FDA BRIEF: Week of September 4, 2017

GE Healthcare, Senographe Pristina mammography system, launch, RSNA 2017, patient comfort

 Senographe Pristina with Self-Compression 

GE Healthcare

INDICATION FOR USE (based on predicate Senographe Pristina): Generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken.

ADDRESSING UNMET NEED:

  •  First 2D digital mammography with patient-assisted compression remote control
  • Enable patient, with the help of a technologist, to set compression that feels right for her
  • Minimize women’s perceived pain and discomfort by giving active role in the application of compression

REG PATHWAY: 510(k)

  • Predicate Device: Senographe Pristina
  • Device Classification Name: Full Field Digital,System,X-Ray,Mammographic
  • Regulation Number: 892.1715
  • Classification Product Code: MUE

DEVICE DESCRIPTION:

  • Senographe Pristina: Full Field Digital Mammography (FFDM) system
  • X-ray image acquisition system dedicated to breast imaging includes Cesium Iodine digital detector, x-ray tube, integrated high voltage generator, compression paddles
  • Control station for image acquisition, processing and display includes touch-screen user interface
  • Pristina Dueta: Addition of handheld wireless remote control to adjust compression force after breast positioning, guided by technologist

EFFECTIVENESS AND SAFETY:

  • Clinical validation: Addition of remote to allow self-compression did not negatively impact image quality
  • Performing a mammogram with patient-assisted compression vs. compression solely applied by the technologist did not significantly increase time of the exam
  • IPSOS Patient satisfaction study (n=160):  Improved the comfort of exam (79%), less anxiety (54%)

510(k) Notification

GE INFORMATION


Image credit: GE

 

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