Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)

The Paruu Wearable Breast Pump is a powered breast pump designed for lactating women to express and collect breast milk. It consists of a motor unit, milk collection set with diaphragm backflow protection, and accessories. The device operates on a rechargeable lithium battery and includes 23 different models divided into P16 and P20 series, each with 4 working modes and 12 suction levels.

Both subject and predicate devices use microcontroller-based diaphragm pumps with 3.7V rechargeable batteries and media separation for backflow protection. Key differences include: subject device offers 12 suction levels per mode versus predicate's variable levels (6-9); different vacuum ranges and cycle frequencies across the two series; and different user interface button configurations. Maximum vacuum is 310/315 mmHg for subject versus 320 mmHg for predicate.

ISO 10993-5:2009 (in vitro cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021 (skin irritation), ANSI AAMI ES60601-1 (electrical safety), IEC 60601-1-11 (home healthcare environment), ANSI AAMI ES60601-1-2 (EMC), and IEC 62133-2 (lithium battery safety). Software validation followed 2023 FDA guidance on device software functions.

The subject and predicate devices share the same indications for use, regulatory classification (Class II), product code, and fundamental design (wearable diaphragm pump). Although specifications for vacuum levels, cycle frequencies, and suction levels differ, these technological differences do not raise new safety or effectiveness questions given comparable materials, safety testing, and performance validation results that demonstrate the device is as safe and effective as the predicate.