(177 days)
The Blood Administration Sets are used to deliver blood, blood components, and IV fluids from a container to a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and the duration of therapy.
Quest Medical's Q2 Blood Administration Sets are single use, disposable intravenous administration sets used to deliver blood, blood components and IV fluids from a container to a patient's vascular system through the use of a hand pump or through gravity flow. The sets include tubing, bag spike, 200 micron blood filter drip chamber, luer connectors, clamps, hand pump, stopcock and needleless connector.
The provided document is a 510(k) Summary for a medical device called "Q2 Blood Administration Sets." This type of document is for demonstrating substantial equivalence to a predicate device, not for proving the performance of an AI/ML device.
Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/ML device performance (like sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) cannot be extracted from this document.
This document describes the regulatory approval process for a physical medical device (blood administration sets) and its equivalence to a previously approved device. The "Performance Data" section refers to bench testing (e.g., ISO standards, particulate matter, mechanical hemolysis), biocompatibility testing, and sterility/shelf-life testing for the physical device, not an AI/ML algorithm.
§ 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.