Vitrea Software Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea has the following additional indications:

The Cerebral Aneurysm Analysis application is intended to facilitate the extraction of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease.

The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries.

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

The Ultrasound Clinical Applications are indication of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

The Spectral Stone Analysis application is intended to serve as an adjunct visualization tool for the differentiation between uric acid and non-uric acid stones greater than 3 mm with Spectral CT studies acquired on the Canon Medical Systems scanner.

The Spectral Composition Analysis application is intended to assist a physician in visualizing the presence of monosodium urate in anatomical structures. The clinical syndrome of gout is characterized by the presence of monosodium urate crystals in joints or soft tissue.

The Embolization Plan application is a post processing software that is intended to assist physicians in the visualization of the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT acquired by Toshiba or Canon Medical Systems. It provides tools to assist the user in analysis of these images. The output is intended to be an adjunct means that allows automatic and manual planning of the liver arterial vessels for guidance of the embolization procedure. The output is a 3D visualization of the hepatic arteries to high dense lesion in the liver.

The Spectral Analysis application is a CT, non-invasive image analysis software package, which may be used to aid in the visualization of anatomical and pathological materials. The software provides quantification of Hounsfield units of iodine attenuation differences and iodine concentration and display by color.

Effective Z and electron density maps may aid in the differentiation of different tissues in the human body.

Device Description

Vitrea Software Package, VSTP-001A, is an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images, Inc. Vitrea Software Package, VSTP-001A, currently includes ten post processing applications, MR Wall Motion Tracking, Cerebral Aneurysm Analysis, MR Coronary Tracking, SUREVolume Synthesis, Angio Viewer, US Cardiac Fusion, Ultrasound Applications Package, Dual Energy Stone Analysis, Dual Energy Composition Analysis and Embolization Planning Tool which use brain, body or cardiac image data, obtained from CT/XA/MR/US systems, to assist physicians in performing specialized measurements and analysis. The Dual Energy applications are being replaced by Spectral Stone Analysis and Spectral Composition Analysis. These applications, along with Spectral Analysis, utilize DiCOM data acquired by the Spectral Scan System from the scanner, K192828.

AI/ML Overview

The provided document describes the Vitrea Software Package, VSTP-001A, specifically detailing the performance testing for its new "Spectral" features: Spectral Stone Analysis, Spectral Composition Analysis, and Spectral Analysis.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the performance in narrative form rather than explicit quantitative acceptance criteria. However, based on the descriptions, we can infer the criteria and reported performance for the new Spectral features:

Feature	Acceptance Criteria (Inferred)	Reported Device Performance
Spectral Stone Analysis	Ability to differentiate uric acid stones from other stones.	"A study was conducted using a phantom with various kidney stones and it was determined that the feature demonstrated the ability to differentiate uric acid stones from other stones."
Spectral Composition Analysis	Ability to extract gout (monosodium urate) and display the extracted value.	"A study was conducted using a hand phantom with various concentrations of monosodium urate. The results demonstrate the feature's ability to extract gout as well as display the extracted monosodium urate value."
Spectral Analysis	Ability to: - Effectively generate iodine maps. - Measure and display iodine concentration. - Measure Effective Z value. - Perform subtraction of iodine in Virtual Non-Contrast (VNC) images. - Generate monochromatic images. - Produce electron density images.	"This application is comprised of several features which were tested using various phantoms in order to demonstrate their ability to perform their intended functionality. Phantoms with various concentrations of iodine were utilized to asses the effective generation of iodine maps, the measurement and display of iodine concentration, the measurement of the Effective Z value and the subtraction of iodine in virtual non-contrast (VNC) images. Phantom studies were also conducted to evaluate the generation of monochromatic images and the ability to produce electron density images, as derived from measurements of known objects embedded in the phantoms. As determined by the results of each of these tests, Spectral Analysis demonstrates the ability to perform as intended across all evaluated criteria."

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

The document states that the studies were conducted using phantoms. This suggests:

Sample Size: Not explicitly stated in terms of number of cases, but "various kidney stones" and "various concentrations of monosodium urate" and "various concentrations of iodine" imply a range of test conditions within the phantom studies. The exact number of phantom configurations or measurements is not provided.
Data Provenance: The data is based on bench testing with phantoms, rather than human patient data. It is not specified if any real-world patient data was used for testing these specific spectral features. The country of origin for the phantom data is not specified but the submitter is Canon Medical Systems Corporation, Japan.

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

The ground truth for these phantom studies would be the known physical properties of the materials within the phantoms (e.g., actual composition of stones, known concentrations of monosodium urate, known iodine concentrations, known effective Z values, known electron densities). Therefore, human experts were likely not used to establish the ground truth for these specific phantom tests; rather, the phantoms themselves served as the "ground truth" based on their construction and known material properties. No information on human experts establishing ground truth is provided.

