IMPAX Volume Viewing 4.0

K161061 · Agfa Healthcare N.V. · LLZ · Jun 22, 2016 · Radiology

Device Facts

• Record ID: K161061
• Device Name: IMPAX Volume Viewing 4.0
• Applicant: Agfa Healthcare N.V.
• Product Code: LLZ · Radiology
• Decision Date: Jun 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Volume Viewing software is a visualization package for PACS workstations. It is intended to support the medical professional in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets. The software is intended as a general purpose digital image processing tool, with optional functionality to facilitate visualization and measurement of vessel features. Other optional functionality is intended for the registration of anatomical (CT) on a second CT dataset or on functional volumetric image data (MR) to facilitate the comparison of various lesions. Volume and distance measurements are intended for evaluation and quantification of tumour measurements, and other analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of a region of interest (ROI), has a dedicated tool set for lung lesion segmentation, quantification and follow-up of lesions selected by the user and provides tools to define and edit paths such as centerlines through structures, which may be used to analyze cross-sections of structures, or to provide flythrough visualizations rendered along such centerline. Caution: Web-browser access is available for review purposes. Images accessed through a web-browser (via a mobile device or by other means) should not be used to create a diagnosis, treatment plan, or other decision that may affect patient care.

Device Story

IMPAX Volume Viewing 4.0 is a PACS workstation software accessory for 3D medical image processing. It inputs DICOM-compliant volumetric datasets (CT, MR). The software performs multi-planar reformatting (MPR), curved planar reformatting (CPR), volume rendering, and image registration. It provides automated tools for table/bone removal, vessel/airway segmentation, and lung lesion quantification. Users (radiologists/clinicians) operate the software on PACS workstations to view, measure, and analyze anatomical structures. Output includes 2D/3D visualizations, cross-sectional views, and quantitative measurements (distance, volume). A web-browser variant allows remote review, though it is restricted from diagnostic use. The device assists clinicians in lesion management and follow-up, potentially improving diagnostic efficiency and patient monitoring.

Clinical Evidence

No clinical trials were performed. Evidence consists of bench-top verification and validation. Verification included regression testing of measurement algorithms against reference values (meeting +/- scanner resolution criteria) and crosshair position checks (meeting half-voxel criteria). Validation involved three radiologists evaluating new functionality (lung nodule segmentation, lesion management, fly-through) in a lab environment using clinical datasets; results met established acceptance criteria.

Technological Characteristics

Software-based PACS accessory. Features 3D volume rendering, MPR, CPR, MIP, MinIP, AvgIP, and multi-modality registration. Includes automated segmentation (vessels, airways, lung lesions) and lesion management tools. Connectivity via PACS network or web-browser. Developed per ISO 13485, ISO 14971, ISO 27001, ISO 62366, and IEC 62304 standards.

Indications for Use

Indicated for medical professionals to read, analyze, and diagnose DICOM-compliant volumetric medical datasets. Supports visualization/measurement of vessel features, registration of CT/MR datasets for lesion comparison, quantification of tumors, and analysis of hard/soft tissues. Includes tools for ROI segmentation, lung lesion segmentation/follow-up, and flythrough visualization of vessels/airways. Not for diagnostic use via web-browser/mobile access.

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

• IMPAX Volume Viewing 3.0 (K133135)
• TeraRecon iNtuition 4.4.11 (K121916)

Submission Summary (Full Text)

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

June 22, 2016

AGFA Healthcare N.V. % ShaeAnn Cavanagh, RAC Regulatory Affairs Manager AGFA HealthCare Corporation 10 South Academy Street GREENVILLE SC 29601

Re: K161061

Trade/Device Name: IMPAX Volume Viewing 4.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 8, 2016 Received: June 8, 2016

Dear Ms. Cavanagh:

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

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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# Indications for Use

510(k) Number (if known) K161061

Device Name IMPAX Volume Viewing 4.0

### Indications for Use (Describe)

The Volume Viewing software is a visualization package for PACS workstations. It is intended to support the medical professional in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets. The software is intended as a general purpose digital mage processing tool, with optional functionality to facilitate visualization and measurement of vessel features.

