EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)

EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation is a 0.9% sodium chloride solution in a 2L sterile, non-PVC bag used to create and maintain hypothermia (cooling) of donor organs during recovery, storage, and transport for transplantation. It is also indicated for topical cooling during open surgical procedures such as cardiovascular, abdominal, and transplant surgeries to reduce metabolic activity and protect tissues during periods of ischemia.

The subject device is identical to the predicate in all technological characteristics: same 0.9% buffered sodium chloride solution, 300 mOsmol/kg osmolality, pH 4.5-7.0, 1,250 mL volume, single-use PVC-free bag with overwrap, terminal gamma irradiation sterilization, 24-month shelf life, and storage at 2-25°C with pre-cooling to -4 to -15°C before use. No changes to formulation, packaging, sterilization method, or mode of action.

ISO 10993-1/2/5/10/12 (biocompatibility); USP monograph for 0.9% Sodium Chloride Irrigation.

The indications for use were expanded to include surgical procedures (open heart and kidney surgery) in addition to organ recovery and storage/transport, but the mechanism of action—topical cooling to induce hypothermia and reduce metabolic activity—remains unchanged. Because there are no new technological characteristics, no changes to the device's formulation or design, and the expanded use operates under the same physiological principle as the original organ transplant applications, the submission argues the new indication does not raise new safety or effectiveness questions and therefore remains substantially equivalent to the predicate K191006 cleared in 2019.