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The Chartis System is indicated for use by bronchoscopists during a bronchoscopy in adult patients with emphysema, a form of Chronic Obstructive Pulmonary Disease (COPD), in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console. The Chartis Console is capital equipment that is reusable and displays the patient information.

The Chartis Precision Catheter is a single-use, sterile balloon catheter designed for use with the Chartis Pulmonary Assessment System (Chartis System), which consists of the Chartis Catheter and the Chartis Console. The catheter is introduced through a bronchoscope, and once positioned, the distal balloon is inflated to temporarily occlude the target airway. The console measures pressure and airflow through the catheter to calculate resistance and quantify collateral ventilation, providing clinicians with information to guide lung volume reduction procedures. The catheter is constructed of biocompatible materials and incorporates a distal balloon, a lumen for airflow and pressure measurements, and a proximal connector to interface with the console. The subject device, Chartis Precision Catheter, incorporates modifications limited to the sterilization method and labeled shelf life. There are no changes to the device's indications for use, intended use, principles of operation, contact materials, or packaging configuration compared to the predicate device (K222340). Despite the changes introduced to predicate Chartis Catheter (K222340), the subject device Chartis Precision Catheter is substantially equivalent to the predicate as demonstrated by verification and validation testing performed using well established and FDA-recognized standards.

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