slide1 l.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Historical overview of FDA regulation of digital pathology imaging applications: the safety and effectiveness issues PowerPoint Presentation
Download Presentation
Historical overview of FDA regulation of digital pathology imaging applications: the safety and effectiveness issues

Loading in 2 Seconds...

play fullscreen
1 / 20

Historical overview of FDA regulation of digital pathology imaging applications: the safety and effectiveness issues - PowerPoint PPT Presentation


  • 262 Views
  • Uploaded on

Historical overview of FDA regulation of digital pathology imaging applications: the safety and effectiveness issues. Tremel A. Faison, MS, RAC, SCT(ASCP) FDA/CDRH/OIVD/DIHD. Outline. Define digital pathology Intended Use Reference standard-Light microscope IVDs that utilize digital imaging

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Historical overview of FDA regulation of digital pathology imaging applications: the safety and effectiveness issues' - soyala


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
slide1

Historical overview of FDA regulation of digital pathology imaging applications: the safety and effectiveness issues

Tremel A. Faison, MS, RAC, SCT(ASCP)

FDA/CDRH/OIVD/DIHD

outline
Outline
  • Define digital pathology
  • Intended Use
  • Reference standard-Light microscope
  • IVDs that utilize digital imaging
  • Lessons from Radiology
  • Safety and effectiveness issues
digital pathology
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
intended use
Intended Use
  • Primary diagnosis of surgical pathology microscope slides in lieu of a microscope
  • Not an adjunct
  • Broad application (not organ or disease specific)
21 cfr 864 3600 microscopes and accessories
21 CFR 864.3600Microscopes and accessories
  • Historical reference standard for surgical pathology diagnosis
  • Optical instruments used to enlarge images of specimens, preparations, and cultures for medical purposes
  • Class I (general controls) exempt from premarket notification (510k) subject to limitations in 864.9.
21 cfr 864 9 limitations of exemptions from 510 k a few
21 CFR 864.9 Limitations of exemptions from 510(k) (a few)

Exemption only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality

  • Different fundamental scientific technology
  • IVD intended for use in diagnosis, monitoring or screening of neoplastic diseases
what does this mean
What does this mean?

Conventional

optical microscope

SLIDE

Image

Processing

software

Digital

image

sensor

Mechanical

scanner

Light

source

Imaging

optics

Display

READER

IMAGE

DATA FILES

  • Microscope one component of the system
  • Image acquisition, processing and display new technology for this intended use
  • Diagnostic for neoplastic disease
  • WSI systems can not be considered Class I exempt
ivd devices that utilize digital imaging
IVD devices that utilize digital imaging

21 CFR 864.5260 Automated cell-locating devices

Examples

  • Automated hematology analyzers (differential cell counters)
  • Chromosome analyzers
  • FISH enumeration systems
  • Urine sediment analyzers
ivd devices that utilize digital imaging9
IVD devices that utilize digital imaging
  • Immunohistochemistry image analysis applications
    • i.e. HER2, ER
    • Used as an adjunct to quantitate amount of “brown” stain
ivd devices that utilize digital imaging10
IVD devices that utilize digital imaging
  • Manual Read of Digital Image
    • Immunohistochemistry with no image analysis
    • Pathologist performs estimation of stain intensity and percent positivity from digital image alone
    • Limited to Breast PR and HER2 applications
ivd devices that utilize digital imaging11
IVD devices that utilize digital imaging
  • Gynecologic Cytology Imaging Systems
    • Cytyc/Hologic ThinPrep Imaging System
    • Becton Dickinson/TriPath FocalPoint Guided Screening System
    • Papanicolaou Stain
    • Class III devices
    • Detection algorithm, neural network
none of these examples can be directly applied to digital whole slide imaging

None of these examples can be directly applied to digital whole slide imaging

Each of these devices has a specific and limited intended use that is not applicable to WSI for the breadth of surgical pathology specimens

conclusion
Conclusion

WSI raises new questions of safety and effectiveness that must answered through premarket submission requirements

what are our concerns
What are our concerns?
  • Is the WSI presented of such quality that the same diagnosis could be made as when using the light microscope for all surgical pathology specimens?
  • What are differences in use between the two methods? i.e. viewing and navigating on a computer screen vs. a light microscope
  • Serious consequences to public health if misdiagnosis is caused by poor quality image or improper use
what can we learn from radiology
What can we learn from radiology?
  • Similarities between switch from film to digital mammography
  • 21 CFR 892.2010 Medical image storage device
  • 21 CFR 892.2020 Medical image communications device
  • 21 CFR 892.2030 Medical image digitizer
  • 21 CFR 892.2040 Medical image hardcopy device
  • 21 CFR 892.2050 Picture archiving and communications system
determination of safety and effectiveness
Determination of safety and effectiveness
  • 21 CFR 860.7
  • Intended use population
  • Conditions of use for the device
  • Probable benefit to health from the use of the device weighed against any probable injury of illness
  • Reliability of the device
safety
Safety

Reasonable assurance, based on valid scientific evidence, that the probable benefits to health from use of the device for its intended uses and conditions of use, when accompanied by adequate directions and warnings against unsafe use, outweigh any probable risks

21 CFR 860.7(d)(1)

effectiveness
Effectiveness

Reasonable assurance, based on valid scientific evidence, that in a significant portion of the target population, the use of the device for its intended use and conditions of use, when accompanied by adequate directions for use and warning against unsafe use, will provide clinically significant results

21 CFR 860.7(e)(1)

how does fda plan to ensure the safety and effectiveness of digital pathology devices
How does FDA plan to ensure the safety and effectiveness of digital pathology devices?
  • Require analytical and clinical studies to objectively and precisely validate performance
  • Knowledge of the risks, benefits and limitations
  • Standardization
  • Postmarket studies
summary
Summary
  • 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