(62 days)
The intended use of the device is to inject fluids into, or withdraw fluids from, parts of body below the surface of the skin.
The PUNTUR-GUARD protects the health care worker from accidental needlestick by providing a blunting that renders safe the needle once it has entered the patient's vein. The PUNCTUR-GUARD is intended to enhance current safety needle programs
The provided text is a 510(k) premarket notification approval letter for the PUNCTUR-GUARD® Winged Set for Blood Collection and Intravenous Infusion. This document does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.
The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information submitted in the 510(k) application, which typically includes device description, indications for use, comparison to predicates, and sometimes performance data if necessary to establish substantial equivalence. However, the details of any performance studies, acceptance criteria, or their results are not present within this specific document.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than a detailed technical report of device performance and testing.
§ 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.