AZE Phoenix software is intended as a radiological review station and for comparison of medical images from multiple imaging modalities and/or time-points. When interpreted by a trained radiologist the images displayed in Phoenix may be used as a basis for diagnosis. AZE Phoenix supports review and comparison by collecting all image data associated with a patient from disparate data servers, modalities, and time-points in a patient centric data list. Users select images from the patient data list for qualitative visual inspection of individual study images and comparison of aligned side-by-side studies or fused visualizations. Users can also make quantitative anatomical measurements in the images including RECIST guideline measurements and save measurements to track changes over time in graphical plots. After selection and comparison of time-series images, individual images may be loaded into AZE VirtualPlaceTM workstation which is launched directly from Phoenix for series specific analysis. In summary, Phoenix enables medical image inspection and diagnosis along with qualitative and quantitative comparison of patient images over time followed by in depth analysis in AZE VirtualPlaceTM workstation.

AZE Phoenix is not indicated for mammography use. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Description

AZE Phoenix is a distributed client-server radiological review station that allows easy selection, review, processing and time-series comparison of multi-modality DICOM-compliant radiological images of patients. The AZE Phoenix software accepts, transfers, displays, stores, and digitally processes DICOM medical images from a variety of diagnostic imaging systems (such as CT, MRI, or image archives) for viewing image manipulation, communication, printing, and quantification. AZE Phoenix queries, retrieves, and sends DICOM compliant radiological images of patients to and from any number of DICOM Picture Archiving and Communication Systems (PACS) images sources. Phoenix collects all retrieved image series from all time-points and imaging modalities associated with a patient in a single patient centric list. Phoenix capabilities include: side-by-side and fusion image display; two-dimensional length, size, and angle measurements; Response Evaluation Criteria in Solid Tumors (RECIST) guideline measurements; image alignment by registration; tagging images to rapidly query and display image; customizable hanging protocol display layouts; and the ability to push specific image series to AZE VirtualPlace™ workstation (cleared under K060453) for in depth series specific analysis.

AI/ML Overview

The AZE Phoenix device is a radiological review station for the comparison of medical images. The submission provided does not contain explicit acceptance criteria or a detailed study report with specific performance metrics against those criteria. Instead, it demonstrates substantial equivalence to predicate devices primarily through a comparison of technological characteristics and a general statement of measurement validation.

Here's an analysis of the provided information, framed to answer the requested points:

AZE Phoenix Device: Analysis of Acceptance Criteria and Performance

1. Table of Acceptance Criteria and Reported Device Performance

As no explicit acceptance criteria are defined in terms of quantitative performance metrics, the "acceptance criteria" can be inferred from the validation tests described and the "reported device performance" is the statement of no significant differences or improvement observed.

Acceptance Criteria (Inferred)	Reported Device Performance
Measurement Accuracy: Geometric measurements (length, size, angle) on CT and MRI images should not differ significantly from a predicate device (VirtualPlace).	"Measurement validation using CD ROM phantom CT images, clinical CT and MRI images comparing subject and predicate (VirtualPlace) geometric measurements, intensity measurements and free drawing RECIST measurements showed no significant differences."
Measurement Accuracy: Intensity measurements on CT and MRI images should not differ significantly from a predicate device (VirtualPlace).	"Measurement validation using CD ROM phantom CT images, clinical CT and MRI images comparing subject and predicate (VirtualPlace) geometric measurements, intensity measurements and free drawing RECIST measurements showed no significant differences."
Measurement Accuracy: Free drawing RECIST measurements should not differ significantly from a predicate device (VirtualPlace).	"Measurement validation using CD ROM phantom CT images, clinical CT and MRI images comparing subject and predicate (VirtualPlace) geometric measurements, intensity measurements and free drawing RECIST measurements showed no significant differences."
Image Alignment/Registration: Demonstrate improved alignment compared to basic DICOM header orientation for time-series images (specifically human breath cycle CT).	"Alignment and fusion image display validation using human breath cycle CT time series images comparing registration methods showed significant improvement in alignment from DICOM header patient orientation information to full registration to liver target registration."
Software Functionality: Formal verification and validation of software functionality.	"Formal software verification and validation." (No specific metrics provided, but implies all intended functionalities were verified as per standard software development practices).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The submission mentions "CD ROM phantom CT images, clinical CT and MRI images" for measurement validation and "human breath cycle CT time series images" for alignment validation. No specific number of cases or images is provided for these test sets.
Data Provenance: Not explicitly stated. The data is described as "CD ROM phantom CT images" and "clinical CT and MRI images" which are generic descriptions. No information on the country of origin of the data or whether it was retrospective or prospective is provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not explicitly stated. The submission does not detail the process of establishing ground truth for the validation tests or the number and qualifications of experts involved.

