(147 days)
The IV Administration Sets with Ultrablock UV-Resistant Tubing are intended for the pump or gravity administration of IV fluids involving light sensitive solutions.
The IV Administration Sets with Ultrablock UV-Resistant Tubing are a single-use, sterile, non-pyrogenic tubing set intended for the administration of light sensitive solutions from a container to a patient's vascular system. The device is composed of UV-Resistant IV tubing and may include one or more of the following: universal chamber assembly, injection site, male luer lock, slide clamp, 0.2 micron air eliminating filter, flow clip assembly, and pump cassette.
This 510(k) pertains to "IV Administration Sets with Ultrablock UV-Resistant Tubing." The provided document is a 510(k) summary and the FDA's clearance letter, which means it describes the device and its intended use, and states that the device is substantially equivalent to predicate devices.
However, the provided text does NOT contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
This type of information is typically found in detailed testing reports, design validation documentation, or perhaps summarized within a more extensive 510(k) submission, but it is not present in the excerpt provided.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets the acceptance criteria from the given text. The document primarily focuses on regulatory clearance based on substantial equivalence to existing devices.
§ 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.