ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)

ARTSMedia Oocyte Aspiration Medium is a reproductive media used to retrieve human oocytes (egg cells) through follicular aspiration or flushing during fertility procedures, and can also be used for washing oocytes. The medium consists of physiological salts, energy substrates, buffering agents, human serum albumin, and gentamicin sulfate, provided in sterile glass bottles with an 18-month shelf life when stored at 2–8°C.

The subject device formulation differs from the predicate (Medi-Cult Flushing Medium) in specific ingredients and measured parameters including pH (7.2–7.6 vs. not known), osmolality (270–300 mOsm/kg vs. not known), endotoxin specification (<0.25 EU/mL vs. not known), and mouse embryo assay method (1-cell assay vs. two-cell assay). Both devices use aseptic filtration for sterilization and are prescription-use only.

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

Although the formulations and some technical specifications differ between the subject and predicate devices, the FDA determined that these differences do not raise different questions of safety and effectiveness because both devices share the same intended use (oocyte retrieval and washing), identical prescription-use classification, identical sterilization method, and both demonstrate appropriate biocompatibility, sterility, and embryo compatibility performance through standardized testing. The variations in specific ingredients and measurable parameters reflect acceptable product design choices that do not affect the fundamental safety and efficacy profile.