Chartis Precision Catheter

The Chartis Precision Catheter is a single-use, sterile balloon catheter used with the Chartis Pulmonary Assessment System during bronchoscopy in adult patients with emphysema (COPD). The catheter is inserted through a bronchoscope, and when positioned, its distal balloon is inflated to isolate a target airway while the Chartis Console measures pressure and airflow to calculate airway resistance and quantify collateral ventilation, helping clinicians plan lung volume reduction procedures.

The subject device has identical design, materials, dimensions, balloon composition (Pellethane 2363 80AE), and packaging to the predicate device K222340. The key differences are: sterilization method changed from E-beam radiation to Ethylene Oxide (EO) with SAL 10⁻⁶, and shelf-life extended from 18 months to 36 months. All other specifications including catheter length (145 cm), working length (72 cm), inflation volume (4 mL), and airway diameter range (5–13 mm) remain unchanged.

ISO 10993-1 standard for biocompatibility testing (cytotoxicity, sensitization, irritation, intracutaneous reactivity); ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices; FDA-recognized standards for gas pathway testing including particulate matter, volatile organic compounds, and toxicological risk assessment.

The subject device is substantially equivalent to predicate K222340 because it has identical intended use, indications for use, design, materials, and performance characteristics. Although the sterilization method and shelf-life claim differ, comprehensive performance testing including functional testing after sterilization and accelerated aging demonstrates that these changes do not raise different questions of safety or effectiveness, and the device passes all applicable biocompatibility and functional standards.