(113 days)
The PULSION PiCCO Plus is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PiCCO Plus measures heart rate, systolic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered. the PiCCO Plus presents the derived parameters indexed to body surface area.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Pulsion Continuous Pulse Contour Cardiac Output (PiCCO Plus) System." This document primarily addresses the FDA's determination of substantial equivalence to a predicate device for market clearance. It does not contain the detailed study information, acceptance criteria, or performance data that would be necessary to answer the questions about device acceptance criteria and the study proving it meets those criteria.
Therefore, I cannot provide the requested information based solely on this document. The document confirms the device's classification, regulation number, and indications for use, but it does not delve into the specifics of the clinical or technical studies that led to its clearance.
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).