FDA has granted de novo premarket notification (510(k)) clearance to Philips Medical Systems BV, Amsterdam, for its IntelliSite pathology solution, a whole-slide imaging system that allows for review and interpretation of digital surgical pathology slides prepared from biopsied tissue.
The IntelliSite system comprises an ultrafast pathology slide scanner, an image management system, and a display, to automate the creation, viewing, and management of digital pathology images. The system is complemented by advanced software tools to manage the scanning, storage, presentation, reviewing, and sharing of information.
The clearance marks the first time that FDA has permitted the marketing of a digital pathology solution for primary diagnostic use in the United States. The technology can help pathologists to view and diagnose digital images of surgical pathology slides. Digital pathology aims to reduce pressure on pathology services by streamlining workflow and extending collaboration, with the goal of increasing diagnostic confidence.
In conventional pathology studies performed to understand the cause and development of a disease or condition, biopsied tissues are mounted onto glass slides and stained for viewing and evaluation. The IntelliSite system uses proprietary hardware and software to scan and digitize conventional slides at resolutions equivalent to 400x magnification. Such digitized images can then be reviewed and interpreted by pathologists.
“The system enables pathologists to read tissue slides digitally in order to make diagnoses, rather than looking directly at a tissue sample mounted on a glass slide under a conventional light microscope,” says Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “Because the system digitizes slides that would otherwise be stored in physical files, it also provides a streamlined slide storage and retrieval system that may ultimately help make critical health information available to pathologists, other healthcare professionals, and patients faster.”
FDA reviewed data for the IntelliSite system through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices that are not substantially equivalent to an already legally marketed device. The agency evaluated data from a clinical study of approximately 2,000 surgical pathology cases using tissue from multiple anatomic sites. One of the largest studies ever conducted to directly compare the use of digital pathology to optical microscopes, the study involved 16 pathologists at four clinical study sites—Advanced Pathology Associates, Cleveland Clinic, Miraca Life Sciences, and the University of Virginia—and recorded approximately 16,000 reads across 2,000 cases. The study found that clinical diagnoses based on IntelliSite images were comparable to those made using glass slides.
As part of its authorization, FDA established special controls that must be met to ensure the digital imaging system’s precision, reliability, and clinical relevance. The risks associated with use of the technology are similar to those for conventional light microscopy. The special controls are necessary to provide reasonable assurance of safety and effectiveness for the digital imaging system.
“Clearance for Philips IntelliSite pathology solution marks a major milestone for innovation in pathology services in the United States” says Russ Granzow, general manager of Philips Digital Pathology Solutions. “Not only will it promote increased efficiencies and collaboration between pathologists, but it also opens a complete new dimension toward computational pathology, which aims to increase accuracies and ultimately enhance patient care.”
For further information, visit Philips digital pathology solutions.