Fast Warm - NX

Fast Warm – NX is a warming medium solution used in assisted reproductive procedures to thaw vitrified (frozen) human blastocyst stage embryos. It is a dual-buffered solution containing Continuous Single Culture Medium, trehalose, dextran, human serum albumin, and gentamicin, supplied as a ready-to-use liquid that can be used for up to 14 days after opening.

The subject device uses a single-step 1-minute warming procedure at 37°C, compared to the predicate's multi-step protocol (1, 4, and 8 minutes). The subject device has a 14-day use-life after bottle opening while the predicate does not specify this. Both share identical formulation, packaging, storage conditions (2–8°C), pH, and sterilization method. Osmolality specifications differ slightly (775–950 mOsm/kg after 1:1 dilution for subject vs. 1,550–1,900 for predicate).

ISO 13408-1:2008/Amd1:2013 and ISO 13408-2:2018 for aseptic filtration and filling validation; USP<71> and 21 CFR § 610.12 for sterility; USP<85> for endotoxin; USP<791> for pH; USP<785> for osmolality; ASTM D4169-22 (DC-13) for transportation testing; Mouse Embryo Assay (MEA) for embryo viability.

Although the subject device narrows the indication to blastocysts only (versus the predicate's broader indication including oocytes and cleavage-stage embryos) and uses a faster single-step warming protocol, these differences do not raise different questions of safety and effectiveness because both devices have the same intended use (embryo warming) with identical formulations. Clinical data comparing the single-step warming protocol to the standard multi-step protocol demonstrated comparable blastocyst survival (100% vs. 100%), clinical pregnancy (54.0% vs. 52.7%), and live birth rates (44.4% vs. 43.1%), supporting equivalent safety and performance.