Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)

Dewin Reproductive Media consists of two kits—a Vitrification Kit and a Thawing Kit—designed for freezing and thawing oocytes, zygotes, and embryos at various developmental stages during in vitro fertilization procedures. The Vitrification Kit contains Equilibration and Vitrification Solutions with cryoprotectants (ethylene glycol, DMSO, trehalose) to prepare reproductive cells for liquid nitrogen storage. The Thawing Kit contains three solutions to reverse the freezing process and remove cryoprotectants.

The subject device differs from the predicate (Kitazato K171748) in several ways: it has two vitrification components versus three in the predicate; different chemical formulations using a physiologic base rather than Medium 199; different sterilization methods (dry heat plus radiation for vials versus radiation only); and shorter shelf-life (7 months versus 12 months). However, pH, bacterial endotoxin limits, and Mouse Embryo Assay performance criteria are equivalent or comparable.

ISO 13408-1:2008 & A1:2013 and ISO 13408-2:2018 (aseptic filtration and filling validation); ISO 20857:2010/(R)2015 (dry heat sterilization); ISO 11137-1:2006 with Amendments 1 and 2, and ISO 11137-2:2013 (radiation sterilization); USP <791>, <785>, <71>, <85> (pH, osmolality, sterility, endotoxin); ASTM D4169-22 (transportation testing); USP <1207.2> (cap/seal leak testing); and 2021 FDA guidance on Mouse Embryo Assay.

Although the formulations and some kit components differ from the predicate, the critical performance parameters—pH, osmolality ranges, sterility, endotoxin levels, and embryo development outcomes in the Mouse Embryo Assay—are equivalent or functionally similar. The intended use is identical (vitrification and thawing of oocytes and embryos for IVF), and comprehensive validation testing demonstrates the subject device meets the same safety and effectiveness specifications. The differences in formulation and sterilization method do not raise different questions of safety and effectiveness because performance is equivalent where it matters clinically.