Instylla Delivery Kit

The Instylla Delivery Kit is a sterile, single-patient-use device comprised of two piston syringes, a syringe holder, and a plunger clip. It is intended for intra-arterial or intra-venous administration of radiographic contrast media, saline, and other aqueous solutions. The syringes are made of polycarbonate with fixed male luer connectors, and the plunger clip and holder are made of ABS plastic.

The subject device uses generic polycarbonate for the syringe barrels (changed from Calibre Megarad 2081-15) and is now compliant with ISO 80369-7 instead of ISO 594-2 for the luer connector. The device is offered only in 1 mL operational volume (vs. the predicate's 1 mL and 3 mL options) and includes a pediatric contraindication. Packaging and labeling were modified with updated label stock suppliers and added patient chart peelable labels, but the fundamental design, materials, sterilization method (EO to SAL 10⁻⁶), and shelf life (6 months) remain identical to the predicate.

ISO 7886-1 (syringe compliance), ISO 80369-7 (luer connector), ISO 10993-1 (biocompatibility evaluation), ISO 11135 (ethylene oxide sterilization validation), AAMI TIR28 (product adoption for EO sterilization), ISO 10993-7 (EO sterilization residuals), and ISO 11607-1 (packaging integrity for sterile devices).