(71 days)
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No
The summary describes standard image processing and visualization tools without mentioning AI or ML.
No.
The device is a software solution that aids in reading and interpreting medical images for diagnosis and pre-operational planning, not for directly treating or preventing disease.
No
The device is described as a software solution that provides "additional information to aid them in reading and interpreting DICOM compliant medical images." It allows for visualization and measurement of structures, but it does not make a diagnosis itself; rather, it supports the clinician in doing so.
Yes
The device description explicitly states it is a "stand-alone software application intended to run on a PC with a Windows operating system." It processes existing medical images and does not include any hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The 3mensio Workstation is a software solution that processes and analyzes medical images (DICOM data) of the heart and vessels. It provides tools for visualization, measurement, and planning based on these images.
- Input Data: The input data is medical imaging data (CT, MRI, XA, etc.), not biological samples from the patient.
- Intended Use: The intended use is to provide additional information to aid in reading and interpreting medical images for pre-operational planning, sizing, and postoperative evaluation. This is image analysis and planning, not a diagnostic test performed on a biological sample.
Therefore, the 3mensio Workstation falls under the category of medical image processing and analysis software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: 3mensio Workstation is a software solution that is intended to provide Cardiologists. Radiologists and Clinical Specialists additional information to aid them in reading and interpreting DICOM compliant medical images of structures of the heart and vessels.
3mensio Structural Heart enables the user to:
- Visualize and measure (diameters, lengths, areas, volumes, angles) structures . of the heart and vessels
- Quantify calcium (volume, density) .
3mensio Vascular enables the user to:
- Visualize and assess stenosis, aneurisms and vascular structures .
- Measure the dimensions of vessels (diameters, lengths, areas, volumes, . angles)
Indications for Use: 3mensio Workstation enables visualization and measurement of structures of the heart and vessels for:
- Pre-operational planning and sizing for cardiovascular interventions and . surgery
- Postoperative evaluation .
To facilitate the above, the 3mensio Workstation provides general functionality such as:
- . Segmentation of cardiovascular structures
- Automatic and manual centerline detection .
- Visualization and image reconstruction techniques: 2D review, Volume . Rendering, MPR, Curved MPR, Stretched CMRP, Slabbing, MIP, AIP, MinIP
- . Measurement and annotation tools
- Reporting tools .
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
3mensio Workstation is a stand-alone software application intended to run on a PC with a Windows operating system. It allows Cardiologists, Radiologists and Clinical Specialists to select patient studies from various data sources, view them, and process the images with the help of a comprehensive set of tools. The 3mensio Workstation contains two modules, 3mensio Structural Heart and 3mensio Vascular, which can be marketed in combination or as separate solutions. 3mensio Structural Heart enables assessment and measurement of different structures of the Heart, e.g. aortic valve, mitral valve, ventricles. It provides simple techniques to assess the feasibility of a transapical, transfemoral or subclavian approach to structures for replacement or repair procedures. 3mensio Vascular enables assessment of vessels and can help the physician identify calcifications, aneurysms and other anomalies to quickly and reliably prepare for various types of vascular surgery. The 3mensio Workstation can combine 2D scan slices into comprehensive 3D models of the patient, and can display supporting ultrasound and X-ray Angio data. The software accurately represents different types of tissue, making it easier to diagnose anomalies in scans. 3mensio Workstation works with all major medical image formats and can access multiple data stores and across networks.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
DICOM compliant medical images; ultrasound; X-ray Angio; CT, enhanced CT, MRI, enhanced MRI, XA, Nuclear Medicine, CR, SC, and Ultrasound images
Anatomical Site
Heart and vessels; cardiovascular structures; aortic valve, mitral valve, ventricles; vasculature
Indicated Patient Age Range
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Intended User / Care Setting
Cardiologists, Radiologists and Clinical Specialists
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
3mensio Workstation is developed and tested by 3mensio Medical Imaging according to their Quality Assurance system. Testing includes software verification and validation. The tests were made to evaluate the 3mensio Workstation and yield accuracy and precision results within the predetermined specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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