IQQA-LIVER SOFTWARE
Device Facts
| Record ID | K061696 |
|---|---|
| Device Name | IQQA-LIVER SOFTWARE |
| Applicant | Edda Technology, Inc. |
| Product Code | LLZ · Radiology |
| Decision Date | Nov 13, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, 3rd-Party Reviewed |
Indications for Use
The IQQA-Liver is a PC-based, self-contained, non-invasive image analysis software application for reviewing serial multi-phase CT acquisitions of the liver. Combining image viewing, processing and reporting tools, the software is designed to support physicians in the visualization, evaluation and reporting of liver and physician-identified liver lesions. The software supports a workflow based on automated image registration for viewing and analyzing multi-phase volume datasets. It also includes tools for interactive segmentation and labeling of liver segments and vascular structures. The software provides functionalities for manual or interactive segmentation of physician-identified lesions, and allows for regional volumetric analysis of such lesions in terms of size, shape, position and enhancement pattern, providing information for physician's assessment of lesion characterization. The software is designed for use by trained physicians. Image source: DICOM.
Device Story
IQQA-Liver is a PC-based, non-invasive software application for analyzing DICOM multi-phase CT liver images. It assists trained physicians in visualizing, evaluating, and reporting on liver anatomy and lesions. Key functions include automated image registration for multi-phase datasets; interactive segmentation and labeling of liver segments and vascular structures; and manual or interactive segmentation of physician-identified lesions. The software performs regional volumetric analysis (size, shape, position, enhancement pattern) to support lesion characterization. Output includes quantitative measurements, lesion ROI images, and illustrative snapshots for clinical reporting. Physicians use these outputs to aid in diagnosis and patient management decisions. The device streamlines workflow by synchronizing multi-phase datasets and providing tools for spatial relationship visualization between lesions and anatomical landmarks.
Clinical Evidence
Bench testing only. Software testing and validation were conducted according to written protocols established prior to testing. Results were reviewed by technical professionals to confirm performance satisfies design intent.
Technological Characteristics
PC-based software application. Inputs: DICOM multi-phase CT images. Processing: Automated image registration, interactive segmentation, and quantitative volumetric analysis. Features: 2D axial viewing, window level adjustment, MPR, MIP, and automated reporting. Connectivity: Standalone PC. Software: Non-invasive image analysis application.
Indications for Use
Indicated for trained physicians to visualize, evaluate, and report on liver and physician-identified liver lesions using serial multi-phase CT acquisitions.
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
Submission Summary (Full Text)
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## EXHIBIT 2
EDDA Technology 510(k) Summary
NOV 1 3 2006
14 Washington Road, Building 2 Princeton Junction, NJ 08550 Tel: 609-936-8282 Fax: 609-799-1545 Contact: Xiaolan Zeng, Vice President Date prepared: May 25, 2006
- 1. Identification of the Device: Proprietary - Trade Name: IQQA-Liver Software Classification Name: System, Image Processing, Radiological, Product Code LLZ Common/Usual Name: Radiological Image Processing System
- 2. Equivalent legally marketed devices:
| Manufacturer | Name of the Predicate<br>Device | FDA 510(k)<br>Number | FDA Clearance<br>Date |
|----------------------------------|-----------------------------------------------|----------------------|-----------------------|
| Mevis Technology<br>GMBH & CO.KG | Mevis LiverAnalyser /<br>LiverViewer Software | K051528 | 07/20/2005 |
| GE Medical<br>Systems | Volume Viewer Plus | K041521 | 06/22/2004 |
- 3. Indications for Use (intended use): The IQQA-Liver is a PC-based, self-contained, noninvasive image analysis software application for reviewing serial multi-phase CT acquisitions of the liver. Combining image viewing, processing and reporting tools, the software is designed to support physicians in the visualization, evaluation and reporting of liver and physician-identified liver lesions. The software supports a workflow based on automated image registration for viewing and analyzing multi-phase volume datasets. It also includes tools for interactive segmentation and labeling of liver segments and vascular structures. The software provides functionalities for manual or interactive segmentation of physician-identified lesions, and allows for regional volumetric analysis of such lesions in terms of size, shape, position and enhancement pattern, providing information for physician's assessment of lesion characterization. The software is designed for use by trained physicians. Image source: DICOM.
- 4. Description of the device: The IQQA-Liver Software is a self-contained, non-invasive radiographic image analysis application that is designed to run on standard PC hardware. The image input is DICOM. Combining image processing, viewing and reporting tools, the software supports physicians in the visualization, evaluation and reporting of liver and physician identified liver lesions. Viewing tools include 2D axial image viewing, window level adjustment, a pre-defined optimized liver window level setting, synchronized viewing of multi-phase datascts, MPR and MIP. Analysis and evaluation tools include segmentation of structures utilizing user input of seeding points, interactive labeling of segmented areas, quantitative measurement derived from segmentation and labeling results, and the measurement of distance between physician specified structures to landmarks. Reporting
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tools in the software automatically assemble information (including physician identified lesion locations, measurement information, physician-input lesion characterization, lesion ROl images across multi-phases, and illustrative snapshots of the GUI taken by physicians) for physician's confirmation and for further diagnosis note input. The IQQA-Liver software supports a workflow based on automated registration for viewing and analyzing multi-phase volume datasets. The software automatically matches the spatial location of axial images across multi-phases, and provides synchronized viewing of multi-phase dataset to aid visualization. The software further includes tools for interactive segmentation and interactive labeling of liver segments and vascular structures (such as liver lobes, vessels and major branches), thus facilitating the visualization of spatial relationship between suspicious liver lesions and specified anatomical structures/landmarks. The tools also allow for interactive segmentation of physician-identified lesions using user input of seed points, and regional analysis of such lesions with respect to size, shape, position and enhancement pattern, thus providing information to help physician's assessment of lesion characterization. The software is designed for use by trained physicians only. Physicians make all final patient management decisions.
