Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])

Dewin Reproductive Media is a family of three solutions used in assisted reproductive procedures: Gamete Buffer (for short-term handling of gametes and embryos outside the incubator, including washing and intracytoplasmic sperm injection), Follicle Flushing Solution (for ovarian follicle flushing and oocyte collection), and One Step Medium (for embryo culture from fertilization to blastocyst stage and embryo transfer). All variants contain gentamicin and are offered in glass bottles with volumes of 25–100 mL.

The subject device and predicate share the same primary ingredient categories (inorganic salts, energy sources, amino acids, antibiotic, HSA, antioxidant, buffer, EDTA, phenol red) and sterilization method (aseptic filtration). Differences include pH specifications (7.2–7.5 vs. 7.2–7.6), osmolality (260–295 vs. 260–290 mOsm/kg), shelf-life (7 months for Gamete Buffer, 12 months for Follicle Flushing, 4 months for One Step vs. 6 months for predicate), and Mouse Embryo Assay (MEA) performance metrics with varying exposure times and developmental timepoints.

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 and ISO 11137-2:2013 (radiation sterilization); USP <791>, <785>, <85>, <71> (pH, osmolarity, endotoxin, sterility); 2021 FDA Guidance Mouse Embryo Assay; ASTM D4169-22 (transportation testing); ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021 (biocompatibility); 2023 FDA guidance on ISO 10993-1.

The subject device is substantially equivalent because it shares the same intended use and primary technological characteristics with the predicate VitaVitro Reproductive Media, uses identical sterilization methodology, and meets the same endotoxin and sterility standards. While formulation, pH, osmolality, shelf-life, and MEA specifications differ, the applicant asserts these differences do not raise different questions of safety and effectiveness. Comprehensive performance testing including aseptic processing validation, shelf-life studies demonstrating product specifications, and biocompatibility testing support that the device is as safe and effective as the predicate.