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Intended Use

Hepatica v1 is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient's liver health. It processes DICOM 3.0 compliant MRI image datasets to produce semi-automatic segmented 3D models of the liver based on Couinaud and Brisbane 2000 terminology with volumetric reporting per segment. It may report iron-corrected T1 (cT1) and PDFF calculated using the IDEAL method from multi-slice acquisitions on a per segment and whole liver basis to measure liver tissue health. Provides additional information to trained clinicians to evaluate liver volume and health on a segmental basis and may support surgical decision making, but it is not intended to replace established liver health assessment procedures.

Technology

Hepatica v1 operates as standalone post-processing software that accepts DICOM 3.0 compliant MRI datasets from multiple vendor MRI systems. It performs semi-automatic liver segmentation into Couinaud segments using landmark placement, then quantifies volumetry, iron-corrected T1 (cT1) and proton density fat fraction (PDFF) per segment and for the whole liver. It creates 2D anatomical views and 3D liver models. cT1 and PDFF metrics are calculated using established MRI relaxometry and chemical shift imaging methods, leveraging the IDEAL technique for fat quantification and correction for iron deposition. The software runs on general-purpose computers in controlled clinical environments, providing images and quantitative reports for clinical interpretation.

Performance

Performance testing of Hepatica v1 demonstrated accuracy and precision of volumetry, cT1 and PDFF measurements compared to radiologist-derived gold standards. Repeatability and reproducibility of volume measurements are high. Inter-operator variability is within acceptance criteria. cT1 and PDFF metrics fall within acceptance criteria established for the predicate device, supporting the device's safety and effectiveness.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    11/6/2020

    2 months
  • 2

    FDA Approval

    1/12/2021

Other devices from Perspectum Ltd.

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