(266 days)
The VolumeView system is indicated for use in critical care patients in which cardio-respiratory function, fluid status, and vascular resistance need constant and/or intermittent assessment. The femoral arterial catheter is indicated for femoral artery insertion.
The VolumeView System consists of a 4 or 5 French, 16 or 20 cm, two lumen femoral artery catheter and a CVC thermistor manifold. One catheter lumen has a thermistor for making blood temperature measurements, and the other is used for pressure monitoring. The manifold is used for injecting thermodilution boli through a central venous catheter. The guidewire is a PTFE-coated nitinol guidewire.
The provided text is a 510(k) Summary for the Edwards Lifesciences VolumeView System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain specific details about acceptance criteria, a study proving the device meets those criteria, or information on aspects like sample sizes, ground truth establishment, or expert involvement in a study.
The 510(k) summary only states:
- "The VolumeView System has been demonstrated to be as safe and effective as the predicate devices for their intended use."
- "The VolumeView System has successfully undergone functional testing. This product has been shown to be equivalent to the predicate devices."
These statements indicate that some form of testing was performed to demonstrate substantial equivalence, but the details required for your request are not present in this summary.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, rather than a detailed study report with specific performance metrics and methodologies.
§ 870.1915 Thermodilution probe.
(a)
Identification. A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.(b)
Classification. Class II (performance standards).