Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)

The Vitrification Freeze Kit (RFD-0101) and Vitrification Thaw Kit (RFD-0201, RFD-0202) are reproductive media used in assisted reproduction to freeze and thaw oocytes, zygotes, cleavage-stage embryos, and blastocysts. The Freeze Kit contains an Equilibration Solution and Vitrification Solution with cryoprotectants; the Thaw Kit contains four sequential thawing solutions to safely restore vitrified embryos.

Both subject and predicate use aseptic filtration sterilization and achieve sterility with <0.5 EU/mL endotoxin. Key differences include: subject device pH range 7.30–7.70 vs. predicate 7.20–7.40; subject osmolality lower (ES 700±70, VS 1000±80 vs. predicate 2331–6849 mOsm/kg); subject shelf-life 7 weeks vs. predicate 52 weeks; and formulation differences (subject uses Quinn's Advantage Medium; predicate uses Modified Human Tubal Fluid with amino acids). Both meet ≥80% embryo development to blastocyst at 96 hours.

ISO 13408-1:2008 (Aseptic Processing Part 1), ISO 13408-2:2018 (Aseptic Processing Part 2 Sterilizing Filtration), USP <791> (pH), USP <785> (Osmolality), USP <85> (Endotoxin), USP <71> (Sterility), Mouse Embryo Assay (MEA), ASTM D4169-22 (Transportation testing), and USP <1207.2> (Shipping).

The subject device has identical indications for use and conditions of use (prescription-only, embryo vitrification and thawing) as the predicate SAGE kits. Although formulation and several parameters differ—pH range, osmolality, shelf-life, and base media composition—the applicant argues these differences do not raise new safety or effectiveness questions because both devices meet the same functional performance endpoint (≥80% blastocyst development). Both use the same sterilization method (aseptic filtration), achieve equivalent sterility and endotoxin levels, and undergo shelf-life and transportation testing. The lower osmolality and shorter shelf-life of the subject device represent conservative specifications rather than reduced safety margins.