Spectra S1 Pro; Spectra S2 Pro

The Spectra S1 Pro and Spectra S2 Pro are single-user, powered breast pumps designed to express and collect milk from lactating women's breasts. Both devices support single (one breast) and dual (both breasts simultaneously) pumping modes with adjustable vacuum levels and cycle speeds. The S1 Pro can operate via AC adapter or rechargeable lithium-ion battery, while the S2 Pro uses AC adapter only.

Both devices are tabletop diaphragm pumps with microcontroller-based cycling control and LCD button interfaces. Key differences from the predicate device include expanded suction ranges (S1 Pro massage mode: 50–180 mmHg vs. predicate 50–130 mmHg) and revised cycle speeds (S1 Pro massage: 70–105 cpm vs. predicate 38–70 cpm), plus 15 expression levels versus the predicate's 12 levels. The fundamental design, power supply architecture, and two-phase expression pattern remain identical to the predicate.

Biocompatibility per ISO 10993-1 (cytotoxicity, skin sensitization, skin irritation); 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; and software evaluation per 2023 FDA guidance on device software functions. Performance testing included vacuum verification, backflow protection, use-life, and battery durability.

The subject devices are substantially equivalent to the predicate (Spectra S1 Plus/S2 Plus, K150476) because both have identical indications for use, the same fundamental design as tabletop diaphragm pumps with comparable technological features, and equivalent or improved performance specifications. The differences in vacuum levels and cycle speeds do not raise new safety or effectiveness concerns; comprehensive non-clinical testing demonstrated biocompatibility, electrical safety, and performance meeting design requirements throughout the device's use life.