4. Adjudication Method for the Test Set

Not explicitly stated. Given the comparison of measurements against a predicate device and registration methods, it's implied that the "ground truth" for comparison was either derived from the predicate device's output or established by a defined reference method, but no specific adjudication process (e.g., 2+1, 3+1) is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described or mentioned in the provided text. The performance testing focuses on technical validation and comparison to a predicate device's measurements, not on the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was conducted. The "Performance Testing (Bench)" describes validation of the device's measurement capabilities ("geometric measurements, intensity measurements and free drawing RECIST measurements") and image alignment independent of human interpretation as the primary outcome. These tests compare the device's output directly to known values (phantoms) or the output of a predicate device.

7. The Type of Ground Truth Used

The types of ground truth used can be inferred as:

Reference Measurements/Calculations: For "geometric measurements, intensity measurements and free drawing RECIST measurements," the ground truth likely came from:
- Phantom data: For the "CD ROM phantom CT images," the ground truth would be the known, precisely defined dimensions and properties within the phantom.
- Predicate device output: For "clinical CT and MRI images comparing subject and predicate (VirtualPlace) geometric measurements, intensity measurements and free drawing RECIST measurements," the predicate device's measurements likely served as the reference for comparison, indicating "no significant differences" if the results were within acceptable variability.
Reference Registration Methods: For "Alignment and fusion image display validation using human breath cycle CT time series images," the "full registration to liver target registration" suggests a specialized, likely more accurate, registration method or expert-derived target registration as the reference ground truth for evaluating the device's alignment improvement.

8. The Sample Size for the Training Set

Not applicable. The AZE Phoenix device described here is a radiological review station with image processing capabilities, not an AI/ML-based algorithm that typically requires a distinct training set. The submission does not mention any machine learning components that would necessitate a training set. The "validation" performed is for the accuracy and functionality of its measurement and display tools.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI/ML algorithm is mentioned or implied.

Summary

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K133521

Traditional 510(k) Summary

APR 1 1 2014

Submitter: AZE Ltd. Marunouchi Trust Tower NORTH 13F 1-8-1 Marunouchi Chiyoda-ku Tokyo 100-0005, Japan

Contact: Karl Diedrich, Ph.D. Office: 1-617-475-1502 Fax: 1-617-588-1889 karl.diedrich@azetech.com

Date Prepared: April 7, 2014

Establishment Registration 3005664732 Number:

Trade Name:	AZE Phoenix
Common Name:	System, Image Processing, Radiology
Device Classification:	Picture, archiving, and communication system
Class:	II
Product Code:	LLZ
Classification Panel:	892 2050

Predicate Device(s):

Predicate Device(s): K060453, VirtualPlace, AZE, Ltd. K093621, syngo.PET & CT Oncology, Siemens AG Healthcare SY K123375, syngo.via, Siemens AG Healthcare SY

Device Description:

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layouts; and the ability to push specific image series to AZE VirtualPlace™ workstation (cleared under K060453) for in depth series specific analysis.

