Search Results

The PULSION PiCCO-2 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-2 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-2 presents the derived parameters indexed to body surface area.

Not Found

This document is a 510(k) clearance letter for the Pulsion PiCCO-2 device, a monitoring system for cardiopulmonary and circulatory variables. It does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.

The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, which means it meets the regulatory requirements based on existing devices, rather than through a new, independent set of clinical trials with pre-defined acceptance criteria tested against a new cohort.

Therefore, I cannot provide the requested information from the provided text. To get this information, you would typically need to consult the original 510(k) submission summary or any associated clinical study reports, which are not included in this FDA clearance letter.

Ask a specific question about this device