VIVACE

The VIVACE is a powered breast pump designed to express and collect milk from the breasts of lactating women. It supports single or double pumping modes (synchronous or alternating) and is intended for use by single or multiple users in home and healthcare environments.

The VIVACE features a microcontroller-based cycling mechanism, diaphragm pump type, adjustable suction levels (50-280 mmHg, 12 levels for expression; 60-160 mmHg, 6 levels for massage), cycle speeds (28-40 cycles/min for expression; 40-80 cycles/min for massage), LCD display with mood light control, and dual power options (rechargeable Li-ion battery 11.1V 2200mAh or AC adapter 100-240VAC). It differs from the predicate in suction ranges, cycle speeds, and user interface design.

IEC 60601-1:2005 + A1:2012 + A2:2020 (electrical safety), IEC 60601-1-11:2015+A1:2020 (home healthcare environments), IEC 62133-2 (lithium battery safety), IEC 60601-1-2:2014 + AMD 1:2021 (electromagnetic compatibility), and ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation). Software evaluated per 2023 FDA guidance on premarket submissions for software functions.

The VIVACE shares the same intended use (expressing and collecting breast milk from lactating women), patient population, regulatory classification (Class II), pump type (diaphragm), fundamental operating principle (microcontroller-based cycling with adjustable suction and cycle control), and backflow protection mechanism as the predicate OPERA device. Although the subject device has differences in suction levels, cycle speeds, power supply details, and user interface (LCD with buttons vs. switch control), these are design variations that do not raise different safety or effectiveness questions, as the core functionality and risk profile remain substantially equivalent.