Search Results

An empty container with sterile fluid path used to hold an admixture of compatible fluids for administration to a patient. Medication transfer is done using aseptic technique.

EVA Empty Solution Container

The provided text is a 510(k) premarket notification letter from the FDA for a device called "EVA Empty Solution Container." This document is a regulatory approval letter and does not contain any information regarding acceptance criteria, study details, or performance metrics for a device that uses an algorithm or AI.

The device described is an "empty container with sterile fluid path used to hold an admixture of compatible fluids for administration to a patient." This is a physical medical device, not a software or AI-driven system.

Therefore, I cannot provide the requested information about acceptance criteria, study design, or performance metrics related to an algorithm's performance, as this information is not present in the given text.

Ask a specific question about this device