(152 days)
Not Found
No
The summary describes image processing, segmentation, and registration tools, but does not mention AI or ML. The automated registration and segmentation features are described as based on user input or standard image processing techniques, not AI/ML algorithms.
No
The device is described as an image analysis software for visualization, evaluation, and reporting of liver and liver lesions, supporting diagnosis and assessment, but not providing any direct treatment or therapy.
Yes
The device aids in the visualization, evaluation, and reporting of liver and liver lesions, providing information for "physician's assessment of lesion characterization" and allowing for "further diagnosis note input." This directly supports the diagnostic process.
Yes
The device is described as a "PC-based, self-contained, non-invasive image analysis software application" and "a self-contained, non-invasive radiographic image analysis application that is designed to run on standard PC hardware." It processes DICOM images and provides viewing, analysis, and reporting tools. There is no mention of proprietary hardware or components included with the device; it relies on standard PC hardware for operation.
Based on the provided information, the IQQA-Liver 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.
- IQQA-Liver Function: The IQQA-Liver is a software application that analyzes medical images (CT scans) of the liver. It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states it's for "reviewing serial multi-phase CT acquisitions of the liver" and "support physicians in the visualization, evaluation and reporting of liver and physician-identified liver lesions." This is image analysis, not in vitro testing.
- Device Description: The description reinforces that it's a "radiographic image analysis application" that takes "DICOM" image input.
Therefore, the IQQA-Liver falls under the category of medical image analysis software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
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 tools in the software automatically assemble information (including physician identified lesion locations, measurement information, physician-input lesion characterization, lesion ROI 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physicians, PC-based. Prescription Use.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Not Found
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
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
-
- 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
-
- Equivalent legally marketed devices:
| Manufacturer | Name of the Predicate
Device | FDA 510(k)
Number | FDA Clearance
Date |
|----------------------------------|-----------------------------------------------|----------------------|-----------------------|
| Mevis Technology
GMBH & CO.KG | Mevis LiverAnalyser /
LiverViewer Software | K051528 | 07/20/2005 |
| GE Medical
Systems | Volume Viewer Plus | K041521 | 06/22/2004 |
-
- 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.
-
- 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
1
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)
submission: | Predicate Device: | Predicate Device: |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | IQQA-Liver Software | Mevis LiverAnalyser
/LiverViewer software | Volume Viewer Plus |
| | | K051528 | K041521 |
| Manufacturer | EDDA Technology, Inc. | Mevis Technology
GMBH & CO.KG | GE Medical Systems |
| 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 | The Mevis LiverAnalyzer
/ LiverViewer
SoftwareTM device is
intended for preoperative
planning in liver surgery.
The device is used to
analyze data and to
display image analysis
and risk analysis results
for the preoperative
planning in liver surgery,
e.g. organ segmentation,
tumor segmentation,
segmentation of
intrahepatic vessels as
well as the approximation
of vascular territories.
Preoperative evaluation
of specific surgery
strategies is supported by
the feature to
interactively define
virtual resections splitting | Volume Viewer Plus is
medical diagnostic software
that allows the processing,
review, analysis and
communication of 3D
reconstructed images and
their relationship to originally
acquired images from CT,
MR, X-Ray Angio and PET
scanning devices. The
combination of acquired
images, reconstructed images,
annotations and
measurements performed by
the clinician are intended to
provide to the referring
physician clinically relevant
information for diagnosis,
surgery and treatment
planning. |
-
- Safety and Effectivencss, comparison to predicate devices:
2
| | also includes tools for
interactive segmentation
and labeling of liver
segments and vascular
structures. The software
provides functionalities
for manual or automated
segmentation of
physician-identified
lesions, and allows for
regional volumetric
analysis of 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. | the liver or to calculate
safety margins
around lesions identifying
affected vascular
branches and vascular
territories supplied or
drained by these
branches. Medical image
data is derived from
various sources (i.e. CT
scanners, MRI scanners).
Typical users of this
system are trained
professionals, including
physicians, nurses, and
technicians. | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Hardware
Configuration | standard PC hardware | standard PC hardware | standard PC hardware |
| User
Interface | A graphical user interface
for users to interact with
the software, select tools
and drive workflow | A graphical user interface
for users to interact with
the software, select tools
and drive workflow | A graphical user interface for
users to interact with the
software, select tools and
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.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal features an eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the symbol.
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.
Image /page/3/Picture/10 description: The image is a circular logo or emblem. The text "1906 - 2006" is at the top of the circle. The letters "FDA" are in the center of the circle, and the word "Centennial" is below the letters. There are four stars at the bottom of the circle.
Protecting and Promoting Public Health
4
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
5
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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