Intended Use:

AZE Phoenix software is intended as a radiological review station and for comparison of medical images from multiple imaging modalities and/or time-points. When interpreted by a trained radiologist the images displayed in Phoenix may be used as a basis for diagnosis. AZE Phoenix supports review and comparison by collecting all image data associated with a patient from disparate data servers, modalities, and time-points in a patient centric data list. Users select images from the patient data list for qualitative visual inspection of individual study images and comparison of aligned side-by-side studies or fused visualizations. Users can also make quantitative anatomical measurements in the images including RECIST guideline measurements and save measurements to track changes over time in graphical plots. After selection and comparison of time-series images, individual images may be loaded into AZE VirtualPlace™ workstation which is launched directly from Phoenix for series specific analysis. In summary, Phoenix enables medical image inspection and diagnosis along with qualitative and quantitative comparison of patient images over time followed by in depth analysis in AZE VirtualPlace™ workstation.

Technological Characteristics:

Performance Testing (Bench):

Similar technological characteristics to currently marketed predicate device listed above. See comparison table, below.

Formal software verification and validation .
Measurement validation using CD ROM phantom CT images, clinical CT and MRI images comparing subject and predicate (VirtualPlace) geometric measurements, intensity measurements and free drawing RECIST measurements showed no significant differences.
Alignment and fusion image display validation using human breath cycle CT time series images comparing registration methods showed significant improvement in alignment from DICOM header patient orientation information to full registration to liver target registration.

Performance Testing (Animal or Clinical):

None

Substantial Equivalence Rationale:

The technological characteristics and performance data for the AZE Phoenix software demonstrates it is substantially equivalent to the predicate devices. See comparison table, below. The differences in

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indications for use for the subject and predicate devices are primarily in the degree of description and are not critical to the intended use of the devices and do not affect the safety or effectiveness of the device when used as labeled.

. .

and the comments of the country

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echnological Comparison of Phoenix vs Predicate Devices

