(142 days)
Huber Infusion Sets are used for infusion of medication to a patient. This particular device is used for Oncology/Chemotherapy treatment.
Huber Infusion Set with Needleless Injection Site
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a letter from the FDA regarding a 510(k) premarket notification for an "Exel Huber Infusion Set with Needleless Injection Site." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed, subject to general controls and other regulations.
The document does not detail any performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. It primarily focuses on the regulatory approval process.
§ 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.