TruPlan is a medical software that helps doctors visualize and measure heart and vessel structures from CT scans to assist in planning the left atrial appendage closure procedure. It provides tools such as segmentation, 3D rendering, and simulated imaging views to support detailed anatomical assessment and device sizing for safe and effective treatment.
Intended Use
TruPlan enables visualization and measurement of structures of the heart and vessels for pre-procedural planning and sizing for the left atrial appendage closure (LAAC) procedure.
Technology
TruPlan is a standalone Windows software that performs segmentation, 2D and 3D visualization, simulated imaging views (fluoroscopy, TEE, ICE), and provides measurement and annotation tools based on user-identified regions from CT images in DICOM format. It uses machine learning methodology for 3D cardiac rendering to support anatomical assessment for device sizing in LAAC procedures.
Performance
Verification and validation testing were conducted using validated phantoms and in compliance with applicable FDA standards and guidance documents. Testing confirmed quantitative measurement accuracy, DICOM conformance, software design compliance, and cybersecurity considerations. No clinical studies were required for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/6/2020
6 months - 2
FDA Approval
2/19/2021
Other devices from Circle Cardiovascular Imaging Inc.
- StrokeSENS ASPECTS Software Application2025 • 510K
- cvi42 Software Application2024 • 510K
- Cardiac CT Function Software Application2024 • 510K
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