Description of Event or Problem · 1
RPTR BELIEVES THAT THE INNOMED NASAL-AIRE NASAL CPAP INTERFACE IS BEING SOLD WITHOUT PROPER 510-K-CLEARANCE FROM THE FDA. THIS DEVICE APPEARS TO HAVE BEEN CLEARED IN A PREVIOUS FORM-K990659-BUT SUBSTANTIAL CHANGES HAVE BEEN MADE SINCE. RPTR BELIEVES THESE CHANGES MAY RAISE SIGNIFICANT CONCERNS ABOUT PT SAFETY AND THE EFFICACY OF TREATMENT. RPTR HAD RECEIVED SEVERAL OF THIS PRODUCT, SHIPPED FROM US DISTRIBUTORS DURING THE LAST 6 MONTHS OF 2002. THESE PRODUCTS EXHIBIT THE FOLLOWING FEATURES THAT APPEAR DIFFERENT FROM THE DEVICE DESCRIBED IN THE AFOREMENTIONED 510-K-DOCUMENTATION. 1 PRODUCT HAS EXHALATION PORTS BUILT INTO THE NOSE PIECE. THE INTENDED USE STATEMENT IN THE 510-K-EXPLICITLY STATES THAT "THE NASAL-AIRE CANNOT EXHAUST EXHALED AIR THEREFORE THIS DEVICE MUST BE USED WITH A VENTILATOR THAT CONTAINS AN ACTIVE EXHALATION VALVE OR WITH AN INTENTIOANL LEAK PORT ADDED INTO THE BREATHING CIRCUIT. 2. THE PRODUCT IS BEING SHIPPED IN 5 SIZES, EXTRA SMALL TO EXTRA LARGE. IN THE 510-K-DOCUMENTATION, THERE IS NO MENTION OF VARIOUS SIZES. IN THE REVIEWED PRODUCT, SOME SAMPLES OF THE EXTRA SMALL AND SMALL SIZES UTILIZE TUBING OF SMALLER DIAMETER AND SHORTER LENGTH THAN THE LARGE SIZES. IN OTHER SAMPLES, ALL SIZES USE THE SAME TUBING. 3. THE 510-K-DOCUMENTATION STATES THAT THE PRODUCT HAS "A SILICONE ELASTOMER Y COUPLING". SOME SAMPLES HAVE A HARD CLEAR PLASTIC CONNECTOR, POSSIBLY POLYCARBONATE OR POLYSTYRENE. MORE RECENTLY, THE PRODUCT HAS COME WITH CONNECTORS OF DIFFERENT MATERIALS. MOST COMMONLY PVC. THE TUBING ON THE REVIEWED PRODUCT APPEARS TO BE SILICONE. WHILE THERE ARE SILICONES THAT CARRY THE TYGON NAME BRAND, IT IS DOUBTFUL THAT THIS WAS THE ORIGINAL MATERIAL, SINCE THE OTHER TWO COMPONENTS IN THE 510-K-SPECIFICALLY WERE IDENTIFIED AS SILICONE. RPTR BELIEVES THAT THESE POSSIBLE CHANGES RAISE QUESTIONS ABOUT THE CO2 REBREATHING CHARACTERISTICS, RESISTANCE TO FLOW AND BIOCOMPATIBILITY OF THE DEVICE.