(123 days)
The All Safe Huber Safety Infusion Sets are used to access surgically implanted vascular ports for the administration of fluids and withdrawal of blood. The All Safe Huber Safety Infusion Sets facilitate the safe removal of the needle and may aid in the prevention of needle stick injuries. The All Safe Huber Safety Infusion Sets are also indicated for power injection of contrast media into the central venous system with implanted vascular ports indicated for power injection. The maximum recommended infusion rate at 11.8 cps is 5 ml/sec for 19 and 20 gauge. Maximum pressure is 325 psi for all gauge sizes.
Not Found
I am sorry, but the provided text from the FDA 510(k) summary for the "All Safe Huber Safety Infusion Set" does not contain information on acceptance criteria, a study proving the device meets those criteria, or any of the specific details outlined in your request (sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, or training set information).
The document is primarily a notification of a substantial equivalence determination by the FDA for a medical device. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It details the device's indications for use and classification.
To answer your request, I would need a different type of document, such as a clinical study report, a performance testing report, or a more detailed 510(k) summary that includes information about specific performance tests and their results against predefined acceptance criteria.
§ 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.