(87 days)
An Empty Container with sterile fluid pathway used to store intravenous solution for administration to patient. Medication transfer in and out of the container is done using aseptic technique.
Acta Medical Empty EVA Solution Container is designed to hold intravenous fluid in a single chamber or in dual chambers separated by a separating partition. Empty EVA Solution Container and Empty EVA Dual Chamber Solution Container has fill ports to fill single and dual chambers, latex free injection port for additions of injectable additives and a spike port to connect intravascular administration tubing. The fill port tubing has a sealing clamp to secure the contents during storage post filling and prior to their administration.
The provided text describes a 510(k) summary for an "Empty EVA Solution Container" and does not contain information about an AI/ML device or its performance criteria. The document is for a Class II medical device, specifically an IV container, and focuses on demonstrating substantial equivalence to predicate devices through various physical and chemical tests.
Therefore, I cannot provide the requested information for acceptance criteria, study details, human reader improvement with AI, or standalone algorithm performance because the provided input does not pertain to such a device or study.
The document discusses tests like:
- Biocompatibility
- Material Strength
- Physical and Chemical Testing
- Leak Testing
- Stability Testing
These are tests typically performed to ensure the safety and functionality of a physical medical device, not to evaluate the performance of an AI/ML algorithm.
§ 880.5025 I.V. container.
(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).