out of 15 patients showed a response upon RLN stimulation, suggesting that synkinesis might play a role in vocal cord immobility. The study was limited by its small sample size and the lack of a broader patient population.
Frequently Asked Questions
What is the Laryngeal Surface Electrode-Endotracheal Tube used for?
It is used to monitor laryngeal nerve function during surgeries to prevent nerve damage.
What specialties typically use this device?
Otolaryngologists and anesthesiologists commonly use this device during relevant surgeries.
What are the FDA-cleared indications?
The device is indicated for monitoring laryngeal nerve function during surgeries to prevent nerve damage and associated complications.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.