Vitrea CT Lung Density Analysis Software

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 10, 2015 Vital Images, Inc. % Ms. Katie Ryan Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343-4414 Re: K151919 Trade/Device Name: Vitrea® CT Lung Density Analysis Software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 18, 2015 Received: September 21, 2015 Dear Ms. Ryan: 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. 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. 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Sincerely yours, Robert Ocks Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K151919 Device Name Vitrea® CT Lung Density Analysis Software Indications for Use (Describe) The Vitrea Lung Density Analysis software provides CT values for the pulmonary tissue from CT thoracic datasets. Three-dimensional (3D) segmentation of the left lung, volumetric analysis, density evaluations and reporting tools are integrated in a specific workflow to offer the physician a quantitative support for diagnosis and followup evaluation of lung tissue images. Type of Use (Select one or both, as applicable) | <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) | |---------------|----------------------------------------------| | <span></span> | 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot on the "i" in "VITAL" is white. # 510K Summary This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c). | Basis for the<br>Submission: | To obtain 510k clearance for Vital's software preset Vitrea CT Lung<br>Density Analysis which is substantially equivalent to the cleared<br>VIDA Pulmonary Workstation 2 (PW2) manufactured by VIDA<br>Diagnostics. | | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Submitter: | Vital Images, Inc.<br>5850 Opus Parkway, Suite 300<br>Minnetonka, MN, 55343-4414 | | | Establishment<br>Registration: | 2134213 | | | Contact Person: | Katie Ryan<br>Regulatory Affairs Specialist<br>Phone : 952-487-9793<br>Fax: 952-487-9510<br>E-mail: kryan@vitalimages.com | | | 510(k) Type: | Traditional | | | Summary Date: | July 20, 2015 | | | Device Trade Name: | Vitrea® CT Lung Density Analysis Software | | | Device Common<br>Name/ Regulatory<br>Description: | Computed Tomography X-ray System | | | Device Classification<br>Name: | System, X-ray, Tomography, Computed | | | Regulation Number: | 21 CFR 892.1750 | | | Product Code: | JAK | | | Regulatory<br>Classification: | Class II | | | Device Panel: | Radiology | | # Predicate Device(s): | Predicate Device | Manufacturer | FDA 510(k) Number | |---------------------------------------|------------------------------------------------------------------------------|-------------------| | VIDA Pulmonary<br>Workstation 2 (PW2) | VIDA Diagnostics<br>100 Oakdale Campus, Suite 225 Tic<br>lowa City, IA 55242 | K083227 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The letters of "VITAL" are spaced apart, and the dot of the "i" is a perfect circle. # Reference Device(s): | Reference Device | Manufacturer | FDA 510(k) Number | |----------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------| | VITREA2, Version 3.7<br>Medical Image Processing<br>System (Lung Analysis) | Vital Images, Inc.<br>5850 Opus Parkway, Suite 300<br>Minnetonka, MN 55343 | K043333 | # Device Description: Vitrea CT Lung Density Analysis assists in analyzing lung densities and volumes. It semiautomatically segments lung tissues with quantifiable controls and renderings to aid communication with the pulmonologist. # The key features are: - Semi-automatic right lung, left lung, and airway segmentation . - Visualization of lung density with color-defined Hounsfield Unit (HU) ranges ● - . Lung density result quantification with HU density range, volume measurements, lunq density index, and the PD15% measurement - . Density graph/histogram of the classified lung voxels' relative frequencies - Comparison of upper and lower lung density index ratios . - Adjustable density thresholds for refining and optimizing HU ranges ● - Overlay of density quantification results and density graph histogram for reporting - Export of density values and curves to CSV tables or copy to clipboard for insertion into a ● report # Intended Use / Indications for Use: The Vitrea Lung Density Analysis software provides CT values for the pulmonary tissue from CT thoracic datasets. Three-dimensional (3D) segmentation of the left lung and right lung, volumetric analysis, density evaluations and reporting tools are integrated in a specific workflow to offer the physician a quantitative support for diagnosis and follow-up evaluation of lung tissue images. # Intended for Disease / Condition / Patient Population: The software provides Thoracic Radiologists and Pulmonologists with a robust dedicated suite of software tools to aid in the creation of evidence to support these physicians with their assessment of patients with chest diseases. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image, with the company information serving as a secondary detail. # Substantial Equivalence Comparison: # Regulatory Comparison | | Subject Device | Predicate Device | | |---------------------|------------------------------------------------|------------------------------------------|------------------------------------------------------| | Characteristic | Vitrea CT Lung<br>Density Analysis<br>Software | VIDA Pulmonary<br>Workstation 2<br>(PW2) | Comparison | | Classification Name | Computed<br>Tomography X-ray<br>System. | Computed<br>Tomography X-<br>ray System. | None | | Regulatory Number | 892.1750 | 892.1750 | None | | Product Code | JAK | JAK | None | | Classification | Class II | Class II | None | | Review Panel | Radiology | Radiology | None | | Decision Date | Under Review | November 8,<br>2008 | Predicate and<br>Reference<br>devices are<br>cleared | # Intended Use Comparison with Predicate Device: | Criteria | Subject Device<br>Vitrea CT Lung<br>Density Analysis<br>Software | Predicate Device<br>VIDA Pulmonary<br>Workstation 2 (PW2) | Comparison | |--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Intended Use | The Vitrea Lung<br>Density Analysis<br>software provides CT<br>values for the<br>pulmonary tissue from<br>CT thoracic datasets.<br>Three-dimensional (3D)<br>segmentation of the left<br>lung and right lung,<br>volumetric analysis,<br>density evaluations and<br>reporting tools are<br>integrated in a specific<br>workflow to offer the<br>physician a quantitative<br>support for diagnosis<br>and follow-up<br>evaluation of lung<br>tissue images. | The VIDA Pulmonary<br>Workstation 2 (PW2)<br>software provides<br>reproducible CT values<br>for pulmonary tissue,<br>which is essential for<br>providing quantitative<br>support for diagnosis and<br>follow up examinations.<br>The PW2 can be used to<br>support the physician in<br>the diagnosis and<br>documentation of<br>pulmonary tissue images<br>(e.g., abnormalities) from<br>CT thoracic datasets.<br>Three-D segmentation<br>and isolation of sub-<br>compartments, volumetric<br>analysis, density<br>evaluations, low density<br>cluster analysis and<br>reporting tools are | The support for low<br>density cluster analysis<br>is not part of the subject<br>device's indications for<br>use. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The letters of the word "VITAL" are spaced apart from each other. | Criteria | Subject Device<br>Vitrea CT Lung<br>Density Analysis<br>Software | Predicate Device<br>VIDA Pulmonary<br>Workstation 2 (PW2) | Comparison | |-----------------------|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | | combined with a<br>dedicated workflow. The<br>VIDA Pulmonary<br>Workstation 2 (PW2)<br>software package is also<br>intended to be a real-time<br>interactive evaluation in<br>space and time for CT<br>volume data sets that<br>provides the<br>reconstruction of two-<br>dimensional images into<br>a three-dimensional<br>image format. | | | Intended Users | Thoracic Radiologists<br>and Pulmonologists | Thoracic Radiologists<br>and Pulmonologists | None | | Patient<br>Population | Patients with<br>pulmonary diseases<br>and abnormalities | Patients with chest<br>diseases, e.g. when<br>examining the pulmonary<br>tissue (i.e. lung<br>parenchyma) in CT<br>thoracic datasets | Similar | | Modality<br>Support | CT /CTA | CT /CTA | None | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot above the "i" in "VITAL" is white. #### Subiect Device Predicate Device Comparison VIDA Pulmonary Workstation 2 Vitrea CT Lung Density Analysis Software (PW2) VIDA Pulmonary Workstation 2 (PW2) Vitrea CT Lung Density Analysis The support for low assists in analyzing lung densities is a self-contained image analysis density cluster and volumes. It semi-automatically software package. This real-time analysis is not part of the subject device interactive evaluation in space and time segments lung tissues with quantifiable controls and renderings for CT volume data sets provides the description. to aid communication with the reconstruction of two-dimensional pulmonologist. images into a three-dimensional image format. VIDA Pulmonary Workstation 2 The key features are: (PW2) can be used to support the physician in the diagnosis and · Semi-automatic right lung, left documentation of chest