(25 days)
The Churchill Medical Systems Wing Safe Huber Type Needle Sets intended use is for the delivery of medical fluids into implantable chemotherapy ports.
Churchill Medical Systems Wing Safe Huber Needle Set
The provided text is a 510(k) premarket notification letter from the FDA to Churchill Medical Systems, Inc., regarding a medical device called "Wing Safe Huber Type Needle Sets." This document primarily grants clearance for the device to be marketed based on its substantial equivalence to a legally marketed predicate device.
It does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement. These details are typically found in the actual 510(k) submission, which is a much more extensive document. The provided letter is merely the FDA's decision letter following their review of such a submission.
Therefore, I cannot fulfill your request for information on acceptance criteria and study details based on the provided text.
§ 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.