CuffGuard

The CuffGuard is an endotracheal tube cuff pressure controller that continuously monitors and automatically maintains user-defined cuff pressure for adult and pediatric patients requiring mechanical ventilation in ICUs, operating rooms, and during intra-hospital transport. It uses embedded software, a pressure sensor, and an air pump to regulate cuff pressure within a 5–40 cmH2O range.

The CuffGuard uses software-controlled pressure supervision with automatic adjustment, a pressure sensor, and ambient air. It offers leak and pressure alarms, audible and visual alerts, cuff deflate/inflate capability, time-limited hold, unit selection, and runs on battery or AC power. The key difference from the predicate (Intellicuff) is a narrower pressure range: 5–40 cmH2O versus 5–50 cmH2O.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-1-8 for electrical safety and electromagnetic compatibility. Software verification and validation documentation was provided per FDA guidance for device software functions.

Both devices share the same product code (BSK), regulatory class (II), and regulation (21 CFR 868.5750). They operate identically: using a pressure sensor and pump under software control to automatically maintain endotracheal tube cuff pressure in the same clinical settings for the same patient populations (adults and pediatrics). The narrower pressure range (5–40 cmH2O) in CuffGuard does not raise safety or effectiveness concerns because this range represents accepted physiological limits and common clinical practice; software verification confirms this specification is valid and clinically appropriate.