nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]

The nSet+ Stabilization Set is a sterile, single-use medical device used in peripheral vascular access systems. It includes a stabilization base, extension tube, tube pinch clamp, and connector terminals. It is designed for direct injection, intermittent infusion, continuous infusion, or aspiration, and can be used with power injectors up to 325 psi at 10 ml/second flow rate.

The nSyte Needle Free Connector (NFC) comprises only the needle-free connector elements using identical materials and Luer connectors as the predicate. The nSet+ Stabilization Set is identical to the predicate in all features including materials, tubing length, and Luer connectors. The nSet+ Stabilization Set with nSyte NFC differs from the predicate only in positioning the needle-free connector along the tubing; materials and configuration are otherwise identical.

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; ISO 10993-1 recommended biocompatibility evaluation endpoints including chemical characterization, cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility.

The proposed devices are substantially equivalent to the predicate device Velano ExT Extension Set (K200439) because they have the same indications for use and design outputs meet design inputs. The minor design differences (needle-free connector positioning and element composition) do not affect final product performance or raise safety or effectiveness concerns, as demonstrated by bench testing results consistent with the predicate device performance.