Philips IntelliSite Pathology Solution 5.1

The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system for pathologists to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It comprises scanners (Ultra Fast Scanner or Pathology Scanner SG series), an Image Management System 4.2, and a clinical display. The device is not intended for frozen section, cytology, or non-FFPE hematopathology specimens.

The subject device introduces a new clinical display option (Barco MDCC-4430) as an alternative to the predicate device's Philips PP27QHD display. The new display has a larger active display area (655 mm × 410 mm, 30.4-inch diagonal vs. 27.0-inch), slightly higher resolution (2560 × 1600 pixels vs. 2560 × 1440), and different calibration software (QAWeb Enterprise 2.14.0 vs. MediCal QAWeb Agent 1.13.12), though the calibration method, targets, and frequency remain unchanged. All other technological characteristics remain identical to the predicate device.

IEC 60601-1 Edition 3.2 (2020) for basic safety and essential performance; IEC 60601-1-6 (4th Ed) for usability; IEC 62471:2006 for photobiological safety; and ISO 14971:2019 for risk management. Per TPA guidance, verification testing included spatial resolution, pixel defects, artifacts, temporal response, luminance (maximum/minimum and uniformity), grayscale, color scale response, color gamut volume, gray tracking, and bidirectional reflection distribution function.

Substantial equivalence is claimed because the new display represents a minor hardware change with equivalent or improved specifications (larger viewable area and higher pixel resolution) that does not raise safety or effectiveness concerns. Verification testing confirmed the display achieves similar image quality and technological performance as the predicate device across all relevant metrics. The intended use, clinical indications, and all other device components remain unchanged, and the new display complies with the same international consensus standards as the predicate, thereby demonstrating that the modification does not alter the device's safety or effectiveness profile.