diseases, e.g. lung and airway segmentation when examining the pulmonary tissue • Visualization of lung density with (i.e. lung parenchyma) in CT thoracic color-defined Hounsfield Unit datasets. Evaluation tools (3D (HU) ranges segmentation & isolation of subcompartments, volumetric analysis, · Lung density result quantification density evaluations, and low density with HU density range, volume cluster analysis) and reporting tools are measurements. Jung density combined with a dedicated workflow. index and the PD15% measurement The PW2 is designed to analyze pulmonary CT slice data and display · Density graph/histogram of the analysis results. Each voxel of the scan classified lung voxels' relative is measured by Hounsfield units (HU), a frequencies measurement of x-ray attenuation that is applied to each volume element in • Comparison of upper and lower three-dimensional space ("voxel"). The lung density index ratios HU are utilized to distinquish between • Adjustable density thresholds for air, water, tissue and bone, such refining and optimizing HU distinction is common in the industry. ranges PW2 provides computed tomography · Overlay of density quantification (CT) viewing, airway analysis, and results and density graph parenchymal density analysis in one histogram for reporting application. PW2 provides imaging of bronchial airwavs that can be used to • Export of density values and assess therapy effectiveness based on curves to CSV tables or copy to CT scan data. PW2 reconstructs clipboard for insertion into a multiple cross-section images from CT report data into a computer model displaying complex bronchial branches. PW2 does not interface directly with any CT or data collection equipment; instead PW2 imports data files previously generated by such equipment. PW2 provides quantitative measurements and tabulates quantitative properties. PW2 focuses on what is visible to the eye and applies volumetric methods that might otherwise be too tedious to use. The software does not perform any function # Device Description Comparison with Predicate Device: 064 510(k) Summary S001 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The logo appears to be for a company called Vital, which is part of the Toshiba Medical Systems Group. | Subject Device | Predicate Device | Comparison | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Vitrea CT Lung Density<br>Analysis Software | VIDA Pulmonary Workstation 2<br>(PW2)<br><br>which cannot be accomplished by a<br>trained user utilizing manual tracing<br>methods; the intent of the software is to<br>save time and automate potential error<br>prone manual tasks.<br><br>The software has functions for loading,<br>analyzing, saving datasets and will<br>generate screen displays, computations<br>and aggregate statistics. | | # Similarities in Technology with Predicate Device: | Criteria | Subject Device | Predicate Device | Comparison | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------|------------| | | Vitrea CT Lung<br>Density Analysis<br>Software | VIDA Pulmonary<br>Workstation 2<br>(PW2) | | | Modality | | | | | CT | Yes | Yes | Same | | Data Loading | | | | | DICOM | Yes | Yes | Same | | Ability to load one or two<br>series of chest CT exam | Yes | Yes | Same | | Data Viewing Support | | | | | MPR | Yes | Yes | Same | | 3D | Yes | Yes | Same | | Segmentation | | | | | Provides 3D Segmentation<br>tool | Yes | Yes | Same | | Provide Left Lung<br>Segmentation | Yes | Yes | Same | | Provides Right Lung<br>Segmentation | Yes | Yes | Same | | Provides airways<br>segmentation (trachea,<br>main bronchi, and some<br>larger bronchioles) | Yes | Yes | Same | | Criteria | Subject Device | Predicate Device | Comparison | | | Vitrea CT Lung<br>Density Analysis<br>Software | VIDA Pulmonary<br>Workstation 2<br>(PW2) | | | User can manually edit<br>segmentation provided by<br>the software | Yes | Yes | Same | | Lung Volume Analysis Support | | | | | Ability to measure and<br>view Left Lung volume | Yes | Yes | Same | | Ability to measure and<br>view Right Lung volume | Yes | Yes | Same | | Lung Density Analysis Support | | | | | Low (ml) Volume for<br>Right Lung:<br>Ability to measure volume<br>of Right lung voxels in the<br>lowest HU density range<br>as defined by the density<br>thresholds | Yes | Yes | Same | | Low (ml) Volume for Left<br>Lung:<br>Ability to measure volume<br>of Left lung voxels in the<br>lowest HU density range<br>as defined by the density<br>thresholds | Yes | Yes | Same | | Low (ml) Volume for<br>Both Lungs:<br>Ability to measure addition<br>of volumes of both lungs<br>voxels in the lowest HU<br>density range as