RemunityPRO™ Pump for Remodulin® (treprostinil) Injection

The RemunityPRO™ Pump is a wearable infusion pump designed to deliver Remodulin® (treprostinil) subcutaneously for treating pulmonary arterial hypertension in patients 17 years and older. It consists of a durable pump with a disposable cassette, a remote interface, rechargeable batteries, and accessories, and can operate for up to 72 hours per cassette.

The subject device uses identical microprocessor-controlled micro-dosing with acoustic volume sensor feedback, same dimensions (6cm x 6cm x 2cm), weight (50g), basal delivery range (8-225 μL/hr), and accuracy (±6%) as the predicate. The key difference is compatibility with an additional infusion set: the Neria Guard Infusion Set (23in, models 704060-5226, 704060-5229) in addition to the three previously supported infusion sets.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-2-24, ISO 11137-1 (gamma sterilization), ISO 10993-1 (biocompatibility), ISO 14971 (risk management), IEC 60601-4-2, ANSI C63.27, and AIM 7351731.

The RemunityPRO is substantially equivalent because all functional and performance specifications remain unchanged from the predicate device (K241736). The only modification is addition of a compatible infusion set (Neria Guard) that has similar physical characteristics to existing cleared infusion sets. Bench performance testing demonstrated the pump performs equivalently with the new infusion set using the same well-established test methods and acceptance criteria from the prior clearance, raising no new safety or effectiveness questions.