Other optional functionality is intended for the registration of anatomical (CT) on a second CT dataset or on functional volumetric image data (MR) to facilitate the comparison of various lesions. Volume and distance measurements are intended for evaluation and quantification of tumour measurements, and evaluation of both hard and soft tissues. The software also supports interactive segmentation of a region of interest (ROI), has a dedicated tool set for lung lesion segmentation, quantification and follow-up of lesions selected by the user and provides tools to define and edit paths such as centerlines through structures, which may be used to analyze cross-sections of structures, or to provide flythrough visualizations rendered along such centerline.

Caution: Web-browser access is available for review purposes. Images accessed through a web-browser (via a mobile device or by other means) should not be used to create a diagnosis, treatment plan, or other decision that may affect patient care.

Type of Use (Select one or both, as applicable)

| <div> <span> <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.236.236 0 0 1 .02-.022z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(K) SUMMARY:

### Agfa IMPAX Volume Viewing 4.0

#### SUBMITTER I.

Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Koen Cobbaert, Prepared: April 14, 2016 Telephone: [phone]

#### II. DEVICE

Name of Device: IMPAX Volume Viewing 4.0 Common Name: System, Image Processing, Radiological Classification Name: Picture Archiving and Communications System (PACS) Regulatory Classification: Class II, 21 CFR 892.2050 Product Code: LLZ

#### III. PREDICATE DEVICES

This is a 510(k) for Agfa's IMPAX Volume Viewing 4.0, which is a picture archiving and communications system. It is substantially equivalent to Agfa's IMPAX Volume Viewing 3.0 (K133135) and TeraRecon's iNtuition 4.4.11 (K121916).

These predicates have not been subject to a design-related recall. No reference devices were used in this submission.

#### DEVICE DESCRIPTION IV.

IMPAX Volume Viewing is a general purpose medical image processing tool for the reading and analysis of 3D image datasets. It is also intended for the registration of anatomical (CT) image data onto functional (MR) data to facilitate the comparison of various lesions. Volume and distance measurements facilitate the quantification of lesions and the analysis of both soft and hard tissue.

A variant of the software also provides web-browser access for review purposes. Images accessed through a web-browser (via a mobile device or by other means) should not be used to create a diagnosis, treatment plan, or other decision that may affect patient care.

The new device is similar to the predicate devices. All are PACS system accessories that allow the user to view and manipulate 3D image data sets. This new version adds a dedicated tool set for lesion management and flythrough visualizations rendered along a centerline for endoscopic view of vessels and airways.

Principles of operation and technological characteristics of the new and predicate devices are the same.

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# INTENDED USE

The Volume Viewing software is a visualization package for PACS workstations. It is intended to support the medical professional in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets. The software is intended as a general purpose digital image processing tool, with optional functionality to facilitate visualization and measurement of vessel features.

Other optional functionality is intended for the registration of anatomical (CT) on a second CT dataset or on functional volumetric image data (MR) to facilitate the comparison of various lesions. Volume and distance measurements are intended for evaluation and quantification of tumour measurements, and other analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of a region of interest (ROI), has a dedicated tool set for lung lesion segmentation, quantification and follow-up of lesions selected by the user and provides tools to define and edit paths such as centerlines through structures, which may be used to analyze cross-sections of structures, or to provide flythrough visualizations rendered along such centerline.

Caution: Web-browser access is available for review purposes. Images accessed through a web-browser (via a mobile device or by other means) should not be used to create a diagnosis, treatment plan, or other decision that may affect patient care.

Intended use has not changed as a result of any labeling modification(s).

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH V. PREDICATE DEVICES

Agfa's IMPAX Volume Viewing 4.0 has an Indication for Use statement largely similar to the statements for the predicate devices (K133135, K121916). Intended uses are the same. As software accessories to PACS systems, the predicates and the new device have the same technological characteristics. The software is used to identify characteristic patterns within 3D image data which the user can then view and manipulate.

