CuffTrek

The CuffTrek is a battery-operated device that measures and regulates the intracuff pressure of endotracheal tubes, tracheotomy tubes, and laryngeal mask airways. It displays pressure on a digital screen with an alarm function (blinking red light) when pressure falls outside the safe range of 20–30 cmH₂O, and is intended for single-patient use from pediatric to adult in hospitals, pre-hospital EMS, extended care facilities, and outpatient clinics.

The CuffTrek operates continuously for up to 7 days (versus the predicate's 100 measurements) with an operating range of 0–99 cmH₂O, digital pressure display, and pressure accuracy of ±2 cmH₂O. Unlike the predicate AG Cuffill, it includes continuous monitoring and an alarm function (blinking red light) when pressure deviates from the target range, features more similar to the reference device Cuffix. Both syringe inflation and luer-lock connection to pilot balloons are identical to predicates.

ANSI/AAMI ES60601-1:2005 and amendments (medical electrical equipment safety), IEC 60601-1-2 Edition 4.1 (electromagnetic compatibility), IEC 60601-1-12 Edition 1.1 (emergency medical services environment), ISO 80369-7 and ISO 80369-20 (small-bore connectors). Non-clinical testing included fluid leakage, pressure accuracy, temperature tolerance, and comparative testing against predicate AG Cuffill.

The CuffTrek is substantially equivalent because it measures and regulates cuff pressure using the same active control method (syringe inflation) and target range (20–30 cmH₂O) as the predicate AG Cuffill, with identical intended use across the same airway types and clinical settings. Although it adds continuous monitoring and an alarm function not present in the predicate, these enhancements align with the reference device Cuffix and do not raise new safety concerns—the non-clinical testing verified compliance with applicable standards and comparable accuracy (±2 cmH₂O). The extended operation time (7 days vs. 100 measurements) falls within the scope of reference devices and was verified by performance testing without introducing new safety or effectiveness questions.