Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)

Minvitro Embryo Transfer Catheters are sterile, single-use medical devices designed to place in vitro fertilized (IVF) embryos into the uterine cavity during assisted reproduction procedures. The system consists of a transfer catheter loaded with embryos, a guide catheter to direct insertion, and optional stylet components, with variations including straight echogenic and pre-curved guide options.

The subject device differs from the predicate in design features (e.g., positioner and bulb-tip design in ETCB20175 series), materials (PE, TPU, PEBAX, silicone vs. polyurethane and fluoric resin), dimensions (transfer catheter OD 0.95 mm vs. 1.55 mm), sterilization method (electron beam vs. ethylene oxide), and shelf-life (2 years vs. 3 years). Despite these differences, both devices share the same fundamental intended use and safety profile.

ISO 11137-1:2006 and ISO 11137-2:2013 (sterilization validation); ASTM D4169-22 (transportation simulation); ASTM F1886/F1886M-16, F88/F88M-23, F1929-23 (packaging integrity); ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021 (biocompatibility); USP <85> (endotoxin); FDA 2021 Mouse Embryo Assay guidance; ASTM F1980-21 (accelerated aging).

Although the subject device and predicate device exhibit different technological characteristics in design, materials, dimensions, sterilization method, and shelf-life, they share the same intended use (embryo transfer into the uterine cavity) and regulatory classification (Class II, 21 CFR 884.6110). Comprehensive non-clinical testing demonstrated equivalent safety and performance, including biocompatibility, endotoxin levels (<20 EU/device), mouse embryo assay results (≥80% blastocyst development), and bench performance testing before and after accelerated aging, supporting a determination of substantial equivalence.