Ultra-Fast Vitri; Ultra-Fast Warm

Ultra-Fast Vitri and Ultra-Fast Warm are reproductive media used to vitrify (cryopreserve) and warm mature oocytes (MII stage eggs) for assisted reproductive technology procedures. Ultra-Fast Vitri contains equilibration and vitrification solutions with cryoprotectants to prepare and freeze oocytes; Ultra-Fast Warm contains thawing solution to warm and remove cryoprotectants from previously frozen oocytes.

The subject device uses a faster, simplified two-step vitrification protocol (1 minute equilibration, 1 minute vitrification) compared to the predicate's 15-minute equilibration plus 1-1.5 minute vitrification. Both contain identical chemical formulations (Medium 199 HEPES, ethylene glycol, DMSO, trehalose, HPC, gentamicin). The subject thawing protocol is one step (1 minute in thawing solution) versus the predicate's multi-step approach using three different solutions. Both are sterilized identically via aseptic filtration and radiation.

Mouse Embryo Assay (MEA) per FDA guidance dated January 5, 2021; USP <71> for sterility testing; LAL methodology for endotoxin; general bench testing including pH, osmolality, color/appearance, and gentamicin content validation.

The subject device uses the identical chemical composition and manufacturer as the predicate, differs only in protocol speed and simplification (fewer steps, shorter timeframes). Clinical data from 1,077 oocytes demonstrated the ultra-fast protocols achieved superior or equivalent outcomes: 100% oocyte survival versus 90.9%, 65.2% clinical pregnancy versus 54.3%, and 56.5% live birth versus 52.2% compared to conventional protocols. Mouse Embryo Assay passed using the revised ultra-fast protocols. Since both devices contain the same formulation, sterilization method, storage conditions, and shelf life, and the clinical evidence shows the faster protocol performs equivalently or better, the faster procedural approach does not raise different safety or effectiveness questions.