Lacevo Wearable Breast Pump (Model S70)

The Lacevo Wearable Breast Pump (Model S70) is a powered, battery-operated breast pump designed for lactating women to express and collect milk from their breasts. It is a single-user, wearable device that can operate in stimulation, expression, massage, or auto modes, with adjustable suction levels controlled via an LED-display interface.

The S70 has a Li-ion battery power supply, microprocessor-controlled cycling and suction, vacuum ranges of 40–150 mmHg (stimulation), 105–245 mmHg (expression), 40–120 mmHg (massage), and 40–245 mmHg (auto mode), with 12 adjustable suction levels. It has an LED user interface with on/off switch, mode selection, and vacuum adjustment controls. Milk-contacting materials are polypropylene (collector/linker), silicone (flange/valve/diaphragm), and ABS (motor/housing).

IEC 60601-1:2005+A1:2012 (medical electrical equipment general safety), IEC 60601-1-11:2015 (home healthcare environment), IEC 60601-1-2:2014/A1:2021 (electromagnetic compatibility), IEC 62133-2:2017 (lithium battery safety), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (sensitization and irritation), and 21 CFR 177 (milk-contacting materials).

The subject device has identical intended use, patient population, anatomical site, and fundamental function to the predicate (Model W8). Though the S70 has narrower ranges in stimulation suction (40–150 vs. 40–170 mmHg), expression suction (105–245 vs. 120–245 mmHg), and cycle speeds across all modes, and features 12 rather than 15 suction levels, these differences are within the performance envelope and do not raise new safety or effectiveness questions. The device uses the same materials, design components, backflow protection, microprocessor control mechanism, and battery technology; meets all applicable electrical safety and biocompatibility standards; and passed bench testing for vacuum, cycle speed, backflow, and battery performance. Therefore, it is as safe and effective as the predicate.