Micro Ace Gold Advanced Micro Access System

The Micro Ace Gold Advanced Micro Access System is a percutaneous catheterization device designed to provide vascular access and facilitate placement of 0.035" or 0.038" guidewires into the vascular system. It is available in 4 French and 5 French sizes and includes a coaxial introducer-dilator pair, a 21 gauge needle, and a 0.018" guidewire.

Key changes from the predicate include: dilator material changed from HDPE to PEEK yellow for improved mechanical properties; silicone coating lubricant added to introducer shaft and tip to reduce insertion force; and dilator hub material changed from HDPE to nylon. All materials maintain ISO 10993 biocompatibility compliance.

ISO 10555-1:2013 (intravascular catheters general requirements), EN ISO 11070 2014/A1:2018 (sterile intravascular catheter introducers), ISO 10993-1:2018 (biological evaluation of medical devices), and ISO 14971:2019 (risk management for medical devices).

The subject device has identical indications for use, sterilization methods, packaging, and fundamental operating principles as the predicate. Material substitutions (HDPE to PEEK and nylon) and the addition of silicone lubrication are design refinements that enhance performance without changing the device's essential function. Comprehensive testing of dimensional, mechanical, and biocompatibility characteristics on both 4F and 5F sizes demonstrated all samples met performance criteria with no unacceptable risks, establishing functional equivalence despite the incremental design improvements.