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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
510K
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.
Clinical Applications
This device is commonly used in surgeries where there is a risk of RLN injury, such as thyroidectomy, parathyroidectomy, and other head and neck surgeries. It is particularly useful in otolaryngology and anesthesiology settings. The primary patient population includes those undergoing surgeries that pose a risk to the vocal cords or laryngeal nerves.
Indications for Use
The device is indicated for use in patients undergoing surgeries where monitoring of laryngeal nerve function is critical. It helps in identifying and preserving nerve function, thus preventing postoperative complications like vocal cord paralysis.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies. It is compatible with standard monitoring equipment. Clinicians should ensure proper placement and secure fixation to obtain accurate readings.
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.