(68 days)
No reference devices were used in this submission.
No
The summary describes standard image processing, visualization, and measurement tools. There is no mention of AI, ML, or related concepts like deep learning, training data for algorithms, or performance metrics typically associated with AI/ML models (e.g., AUC, sensitivity/specificity from an AI perspective). The performance studies focus on accuracy of measurements and user evaluation of features, not on the performance of an AI/ML algorithm.
No
The device is described as a "visualization package for PACS workstations" and a "general purpose medical image processing tool" for reading and analyzing medical datasets. Its functions such as measurement, segmentation, and visualization are intended to support diagnosis and analysis, not to provide therapy or treatment. The caution specifically states that images should "not be used to create a diagnosis, treatment plan, or other decision that may affect patient care" when accessed via web-browser, further indicating its role is not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software "is intended to support the medical professional in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets." The mention of "diagnosis" directly indicates its role as a diagnostic device.
Yes
The device is described as "Volume Viewing software" and "IMPAX Volume Viewing is a general purpose medical image processing tool". The description focuses entirely on the software's functionality for processing and visualizing medical images, and it is intended to be used on "PACS workstations". There is no mention of any accompanying hardware component that is part of the device itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this software is a "visualization package for PACS workstations" and a "general purpose medical image processing tool for the reading and analysis of 3D image datasets." It works with medical images (DICOM compliant volumetric medical datasets, CT, MR), not biological samples.
- Intended Use: The intended use is to "support the medical professional in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets." This involves interpreting images, not analyzing biological samples.
The software's purpose is to help medical professionals interpret medical images for diagnosis and analysis, which falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM compliant volumetric medical datasets, CT, MR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professional, PACS workstations
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
Agfa invited 3 radiologists from several Belgian hospitals to its facilities to evaluate the new functionality. In a lab environment the radiologists selected and loaded representative clinical datasets on IMPAX Clinical Applications 4.0 and its predicate devices. They executed typical workflows and scored the features under investigation. A scoring scale was implemented and acceptance criteria established. Results met acceptance criteria.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing confirmed the device meets performance, safety, usability and security requirements. No clinical trials were performed in the development of the device.
Verification:
Regression testing assured the different measurement algorithms still provide the same output as the previous version IMPAX Volume Viewing 3.0 (K133135). Testers made identical measurements of diameters, areas and volumes and compared those against reference values. Results met the established acceptance criteria of +/- scanner resolution (for dataset uncertainty).
The tests also included crosshair position checks to verify whether viewports link to the same location in every dataset. Results met the established acceptance criteria of half a voxel (for rounding differences across graphic video cards).
Validation:
Agfa invited 3 radiologists from several Belgian hospitals to its facilities to evaluate the new functionality. In a lab environment the radiologists selected and loaded representative clinical datasets on IMPAX Clinical Applications 4.0 and its predicate devices. They executed typical workflows and scored the features under investigation. A scoring scale was implemented and acceptance criteria established. Results met acceptance criteria.
The tests concluded that IMPAX Clinical Applications 4.0 is substantially equivalent to the predicate iNtuition 4.4.11 in terms of endoscopic viewing of tubular structures (vessels and airways) and to the predicate IMPAX Volume Viewing 3.0 in terms of image rendering. Also the accuracy of the lung nodule segmentation and the capabilities of the lesion management module were scored. These features were found to be adequate to segment lesions, analyze them and follow-up on their growth over the time.
All verification and validation testing has been successfully completed.
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.
No reference devices were used in this submission.
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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with medicine and healthcare.
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.
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.
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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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: +32 3 444 7539
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.
4
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:
-
- 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.
-
- 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,
-
- 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
5
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.
6
| | IMPAX
Volume Viewing
4.0
NEW DEVICE | IMPAX
Volume Viewing 3.0
(K133135)
PRIMARY
PREDICATE | TeraRecon
iNtuition 4.4.11
(K121916)
PREDICATE |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 3D Volume rendering | SAME AS PREDICATES | √ | √ |
| MPR, CPR | SAME AS PREDICATES | √ | √ |
| MIP, MinIP, AvgIP | SAME AS PREDICATES | √ | √ |
| Fusion and subtraction
views | SAME AS PREDICATES | √ | √ |
| Can load and register two
data sets for comparison
(landmark based,
automated, manual) | SAME AS PREDICATES | √ | √ |
| Multi-modality (CT and
MR) image registration | SAME AS PREDICATES | √ | √ |
| Anaglyphic stereo 3D
Viewing | SAME AS PREDICATES | √ | √ |
| Segmentation tools | SAME AS PREDICATES | √ | √ |
| Automated removal of the
CT-table | SAME AS PREDICATES | √ | √ |
| Automated removal of
bone-like structures | SAME AS PREDICATES | √ | √ |
| Volume measurements | SAME AS PREDICATES | √ | √ |
| Semi-automatied region
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 | √ | √ |
| Color maps & Annotations | SAME AS PREDICATES | √ | √ |
| Intra- or internet access for
review purposes (mobile
use) | SAME AS PREDICATES | √ | √ |
| Lesion Management
Module | SAME AS K121916 | X | √ |
| Automated lung nodule
segmentation | SAME AS K121916 | X | √ |
| Endoscopic fly-through for
vessels and airways | SAME AS K121916 | X | √ |
| Calcium Scoring of
atherosclerotic plaque | SAME AS K133135 | X | √ |
| Interpretation of
mammography images | SAME AS K133135 | X | √ |
| Tumor evaluation using
RECIST criteria | SAME AS K133135 | X | √ |
| | IMPAX
Volume Viewing
4.0
NEW DEVICE | IMPAX
Volume Viewing 3.0
(K133135)
PRIMARY
PREDICATE | TeraRecon
iNtuition 4.4.11
(K121916)
PREDICATE |
| Liver measurements | SAME AS K133135 | X | √ |
| Time-Volume Analysis
(TVA), Cardiac function
and Time Dependent
Analysis (TDA) of blood
flow | SAME AS K133135 | X | √ |
| Tools for Endovascular
Aortic Repair (for stent
placement) | SAME AS K133135 | X | √ |
| Virtual Colonoscopy | SAME AS K133135 | X | √ |
| User interface | SAME AS K133135 | IMPAX | iNtuition |
| Indications for Use | 1. Visualization package for
PACS workstations.
