Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)

The Minvitro® Vitrification Straw is a single-use, sterile cryopreservation device designed to store human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos during vitrification procedures. It consists of a handle, carrier sheet with fine tip, and a cap with balancing head, and is available in five color variants (red, yellow, blue, green, purple).

Key differences from the predicate include: subject device uses ethylene oxide sterilization versus predicate's gamma radiation; subject materials include PETG carrier sheet and ABS handle versus predicate's polypropylene/stainless steel; subject warming rate is 40,000°C/min versus predicate's 44,000°C/min; dimensions differ slightly (total length 131 mm versus 116 mm). Both use closed vitrification systems with identical -3,000°C/min cooling rates and SAL 10⁻⁶ sterilization assurance levels.

ISO 11135:2014 (ethylene oxide sterilization), ISO 11607-1-2006/Amd 1-2014 and ISO 11607-2-2006/Amd 1-2014 (sterilization packaging), ISO 11737-1:2018 and ISO 11737-2:2009 (sterility testing), ISO 11138-2:2017 (biological indicators), ISO 10993-7:2008 (ethylene oxide residues), ASTM D4169-22 and ASTM D4332-22 (transportation and conditioning), ASTM F1980-21 (stability testing), USP <85> (endotoxin LAL method), ASTM F1886/F88/F1929 (package integrity), and 2021 FDA guidance on Mouse Embryo Assay.

The subject and predicate devices serve identical intended uses (vitrification storage of human oocytes, 4-8 cell embryos, and blastocysts) under the same regulation (21 CFR 884.6160) and product code. Although technological differences exist in sterilization method, materials, dimensions, and warming rate, these differences do not raise new safety or effectiveness concerns. The subject device's non-clinical performance testing—including sterilization validation, endotoxin testing, cooling/warming rate verification, and mouse embryo assays meeting ≥80% blastocyst development criteria—demonstrates equivalent safety and effectiveness to the legally marketed predicate device.