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510(k) Data Aggregation
(34 days)
The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron 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.
This CT system can be used for low dose lung cancer screening in high risk populations. *
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365; 395-409) and subsequent literature, for further information.
The Biograph Vision and Biograph mCT PET/CT 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 Vision and Biograph mCT 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 Vision and Biograph mCT software is a command-based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The software for the Biograph Vision and Biograph mCT systems, which are the subject of this application, is substantially equivalent to the commercially available Biograph Vision and Biograph mCT software.
- Somaris Software (cleared in K230421)
- Upgrade to the latest revision of Somaris Software (Somaris/7 syngo CT VB30) with modified software features:
- FAST Bolus
- FAST 4D
- FAST Applications (FAST Spine, FAST Planning)
- Automatic Patient Instructions
- Additional default exam protocols
- Additional kV setting for Tin Filtration
- Upgrade to the latest revision of Somaris Software (Somaris/7 syngo CT VB30) with modified software features:
- PETsyngo software
- SMART Image Framer (available for Vision 600 and X models only – cleared in K223547)
- Updated computer hardware due to obsolescence issues (cleared in K230421). These changes do not affect system performance characteristics and have no impact on safety or effectiveness.
The Biograph Vision may also use the names Biograph Vision Quantum and Peak for marketing purposes.
Here's an analysis of the provided FDA 510(k) clearance letter for Siemens Biograph Vision and mCT PET/CT Systems, focusing on acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the performance of the updated software (VG85) for the Siemens Biograph Vision and Biograph mCT PET/CT Systems, comparing it to the predicate device (VG80). The "Acceptance Criteria" for the subject device are explicitly stated as "Same" as the predicate device's performance values. This implies that the updated system must perform at least as well as the predicate device across all tested metrics.
| Performance Criteria (NEMA NU2-2018) | Predicate Device Acceptance Values (K193248) | Reported Device Performance (VG85) | Meets Criteria? |
|---|---|---|---|
| Resolution – Full Size | |||
| Transverse Resolution FWHM @ 1 cm | ≤ 4.0 mm (Vision) / ≤ 4.7 mm (mCT) | Same | Pass |
| Transverse Resolution FWHM @ 10 cm | ≤ 4.8 mm (Vision) / ≤ 5.4 mm (mCT) | Same | Pass |
| Transverse Resolution FWHM @ 20 cm | ≤ 5.2 mm (Vision) / ≤ 6.3 mm (mCT) | Same | Pass |
| Axial Resolution FWHM @ 1 cm | ≤ 4.3 mm (Vision) / ≤ 4.9 mm (mCT) | Same | Pass |
| Axial Resolution FWHM @ 10 cm | ≤ 5.4 mm (Vision) / ≤ 6.5 mm (mCT) | Same | Pass |
| Axial Resolution FWHM @ 20 cm | ≤ 5.4 mm (Vision) / ≤ 8.8 mm (mCT) | Same | Pass |
| Count Rate / Scatter / Sensitivity | |||
| Sensitivity @435 keV LLD | ≥ 8.0 cps/kBq (Vision 450) | ||
| ≥ 15.0 cps/kBq (Vision 600) | |||
| ≥ 5.0 cps/kBq – (mCT 3R) | |||
| ≥ 9.4 cps/kBq – (mCT 4R) | Same | Pass | |
| Count Rate peak NECR | ≥140 kcps @ ≤ 32 kBq/cc (Vision 450) | ||
| ≥250 kcps @ ≤ 32 kBq/cc (Vision 600 and X) | |||
| ≥95 kcps @ ≤ 30 kBq/cc (mCT 3R) | |||
| ≥165 kcps @ ≤ 40 kBq/cc (mCT 4R) | Same | Pass | |
| Count Rate peak trues | ≥600 kcps @ ≤ 56 kBq/cc (Vision 450) | ||
| ≥1100 kcps @ ≤ 56 kBq/cc (Vision 600 and X) | |||
| ≥350 kcps @ ≤ 46 kBq/cc (mCT 3R) | |||
| ≥575 kcps @ ≤ 40 kBq/cc (mCT 4R) | Same | Pass | |
| Scatter Fraction (435 keV LLD) | ≤43% @ Peak *\ |
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