(43 days)
The EW200 System is indicated for use in patients requiring monitoring of hemodynamic parameters, including oxygen saturation and hemoglobin.
The PreSep Oximetry catheter is indicated for hemodynamic monitoring through oxygen saturation measurement and hemoglobin measurement.
Edwards oximetry catheters are indicated for oxygen saturation and hemoglobin measurement.
The EW200 System is a microprocessor-based instrument that, when connected to an Edwards oximetry catheter, provides continuous measurement of oxygen saturation (SO2) and hemoglobin (HGB)/hematocrit (HCT) levels in human blood. The system is comprised of a system console, laptop computer, optical module and Edwards oximetry catheter. The system console emits light that is transmitted into the blood stream through the optical module that connects to the oximetry catheter. The light is reflected back through the catheter to the system console and the spectral data is used to calculate SO2 and HGB.
The PreSep Oximetry catheter is a catheter that is used with Edwards oximetry monitors to measure oxygen saturation and also provides the means for measuring hemoglobin with the EW200 System.
The provided text is a 510(k) Summary for the EW200 System and PreSep Oximetry Catheter. It describes the device, its intended use, and states that it has been demonstrated to be as safe and effective as predicate devices through functional and safety testing. However, it does not contain specific acceptance criteria, reported device performance metrics, or details about a study proving the device meets acceptance criteria.
Therefore, I cannot provide a detailed answer to your request based on the input document. The summary only generally states:
"The EW200 System and PreSep catheter have been demonstrated to be as safe and effective as the predicate devices for their intended use."
And:
"The EW200 System and PreSep catheter have successfully undergone functional testing. In addition, the EW200 System was also subjected to electrical safety testing. These products have been shown to be equivalent to the predicate devices."
These statements indicate that some form of testing was performed, but the results, acceptance criteria, study design details (like sample size, ground truth, expert involvement, or adjudication methods), or any comparative effectiveness study details are not provided in this document.
§ 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).