(151 days)
Not Found
No
The summary describes standard image processing and visualization techniques, segmentation, and measurement tools. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or automated interpretation based on learned patterns. The focus is on providing tools for manual and semi-automatic analysis by the user.
No
The device is described as a workstation and software for visualization and measurement of the heart and vessels, intended for pre-operational planning, postoperative evaluation, and support of clinical diagnosis. It does not perform any therapeutic action.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "Support[s] of clinical diagnosis by quantifying dimensions in coronary arteries" and "Support[s] of clinical diagnosis by quantifying calcifications (calcium scoring) in the coronary arteries," which directly indicates its role in diagnosis.
Yes
The device description explicitly states "The 3mensio Workstation software allows cardiologists, radiologist 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." and the entire description focuses on software functionalities for image processing and analysis. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, the 3mensio Workstation is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The 3mensio Workstation processes medical images (CT data) of the heart and vessels, which are not specimens in the sense of blood, tissue, urine, etc., that are typically analyzed by IVDs.
- The intended use and device description focus on image visualization, measurement, and planning for interventions and diagnosis based on imaging data. This aligns with the function of medical image processing systems, not IVDs.
- The classification name is "Image Processing System". This further supports that the device falls under the category of medical imaging software, not IVDs.
- There is no mention of analyzing biological samples or performing tests on bodily fluids or tissues.
The 3mensio Workstation is a medical device that aids in the diagnosis and planning of procedures by processing and analyzing medical images. It is not designed to perform tests on samples taken from the body, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
Indications for Use:
3mensio Workstation enables visualization and measurement of the heart and vessels for:
- · Pre-operational planning and sizing for cardiovascular interventions and surgery
- · Postoperative evaluation
- · Support of clinical diagnosis by quantifying dimensions in coronary arteries
- · Support of clinical diagnosis by quantifying calcifications (calcium scoring) in the coronary arteries
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 - CMPR, Slabbing, MIP, AIP, MinIP
- · Measurement and annotation tools
- Reporting tools
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)
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The 3mensio Workstation software allows cardiologists, radiologist 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. 3mensio Workstation works with all major medical image formats and can access multiple data stores and across networks.
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 contains two modules, 3mensio Structural Heart (containing submodule cCTA), and 3mensio Vascular which can be marketed in combination or as separate solutions:
- 3mensio Structural Heart enables assessment and measurement of differen structures of the heart, e.g. aortic valve, mitral valve and ventricles. It provides analysis of the feasibility of a transapical, transfemoral or subclavian approach to structures for replacement or repair procedures.
- 3mensio cCTA enables assessment and measurement of the coronary arteries and can help in the quantification of the dimensions of the coronary arteries and of the calcified plaques present in coronary arteries.
- 3mensio Vascular enables assessment of vessels and can help identify calcifications, aneurysms and other anomalies to quickly and reliably prepare for various types of vascular procedures.
The results can be displayed, printed or saved in a variety of formats to a hard disk, network, PACS system or CD. Results can also be printed as a hardcopy.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT data in DICOM format (vendor independent)
Anatomical Site
Heart and vessels, coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Cardiologists, Radiologists and Clinical Specialists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The verification and validation of the 3mensio Workstation functionality was performed according to the Design Control procedure. Verification of the 3mensio Workstation showed that the system requirements – derived from the intended use and indications for use – were implemented correctly, demonstrating the effectiveness of the device.
