ARTSMedia Semen Wash Medium

ARTSMedia Semen Wash Medium is a reproductive media intended for washing sperm and sperm swim-up procedures in assisted reproduction. It can also be used for intrauterine insemination (IUI). The medium is aseptically filtered and supplied in 20 mL, 50 mL, and 100 mL glass bottles with an 18-month shelf-life when stored at 2–8°C.

The subject device formulation differs from the predicate (includes Gentamicin, glucose, HEPES, human serum albumin, sodium pyruvate, sodium bicarbonate, calcium/magnesium salts, potassium salts, insulin, sodium selenite, and ethanolamine), but both meet identical or similar critical specifications: pH 7.2–7.6, osmolality 270–300 mOsm/kg, endotoxin <0.25 EU/mL, sterility with no growth, human sperm survival ≥80% motility at 24 hours, and aseptic filtration sterilization. The subject device has an 18-month shelf-life versus the predicate's 2 years.

ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (sensitization), ISO 10993-23:2021 (vaginal irritation), ISO 13408-1:2008 & A1:2013 and ISO 13408-2:2018 (aseptic filtration and filling), ASTM F1980-21 (accelerated aging), ASTM D4169-22 (transportation), USP <791>, <785>, <85>, <71>, and <1207.2>.

Although the formulations differ, both devices achieve identical functional performance specifications critical to safety and effectiveness (pH, osmolality, endotoxin, sterility, sperm survival). Biocompatibility testing demonstrated the subject formulation is non-cytotoxic, non-sensitizing, and minimally irritating, meeting ISO 10993 standards for devices with patient contact. Shelf-life testing under accelerated conditions confirmed all specifications are maintained at 18 months. The formulation differences do not raise different questions of safety or effectiveness because both mediums support equivalent sperm viability and clinical outcomes in the same indications.