(121 days)
No
The document describes various image processing and analysis applications but does not mention AI, ML, or related terms. The performance studies focus on phantom studies and the ability to differentiate materials based on spectral data, not on training or testing of AI/ML models.
No
The device is a medical diagnostic system and image processing software used to assist physicians in diagnosis, not to provide therapy.
Yes
Several applications within the Vitrea Software Package, such as "Cerebral Aneurysm Analysis," "MR Wall Motion Tracking," and "Ultrasound Clinical Applications," explicitly state their intention to provide information or assist in diagnosis. For example, "Ultrasound Clinical Applications ... provide image information for diagnosis." Additionally, the "Intended Use / Indications for Use" section repeatedly uses terms like "adjunct to diagnosis," "assist physicians," and "aid in the visualization of anatomical and pathological materials," all of which point to a diagnostic purpose.
Yes
The device is described as a "Software Package" and its function is to process, review, and analyze digital images acquired from various imaging devices. The description focuses solely on the software applications and their functionalities, without mentioning any accompanying hardware components that are part of the device itself. While it relies on input from hardware imaging systems, the device being cleared is the software package.
Based on the provided information, the Vitrea Software Package is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Vitrea Software Package Function: The Vitrea Software Package processes and analyzes medical images acquired from various imaging modalities (CT, XA, MR, US, Cone Beam CT, Spectral CT). It does not directly examine biological specimens from the human body.
- Intended Use: The intended uses described all relate to the analysis and visualization of anatomical structures and pathological conditions based on imaging data, not the analysis of biological samples.
- Device Description: The description explicitly states it's a "medical image processing software."
While the software provides information that can be used for diagnosis, it does so by processing images, not by analyzing biological specimens in vitro. Therefore, it falls under the category of medical imaging software or a medical device that aids in diagnosis through image analysis, but not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, JAK
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray CT, X-ray angiography, MRI, Ultrasound, Cone Beam CT
Anatomical Site
Cerebral arteries, heart, whole-body, liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / Not Found
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
Spectral Stone Analysis: A study was conducted using a phantom with various kidney stones.
Spectral Composition Analysis: A study was conducted using a hand phantom with various concentrations of monosodium urate.
Spectral Analysis: Phantom studies were conducted using phantoms with various concentrations of iodine and phantoms with known objects embedded in them.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Spectral Stone Analysis:
Study Type: Bench testing using a phantom.
Key Results: The feature demonstrated the ability to differentiate uric acid stones from other stones.
Spectral Composition Analysis:
Study Type: Bench testing using a phantom.
Key Results: The results demonstrate the feature's ability to extract gout as well as display the extracted monosodium urate value.
Spectral Analysis:
Study Type: Bench testing using phantoms.
Key Results: Spectral Analysis demonstrates the ability to perform as intended across all evaluated criteria, including effective generation of iodine maps, measurement and display of iodine concentration, measurement of Effective Z value, subtraction of iodine in virtual non-contrast (VNC) images, generation of monochromatic images, and ability to produce electron density images.
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.
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
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
1
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
2
Indications for Use
510(k) Number (if known)
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 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.
3
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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
4
Made For life
510(k) Summary
- SUBMITTER'S NAME 1. Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
-
- OFFICIAL CORRESPONDENT Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance
-
- ESTABLISHMENT REGISTRATION 9614698
- CONTACT PERSON 4. Paul Biggins Sr. Director, Regulatory Affairs Canon Medical Systems USA, Inc.
- DATE PREPARED 5. October 29, 2019
-
- TRADE NAME(S) Vitrea Software Package, VSTP-001A
-
- COMMON NAME Radiological Image Processing Software
-
- DEVICE CLASSIFICATION Class II (per 21 CFR 892.2050, Picture Archiving and Communications System)
-
- PRODUCT CODE/DESCRIPTION 90LLZ / Picture Archiving and Communications System
-
- PERFORMANCE STANDARD: None
5
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 Energy
System Package,
CSDP-001A
(Reference
Predicate) | Canon
Medical
Systems,
USA | 21 CFR
892.1750 | Computed
Tomography
X-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
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.
14. INDICATIONS FOR USE
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 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
6
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 indicated for the visualization 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 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
7
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 by
spectral scan*) | DE Stone Analysis
• kV images (acquired by two axial scans
with differing kV) |
| | Spectral Composition Analysis
• Basis material images and
monochromatic image (acquired by
spectral scan*) | DE Composition Analysis
• kV images (acquired by two axial scans
with differing kV) |
| | Spectral Analysis
• Basis material images (acquired by
spectral scan*) | DE System (K132813)
• kV images and basis material images
(acquired by two axial scans with
differing 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 differentiation
between uric acid and non-uric acid
stones | DE Stone Analysis
• Visualization of the differentiation
between uric acid and non-uric acid
stones |
| | Spectral Composition Analysis
• Visualization of monosodium urate
presence within surrounding anatomical
structures | DE Composition Analysis
• Visualization of uric acid presence within
surrounding 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 differentiation
between Uric Acid and non-uric acid
stones
• Visualization of uric acid concentrations
within 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 set
CT numbers is extracted.
Spectral Composition Analysis
• The compositions are extracted based
on the composition setting. | DE Stone Analysis
• The region included in the range of set
CT numbers is extracted.
DE Composition Analysis
• The compositions are extracted based
on the composition setting. |
8
- 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.
9
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.