IMPAX Volume Viewing 4.0 comprises the same functionality to manipulate and analyze 3D image data as its primary predicate IMPAX Volume Viewing 3.0. The device subject of this submission however differs on the following technological characteristics:

- 1. The visualization algorithm for multi-planar reformatting (MPR) now employs a different interpolation. MPR visualization is present in the primary predicate IMPAX Volume Viewing 3.0, but uses a different algorithm.
- 2. It includes additional visualization tools for fly-through along a centerline intended for endoscopic viewing of vessels and airways. This functionality is present in the secondary predicate TeraRecon's inNuition, but uses proprietary algorithms,
- 3. New tools were added for the automated segmentation and management of lung lesions. This functionality is present in the secondary predicate TeraRecon's inNuition, but uses proprietary algorithms.

Descriptive characteristics and performance data are adequate to ensure equivalence.

Differences in devices do not alter the intended therapeutic/diagnostic effect.

IMPAX Volume Viewing 4.0 is an accessory to Agfa's IMPAX PACS systems. It is a general

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purpose medical image processing tool for the reading and analysis of 3D image datasets. It is the successor to Agfa's Volume Viewing 3.0 (K133135) and adds the following new functionality: a dedicated tool set for lung lesion segmentation, quantification and follow-up of lesions selected by the user and tools to define and edit paths such as centerlines through structures, which may be used to analyze cross-sections of structures, or to provide flythrough visualizations rendered along such centerline.

It is a tool for conveniently viewing and manipulating cross-sectional image series for display in any orientation and slice thickness. A second series can be registered or fused to the first automated, manually or with user defined landmarks. Automated table removal, removal of bonelike structures and segmentation of blood vessels and air-filled structures facilitate the visualization of vessels and airways. The software includes measurement tools for stenosis and lesions. A web-browser variant with a limited tool set provides remote access for review purposes.

In addition the software provides color maps, subtraction views, multiple screen layouts and anaglyphic images. Anaglyphic images are used to provide a stereoscopic 3D effect, when viewed with glasses where the two lenses are different (usually chromatically opposite) colors, such as red and cyan. Images are made up of two color lavers, superimposed, but offset with respect to each other to produce a depth effect. The stereoscopic 3D view is available next to the "regular" 3D view. A user can toggle the image from the regular 3D view to stereo 3D. Tests by medical professionals showed that there are no specific medical or clinical benefits to using the stereoscopic 3D view. It is perceived as useful to train medical students, but has no clinical benefits in comparison to the "regular" 3D view.

The table on the next page summarizes the similarities and differences between the new device and the predicates.

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| | IMPAX<br>Volume Viewing<br>4.0<br>NEW DEVICE | IMPAX<br>Volume Viewing 3.0<br>(K133135)<br>PRIMARY<br>PREDICATE | TeraRecon<br>iNtuition 4.4.11<br>(K121916)<br>PREDICATE |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 3D Volume rendering | SAME AS PREDICATES | √ | √ |
| MPR, CPR | SAME AS PREDICATES | √ | √ |
| MIP, MinIP, AvgIP | SAME AS PREDICATES | √ | √ |
| Fusion and subtraction<br>views | SAME AS PREDICATES | √ | √ |
| Can load and register two<br>data sets for comparison<br>(landmark based,<br>automated, manual) | SAME AS PREDICATES | √ | √ |
| Multi-modality (CT and<br>MR) image registration | SAME AS PREDICATES | √ | √ |
| Anaglyphic stereo 3D<br>Viewing | SAME AS PREDICATES | √ | √ |
| Segmentation tools | SAME AS PREDICATES | √ | √ |
| Automated removal of the<br>CT-table | SAME AS PREDICATES | √ | √ |
| Automated removal of<br>bone-like structures | SAME AS PREDICATES | √ | √ |
| Volume measurements | SAME AS PREDICATES | √ | √ |
| Semi-automatied region<br>growing | SAME AS PREDICATES | √ | √ |
| Vessel analysis | SAME AS PREDICATES | √ | √ |
| Stenosis measurements | SAME AS PREDICATES | √ | √ |
| AVI movie generation | SAME AS PREDICATES | √ | √ |
| Reformat to a new dataset | SAME AS PREDICATES | √ | √…