A validation plan for the final validation of the release build is created and was executed on the final build. A test report comparing the numerical results of the device compared with the predicate devices is also available.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 27, 2016
Pie Medical Imaging B.V. % Ms. Annemeik Bouts Regulatory Affairs Coordinator Philipsweg 1 Maastricht 6227 AJ THE NETHERLANDS
Re: K153736
Trade/Device Name: 3mensio Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 20, 2016 Received: May 2, 2016
Dear Ms. Bouts:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Ochs
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name 3mensio Workstation
Indications for Use (Describe)
3mensio Workstation enables visualization and measurement of the heart and vessels for:
- · Pre-operational planning and sizing for cardiovascular interventions and surgery
- · Postoperative evaluation
- · Support of clinical diagnosis by quantifying dimensions in coronary arteries
- · Support of clinical diagnosis by quantifying calcifications (calcium scoring) in the coronary arteries
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
- CMPR, Slabbing, MIP, AIP, MinIP · Measurement and annotation tools
- Reporting tools
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary | 3mensio Workstation 8.0 | [GEN2261]v1.0 |
|---|---|---|
| Submitter/Owner Name | Pie Medical Imaging BV | |
| Address | Philipsweg 1, 6227 AJ Maastricht, The Netherlands | |
| Phone Number | +31 43 32 81 328 | |
| Fax Number | +31 43 32 81 329 | |
| Contact Person: | Annemiek Bouts, Regulatory Affairs Coordinator | |
| Email Address | annemiek.bouts@pie.nl | |
| Preparation Date | 16-dec-15 | |
| Trade Name | 3mensio Structural Heart / 3mensio Vascular | |
| Common Name | 3mensio Workstation | |
| Classification: | Classification Name: Image Processing System | |
| Classification Panel: Radiology | ||
| Regulation Class: Class II | ||
| Regulation number: 21 CFR 892.2050 | ||
| Classification Product Code: LLZ | ||
| Predicate Devices | 3mensio Workstation (K120367) | |
| Philips Intellispace Cardiovascular (K153022) | ||
| Device Description | The 3mensio Workstation software allows cardiologists, radiologist 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. 3mensio | ||
| Workstation works with all major medical image formats and can access multiple | ||
| data stores and across networks. |
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 contains two modules, 3mensio Structural Heart
(containing submodule cCTA), and 3mensio Vascular which can be marketed in
combination or as separate solutions:
3mensio Structural Heart enables assessment and measurement of differen
structures of the heart, e.g. aortic valve, mitral valve and ventricles. It provides
analysis of the feasibility of a transapical, transfemoral or subclavian approach to
structures for replacement or repair procedures. 3mensio cCTA enables assessment and measurement of the coronary
arteries and can help in the quantification of the dimensions of the
coronary arteries and of the calcified plaques present in coronary
arteries. 3mensio Vascular enables assessment of vessels and can help identify
calcifications, aneurysms and other anomalies to quickly and reliably prepare for
various types of vascular procedures. | |
| The results can be displayed, printed or saved in a variety of formats to a hard disk, network, PACS system or CD. Results can also be printed as a hardcopy. | | |
| 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 Support of clinical diagnosis by quantifying dimensions in coronary arteries Support of clinical diagnosis by quantifying calcifications (calcium scoring) in the coronary arteries To facilitate the above, the 3mensio Workstation provides general functionality such as: Segmentation of cardiovascular structures Automatic and manual centerline detection | |
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- Measurement and annotation tools ●
- . Reporting tools
Technological Characteristics Comparison
A comparison of the technological characteristics of the predicate and subject device is given the table below.
New Device Predicate Device Predicate Device 3mensio Workstation Device name 3mensio Workstation Intellispace Cardiovascular Pie Medical Imaging Manufacturer Pie Medical Imaging Philips K120367 510(k) number K153022 Intended Use and Indications for Use Intended use 3mensio Workstation is a software 3mensio Workstation is a software Philips IntelliSpace Cardiovascular solution that is intended to provide solution that is intended to provide software product is an integrated cardiologists, radiologists and clinical cardiologists, radiologists and clinical multimodality image and information specialists additional information to aid specialists additional information to aid system designed to perform the them in reading and interpreting them in reading and interpreting DICOM necessary functions required for DICOM compliant medical images of compliant medical images of structures of import, export, storage, archival, structures of the heart and vessels. the heart and vessels. review, analysis, quantification, reporting and database management 3mensio Structural Heart enables the 3mensio Structural Heart enables the user of digital medical images. user to: to: · Visualize and measure (diameters, · Visualize and measure (diameters, lengths, areas, volumes, angles) lengths, areas, volumes, angles) structures of the heart and vessels structures of the heart and vessels · Quantify calcium (volume, density) · Quantify calcium (volume, density) 3mensio Vascular enables the user to: 3mensio Vascular enables the user to: · Visualize and assess stenosis, · Visualize and assess stenosis, aneurisms aneurisms and vascular structures and vascular structures · Measure the dimensions of vessels · Measure the dimensions of vessels (diameters, lengths, areas, volumes, (diameters, lengths, areas, volumes,
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| New Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| Device name | 3mensio Workstation | 3mensio Workstation | Intellispace Cardiovascular |
| Manufacturer | Pie Medical Imaging | Pie Medical Imaging | Philips |
| 510(k) number | - | K120367 | K153022 |
| angles) | 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 | |||
| • Support of clinical diagnosis by | |||
| quantifying dimensions in coronary | |||
| arteries | |||
| • Support of clinical diagnosis by | |||
| quantifying calcified plaques (calcium | |||
| scoring) in the coronary arteries |
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 | 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 | Philips IntelliSpace Cardiovascular
software product is an integrated
multimodality image and information
system designed to perform the
necessary functions required for
import, export, storage, archival,
review, analysis, quantification,
reporting and database management
of digital cardiovascular images,
waveforms
and data related to cardiology.
