CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)

CaseMONO Culture and CaseBioscience HTF are reproductive media intended for embryo culture from fertilization through blastocyst or cleavage stage, with the ability to be used for embryo transfer to the uterus. CaseMONO w/HEPES and CaseBioscience HTF w/HEPES are short-term handling media for gamete and embryo manipulation including washing and intracytoplasmic sperm injection, not intended for embryo transfer.

The subject devices differ from the predicate in media formulation, pH specification (7.2-7.4 or 7.2-7.6 depending on variant), osmolality (260-270 or 285-295 mOsm/kg), bacterial endotoxin (<0.1 EU/mL), and mouse embryo assay performance (≥80% blastocyst development). The sterilization method is similar (aseptic filtration and radiation), and shelf-life is 90 days at 2-8°C.

ISO 13408-1:2008 and ISO 13408-2:2018 (aseptic filtration and filling); ISO 11137-1:2006 and ISO 11137-2:2013 (radiation sterilization); USP <791>, <785>, <71>, <85> (pH, osmolality, sterility, endotoxin); ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021 (biocompatibility); ASTM D4169-22 (transportation); 2021 FDA guidance on Mouse Embryo Assay.

Although the subject devices differ in formulation, pH, osmolality, and MEA specifications from the predicate, the submitter argues these differences do not raise different questions of safety and effectiveness because all four subject variants meet the same indications for use as the predicate (embryo culture and handling during IVF procedures). The performance testing demonstrates equivalent safety and effectiveness through passing biocompatibility, sterility, endotoxin, and embryo development benchmarks, supporting that functional equivalence exists despite compositional differences.