(43 days)
The Mix2vial Transfer Device is intended for transferring and mixing drugs contained in two vials.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Mix2vial Transfer Device". This document does not contain information regarding acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria in the computational or AI sense.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This means the FDA granted clearance based on the device being substantially equivalent to a predicate device, rather than requiring performance data from a specific study against predefined acceptance criteria for the new device. The FDA process for 510(k) clearance primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.
Therefore, I cannot extract the requested information (acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) from the provided text, as it pertains to a different type of regulatory review that doesn't involve these elements in the context of AI/computational device performance validation.
§ 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.