*As of European product introduction in 2013.
1. Based on internal testing. Comparative ventilator air leak test performed using the Shiley™ 4.0PCF and 6.5PLCF pediatric tracheostomy tubes with taper-shaped cuff vs. predicate Shiley™ 4.0PDC and 6.5PLC pediatric tracheostomy tubes with barrel-shaped cuff
2. Internal bench testing. Comparative fluid seal test performed using the Shiley™ 4.0PCF and 6.5PLCF pediatric tracheostomy tubes with taper-shaped cuff vs. predicate Shiley™ 4.0PDC and 6.5PLC pediatric tracheostomy tubes with barrel-shaped cuff.
3. Internal bench testing. Comparative ventilator air leak test performed using the Shiley™ 4.0PCF and 6.5PLCF pediatric tracheostomy tubes with taper-shaped cuff vs. predicate Shiley™ 4.0 PDC and 6.5PLC pediatric tracheostomy tubes with barrel-shaped cuff.
4. Internal bench testing. Comparative removal force test performed using the Shiley™ 4.0PCF and 6.5PLCF Pediatric Tracheostomy Tubes with taper-shaped cuff vs. the predicate Shiley™ 4.0PDC and 6.5PLC pediatric tracheostomy tubes with barrel-shaped cuff.