2. Support the medical
professional in the reading,
analysis and diagnosis of
DICOM compliant
volumetric medical datasets.
3. General purpose digital
medical image processing
tool, with optional
functionality to facilitate
visualization and
measurement of vessel
features.
4. Optional functionality -
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 image data (MR) to
measurements - evaluation
and quantification of tumor
measurements, and other
analysis and evaluation of
both hard and soft tissues.
5. 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.
6. Web-browser access is | 1. Visualization package
for PACS workstations.
2. Support the medical
professional in the
reading, analysis and
diagnosis of DICOM
compliant volumetric
medical datasets.
3. General purpose
digital medical image
processing tool, with
optional functionality to
facilitate visualization
and measurement of
vessel features.
4. Optional functionality
- 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 -
evaluation and
quantification of tumor
measurements, and other
analysis and evaluation
of both hard and soft
tissues.
- Supports interactive
segmentation of a region
of interest (ROI). - Web-browser access is
available for review
purposes. Images | 1. Provide access to images via client-
server software, web browser and
mobile technology. - Support healthcare professionals
assist physicians in diagnosis by
receiving, storing, transmitting, post-
processing, displaying and allowing
manipulation of reports and medical
images from acquisition devices,
including optical or other non-DICOM
format images. - Visualization in combination of 2D,
3D and 4D are supported for single or
multiple datasets. - Tools are provided to define and
edit paths through structures such as
centerlines, which may be used to
analyze cross-sections of structures, or
to provide flythrough visualizations
rendered. Region Segmentation and
quantitative analysis tools - images of
vasculature, pathology and
morphology and tracking of quantities
over time. - Database - track and compare
results using published comparison
techniques. Calcium scoring for
quantification of atherosclerotic plaque
and digital image processing to derive
metadata or new images from input
image sets are supported. Image
processing - extract metadata to derive
parametric images from combinations
of multiple input images. - Interpretation of mammographic
images or digitized film screen images
is only supported when software is |
| IMPAX
Volume Viewing
4.0
NEW DEVICE | IMPAX
Volume Viewing 3.0
(K133135)
PRIMARY
PREDICATE | TeraRecon
iNtuition 4.4.11
(K121916)
PREDICATE | |
| 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. | 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. | used without compression and with an
FDA-Approved monitor. Not intended
to replace full workstations and should
only be used when there is no access
to a workstation. Not intended for
web-browser or mobile diagnostic use. | |
7
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Table 1: Device Comparison Table
VI. PERFORMANCE DATA
Verification and validation testing confirmed the device meets performance, safety, usability and security requirements. No clinical trials were performed in the development of the device.
There are no applicable FDA mandated performance standards for this device. However, Agfa's in-house standard operating procedures were used for the development of the software; these procedures conform to the following standards:
- ISO 13485:2003 Medical Devices Quality Management Systems ●
- ISO 14971:2007 Application of Risk Management to Medical Devices
- ISO 27001:2013 Information Security Management ●
- ISO 62366:2007 Medical Devices Application of usability engineering to medical devices ●
- IEC 62304:2006 Medical Device Software Software life cycle processes ●
Verification
Verification tests for IMPAX Clinical Applications 4.0 covered all requirements and identified risk control measures.
Regression testing assured the different measurement algorithms still provide the same output as the previous version IMPAX Volume Viewing 3.0 (K133135). Testers made identical measurements of diameters, areas and volumes and compared those against reference values. Results met the established acceptance criteria of +/- scanner resolution (for dataset uncertainty).
The tests also included crosshair position checks to verify whether viewports link to the same location in every dataset. Results met the established acceptance criteria of half a voxel (for rounding differences across graphic video cards).
Validation
Agfa invited 3 radiologists from several Belgian hospitals to its facilities to evaluate the new functionality. In a lab environment the radiologists selected and loaded representative clinical
9
datasets on IMPAX Clinical Applications 4.0 and its predicate devices. They executed typical workflows and scored the features under investigation. A scoring scale was implemented and acceptance criteria established. Results met acceptance criteria.
The tests concluded that IMPAX Clinical Applications 4.0 is substantially equivalent to the predicate iNtuition 4.4.11 in terms of endoscopic viewing of tubular structures (vessels and airways) and to the predicate IMPAX Volume Viewing 3.0 in terms of image rendering. Also the accuracy of the lung nodule segmentation and the capabilities of the lesion management module were scored. These features were found to be adequate to segment lesions, analyze them and follow-up on their growth over the time.
All verification and validation testing has been successfully completed.
Summary
Based on the performance data as documented in the above testing, IMPAX Volume Viewing 4.0 is found to have a safety and effectiveness profile that is similar to the predicate devices.
CONCLUSIONS VII.
The device has indications for use that are consistent with those of the legally marketed predicate devices. Where technological characteristics differ lab tests concluded that the device is substantially equivalent to the predicates in that it does not alter the intended therapeutic/diagnostic effect.
This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
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