OrganProtex HTK Solution

OrganProtex™ HTK Solution is a sterile, clear liquid organ preservation solution containing electrolytes and amino acids. It is indicated for perfusion and flushing of donor kidneys, liver, pancreas, and heart before or immediately after removal from the donor, then left in the organ's vasculature during cold storage and transport to the recipient. It is not for continuous machine perfusion.

Both the subject and predicate devices have identical composition (same electrolyte and amino acid formulation), osmolality of 310 mOsmol/kg, pH range 6.5-7.5, storage temperature 2–8°C, 12-month shelf life, single-use sterile bag packaging, terminal steam sterilization, and non-pyrogenic status. The subject device is available in 1,000 mL format versus the predicate's multiple sizes (1,000, 2,000, 5,000 mL).

ISO 10993-1/2/5/10/12 for biocompatibility assessment; terminal steam sterilization for sterility; stability studies for shelf life validation. Specific test methods or ASTM/IEC standards are not detailed in this summary.

OrganProtex™ HTK and Custodiol® HTK have identical chemical composition per liter, same osmolality, equivalent pH ranges (both within physiologically acceptable limits for cold preservation), identical storage and use conditions, same sterilization method, equivalent biocompatibility testing, and identical intended use in organ preservation. The predicate was already cleared for these organs under the same regulatory classification (876.5880), and the subject device replicates all material and functional characteristics that support safety and efficacy in hypothermic organ preservation.