CENTRICITY AW SUITE OPTION by GE HEALTHCARE INFORMATION TECHNOLOGIES

Centricity AW Suite is an optional software package that provides an interface between the Centricity PACS Workstation and Volume Viewer such that both applications can run on a single platform while maintaining common patient & exam context. Optional advanced analysis extensions of the Volume Viewer application include: AutoBone, Advanced Vessel Analysis, CT Colonography, CardIQ Analysis, and Advanced Lung Analysis.

Volume Viewer allows the processing, review, analysis and communication of 3D reconstructed images and their relationship to originally acquired images from CT, MR, X-Ray Angio, NM 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.

Advanced Vessel Analysis can be used in the analysis of 3D angiography data. It provides a number of display, measurement and batch archive features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization.

CardIQ Analysis allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionality for 20/30 rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician to process, render, review, archive and visualize cardiac anatomy and coronary vessels.

CT Colonography allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of the 2D. 3D and 360 dissection views, and an object oriented endoluminal display. In comparison to Colonoscopy, this tool has an advantage of depth penetration due to its 3D presentation capability. It is intended for use by Radiologists, Clinicians, and referring Physicians to process, render, review, archive and distribute colon image studies.

AutoBone is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data.

Advanced Lung Analysis is intended to provide an optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lesions, etc.) from a set of Computed Tomography (CT) images. The software is designed to support the physician in confirming the presence of physician identified lung lesions (e.g. nodules). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. ALA software allows andlysis and displays statistics for nodule characterization all the different nodule types. ALA optional Digital Contrast Agent (DCA) module is an automated highlight feature for the visual identification of possible lesions. Digital Contrast Agent (DCA) is a 3D filter that produces images that highlight spherical (S) and cylindrical (C) anatomical regions, such as nodules, cysts, scars, and vessels. Images are made available to the physician to aid in characterization of suspicious nodules and thus, the patient management care decision process. ALA provides additional information to the physician and is intended to compliment diagnosis based on classical techniques.

Device Description

Centricity AW Suite is a software option that provides an interface between the Centricity Workstation (on a Windows platform) and Volume Viewer with advanced analysis options such that both these applications can run on a single platform while maintaining common patient and exam context.

Volume Viewer is a previously FDA cleared image analysis software option. Optional advanced analysis extensions of the Volume Viewer application have been previously cleared by FDA and include AutoBone, Advanced Vessel Analysis, CT Colonography, CardiQ Analysis and Advanced Lung Analysis.

AI/ML Overview

The provided document (K061372) is a 510(k) summary for the GE Healthcare Information Technologies' Centricity AW Suite Option, which is a software option providing an interface between the Centricity PACS Workstation and Volume Viewer with advanced analysis options.

The document does NOT explicitly describe specific acceptance criteria and a detailed study proving the device meets these criteria in the typical format of a performance study with quantitative results against specific criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The "Test Summary" section describes the quality assurance measures applied during development, which are standard software development and quality control practices rather than a specific performance study against defined acceptance metrics.

Therefore, the following information, as requested, cannot be fully extracted or is explicitly stated as not applicable based on the provided text.

Acceptance Criteria and Device Performance Summary for K061372

Since specific performance acceptance criteria and a detailed study proving the device meets them are not presented in the provided 510(k) summary, the table below reflects what can be inferred or explicitly stated from the document regarding its equivalence claim rather than a direct performance report.

Acceptance Criterion (Inferred from Substantial Equivalence)	Reported Device Performance (as described in 510(k) Summary)
Functional Equivalence	The Centricity AW Suite Option provides an interface between the Centricity Workstation and Volume Viewer, allowing both applications to run on a single platform while maintaining common patient and exam context. The advanced analysis options (AutoBone, Advanced Vessel Analysis, CT Colonography, CardIQ Analysis, Advanced Lung Analysis) are described as similar in function to previously cleared predicate devices. The technology is stated to employ the "same functional scientific technology as its predicate devices."
Safety and Effectiveness Equivalence	The device is deemed "substantially equivalent" to legally marketed predicate devices, implying similar safety and effectiveness based on regulatory review. The safety testing conducted during development is mentioned as part of the quality assurance.
Compliance with Standards	The Centricity PACS System (which the AW Suite is an option for) "complies with the voluntary standards as detailed in Section 12 Specific Standards and Guidance" (though Section 12 itself is not provided). Quality assurance measures like Risk Analysis, Requirements Reviews, Design Reviews, Unit Testing, Integration Testing, Final Acceptance Testing, and Performance Testing were applied.

