E1000 Dx Digital Pathology Solution

The Epredia E1000 Dx Digital Pathology Solution is an automated system that creates, views, and manages digital images of surgical pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue. It is intended for in vitro diagnostic use as an aid to pathologists in reviewing and interpreting digital slide images as an alternative to conventional light microscopy, and is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

The E1000 Dx uses MRXS image file format (versus iSyntax in the predicate), has a 1000-slide feeder capacity (versus 300 slides), and displays images on a Barco MDPC-8127 monitor (versus PS27QHDCR). Both systems include a scanner, image management system, viewer software, and display monitor. Despite these differences, the devices serve the same functional purpose and specimen types.

IEC 61010-1, IEC 61010-2-101, and IEC 61326-2-6 for electrical safety and electromagnetic compatibility testing. The device was evaluated according to 21 CFR 864.3700 (Whole Slide Imaging System) special controls and FDA's guidance document 'Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices.'

Clinical accuracy data demonstrated non-inferiority to optical microscopy with a major discordance rate difference of −0.15% (95% CI: −0.40%, 0.41%). Precision studies across intra-system, inter-system, and inter-site conditions all exceeded acceptance criteria (lower 95% CI limits >85%), with agreement rates of 96.9%, 95.1%, and 95.4% respectively. Component-level bench testing and human factors validation confirmed the device performs safely and effectively for its intended use, supporting substantial equivalence despite technological differences in capacity, file format, and display specifications.