Remunity 2.0 Pump for Remodulin (treprostinil) Injection

The Remunity 2.0 Pump is a wearable infusion pump that delivers Remodulin (treprostinil) subcutaneously to treat pulmonary arterial hypertension. It consists of a durable pump body, disposable single-use cassette with user-filled drug reservoir, remote touchscreen interface, and accessories. The system delivers medication at individualized programmed rates based on acoustic volume sensor feedback for accuracy.

The subject device has an expanded basal delivery rate range (8–225 μL/hr versus 16–225 μL/hr in the predicate), improved post-occlusion bolus volume performance (<8 μL versus <40 μL), a touchscreen remote interface instead of push-button, automatic pump-based priming instead of manual user priming, and a cassette design removing the filling aid. The ±6% delivery accuracy, occlusion detection, dimensions, weight, battery type, and storage/operating conditions remain unchanged.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-2-24, IEC 60601-1-6:2020, IEC 60601-1-8:2020, IEC 60601-4-2, ISO 11137-1, ISO 10993-1, ISO 14971, ANSI AAMI IEC 62304:2006/A1:2016, ANSI AAMI IEC 62366-1:2015+A1:2020, ANSI C63.27, and AIM 7351731.

The subject device uses identical pump and cassette hardware and remote interface functionality to previously cleared reference devices (ACE Pump and Remunity System). The expanded age indication (17+ versus >22 years) aligns with approved Remodulin drug labeling and was validated through human factors and bench testing. Key design changes—lower flow rate capability, improved occlusion performance, touchscreen control, and automatic priming—either improve safety margins or simplify user workflows validated through testing. No changes introduce different safety or effectiveness questions relative to the predicate device (K190182).