4. Adjudication Method for the Test Set

Given that the testing involved phantoms with known physical properties serving as the ground truth, an adjudication method for human interpretation is not applicable. The device's output would be compared directly to the known phantom properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done for the new Spectral features based on the provided text. The testing described focuses on the standalone performance of the algorithms using phantoms.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, standalone (algorithm only) performance testing was done. The descriptions of the studies for Spectral Stone Analysis, Spectral Composition Analysis, and Spectral Analysis clearly indicate that the device's ability to differentiate, extract, display, generate, and measure was evaluated based on phantom studies, without mentioning human readers in the loop for these specific performance evaluations.

7. The Type of Ground Truth Used

The type of ground truth used was known physical properties/composition of phantoms.

For Spectral Stone Analysis: Known types of kidney stones (uric acid vs. non-uric acid).
For Spectral Composition Analysis: Known concentrations of monosodium urate in a hand phantom.
For Spectral Analysis: Known concentrations of iodine, known effective Z values, and known electron densities of objects embedded in phantoms.

8. The Sample Size for the Training Set

The document does not provide any information about the sample size used for the training set for these algorithms.

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

The document does not provide any information on how the ground truth for the training set was established.

Summary

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February 14, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

Canon Medical Systems Corporation % Mr. Paul Biggins Senior Director Regulatory Affairs Canon Medical Systems U.S.A 2441 Michelle Drive TUSTIN CA 92780

Re: K192923

Trade/Device Name: Vitrea Software Package, VSTP-001A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, JAK Dated: January 23, 2020 Received: January 24, 2020

Dear Mr. Biggins:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Division Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K192923

Device Name

Vitrea Software Package, VSTP-001A

Indications for Use (Describe)

Vitrea Software Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimens acquired from a variety of imaging devices. Vitrea has the following additional indications:

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

The Ultrasound Clinical Applications are indication of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

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Effective Z and electron density maps may aid in the differentiation of different tissues in the human body.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Made For life

510(k) Summary

SUBMITTER'S NAME 1. Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
1. OFFICIAL CORRESPONDENT Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance
1. ESTABLISHMENT REGISTRATION 9614698
CONTACT PERSON 4. Paul Biggins Sr. Director, Regulatory Affairs Canon Medical Systems USA, Inc.
DATE PREPARED 5. October 29, 2019
1. TRADE NAME(S) Vitrea Software Package, VSTP-001A
1. COMMON NAME Radiological Image Processing Software
1. DEVICE CLASSIFICATION Class II (per 21 CFR 892.2050, Picture Archiving and Communications System)
1. PRODUCT CODE/DESCRIPTION 90LLZ / Picture Archiving and Communications System
1. PERFORMANCE STANDARD: None

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11. PREDICATE DEVICE

Product	Marketed by	Regulation Number	Regulation Name	Product Code	510(k) Number	Clearance Date
Vitrea Software Package, VSTP-001A* (Primary Predicate)	Canon Medical Systems, USA	21 CFR 892.2050	Picture Archiving and Communications System	LLZ	K183013	11/26/2018

Includes: MR Wall Motion Tracking, Cerebral Aneurysm Analysis, (CT/XA Cerebral Artery Morphological Analysis), MR Coronary Tracking, SyREVolume Synthesis, Angio Viewer, US Cardiac Fusion, Ultrasound Applications Package, Dual Energy Stone Analysis, Dual Energy Composition Analysis, Embolization Planning Tool

Dual EnergySystem Package,CSDP-001A(ReferencePredicate)	CanonMedicalSystems,USA	21 CFR892.1750	ComputedTomographyX-ray system	JAK	K132813	02/06/2014
-------------------------------------------------------------------------	-------------------------------------	--------------------	----------------------------------------	-----	---------	------------

12. REASON FOR SUBMISSION

Modification of an existing medical device - Porting of application software submitted with K192828.

13. DEVICE DESCRIPTION

14. INDICATIONS FOR USE

The Cerebral Aneurysm Analysis application is intended to facilitate the extraction and segmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides

PHONE: 800-421-1968 2441 Michelle Drive, Tustin, CA 92780 https://us.medical.canon

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measurements of global and regional myocardial function that is used for patients with suspected heart disease.

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

The Ultrasound Clinical Applications are indicated for the visualization of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

Effective Z and electron density maps may aid in the differentiation and characterization of different tissues in the human body.

