CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)

CaseBio Culture w/HSA is a one-step culture medium for embryo development from fertilization to blastocyst stage and can be used for embryo transfer to the uterus. CaseBio Handling w/HSA is a short-term handling medium for gamete and embryo manipulation, including washing and intracytoplasmic sperm injection, but is not intended for embryo transfer.

Both devices contain nearly identical compositions of salts, amino acids, gentamicin, and human serum albumin, with differences in NaHCO3 and phenol red amounts and the presence of HEPES in the handling formulation. They have a 90-day shelf-life at 2–8°C, are provided in PETG bottles with HDPE caps, and are sterilized by aseptic filtration with vials sterilized by radiation.

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

The subject device has identical indications for use and the same intended prescription-use conditions as the predicate device (CaseMONO Culture and CaseMONO w/HEPES). Although there are minor differences in media composition and pH range, these differences do not raise different questions of safety and effectiveness, as both devices meet the same performance standards including osmolality, endotoxin levels, sterility, and mouse embryo assay criteria.