X°Port Lung Preservation System; X°Port Lung Preservation Solution

The X°Port Lung Preservation System is a portable, insulated chamber with cooling packs designed to store and transport human donor lungs at 4°C–10°C for up to 8 hours before transplantation. The X°Port Lung Preservation Solution is a sterile, colloid-based preservation fluid used to flush, cool-store, and transport isolated lungs after removal from the donor. Both devices work together to maintain organ viability during the transplantation process.

The X°Port System maintains storage temperatures of 4°C–10°C (versus the predicate SherpaPak's 4°C–8°C), which has been validated through non-clinical thermal testing and clinical data. The X°Port Solution requires supplementation with 0.5 mmol/l Calcium Chloride prior to use to ensure suitability at the higher 10°C temperature, differentiating it from the LungProtect predicate (which operates at 4°C–8°C). Both devices share the same fundamental preservation technology, system components, composition, and mode of operation as their respective predicates.

Not stated in this summary. The document describes non-clinical testing categories (basic safety, electromagnetic compatibility, thermal performance, software/cybersecurity, packaging validation, biological safety including cytotoxicity and hemolysis) and clinical study designs but does not cite specific ISO, IEC, or ASTM standards.

Substantial equivalence is based on: (1) identical indications for use—static hypothermic preservation of lungs during transport and transplantation; (2) same fundamental technology, components, and operational modes as predicates; (3) the expanded temperature range (4°C–10°C) is supported by non-clinical validation and two retrospective clinical studies showing equivalent or improved outcomes compared to standard ice preservation and predicate registry data, with no statistically significant differences in primary graft dysfunction or 1-year survival; (4) clinical data demonstrate that 10°C preservation does not add additional safety risks and shows improved chronic allograft dysfunction-free survival and lower infection rates versus conventional methods.