3MENSIO WORKSTATION

K120367 · Pie Medical Imaging BV · LLZ · Apr 17, 2012 · Radiology

Device Facts

• Record ID: K120367
• Device Name: 3MENSIO WORKSTATION
• Applicant: Pie Medical Imaging BV
• Product Code: LLZ · Radiology
• Decision Date: Apr 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for 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)

Device Story

3mensio Workstation is a standalone PC-based software application for cardiologists, radiologists, and clinical specialists. It ingests DICOM-compliant medical images (CT, MRI, XA, Ultrasound, etc.) from various network sources. The software provides tools for image segmentation, automatic/manual centerline detection, and multi-planar reconstruction (MPR, curved MPR, volume rendering, MIP, MinIP). Users interact with the workstation to visualize, measure (diameters, lengths, areas, volumes, angles), and quantify calcium in heart and vascular structures. The output consists of processed images, measurements, and reports, which assist clinicians in pre-operative planning, sizing for interventions, and post-operative evaluation. By providing detailed anatomical assessments and measurements, the device aids in the diagnosis of anomalies and the preparation for vascular or structural heart surgeries.

Clinical Evidence

No clinical data. The submission relies on software verification and validation testing performed under the manufacturer's Quality Assurance system to demonstrate that the device meets predetermined specifications for accuracy and precision.

Technological Characteristics

Standalone software application for Windows OS. Features include DICOM-compliant image processing, segmentation, centerline detection, and various visualization techniques (MPR, Volume Rendering, MIP, MinIP). Connectivity via network access to DICOM data stores. No specific hardware materials or energy sources; software-based processing.

Indications for Use

Indicated for visualization and measurement of cardiovascular structures for pre-operational planning, sizing for cardiovascular interventions/surgery, and postoperative evaluation in patients requiring cardiac or vascular assessment.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• 3vision/surgery (K072653)

Submission Summary (Full Text)

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# APR 1 7 2012

### 510(k) Summary

#### 3mensio Workstation

[QA693]v2.0

| Submitter Name | Pie Medical Imaging BV | | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Submitter Address | Becanusstraat 13 D, 6216 BX Maastricht, The Netherlands | | |
| Contact Person: | Florie Daniels, Product Registration Coordinator | | |
| Phone Number | [phone] | | |
| Fax Number | [phone] | | |
| Email Address | Florie. [e-mail] | | |
| Preparation Date | 31 January 2012 | | |
| Trade Name | 3mensio Structural Heart / 3mensio Vascular | | |
| Common Name | 3mensio Workstation | | |
| Regulation Class | Class II (21 CFR, part 892.2050, LLZ) | | |
| Classification Name | Picture Archiving and Communications System | | |
| Predicate Devices | 3vision/surgery, cleared under K072653 | | |
| Device Description | 3mensio Workstation is a stand-alone software application intended to run on a<br>PC with a Windows operating system. It allows Cardiologists, Radiologists and<br>Clinical Specialists to select patient studies from various data sources, view them,<br>and process the images with the help of a comprehensive set of tools. The<br>3mensio Workstation contains two modules, 3mensio Structural Heart and<br>3mensio Vascular, which can be marketed in combination or as separate<br>solutions. 3mensio Structural Heart enables assessment and measurement of<br>different structures of the Heart, e.g. aortic valve, mitral valve, ventricles. It<br>provides simple techniques to assess the feasibility of a transapical, transfemoral<br>or subclavian approach to structures for replacement or repair procedures.<br>3mensio Vascular enables assessment of vessels and can help the physician<br>identify calcifications, aneurysms and other anomalies to quickly and reliably<br>prepare for various types of vascular surgery. The 3mensio Workstation can<br>combine 2D scan slices into comprehensive 3D models of the patient, and can<br>display supporting ultrasound and X-ray Angio data. The software accurately<br>represents different types of tissue, making it easier to diagnose anomalies in<br>scans. 3mensio Workstation works with all major medical image formats and can<br>access multiple data stores and across networks. | | |

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)

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K120367
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### 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 .

