FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin

FertiCult Flushing medium is a sterile solution intended for in vitro assisted reproductive technology (ART) procedures, including washing and handling of human sperm and egg cells, sperm swim-up procedures, intrauterine insemination, intracytoplasmic sperm injection, embryo washing, holding, and embryo transfer. Two formulations are cleared: the base medium and a variant containing phenol red and gentamicin. The medium is specifically NOT intended for oocyte pick-up or follicle flushing.

The subject device has a different chemical formulation than the predicate (sodium lactate vs. sodium-D,L-lactate; different phosphate species; includes Human Serum Albumin, phenol red, and gentamicin). pH range is 7.3-7.9 (vs. predicate 7.2-7.4). Osmolality is 270-290 mOsmol/kg. Sterilization uses aseptic filtration with vials further sterilized by radiation and moist heat. Shelf-life is 18 months in glass and 6 months in PETG bottles.

ISO 13408-1:2023 and ISO 13408-2:2018 (aseptic processing and sterilizing filtration); ISO 11137-1:2006 with Amendments 1 and 2 (radiation sterilization); ISO 17665-1:2006 (moist heat sterilization); USP <791>, <785>, <71>, <85> (pH, osmolality, sterility, endotoxin); 2021 FDA Mouse Embryo Assay guidance; ASTM D4169-22 (transportation testing); ISO 10993 series (cytotoxicity, sensitization, vaginal irritation).

Although the subject and predicate devices differ in formulation, pH range, and sterilization methods, these differences do not raise different safety and effectiveness questions because both products serve identical or overlapping intended uses in ART procedures (gamete and embryo handling). Performance testing demonstrates equivalent specifications for sterility, endotoxin, osmolality, and embryo development outcomes (≥80% blastocyst development in mouse embryo assay). The biocompatibility testing confirms safety for brief tissue contact during IUI and embryo transfer. The differences in composition and processing are within normal variation for reproductive media products and do not introduce new risks or alter the fundamental safety profile.