(27 days)
The Vigileo APCO/Oximetry Monitor is indicated for continuously measuring hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics.
The Vigileo APCO/Oximetry Monitor is a microprocessor- based instrument which, when connected to a FloTrac sensor, continuously measures arterial pressure cardiac output (APCO). When connected to an Edwards oximetry catheter, the monitor measures oxygen saturation (oximetry) in adults or pediatrics. The monitor also calculates other derived parameters including cardiac index, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, systemic vascular resistance, delivered oxygen, delivered oxygen index, and pulse oximetry saturation.
The provided text is a 510(k) summary for the Vigileo APCO/Oximetry Monitor. It is a regulatory document and does not contain detailed information about acceptance criteria or specific study designs to prove device performance against such criteria. The document states that the device has undergone "functional testing demonstrating equivalence to the predicate device" and that a "Comparative Analysis" demonstrated it to be "as safe and effective as the predicate device." However, it does not provide the specifics of these tests or analyses.
Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence to a predicate device rather than a detailed performance study with acceptance criteria.
§ 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).