(70 days)
The AngioDynamics, Inc. Tumescent Infusion Device is indicated for the introduction of dilute lidocaine solutions into subcutaneous tissues for the purpose of tumescent local anesthesia.
Not Found
This document is a 510(k) clearance letter for the AngioDynamics, Inc. Tumescent Infusion Device. It states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.
This document DOES NOT contain the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to AI/algorithm performance.
The letter is a regulatory approval document and does not include performance data or studies typically required for AI/ML device submissions. Therefore, I cannot provide a response to your numbered requests based on the content of this document.
§ 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.