Philips IntelliSpace Cardiovascular
offers support for third party
applications in order to enable the use
of commercially available tools and
specified applications for analysis,
quantification and reporting. It allows
multiple users fast access to, and
exchange of specific and/or multiple
cardiology exams.
Philips IntelliSpace Cardiovascular
software runs on standard information
technology hardware and software,
utilizing the standard information
technology operating systems and
user interface.
Communication and data exchange
are done using standard protocols.
Philips IntelliSpace
Cardiovascular will also be made
available for use on specified
Cardiovascular Monitoring Systems,
which use suitable hardware
components.
The modular design allows
configurability to tailor the image
import, archive and communications
solution
to one's particular budgetary and
performance needs. The number of
modalities and reporting and/or
viewing sites can be configured per
system. |
| | Technological Characteristics | | |
| Data type | • CT data in DICOM format (vendor
independent) | • CT data in DICOM format (vendor
independent) | • Any image modality data in
DICOM format (vendor
independent) |
| Input of Patient
Data | • Manual through keyboard/mouse
• Command line interface | • Manual through keyboard/mouse
• Command line interface | • Manual through
keyboard/mouse
• Command line interface |
| Study list image
functionality | • Exporting
• Deleting
• Anonymizing (no automatic deletion
of original patient data)
• Search | • Exporting
• Deleting
• Anonymizing (no automatic deletion
of original patient data)
• Search | Full patient/study list support |
| Centreline
extraction | • Realign orthogonal MPRs
• Segmentation toolset:
- Automatic segmentation
- Automatic centreline
- Manual centreline | • Realign orthogonal MPRs
• Segmentation toolset: - Automatic segmentation
- Automatic centreline
- Manual centreline | (Features not mentioned since they
are not relevant for the equivalence) |
| | New Device | Predicate Device | Predicate Device |
| Device name | 3mensio Workstation | 3mensio Workstation | Intellispace Cardiovascular |
| Manufacturer | Pie Medical Imaging | Pie Medical Imaging | Philips |
| 510(k) number | | K120367 | K153022 |
| | - Centreline editing Undo/redo operations Volume sculpting | - Centreline editing Undo/redo operations Volume sculpting | |
| Image
Assessment
X-Ray | Linear (length and diameter), angular and ROI measurements Volume measurements C-Arm angulation calculation Text and arrow annotations Calcium scoring for assessment of calcium in the aortic root Calcium scoring for assessment of calcium in the coronary arteries Segmentation and analysis of coronary artery tree centerline | Linear (length and diameter), angular and ROI measurements Volume measurements C-Arm angulation calculation Text and arrow annotations Calcium scoring in vasculature | Calcium scoring for assessment of calcium in the coronary arteries (HeartBeat CS module) (Other features not mentioned since they are not relevant for the equivalence) |
| Image
Assessment –
IVUS / OCT | Orthogonal, oblique, double oblique, curved, cross-curved, stretched MPR rendering MIP, AveIP, MinIP and color volume slabs MIP volume rendering Color volume rendering Grayscale volume rendering 2D slice review and stack comparison 4D cine Interactive VOI clipping Multi-tissue color and opacity control Active presets User-defined presets | Orthogonal, oblique, double oblique, curved, cross-curved, stretched MPR rendering MIP, AveIP, MinIP and color volume slabs MIP volume rendering Color volume rendering Grayscale volume rendering 2D slice review and stack comparison 3D view Interactive VOI clipping Multi-tissue color and opacity control Active presets User-defined presets | (Features not mentioned since they are not relevant for the equivalence) |