Additional Study Information:

Sample sizes used for the test set and the data provenance:
- Not explicitly stated. The document mentions "Testing on unit level (Module verification)", "Integration testing (System verification)", and "Final acceptance testing (Validation)" as part of general quality assurance, but no specific test set sample sizes or data provenance (e.g., country of origin, retrospective/prospective) are provided for these activities in the summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated, and likely not applicable in the context of this 510(k). This 510(k) focuses on the substantial equivalence of a software application integrating existing functionalities and adding minor enhancements. It does not describe a clinical performance study requiring expert ground truth for diagnostic accuracy where primary endpoints are evaluated. The "ground truth" here would relate more to the software performing its intended functions accurately and reliably, which is verified through software testing processes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not explicitly stated. Adjudication methods are typically used in clinical studies for establishing ground truth, which is not detailed in this 510(k) summary focused on substantial equivalence of software functionality.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not explicitly mentioned or performed as described. The device is presented as an interface with advanced analysis options that are extensions of previously cleared applications (Volume Viewer, AutoBone, etc.). The 510(k) focuses on the equivalence of these combined functionalities and the technological approach, not on improving human reader performance with new AI algorithms. The "Advanced Lung Analysis" description mentions the software "is designed to support the physician in confirming the presence or absence of physician identified lung lesions" and "provides additional information... and is intended to compliment diagnosis based on classical techniques," but this is a statement of intended use, not a result from an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly described as a standalone performance study in the document. The software is presented as supporting physicians and providing tools, implying a human-in-the-loop context. General "Performance testing" is mentioned as part of quality assurance but without specifics of standalone algorithmic performance metrics.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. Given the nature of the device (software integration and advanced visualization tools building on predicate devices), the "ground truth" for its acceptance would primarily revolve around the accuracy of its software functions in processing, rendering, and measuring images as intended, consistent with its predicate devices. This would typically be established through validation against known good data, software specifications, and expected outputs, rather than a clinical ground truth like pathology for diagnostic accuracy.
The sample size for the training set:
- Not applicable / Not explicitly stated. This device is described as an "optional software package" and advanced analysis extensions, employing "the same functional scientific technology as its predicate devices." It is not presented as an AI/ML algorithm that requires a distinct training dataset in the modern sense. The "training set" concept is not relevant to this type of traditional software submission.
How the ground truth for the training set was established:
- Not applicable. As a training set for an AI/ML algorithm is not described, the establishment of its ground truth is also not applicable.