| | Device of 510(k)<br>submission: | Predicate Device: | Predicate Device: |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | IQQA-Liver Software | Mevis LiverAnalyser<br>/LiverViewer software | Volume Viewer Plus |
| | | K051528 | K041521 |
| Manufacturer | EDDA Technology, Inc. | Mevis Technology<br>GMBH & CO.KG | GE Medical Systems |
| Indications<br>for Use | The IQQA-Liver is a PC-<br>based, self-contained,<br>non-invasive image<br>analysis software<br>application for reviewing<br>serial multi-phase CT<br>acquisitions of the liver.<br>Combining image<br>viewing, processing and<br>reporting tools, the<br>software is designed to<br>support physicians in the<br>visualization, evaluation<br>and reporting of liver and<br>physician-identified liver<br>lesions.<br><br>The software supports a<br>workflow based on<br>automated image<br>registration for viewing<br>and analyzing multi-<br>phase volume datasets. It | The Mevis LiverAnalyzer<br>/ LiverViewer<br>SoftwareTM device is<br>intended for preoperative<br>planning in liver surgery.<br>The device is used to<br>analyze data and to<br>display image analysis<br>and risk analysis results<br>for the preoperative<br>planning in liver surgery,<br>e.g. organ segmentation,<br>tumor segmentation,<br>segmentation of<br>intrahepatic vessels as<br>well as the approximation<br>of vascular territories.<br>Preoperative evaluation<br>of specific surgery<br>strategies is supported by<br>the feature to<br>interactively define<br>virtual resections splitting | Volume Viewer Plus is<br>medical diagnostic software<br>that allows the processing,<br>review, analysis and<br>communication of 3D<br>reconstructed images and<br>their relationship to originally<br>acquired images from CT,<br>MR, X-Ray Angio and PET<br>scanning devices. The<br>combination of acquired<br>images, reconstructed images,<br>annotations and<br>measurements performed by<br>the clinician are intended to<br>provide to the referring<br>physician clinically relevant<br>information for diagnosis,<br>surgery and treatment<br>planning. |
- 5. Safety and Effectivencss, comparison to predicate devices:
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| | also includes tools for<br>interactive segmentation<br>and labeling of liver<br>segments and vascular<br>structures. The software<br>provides functionalities<br>for manual or automated<br>segmentation of<br>physician-identified<br>lesions, and allows for<br>regional volumetric<br>analysis of lesions in<br>terms of size, shape,<br>position and<br>enhancement pattern,<br>providing information for<br>physician's assessment of<br>lesion characterization.<br>The software is designed<br>for use by trained<br>physicians. Image source:<br>DICOM. | the liver or to calculate<br>safety margins<br>around lesions identifying<br>affected vascular<br>branches and vascular<br>territories supplied or<br>drained by these<br>branches. Medical image<br>data is derived from<br>various sources (i.e. CT<br>scanners, MRI scanners).<br>Typical users of this<br>system are trained<br>professionals, including<br>physicians, nurses, and<br>technicians. | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Hardware<br>Configuration | standard PC hardware | standard PC hardware | standard PC hardware |
| User<br>Interface | A graphical user interface<br>for users to interact with<br>the software, select tools<br>and drive workflow | A graphical user interface<br>for users to interact with<br>the software, select tools<br>and drive workflow | A graphical user interface for<br>users to interact with the<br>software, select tools and<br>drive workflow |
## 6. Testing Information and Conclusion
In all material respects, the IQQA-Liver Software is substantially equivalent to the predicate systems. Testing was performed according to internal company procedures. Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent.
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
EDDA Technology, Inc. % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747
NOV 13 2016
Re: K061696
Trade/Device Name: IQQA-Liver Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 23, 2006 Received: October 30, 2006
Dear Mr. Conry:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
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Protecting and Promoting Public Health
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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); good manufacturing practice requirements as set Orth 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.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known): __ Ko61696__________________________________________________________________________________________________________________________________________
## Device Name: IQQA-Liver Software
The IQQA-Liver is a PC-based, sclf-contained, non-invasive image analysis software application for reviewing serial multi-phase CT acquisitions of the liver. Combining image viewing, processing and reporting tools, the software is designed to support physicians in the visualization, evaluation and reporting of liver and physician-identified liver lesions.
The software supports a workflow based on automated image registration for viewing and analyzing multi-phase volume datasets. It also includes tools for interactive segmentation and labeling of liver segments and vascular structures. The software provides functionalities for manual or interactive segmentation of physician-identified lesions, and allows for regional volumetric analysis of such lesions in terms of size, shape, position and enhancement pattern, providing information for physician's assessment of lesion characterization.
The software is designed for use by trained physicians. Image source: DICOM.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy L. Broadon
(Division Sign-Off)
Division of Reproductive, A and Radiological Devices 510(k) Number
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