Simplicit90Y™ Personalized Dosimetry Software

Indications, Safety, and Warnings

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE (US ONLY)

Simplicit90Y™ is intended to be used by trained medical professionals for TheraSphere™ pre-treatment dosimetry planning and post-treatment dosimetry evaluation following Y90 treatment. Simplicit90Y is a medical image and information management system that is intended to receive, transmit, store, retrieve, display and process digital medical images, as well as create, display and print reports from those images. The medical modalities of these medical imaging systems include, but are not limited to, CT, MRI, SPECT and PET. Simplicit90Y provides the user with the means to display, register and fuse medical images from multiple modalities. Simplicit90Y provides tools to create, transform, and modify contours for the user to define objects in medical image volumes for use in TheraSphere pre-treatment dosimetry planning and for post-treatment dosimetry. The objects include, but are not limited to, tumors and normal tissues. For post-Yttrium-90 (Y90) treatment, Simplicit90Y should only be used for the retrospective determination of dose and should not be used to prospectively calculate dose or for the case where there is a need for retreatment using Y90 microspheres. 
 

INTENDED USE 

Simplicit90Y is a standalone software device that is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. Simplicit90Y supports the reading, rendering and display of a range of DICOM compliant imaging and related formats including but not limited to CT, PT, NM, SPECT, MR, SC, RTSS. Simplicit90Y enables the saving of sessions in a proprietary format as well as the export of formats including CSV and PDF files. Simplicit90Y is indicated, as an accessory to TheraSphere, to provide pre-treatment dosimetry planning support including Lung Shunt Fraction estimation (based on planar scintigraphy) and liver single-compartment MIRD schema dosimetry, in accordance with TheraSphere labelling. Simplicit90Y provides tools to create, transform, and modify contours/Regions of Interest for calculation of Lung Shunt Fraction and Perfused Volume. Simplicit90Y includes features to aid in TheraSphere dose vial selection, dose vial ordering and creation of customizable reports. Simplicit90Y is indicated for post-treatment dosimetry and evaluation following Yttrium-90 (Y-90)  microsphere treatment. Simplicit90Y provides tools to create, transform, and modify  ontours/Regions of Interest for the user to define objects in medical image volumes to support TheraSphere post-Y-90 treatment calculation and evaluation. The objects include,  but are not limited to, tumors and normal tissues, and liver volumes. Simplicit90Y is indicated for registration, fusion display and review of medical images allowing medical professionals to incorporate images, such as CT, MRI, PET, CBCT and SPECT in TheraSphere Yttrium-90 (Y-90) microspheres pre-treatment planning and post-Y-90 treatment evaluation For post-Yttrium-90 (Y-90) treatment, Simplicit90Y should only be used for the retrospective determination of dose and should not be used to prospectively calculate dose or for the case where there is a need for retreatment using Y-90 microspheres. 

PI-994110-AA
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