(262 days)
The Empty EVA Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.
The Empty EVA Bag is an empty container used for administration of intravenous solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.
The empty bags are filled by connecting them to containers - generally glass bottles closed by a pierceable membrane - containing one or more solutions through standard spikes and tubing. After filling, the transfer set is removed and the bags are clamped by means of inviolable clamps to secure the contents prior to their administration. To make the fluid outflow from the bag towards the patient, the container can be then attached to an intravascular administration set via the spike port and twist - off connector.
When the bag is already filled, other medications can be added using the injection port. The bags range in volume capacity from 150 ml to 5000 ml.
The device is sold sterile and cannot be re-used or re-sterilized; it is discarded after use. The Empty EVA Bag is intended for use by qualified staff.
The provided text describes the 510(k) premarket notification for the "Empty EVA Bag" (K181393) and its substantial equivalence to a predicate device. However, this document does not contain information about the acceptance criteria and study design for performance comparison that would be typically associated with AI/ML-driven medical devices.
Instead, this document focuses on demonstrating substantial equivalence of a physical medical device (an empty IV bag) through:
- Comparison of technological characteristics with a predicate device.
- Non-clinical bench testing to demonstrate compliance with standards and safety/performance aspects of the device itself (e.g., biocompatibility, sterilization validation, physical performance tests).
Therefore, I cannot provide the requested information about acceptance criteria for AI/ML performance, sample sizes for test sets (as there isn't an AI test set described), expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The "studies" mentioned in this document are non-clinical bench tests for the physical properties and safety of the IV bag, not observational or interventional studies on human subjects with an AI component.
Key takeaway: The provided text is for a sterile IV container, not an AI/ML device. Thus, the specific metrics and study designs requested for AI/ML are not applicable here.
§ 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).