(81 days)
The Remington Medical Bag Decanter is used for the aseptic decanting of fluids from flexible containers. The decanter is a sterile, disposable device.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any criteria.
The document is a US FDA 510(k) clearance letter for the "Bag Decanter" device, indicating that the device is substantially equivalent to legally marketed predicate devices. This letter does not contain details about specific performance acceptance criteria or study results demonstrating such performance.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.