Summary

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K06 1372

MAY 3 0 2006

Section 2 510(k) Summary of Safety and Effectiveness

Date:	May 4, 2006
Submitter:	GE Healthcare Information Technologies540 W Northwest HighwayBarrington, IL 60010
Contact Person:	Karen M. LundeSr. Regulatory Affairs LeaderGE Healthcare Information TechnologiesPhone: (847) 277-6092Fax: (414) 755-0655
Device:Trade Name:	Centricity® AW Suite Option
Common/Usual Name:	Picture Archiving and Communications Systems and Workstation
Classification Names:	The Centricity PACS is classified as:21 CFR 892.2050 System, Image Processing, Radiological
	The predicate advanced applications are classified as:21 CFR 892.1750 Computed Tomography X-ray System (accessory to)
Predicate Device:	K043415 Centricity PACS SystemK993792: Smart Vessel Analysis OptionK042694: Advanced Lung Analysis II OptionK031871: AutoBone OptionK041267: Card IQ Analysis III OptionK041270: CT Colonography II OptionK041521: Volume Viewer Plus Option
Device Description:	Centricity AW Suite is a software option that provides an interface betweenthe Centricity Workstation (on a Windows platform) and Volume Viewerwith advanced analysis options such that both these applications can runon a single platform while maintaining common patient and exam context.Volume Viewer is a previously FDA cleared image analysis software option.Optional advanced analysis extensions of the Volume Viewer applicationhave been previously cleared by FDA and include AutoBone, AdvancedVessel Analysis, CT Colonography, CardiQ Analysis and Advanced LungAnalysis.
Intended Use:	Centricity AW Suite is an optional software package that provides aninterface between the Centricity PACS Workstation and Volume Viewersuch that both applications can run on a single platform while maintainingcommon patient & exam context. Optional advanced analysis extensions ofthe Volume Viewer application include: AutoBone, Advanced VesselAnalysis, CT Colonography, CardIQ Analysis, and Advanced Lung Analysis.Volume Viewer allows the processing, review, analysis and communicationof 3D reconstructed images and their relationship to originally acquiredimages from CT, MR, X-Ray Angio, NM and PET Scanning devices. Thecombination of acquired images, reconstructed images, annotations andmeasurements performed by the clinician are intended to provide to thereferring physician clinically relevant information for diagnosis, surgery andtreatment planning.Advanced Vessel Analysis can be used in the analysis of 3D angiographydata. It provides a number of display, measurement and batch archive

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features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization.

CardIQ Analysis allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionality for 20/3D rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician to process, render, review, archive and visualize cardiac anatomy and coronary vessels.

CT Colonography allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of the 2D, 3D and 360 dissection views, and an object oriented endoluminal display. In comparison to Colonoscopy, this tool has an advantage of depth penetration due to its 3D presentation capability. It is intended for use by Radiologists, Clinicians, and referring Physicians to process, render, review, archive and distribute colon image studies.

AutoBone is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data.

Advanced Lung Analysis is intended to provide an optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lesions, etc.) from a set of Computed Tomography (CT) images. The software is designed to support the physician in confirming the presence or absence of physician identified lung lesions (e.g. nodules). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. ALA software allows analysis and displays statistics for nodule characterization all the different nodule types. ALA optional Digital Contrast Agent (DCA) module is an automated highlight feature for the visual identification of possible lesions. Digital Contrast Agent (DCA) is a 3D filter that produces images that highlight spherical (S) and cylindrical (C) anatomical regions, such as nodules, cysts, scars, and vessels. Images are made available to the physician to aid in characterization of suspicious nodules and thus, the patient management care decision process. ALA provides additional information to the physician and is intended to compliment diagnosis based on classical techniques.

The Centricity AW Suite Option employs the same functional scientific Technology: technology as its predicate devices.
The subject of this 510k is a software option for the Centricity PACS Test Summary: workstation. The Centricity PACS System complies with the voluntary standards as detailed in Section 12 Specific Standards and Guidance. The following quality assurance measures were applied to the development of the Centricity AW Suite Option:
- Risk Analysis .
- Requirements Reviews .
- Design Reviews .

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Testing on unit level (Module verification) ●
Integration testing (System verification) .
. Final acceptance testing (Validation)
Performance testing .
Safety testing .

GE considers features of the Centricity AW Suite Option equivalent to those Conclusion: of the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird-like figure.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 3 0 2006

GE Healthcare Information Technologies % Ms. Elizabeth Drew Senior Project Engineer/510(k) Reviewer Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA 95131

Re: K061372

Trade/Device Name: Centricity AW Suite Option Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 16, 2006 Received: May 17, 2006

Dear Ms. Drew:

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 shows a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906 - 2006" are printed. Below the letters, the word "Centennial" is printed in a cursive font. The logo is surrounded by text that reads "United in Commitment to Consumer Protection & Health Through the Science of Food."

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 forth in the quality systems (OS) 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.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology).	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 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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Ko61372

Page 1 of 1

510(k) Number (if known): Unknown;

510(k) filed on May 4, 2006

Device Name: Centricity® AW Suite Option

Indications for Use:

AutoBone is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data.

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K061372
Page 2 of 2

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ X (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Daniel A. Benson

(Division Sign Division of F and Radio 510(k) Nu

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Regulation Number and Section

§ 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).