(188 days)
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.
The Swan-Ganz catheters are flow-directed pulmonary artery catheters used to monitor hemodynamic pressures. The Swan-Ganz thermodilution catheters provide diagnostic information to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.
The provided text is an FDA 510(k) clearance letter and summary for the Swan-Ganz catheter. It primarily details the regulatory process, device description, and indications for use.
Crucially, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the context of proving device performance against specific metrics. The document explicitly states:
"The subject Swan-Ganz Base and Advanced catheters are identical to the predicate devices cleared in K160084 and K222117 in terms of design, performance specifications, and technological characteristics with the exception of the indications for use statement and other portions of the labeling. The are no changes to the design, technology, performance, materials, or specifications of the devices in this 510(k). The modifications to the subject devices are limited to labeling changes."
This indicates that the current submission (K233824) is for a labeling change only, and therefore, the performance of the device itself (its ability to accurately monitor hemodynamic pressures) would have been established during the clearance of the predicate devices (K160084 and K222117), not in this particular submission.
Therefore, I cannot provide the requested information from the given text. The text does not describe an acceptance criteria or a study proving the device meets acceptance criteria related to its performance.
§ 870.1240 Flow-directed catheter.
(a)
Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)
Classification. Class II (performance standards).