VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)

The VANGUARD Blood Cardioplegia Systems are single-use, sterile cardiopulmonary bypass devices designed to deliver cardioplegic solution during cardiac surgery. They regulate cardioplegia fluid temperature, trap air emboli, and are intended for use up to 6 hours during surgical procedures requiring cardiopulmonary bypass.

The devices have identical fundamental technological characteristics and operating principles to their predicates. Key modifications include: replacement of PVC tubing and connectors to remove DEHP plasticizer and DOTE thermal stabilizer; substitution of PP Purell line clamp material with Bormed PP material; and replacement of Versapor mesh in vented spike components. Technical specifications were updated to reflect current state-of-the-art standards. The devices remain ethylene oxide sterilized with non-pyrogenic fluid paths for single use only.

The Vanguard Blood Cardioplegia Systems comply with all applicable voluntary standards related to cardiovascular systems and passed testing in accordance with national and international standards, though specific standard numbers (ISO, IEC, ASTM) are not cited in this summary.

Substantial equivalence is based on three pillars: (1) identical intended use—both systems deliver cardioplegic solution with temperature regulation and air emboli trapping for up to 6 hours during CPB procedures; (2) equivalent technological characteristics—the material substitutions (DEHP removal, alternative plastics) maintain the same fundamental design, operation, and control mechanisms; and (3) equivalent non-clinical performance testing—the devices passed all applicable voluntary cardiovascular standards. The predicate devices have several years of proven safety and efficacy on the market, and the modifications do not raise new safety or effectiveness questions.