The technological comparision table shows the equivalence between the 3mensio Workstation software and the predicated device.

| New Device | Predicate Device |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| 3mensio Workstation | 3viseon/surgery |
| Pie Medical Imaging | 3mensio |
| K120367 | K072653 |
| Interface to image sources | Interface to image sources |
| DICOM image data | DICOM image data |
| Import of Patient Data | Import of Patient Data |
| Manual through keyboard/mouse | Manual through keyboard/mouse |
| Automatic import with image file | Automatic import with image file |
| Study List creation | Study List creation |
| Study list image functionality | Study list image functionality |
| Exporting | Exporting |
| Deleting | Deleting |
| Anonymizing (no automatic deletion of original patient data) | Anonymizing (no automatic deletion of original patient data) |
| Search | Search |
| Image processing: | Image processing: |
| Realign orthogonal MPRS | Realign orthogonal MPRS |
| Segmentation toolset: | Segmentation toolset: |
| - Automatic segmentation | - Automatic segmentation |
| - Automatic centreline | - Automatic centreline |
| - Manual centreline | - Manual centreline |
| - Centreline editing | - Centreline editing |
| Undo/redo operations | Undo/redo operations |
| Volume sculpting | Volume sculpting |
| Image assessment: | Image assessment: |
| Linear (length and diameter), angular and ROI measurements | Linear (length and diameter), angular and ROI measurements |
| Volume measurements | Volume measurements |
| C-Arm angulation calculation | C-Arm angulation calculation |
| Text and arrow annotations | Text and arrow annotations |
| Calcium scoring for assessment of calcium in the aortic root | Calcium scoring in vasculature |
| Image display: | Image display: |
| Orthogonal, oblique, double oblique, curved, cross-curved, stretched MPR rendering | Orthogonal, oblique, double oblique, curved, cross-curved, stretched MPR rendering |
| MIP, AvelP, MinIP and color volume slabs | MIP, AveIP, MinIP and color volume slabs |
| MIP volume rendering | MIP volume rendering |

## Technological Characteristics Comparison

· Pie Medical Imaging BV

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K1206367
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| New Device | Predicate Device |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 3mensio Workstation | 3viseon/surgery |
| Pie Medical Imaging | 3mensio |
| K120367 | K072653 |
| 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 | 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 | User-defined presets |
| DICOM Support:<br>Compatible with all scanner vendor<br>DICOM datasets Storage SCP Import DICOM files DICOM compliance for CT, enhanced<br>CT, MRI, enhanced MRI, XA, Nuclear<br>Medicine, CR, SC, and Ultrasound images Import from DICOMDIR Storage SCU Query/retrieve SCU Automatic grouping of images into<br>volumes Windows printing or send to PACS | DICOM Support:<br>Compatible with all scanner vendor<br>DICOM datasets Storage SCP Import DICOM files DICOM compliance for CT, MRI,<br>XA, Nuclear Medicine, CR, SC, and<br>Ultrasound images Import from DICOMDIR Storage SCU Query/retrieve SCU Automatic grouping of images into<br>volumes Windows printing or send to PACS |
| Storage of Results<br>Printout Session state PDF format DICOM PDF report | Storage of Results<br>Printout Session state PDF format DICOM SC report |
| MS Windows | MS Windows |

### Performance Data

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.

3mensio Workstation is produced and marketed under the responsibility of manufacturer Pie Medical Imaging.

Substantial Equivalence

·

Substantial Equivalence The intended use and technological characteristics of 3mensio Workstation are substantial equivalent to the intended use and technological characteristics of the predicate device.

Conclusion

The testing reported in this 510(k) establishes that 3mensio Workstation is substantial equivalent to the predicate device and is safe and effective for its intended use.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

APR 1 7 2012 -

Ms. Florie Daniels Regulatory Affairs Coordinator Pie Medical Imaging BV Becanusstraat 13D Maastricht, Limburg 6216 BX THE NETHERLANDS

Re: K120367

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: January 31, 2012 Received: February 6, 2012

## Dear Ms. Daniels:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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### Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809); please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K120367

# Indications for Use

### 510(k) Number:

.

Device Name: 3mensio Workstation

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, 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

Prescription Use 2 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radfological Devices Vitro Diagnostic Device Evaluation and Safety Office of Ya

510K. K120367