Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter

The Affinity Pixie™ Arterial Filter with Balance™ Biosurface and Affinity® Pediatric Arterial Blood Filter are single-use, sterile devices designed to filter microemboli from blood during cardiopulmonary bypass surgery for up to 6 hours. The Pixie model features a biocompatible Balance coating for enhanced blood compatibility, while the Pediatric model is uncoated. Both remove particulate and gaseous microemboli from the arterial line during heart-lung bypass procedures.

The primary change is replacement of the polyethylene film material in the cone filter component from Chevron HD 9640 HDPE to Formolene E927ND HDPE, which seals the two layers of the cone filter together. The filter component maintains the same medical-grade polyester material, inlet/outlet port design, and filtration principles. No changes were made to sterilization processes or finished device operating principles.

ISO 10993 (Biological Evaluation of Medical Devices – Part 1), ASTM Partial Thromboplastin Time testing, and FDA Guidance on Use of 10993-1. Biocompatibility testing included cytotoxicity, sensitization, reactivity, acute systemic toxicity, pyrogenicity, hemolysis, blood coagulation, platelet/leukocyte effects, complement activation, and genotoxicity assays.

The modified device is substantially equivalent because it maintains identical intended use, operating principles, shelf life, and sterilization requirements as predicate devices K100646 and K071253. Comprehensive biocompatibility testing confirmed the new polyethylene formulation passes all biological endpoints with no impact on device functionality or performance, and design assessment confirmed the material change does not affect final product performance.