Ultra-Fast Warm

Ultra-Fast Warm is a warming solution for assisted reproductive technology that thaws previously vitrified (frozen) oocytes (egg cells) and blastocyst-stage embryos. The product consists of a single thawing solution (TS) provided in four 4.0 mL vials that removes cryoprotectants and prepares gametes and embryos for use in fertility treatment.

The subject device has identical technological characteristics to the predicate device (K251305), including the same Medium 199 HEPES buffered formulation, hydroxypropyl cellulose, gentamicin, trehalose, pH range (7.20-7.60), storage conditions (2-8°C), and 12-month shelf life. The differences are an expanded indication to include blastocyst-stage embryos (versus MII oocytes only in the predicate) and a simplified one-step thawing protocol versus the predicate's single-step protocol.

The document cites USP <71> for sterility testing and LAL (Limulus Amebocyte Lysate) methodology for endotoxin testing with limits <0.25 EU/mL. Mouse embryo assay performance standards (>80% one-cell viability at 96 hours) and biocompatibility testing are mentioned but no specific ISO or ASTM standards are explicitly named.

The subject device is substantially equivalent because it shares identical technological and chemical characteristics with the predicate device and the same intended use as a reproductive media supplement. The expanded indication to include blastocyst-stage embryos does not raise different safety or effectiveness questions, as supported by a retrospective clinical study (Yelke et al. 2025) demonstrating comparable post-warming survival rates, pregnancy rates, and live birth rates between the one-step Ultra-Fast Warm protocol and traditional multi-step warming protocols.