FDA Permits Marketing for Digital Pathology Solution for Primary Diagnostic Use
The U.S. Food and Drug Administration (FDA) has permitted marketing of the Philips IntelliSite Pathology Solution (PIPS, Philips Medical Systems Nederland B.V.), as an aid to pathologists to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded tissue.
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 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 system available for these purposes.
The 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, the FDA evaluated data from a multisite, multireader, multi-organ, multimodality clinical study of approximately 2,000 surgical pathology cases. Efficacy was determined as whether the major discordance rate of the digital whole-slide imaging modality was noninferior to the discordance rate of the glass slide modality. The study determined a manual digital major discordance rate of 4.7%, a manual optical major discordance rate of 4.4%, and manual digital/manual optical rate difference of 0.4% (difference does not equal 0.3 due to rounding) (95% confidence interval [CI] = -0.30% to 1.01%). The clinical reference standard was based on the original pathology report.
The FDA also evaluated data from a feature study to evaluate both intersystem precision and intersite reproducibility for the PIPS. The overall intersystem agreement rate was 93.8% (95% CI = 92.6%–95.0%), and the overall intersite agreement rate was 90.2% (95% CI = 87.9%–92.4%).
Further information about the Philips IntelliSite Pathology Solution (PIPS) is available at https://www.accessdata.fda.gov/cdrh_docs/pdf16/DEN160056.pdf.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
