(97 days)
Empty bags made from ethyl vinyl acetate (EVA) film intended to contain total parenteral nutrition (TPN) solutions and compatible medications.
empty TPN bags made from EVA (ethylene vinyl acetate) plastic film in sizes ranging from 100mL to 3000mL in capacity
This document is a 510(k) premarket notification for a medical device submitted in 1997. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain a study that proves the device meets acceptance criteria.
The 510(k) summary focuses on demonstrating that the CharterMed TPN-EVA Bag is substantially equivalent to legally marketed predicate devices, rather than presenting a performance study with acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text.
Specifically, the document states:
- "The proposed CharterMed device is an empty bag made from ethylene vinyl acetate (EVA) plastic film. The bag is intended for containment of total parenteral nutrition solutions and is substantially equivalent in design and intended use to comparable products currently in commercial distribution."
- It then references two predicate devices (CharterMed's TOTM plasticized PVC container and Stedim Laboratories' EVA TPN Bag) to support the claim of substantial equivalence.
In summary, none of the requested information (points 1-9) about acceptance criteria and a study proving their fulfillment is present in the provided 510(k) submission. The document's purpose is to establish substantial equivalence for regulatory clearance, not to detail device performance against specific acceptance criteria through a clinical or performance study.
§ 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).