FDA Approves Marketing of First Digital Pathology Whole Slide Imaging System

PIPS is an automated digital slide creation, viewing, and management system that will allow pathologists to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue, rather than having to look directly under a conventional light microscope at a tissue sample mounted on a glass slide. This is the first FDA-authorized digital pathology whole slide imaging (WSI) system available for these purposes.

FDA reviewed the data for the PIPS through the de novo premarket review pathway to provide a reasonable assurance of safety and effectiveness of the device. During this process, FDA evaluated data from a multi-site, multi-reader, multi-organ, multi-modality clinical study of approximately 2,000 surgical pathology cases. Efficacy was determined as whether the major discordance rate of the digital WSI modality was non-inferior to the discordance rate of the glass slide modality. The study determined MD (Manual Digital) major discordance rate of 4.7%, MO (Manual Optical) major discordance rate of 4.4%, and MD-MO rate difference of 0.4% (difference does not equal 0.3 due to rounding) with a 95% confidence interval of (-0.30%; 1.01%). The clinical reference standard was based on the original pathology report.

FDA also evaluated data from a feature study to evaluate both inter-system precision and inter-site reproducibility for the PIPS. The overall inter-system agreement rate was 93.8% with a 95% CI of (92.6%; 95.0%). The overall inter-site agreement rate was 90.2% with a 95% CI of (87.9%; 92.4%).

Further information about the Philips IntelliSite Pathology Solution (PIPS)is available (https://www.accessdata.fda.gov/cdrh_docs/pdf16/DEN160056.pdf).

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