· 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

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.

AI/ML Overview

The provided document describes the 3mensio Workstation, a software device for visualizing and measuring the heart and vessels. The submission focuses on demonstrating substantial equivalence to predicate devices, particularly for newly added features: 3mensio cCTA Calcium scoring and 3mensio cCTA Coronary vessel measurement.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds) for the device's performance. Instead, it relies on demonstrating that the new features are "very similar" in technology and user interface to legally marketed predicate devices and that they produce "the same results" as a comparable module in a predicate.

Acceptance Criterion (Implied)	Reported Device Performance
3mensio cCTA Calcium scoring:	"Technologically and in terms of GUI interaction, both features are very similar." (in comparison to HeartBeat CS module of Philips Intellispace Cardiovascular K153022)
Functional equivalence to predicate for calcium scoring
3mensio cCTA Coronary vessel measurement:	"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 centerline." "Technologically and in terms of GUI interaction, both features are very similar." (in comparison to the vascular measurement module of 3mensio Workstation K120367)
Functional equivalence to predicate for coronary vessel measurement
Overall device functionality Verification	"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 was executed, and "A test report comparing the numerical results of the device compared with the predicate devices is also available." (Specific numerical results are not provided in this document.)

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the studies performed. It only mentions that a "test report comparing the numerical results of the device compared with the predicate devices is also available."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth. The nature of the comparison ("producing the same results" as predicate devices) suggests that the ground truth might implicitly be the results generated by the predicate devices, rather than a separate expert-derived ground truth.

4. Adjudication Method

The document does not specify any adjudication method for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this document. The submission focuses on technical equivalence to predicate devices, not on demonstrating improved human reader performance with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This appears to be a standalone algorithm, as the comparison is made directly between the device's numerical results and those of predicate devices. The document does not describe any human-in-the-loop performance studies, but rather the device's ability to render, segment, and measure cardiovascular structures by itself, similar to the predicate. Specifically, the "3mensio cCTA Calcium scoring" and "3mensio cCTA Coronary vessel measurement" are standalone features being compared to their counterparts in predicate devices. The overall 3mensio Workstation is a software solution for clinicians to use, but the testing reported here refers to the functional equivalence of the algorithms within it.

7. The Type of Ground Truth Used

The ground truth implicitly used for the performance comparison is the results generated by the predicate devices. The document states that the new features "produce the same results" and are "very similar" in technology and GUI interaction to the predicate devices. This indicates that the predicate's output serves as the reference for equivalence.

8. The Sample Size for the Training Set

The document does not specify any sample size for a training set. This is consistent with the nature of the submission, which is for equivalence based on functional similarity to predicates, rather than a de novo submission for a novel AI algorithm requiring extensive training data validation.

9. How the Ground Truth for the Training Set Was Established

Since no training set is described, information on how its ground truth was established is not provided.

Summary

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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.

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K153736

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 SystemClassification Panel: RadiologyRegulation Class: Class IIRegulation number: 21 CFR 892.2050Classification Product Code: LLZ
Predicate Devices	3mensio Workstation (K120367)Philips Intellispace Cardiovascular (K153022)
Device Description	The 3mensio Workstation software allows cardiologists, radiologist and clinicalspecialists to select patient studies from various data sources, view them, andprocess the images with the help of a comprehensive set of tools. 3mensioWorkstation works with all major medical image formats and can access multipledata stores and across networks.3mensio Workstation can combine 2D scan slices into comprehensive 3D modelsof the patient, and can display supporting ultrasound and X-ray Angio data. Thesoftware accurately represents different types of tissue, making it easier todiagnose anomalies in scans.3mensio Workstation contains two modules, 3mensio Structural Heart(containing submodule cCTA), and 3mensio Vascular which can be marketed incombination or as separate solutions:3mensio Structural Heart enables assessment and measurement of differenstructures of the heart, e.g. aortic valve, mitral valve and ventricles. It providesanalysis of the feasibility of a transapical, transfemoral or subclavian approach tostructures for replacement or repair procedures. 3mensio cCTA enables assessment and measurement of the coronaryarteries and can help in the quantification of the dimensions of thecoronary arteries and of the calcified plaques present in coronaryarteries. 3mensio Vascular enables assessment of vessels and can help identifycalcifications, aneurysms and other anomalies to quickly and reliably prepare forvarious 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)
Indicationsfor Use	3mensio Workstation enablesvisualization and measurement ofstructures of the heart and vessels for:• Pre-operational planning and sizingfor cardiovascular interventions andsurgery• Postoperative evaluation• Support of clinical diagnosis byquantifying dimensions in coronaryarteries• Support of clinical diagnosis byquantifying calcified plaques (calciumscoring) in the coronary arteriesTo facilitate the above, the 3mensioWorkstation provides generalfunctionality such as:• Segmentation of cardiovascularstructures• Automatic and manual centerlinedetection• Visualization and imagereconstruction techniques: 2D review,Volume Rendering, MPR, CurvedMPR, Stretched CMRP, Slabbing,MIP, AIP, MinIP• Measurement and annotation tools• Reporting tools	3mensio Workstation enables visualizationand measurement of structures of the heartand vessels for:• Pre-operational planning and sizing forcardiovascular interventions andsurgery• Postoperative evaluationTo facilitate the above, the 3mensioWorkstation provides general functionalitysuch as:• Segmentation of cardiovascularstructures• Automatic and manual centerlinedetection• Visualization and imagereconstruction techniques: 2D review,Volume Rendering, MPR, CurvedMPR, Stretched CMRP, Slabbing,MIP, AIP, MinIP• Measurement and annotation tools• Reporting tools	Philips IntelliSpace Cardiovascularsoftware product is an integratedmultimodality image and informationsystem designed to perform thenecessary functions required forimport, export, storage, archival,review, analysis, quantification,reporting and database managementof digital cardiovascular images,waveformsand data related to cardiology.Philips IntelliSpace Cardiovascularoffers support for third partyapplications in order to enable the useof commercially available tools andspecified applications for analysis,quantification and reporting. It allowsmultiple users fast access to, andexchange of specific and/or multiplecardiology exams.Philips IntelliSpace Cardiovascularsoftware runs on standard informationtechnology hardware and software,utilizing the standard informationtechnology operating systems anduser interface.Communication and data exchangeare done using standard protocols.Philips IntelliSpaceCardiovascular will also be madeavailable for use on specifiedCardiovascular Monitoring Systems,which use suitable hardwarecomponents.The modular design allowsconfigurability to tailor the imageimport, archive and communicationssolutionto one's particular budgetary andperformance needs. The number ofmodalities and reporting and/orviewing sites can be configured persystem.
	Technological Characteristics
Data type	• CT data in DICOM format (vendorindependent)	• CT data in DICOM format (vendorindependent)	• Any image modality data inDICOM format (vendorindependent)
Input of PatientData	• Manual through keyboard/mouse• Command line interface	• Manual through keyboard/mouse• Command line interface	• Manual throughkeyboard/mouse• Command line interface
Study list imagefunctionality	• Exporting• Deleting• Anonymizing (no automatic deletionof original patient data)• Search	• Exporting• Deleting• Anonymizing (no automatic deletionof original patient data)• Search	Full patient/study list support
Centrelineextraction	• 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 theyare 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
ImageAssessmentX-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)
ImageAssessment –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 ofResults	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.

Regulation Number and Section

§ 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).