(53 days)
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Position Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.
The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging.
These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
The Biograph TruePoint Family of systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph TruePoint systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.
Biograph TruePoint PET/CT Family software is a command based program used for patient manaqement, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The updates to the Biograph TruePoint systems software which are the subject of this application are considered substantially equivalent to the commercially available Biograph TruePoint software. Major modifications to the family of systems include:
- . General
- Update of the operating system to Windows 7 for the ACS and PRS components O for improved sustainability
- Support for SolidCore implemented for chanqe protection and software O security.
- updates to address anomalies for CT and PET software o
- synqo software upgrade .
- o Update of the synqo software to the latest revision (drivers, etc...)
- . Somaris Software Update
- Upgrade to the latest revision Somaris Software (VB42) (K140232) O
- Inclusion of MITA Dose check features to be compliant with the MITA dose о requirements. Dose Notification and Dose Alert; Dose Logs; Access and CARE Analytics, CARE Dose 4D etc ...
- Improvements to scanning and reconstruction workflows o
- PETsynqo software .
- Update of software to provide for improved consistency of features between all O TruePoint models
- Update to add Variable Bed Time O
- Update of the software scatter correction and bed removal O
- Update of the TrueD software O
- Improvements to the service tools O
- O Improvements to workflow
This document describes the Biograph TruePoint PET/CT Family Software, focusing on its substantial equivalence to predicate devices and performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The performance testing for the PET subsystem was conducted in accordance with NEMA NU2:2007 for two configurations: a 3-ring and a 4-ring version of the Biograph TruePoint systems.
| Performance Criteria (Standard) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Transverse Resolution FWHM @ 1 cm | = 4.0 cps/kBq (3R) |
= 7.0 cps/kBq (4R) | Pass |
| Count Rate peak NECR | 86 kcps @ 42 kBq/cc (3R)
148 kcps @ 42 kBq/cc (4R) | Pass |
| Count Rate peak trues | 306 kcps @ 42 kBq/cc (3R)
467 kcps @ 42 kBq/cc (4R) | Pass |
| Count Rate bias (mean) |
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.