Feature	Phoenix(K133521)	VirtualPlace(K060453)	Syngo.PET & CT Oncology(K093621)	Syngo.Via(K123375)
Indications forUse	AZE Phoenix software isintended as a radiologicalreview station and forcomparison of medical imagesfrom multiple imagingmodalities and/or time-points.When interpreted by a trainedradiologist the imagesdisplayed in Phoenix may beused as a basis for diagnosis.AZE Phoenix supports reviewand comparison by collectingall image data associated witha patient from disparate dataservers, modalities, and time-points in a patient centric datalist. Users select images fromthe patient data list forqualitative visual inspection ofindividual study images andcomparison of aligned side-by-side studies or fusedvisualizations. Users can alsomake quantitative anatomicalmeasurements in the imagesincluding RECIST guidelinemeasurements and savemeasurements to trackchanges over time in graphicalplots. After selection andcomparison of time-seriesimages, individual images maybe loaded into AZE	AZE VirtualPlace is an imageprocessing workstation thataccepts, transfers, displays,stores, and digitally processesDICOM medical images from avariety of diagnostic imagingsystems (such as CT, MRI, orfrom image archives) for viewing,image manipulation,communication, printing, andquantification. When interpretedby a trained physician, filmed ordisplayed images on theVirtualPlace monitor may beused as a basis for diagnosis,except in the case ofmammography images. Lossycompressed mammographicimages and digitized film screenimages must not be reviewed forprimary image interpretations.Mammographic images may onlybe interpreted using an FDAapproved monitor that offers atleast 5M pixel resolution andmeets other technicalspecifications reviewed andaccepted by FDA.	Syngo.PET & CT Oncology is amedical diagnostic applicationfor viewing, manipulation, 3D-visualization and comparison ofmedical images from multipleimaging modalities and/or time-points. The application supportsfunctional data, such as PET orSPECT as well as anatomicaldatasets, such as CT or MR.Syngo.PET & CT Oncologyenables visualization ofinformation that wouldotherwise have to be visuallycompared disjointly. Syngo.PET& CT Oncology providesanalytical tools to help the userassess, and document changes inmorphological or functionalactivity at diagnostic and therapyfollow-up examinations.Syngo.PET & CT Oncology isdesigned to support theoncological workflow includinginterpretation and evaluation ofexamination, and follow updocumentation of findings.	Syngo.via is a software solutionintended to be used for viewing,manipulation, communication,and storage of medical images. Itcan be used as a stand-alonedevice or together with a varietyof cleared and unmodified syngobased software options.Syngo.via supportsinterpretation and evaluation ofexaminations within healthcareinstitutions, for example, inRadiology, Nuclear Medicine,and Cardiology environments.The system is not intended forthe displaying of digitalmammography images fordiagnosis in the U.S.
Feature	Phoenix(K133521)	VirtualPlace(K060453)	Syngo.PET & CT Oncology(K093621)	Syngo.Via(K123375)
	VirtualPlaceTM workstationwhich is launched directly fromPhoenix for series specificanalysis. in summary Phoenixenables medical imageinspection and diagnosis alongwith qualitative andquantitative comparison ofpatient images over timefollowed by in depth analysisin AZE VirtualPlaceTMworkstation.AZE Phoenix is not indicatedfor mammography use. Lossycompressed mammographicimages and digitized filmscreen images must not bereviewed for primary imageinterpretations.Mammographic images mayonly be interpreted using anFDA-approved monitor thatoffers at least 5 Mpixelresolution and meets othertechnical specificationsreviewed and accepted byFDA.
Input Image	DICOM compliant radiologicalimages	DICOM compliant radiologicalimages	DICOM compliant radiologicalimages	DICOM compliant radiologicalimages
Image Modality(s)	CT, MR, US, PET, SPECT	CT, MR, US, PET, SPECT	CT, PET, SPECT	CT, MR, US, PET, SPECT
Phoenix(K133521)	VirtualPlace(K060453)	Syngo.PET & CT Oncology(K093621)	Syngo.Via(K123375)
Multiplanar reconstruction(MPR)	Multiplanar reconstruction(MPR)	[Not specified]	Multiplanar reconstruction(MPR)
Reslice images usinginterpolation	Reslice images usinginterpolation	[Not specified]	Reslice images usinginterpolation
Segmentation			Segmentation
Image Registration			Image Registration
Change slab thickness byintensity averaging	Change slab thickness byintensity averaging		Change slab thickness byintensity averaging
Anatomical line measurements• Diameter• Angle• Ratio	Anatomical line measurements• Diameter• Angle• Ratio
Region of interest (ROI)• Area• Mean intensity• Intensity histogram	Region of interest (ROI)• Area• Mean intensity• Intensity histogram		Region of interest (ROI)• Area• Mean intensity• Intensity histogram
Tumor time-point comparison			Tumor time-point comparison

・

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 11, 2014

AZE, Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Service. LI.C 1394 25TH STREET NW BUFFAI.O MN 55313

Re: K133521

Trade/Device Name: AZE Phoenix Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 14, 2014 Received: March 18, 2014

Dear Mr. Job:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRFI does not cyaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA.'s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dcfault.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 Small Manufacturers, International and Consumer Assistance 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 vours.

Michael D. O'Hara . For

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133521

Device Name AZE Phoenix

Indications for Use (Describe)

AZE Phoenix software is intended as a radiological review station and for comparison of medical images from multiple imaging modalities and/or time-points. When interpreted by a trained radiologist the images displayed in Phoenix may be used as a basis for diagnosis. AZE Phoenix supports review and comparison by collecting all image data associated with a patient from disparate data servers, modalities, and time-points in a patient centric data list. Users select images from the patient data list for qualitative visual individual study images and comparison of aligned side-by-side studies or fused visualizations. Users can also make quantitative anatomical measurements in the images including RECIST guideline measurements and save measurements to track changes over time in graphical plots. After selection and comparison of time-series images may be loaded into AZE VirtualPlaceTM workstation which is launched directly from Phoenix for series specific analysis. In summary, Phoenix enables medical image inspection and diagnosis along with qualitative and quantitative comparison of patient images over time followed by in depth analysis in AZE VirtualPlaceTM workstation.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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).