ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)

The ALM Tube is an endotracheal intubation tube that provides airway ventilation and intraoperative neuromonitoring by recording EMG signals from the laryngeal musculature. It is inserted orally into the trachea during surgery and connects to an external neuromonitoring system to monitor recurrent laryngeal nerve or vagal nerve function.

The ALM Tube features 8 electrodes with conductive silver ink on a PVC tube, compared to the predicate device's 2–4 electrodes. Individual electrode areas are slightly larger (~90–99 mm² vs. up to 617 mm²), with comparable cumulative active electrode surface (756 mm² vs. 1456 mm²). Electrode impedance is nearly identical (0.27 kΩ vs. 0.30 kΩ average). Both use ethylene oxide sterilization, dielectric coating insulation, and single-use design; the ALM Tube offers a 1-year shelf life versus the predicate's 3 years and supports up to 12 hours of intubation.

Biocompatibility: ISO 10993 series (parts 1, 2, 5, 7, 10, 11, 12, 17, 18, 23) and ISO 18562-1. Sterilization: ISO 11135. Packaging and shelf-life: ISO 11607 series. Performance: ISO 5356-1 and ISO 5361. Electrical safety and EMC: device used with IEC 60601-1 and IEC 60601-1-2 compliant neuromonitoring systems.

Both devices share identical intended use (airway and EMG monitoring), materials (silver ink electrodes, PVC tube), electrical insulation design, and single-use sterilization method. Although the ALM Tube uses 8 electrodes versus the predicate's 2–4, electrode impedance values are equivalent (0.27 vs. 0.30 kΩ), and comparative impedance testing with neuromonitoring systems demonstrates similar performance. The slightly larger individual electrode areas and greater cumulative surface are not expected to adversely affect performance. Both provide direct and indirect tissue contact in the same anatomical location (oral/tracheal). Testing confirms biocompatibility and performance compliance; human factors evaluation validates usability.