INFINITT DPS

INFINITT DPS is a web-based software device that enables pathologists to view, manage, and interpret whole slide digital images of formalin-fixed, paraffin-embedded (FFPE) tissue specimens for primary pathology diagnosis. It works with the Hamamatsu NanoZoomer S360MD scanner and Barco MDPC-8127 display, providing image navigation, measurement, and annotation tools through a standard web browser.

INFINITT DPS is software-only, whereas the predicate NanoZoomer S360MD is a complete system including scanner and hardware. Both devices accept FFPE surgical pathology specimens, store images on networked storage, and provide similar image manipulation functions (zoom, pan, rotate, measurements). INFINITT DPS uses a proprietary viewer instead of the predicate's NZViewMD software but relies on the same FDA-cleared scanner for image acquisition.

The document cites the FDA guidance 'Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices' (April 20, 2016) and references the CIEDE2000 (ΔE₀₀) metric for color comparison testing. Human Factors Engineering testing followed FDA standards, and cybersecurity testing employed the MITRE ATT&CK framework.

INFINITT DPS is substantially equivalent because it performs the same intended function as the predicate—viewing and interpreting WSI images of FFPE surgical pathology slides for primary diagnosis. Non-clinical bench tests (pixel-wise color comparison, measurement accuracy, turnaround time) demonstrated equivalent performance. Both devices have identical indications for use, specimen types, and diagnostic workflows, with no new safety risks introduced by INFINITT's software-only approach or proprietary viewer.