| DICOM support | Compatible with all scanner vendor DICOM datasets Storage SCP Import DICOM files DICOM compliance for CT, enhanced CT, MRI, enhanced MRI, XA, Nuclear Medicine, CR, SC, and Ultrasound images Import from DICOMDIR Storage SCU Query/retrieve SCU Automatic grouping of images into volumes Windows printing or send to PACS | Compatible with all scanner vendor DICOM datasets Storage SCP Import DICOM files DICOM compliance for CT, MRI, XA, Nuclear Medicine, CR, SC, and Ultrasound images Import from DICOMDIR Storage SCU Query/retrieve SCU Automatic grouping of images into volumes Windows printing or send to PACS | Full DICOM support (identifical to or more extensive than new device) |
| Storage of
Results | Printout Session state PDF format DICOM PDF report | Printout Session state PDF format DICOM SC report | (Features not mentioned since they are not relevant for the equivalence) |
| Operating | Microsoft Windows | Microsoft Windows | Microsoft Windows |
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Conformance Standards The device complies with the following conformance standards:
- NEMA PS 3.1 3.20 (2011), Digital Imaging and Communication in . Medicine (DICOM) Set. (Radiology)
- ISO 14971:2007 Medical devices Application of risk management to • medical devices
Performance Data The verification and validation of the 3mensio Workstation functionality was performed according to the Design Control procedure. Verification of the
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| 3mensio Workstation showed that the system requirements – derived from the |
|---|
| intended use and indications for use – were implemented correctly, demonstrating |
| the effectiveness of the device. |
A validation plan for the final validation of the release build is created and was executed on the final build.
A test report comparing the numerical results of the device compared with the predicate devices is also available.
Substantial Equivalence The analysis workflows 3mensio Structural Heart and 3mensio Vascular in the previously cleared device 3mensio Workstation (K120367) are available in 3mensio Workstation and are the same in terms of intended use and indications for use and have the same technological characteristic. The difference between these two devices is that the workflow '3mensio cCTA' has been added in 3mensio Workstation. With the addition of the '3mensio cCTA' workflow, the new 3mensio Workstation is, like the predicate 3mensio Workstation (K120367), intended to support the interventional cardiologist and radiologist with diagnoses and assist them during intervention of cardiovascular conditions.
3mensio cCTA consists of 2 features: Calcium scoring for coronary vessels and coronary vessel measurement.
3mensio cCTA Calcium scoring is compared to the HeartBeat CS module of Philips Intellispace Cardiovascular (K153022), which has similar intended use and indications for use as the new device. HeartBeat CS also performs calcium scoring in coronary vessels on DICOM CT images, like the predicate device. Technologically and in terms of GUI interaction, both features are very similar.
3mensio cCTA Coronary vessel measurement is compared to the vascular measurement module of 3mensio Workstation (K120367). Both types of measurements produce the same results, are measured in the same type of images, and use the same techniques: perform measurement on areas in reconstructed cross-sectional images based on a 3D centreline. Technologically and in terms of GUI interaction, both features are very similar.
Conclusion From the comparison table and substantial equivalence analysis we conclude that the intended use and technological characteristics of 3mensio Workstation are substantially equivalent to a combination of the predicate device 3mensio Workstation (K120367) and the predicate device Philips Intellispace Cardiovascular (K153022). Based on the application of risk management and performance testing we conclude that 3mensio Workstation is as safe and effective as its predicate devices and does not raise any new issues related to safety and effectiveness compared to the predicate devices, and has a comparable performance.