Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)

The Horizon AF Plus System is a cardiopulmonary bypass oxygenator intended for use in adult and small adult surgical procedures requiring heart-lung support. It provides gas exchange and blood temperature control for up to 6 hours, with an integrated arterial filter to remove air and solid emboli from the patient's blood.

The device is a microporous hollow-fiber membrane oxygenator with integrated heat exchanger and 38-micrometer arterial filter. It features A.G.I.L.E. (Advanced Generation Inert Layer E.C.C.) phosphorylcholine-based inner contact surface coating and includes a hard-shell cardiotomy/venous reservoir with two integrated filters and vacuum-assisted venous drainage capability.

ISO 7199:2016 Cardiovascular implants and artificial organs, ISO 15674:2016 Cardiovascular implants and artificial organs—Hard-shell cardiotomy/venous reservoir systems, ASTM D4169 Packaging Configuration—Shipping Validation, and FDA guidance documents for cardiopulmonary bypass oxygenators issued November 13, 2000 and November 29, 2000.

The Horizon AF Plus System shares the same principle of operation and intended use as the predicate devices (Inspire 8F M and LivaNova Inspire 6F oxygenators), both intended for use up to 6 hours in cardiopulmonary bypass procedures. Nonclinical bench performance testing demonstrates substantial equivalence in all relevant functional parameters including gas transfer, blood damage, heat exchange efficiency, and filter effectiveness, with results meeting predefined acceptance criteria aligned with established safety and performance benchmarks.