15. SUBSTANTIAL EQUIVALANCE

The Vitrea Software Package, VSTP-001A, is substantially equivalent to and has the same intended use as the primary predicate device, which received premarket clearance under K180323, and is marketed by Canon Medical Systems USA. The changes being made to the existing device are to incorporate three applications (Spectral Stone Analysis, Spectral Composition Analysis and Spectral Analysis) which utilize DiCOM data acquired by the Spectral Scan System from the scanner, K192828. The integration of these modifications

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were evaluated by risk analysis and a regression review and it was determined that the software modifications were integrated with all risks reduced to an acceptable level.

Item	Vitrea Software Package(VSTP-001A) V8.5	Vitrea Software Package(VSTP-001A) V8.1
510(k) Number	(Subject Device)	K183013
Anatomical region	Whole body	Whole body
Type of Input Data	Spectral Stone Analysis• Monochromatic images (acquired byspectral scan*)	DE Stone Analysis• kV images (acquired by two axial scanswith differing kV)
	Spectral Composition Analysis• Basis material images andmonochromatic image (acquired byspectral scan*)	DE Composition Analysis• kV images (acquired by two axial scanswith differing kV)
	Spectral Analysis• Basis material images (acquired byspectral scan*)	DE System (K132813)• kV images and basis material images(acquired by two axial scans withdiffering kV)
Type of Output Data	Spectral Stone Analysis• Analysis result display• Secondary capture (RGB image)	DE Stone Analysis• Analysis result display
	Spectral Composition Analysis• Analysis result display• Secondary capture (RGB image)	DE Composition Analysis• Analysis result display
	Spectral Analysis• Analysis result display• Secondary capture (RGB image)	DE System (K132813)• Analysis result display• Secondary capture (RGB image)
Image Processing	Spectral Stone Analysis• Visualization of the differentiationbetween uric acid and non-uric acidstones	DE Stone Analysis• Visualization of the differentiationbetween uric acid and non-uric acidstones
	Spectral Composition Analysis• Visualization of monosodium uratepresence within surrounding anatomicalstructures	DE Composition Analysis• Visualization of uric acid presence withinsurrounding anatomical structures
	Spectral Analysis• Generation of monochromatic images(ranging from 35keV - 135keV)• Generation of lodine map• VNC image• Generation of Electron Density Image• Generation of Effective Z Image	DE System (K132813)• Visualization of the differentiationbetween Uric Acid and non-uric acidstones• Visualization of uric acid concentrationswithin surrounding anatomical structure• Generation of monochromatic images(ranging from 35keV - 135keV)• Generation of iodine map• lodine map subtraction
Item	Vitrea Software Package(VSTP-001A) V8.5	Vitrea Software Package(VSTP-001A) V8.1
510(k) Number	(Subject Device)	K183013
Segmentation	Spectral Stone Analysis• The region included in the range of setCT numbers is extracted.Spectral Composition Analysis• The compositions are extracted basedon the composition setting.	DE Stone Analysis• The region included in the range of setCT numbers is extracted.DE Composition Analysis• The compositions are extracted basedon the composition setting.

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Spectral Scan System, K192828

16. SAFETY

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC62304 and IEC62366.

17. TESTING

Risk analysis and verification/validation activities conducted through bench testing demonstrate that the established specifications for the device have been met.

The new Spectral features were subject to risk analysis and performance testing was conducted through bench testing in order to demonstrate that the requirements for the applications have been met.

Spectral Stone Analysis

A study was conducted using a phantom with various kidney stones and it was determined that the feature demonstrated the ability to differentiate uric acid stones from other stones.

Spectral Composition Analysis

A study was conducted using a hand phantom with various concentrations of monosodium urate. The results demonstrate the feature's ability to extract gout as well as display the extracted monosodium urate value.

Spectral Analysis

This application is comprised of several features which were tested using various phantoms in order to demonstrate their ability to perform their intended functionality. Phantoms with various concentrations of iodine were utilized to asses the effective generation of iodine maps, the measurement and display of iodine concentration, the measurement of the Effective Z value and the subtraction of iodine in virtual non-contrast (VNC) images. Phantom studies were also conducted to evaluate the generation of monochromatic images and the ability to produce electron density images, as derived from measurements of known obiects embedded in the phantoms. As determined by the results of each of these tests. Spectral Analysis demonstrates the ability to perform as intended across all evaluated criteria.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.

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18. CyberSecurity

The VSTP-001A is a portfolio of software applications developed by Canon that are integrated into the Vital Images Vitrea workstations. As such this software has no connections to the internet, wired or wireless networks, etc. All import and export of data is within the domain of the Vital product. Based upon this information it should be noted that CyberSecurity requirements do not apply to this device.

19. CONCLUSION

The software applications included in the Vitrea Software Package, VSTP-001A, perform in a manner similar to and are intended for the same use as the predicate devices. Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance data presented in this submission it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate devices.

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).