Motif Aura Glow breast pump (Model Motif Aura Glow)

The Motif Aura Glow is a powered breast pump intended for use by lactating women to express and collect milk from their breasts. It is a single-user, wearable device powered by a rechargeable lithium-ion battery with an embedded control program managing all functions including massage, expression, cluster feeding, and general pumping modes.

The subject device offers four suction modes (massage, expression, cluster feeding, general pumping) with 5-9 adjustable vacuum levels per mode, compared to the predicate's two modes with 9 levels. Vacuum ranges and cycle speeds differ: subject ranges from 40-245 mmHg across modes versus predicate's 40-245 mmHg; cycle speeds range from 30-120 cycles/minute in subject versus 23-114 in predicate. Both use lithium-ion batteries, microcontroller cycling control, backflow protection, and wearable design with combined milk collector and flange.

Biocompatibility tested per ISO 10993-1 (2023 FDA guidance). Electrical safety per ANSI/AAMI ES60601-1:2005/A2:2010, IEC 62133-2:2017, and IEC 60601-1-11:2015. Electromagnetic compatibility per IEC 60601-1-2:2014. Software evaluated at Basic Documentation level per 2023 FDA guidance on device software functions.

The subject and predicate devices share identical indications for use, same patient population, same regulatory classification (Class II, HGX code), and similar fundamental design (wearable pump with combined milk collector). Though the subject device offers additional modes and different vacuum/cycle specifications, these differences do not raise different questions of safety and effectiveness because they represent engineering variations within the same functional category of powered breast pumps with established safety parameters, and the subject device demonstrates equivalent performance through comprehensive testing.