(47 days)
The MPS Reservoir Bag is intended for use with Ambulatory PCA or APII 1. pumps for continuous infusion therapy. For use for infusion of I.V. fluids, and drugs. Refer to the directions for use of the infusion pump for compatible indications for use. For use up to 24 hours per CDC guidelines or per hospital protocol. For use with standard luer taper connections. For single patient use.
Each MPS Reservoir Bag is sterilized in sealed individual pouches. Full labeling information is provided with each MPS Reservoir Bag. Multi-unit shelf packs of individual pouches or trays are provided for convenience.
I am sorry, but the provided text describes a 510(k) premarket notification for a medical device called the "MPS Reservoir Bag." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study that establishes acceptance criteria and proves the device meets them through performance data.
The document highlights:
- Technological comparison to a predicate device: The MPS Reservoir Bag is compared to the "Baxter Drug Bag" in terms of materials, design, and intended use, asserting substantial equivalence. Minor differences in color coding and slide clamp attachment are noted.
- Nonclinical test summary: Materials and bonding agents were tested per ISO 10993 for biocompatibility.
Therefore, the information required to answer your request (acceptance criteria, device performance table, study details, human reader studies, ground truth establishment, training set details) is not present in the provided 510(k) summary. This type of submission typically relies on equivalence to a legally marketed device rather than extensive new clinical performance studies with defined acceptance criteria and performance metrics against human experts or pathology.
§ 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).