Digital Pathology Devices Panel Meeting October 23, 2009 Tremel Faison, MS, RAC, SCT(ASCP)

Day 1 Defined digital pathology Intended use Reference standard-light microscope IVDs that utilize digital imaging Lessons from Radiology Safety and effectiveness issues

Digital Pathology The use of computer technology to convert analog microscopic images into digital images Whole slide imaging (WSI), aka digital imaging, virtual slides, virtual microscopy System consisting of hardware; microscope, camera, scanner, computer, and monitor, and software. Encompasses image acquisition, processing, archiving and retrieval Digital pathology is the use of computer technology to convert analog microscopic images into digital images. For this meeting we will be using the term whole slide imaging, abbreviated “WSI”, also known as digital imaging, virtual slides, or virtual microscopy. I’m sure there are other synonyms out there. Whole slide imaging systems consist of hardware—a microscope, camera, scanner, computer and monitor and the accompanying image software. The system performs image acquisition, processing, archiving and retrieval.

Intended Use Primary diagnosis of surgical pathology microscope slides in lieu of a microscope Not an adjunct Broad application (not organ or disease specific) Everything here at the FDA starts with the intended use. Intended use shapes how the device will be regulated, in what population and ultimately-the study design. For the scope of this panel meeting the intended use is defined as the use of WSI for primary diagnosis of surgical pathology microscope slides in lieu of a microscope. This is not an adjunctive intended use and for our purposes we will be considering the use of WSI for all surgical pathology specimens---it is not organ or disease specific.

Light microscope Historical reference standard

Regulation of digital pathology devices FDA recognizes that the technological advances associated with WSI make its use a reality WSI systems are not Class I exempt and are therefore, subject to premarket requirements Current IVDs that utilize digital imaging for limited applications are not applicable to the WSI paradigm Digital mammography may provide useful lessons but does not address all of the concerns for WSI Our goal is to gain information about the technology in order to ensure safe and effective use …..Just a note for the panel members the set of questions in the panel packet have been condensed from the original version that was sent to you earlier.