(488 days)
The Marquette Medical Safety Huber Infusion Set is a safety IV administration set used to access surgically implanted vascular ports. The Medical Safety Huber Needle is used to administer fluids or drugs and blood sampling. The Marquette Medical Safety Huber Infusion Set facilitates safe removal of the needle by encapsulating the needle within a telescoping plastic cone to help prevent needlestick injuries when using the device for vascular port access.
The Marquette Medical Safety Huber Infusion Set is a safety IV administration set used to access surgically implanted vascular ports. The Medical Safety Huber Needle is used to administer fluids or drugs and blood sampling. The Marquette Medical Safety Huber Infusion Set facilitates safe removal of the needle by encapsulating the needle within a telescoping plastic cone to help prevent needlestick injuries when using the device for vascular port access.
I'm sorry, I cannot fulfill this request. The provided text is a U.S. Food and Drug Administration (FDA) clearance letter for a medical device (Marquette Huber Trap Safety Infusion Set). This type of document typically does not contain the detailed study information required to answer the requested questions about acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment.
FDA clearance letters primarily state that a device has been found substantially equivalent to a legally marketed predicate device and outline regulatory compliance requirements. They do not usually include the clinical study results or technical details that would allow me to populate the table and answer the specific questions about the device's performance characteristics or the studies used to prove them.
§ 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.