defined<br>by the density thresholds | Yes | Yes | Same | | Medium (ml) Volume for<br>Right Lung:<br>Ability to measure volume<br>of Right lung voxels in the<br>middle HU density range<br>as defined by the density<br>thresholds | Yes | Yes | Same | | Medium (ml) Volume for<br>Left Lung: | Yes | Yes | Same | | Criteria | Subject Device | Predicate Device | Comparison | | | Vitrea CT Lung<br>Density Analysis<br>Software | VIDA Pulmonary<br>Workstation 2<br>(PW2) | | | Ability to measure volume<br>of Left lung voxels in the<br>middle HU density range<br>as defined by the density<br>thresholds | Yes | | | | Medium (ml) Volume for<br>Both Lungs:<br>Ability to measure addition<br>of volumes of both lungs<br>voxels in the middle HU<br>density range as defined<br>by the density thresholds | Yes | Yes | Same | | High (ml) Volume for<br>Right Lung:<br>Ability to measure volume<br>of Right lung voxels in the<br>highest HU density range<br>(such as vessels) as<br>defined by the density<br>thresholds | Yes | Yes | Same | | High (ml) Volume for<br>Left Lung:<br>Ability to measure volume<br>of Left lung voxels in the<br>highest HU density range<br>(such as vessels) as<br>defined by the density<br>thresholds | Yes | Yes | Same | | High (ml) Volume for<br>Both Lungs:<br>Ability to measure addition<br>of volumes of both lungs<br>voxels in the highest HU<br>density range (such as<br>vessels) as defined by the<br>density thresholds | Yes | Yes | Same | | Right Lung (ml) Volume:<br>Ability to provide Right<br>lung volume including only<br>the voxels designated as<br>Low and Medium Right | Yes | Yes | Same | | Criteria | Subject Device | Predicate Device | Comparison | | | Vitrea CT Lung<br>Density Analysis<br>Software | VIDA Pulmonary<br>Workstation 2<br>(PW2) | | | lung tissues | | | | | Left Lung (ml) Volume:<br>Ability to provide Left lung<br>volume including only the<br>voxels designated as Low<br>and Medium Left lung<br>tissues | Yes | Yes | Same | | Lung (ml) Volume:<br>Ability to provide addition<br>of both lungs volumes<br>including only the voxels<br>designated as Low and<br>Medium Right and Left<br>lung tissues | Yes | Yes | Same | | Low Density (LD) Index<br>(%) for Right Lung:<br>$Low RightLung volume(Low RightLung volume+Medium RightLung volume)$ | Yes | Yes | Same | | Low Density (LD) Index<br>(%) for Left Lung:<br>$Low LeftLung volume(Low LeftLung volume+Medium LeftLung volume)$ | Yes | Yes | Same | | Low Density (LD) Index<br>(%) for Both Lungs: | Yes | Yes | Same | | Criteria | Subject Device<br>Vitrea CT Lung<br>Density Analysis<br>Software | Predicate Device<br>VIDA Pulmonary<br>Workstation 2<br>(PW2) | Comparison | | Addition of Left<br>and Right Lungs<br>Low volumes<br>(Addition of Left<br>and Right Lungs<br>Low volumes<br>+<br>Addition of Left<br>and Right Lungs<br>Medium volumes) | | | | | PD15 (g/l) measurement<br>for Right Lung:<br>The HU value which a<br>certain percentage (15%)<br>of the voxels in the<br>cumulative frequency<br>distribution histogram<br>have a lower density in<br>Right Lung | Yes | Yes | Same | | PD15 (g/l) measurement<br>for Left Lung:<br>The HU value which a<br>certain percentage (15%)<br>of the voxels in the<br>cumulative frequency<br>distribution histogram<br>have a lower density in<br>Left Lung | Yes | Yes | Same | | PD15 (g/l) measurement<br>for Both Lungs:<br>The HU value which a<br>certain percentage (15%)<br>of the voxels in the<br>frequency distribution<br>histogram have a lower<br>density in both Lungs | Yes | Yes | Same | | Ability to generate Density<br>graphs | Yes | Yes | Same | | Criteria | Subject Device | Predicate Device | Comparison | | | Vitrea CT Lung<br>Density Analysis<br>Software | VIDA Pulmonary<br>Workstation 2<br>(PW2) | | | Analyzed Data Export | | | | | Ability to take snapshot | Yes | Yes | Same | | Ability to generate report | Yes | Yes | Same | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The "i" in "VITAL" is lowercase and has a circular dot above it. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, sans-serif font. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The letters are black, and the dot above the "i" is a solid black circle. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot above the "i" in "VITAL" is a solid black circle. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is in black, and the dot above the "i" is a perfect circle. {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot on the "i" in "VITAL" is a perfect circle. # Differences in Technology with the Predicate Device: | | Subject Device | Predicate Device | | |---------------------------------|------------------------------------------|------------------------------------|------------------------------------------------------------------------------------------| | Criteria | Vitrea CT Lung Density Analysis Software | VIDA Pulmonary Workstation 2 (PW2) | Comparison | | Low density<br>cluster analysis | No | Yes | The support for low<br>density cluster<br>analysis is not part of<br>the subject device. | # Similarities in Technology with the Reference Device: | | Subject Device | Reference Device | Comparison | |--------------|------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Criteria | Vitrea CT Lung<br>Density Analysis<br>Software | VITREA2, Version 3.7<br>Medical Image<br>Processing System<br>(Lung Analysis) | | | Segmentation | Yes | Yes | Similar<br><br>Note: The Lung Analysis preset shows lung segmentation as a single region while the CT Lung Density Analysis preset provides left and right lung regions. The sum of left and right lung regions in the Lung Density Analysis preset is equivalent to the lung region in Lung Analysis preset. | {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the word "VITAL" in black font. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in red font. The "i" in "VITAL" has a circular dot above it. # Summary of Non-Clinical Tests: The Vitrea CT Lung Density Analysis software was designed, developed, and tested according to written procedures that included risk management. Software testing was completed to ensure the new features operate according to defined requirements. The following design control measures were applied to the development of the Vitrea CT Lung Density Analysis software: - . Risk Management - Requirements Reviews ● - Code Designs . - Code Development Testing . - Code Reviews - Design Reviews - Verification of the software that included performance and safety testing ● - Validation of the software that included phantom testing and simulated usability testing . by experienced professionals. # Risk Management: Each risk pertaining to these features have been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of "Improbable." All risks for this feature were collectively reviewed to determine if the benefits outweigh the risk. Because of the risk control measures included in this feature, it is believed that the risk for the feature as a whole is extremely low. Taking into account all risks against the benefits of this feature, it has been assessed that the benefits do outweigh the risks for this feature. During the design review, the following conclusions were reached: - The medical benefits of the device outweigh the residual risk for each individual risk and ● all risks together - . The overall residual risk for the project is deemed acceptable # Verification: The software verification team's primary goal was to assure that the software fully satisfies all expected system requirements and features. Test cases were executed against the system features and requirements. As a part of creating the test cases, the verification team reviewed and monitored the Requirements Traceability Matrix ("RTM") to ensure coverage of the items within the RTM. #### Validation: The software validation team's primary goal was assuring the software conforms to user needs and intended use. The validation team conducted workflow testing that provided evidence that the system requirements and features were implemented, reviewed and met. # Internal Validation (Phantom Testing): The software validation team provided internal validation of Vitrea CT Lung Density Analysis software. Internal validation included internal user acceptance testing using various phantoms. Results of numerical quantities calculated by CT Lung Density Analysis were verified using CT semi-synthetic phantoms and patient based CT datasets. {15}------------------------------------------------ Image /page/15/Picture/0 description: The image shows the word "VITAL" in bold, black letters. The "i" in "VITAL" has a circular dot above it. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. # External Validation: During external validation of the CT Lung Density Analysis software, experienced users evaluated the visualization, axial plane location, quantification of density, and snapshots among other features. Each user felt that the Vitrea CT Lung Density Analysis software enables the user to assess and quantify lung density. #### Summary of Clinical Tests: The subject of this 510(k) notification, Vitrea CT Lung Density Analysis software, did not require clinical studies to support safety and effectiveness of the software. #### Cyber and Information Security: #### Confidentiality The Vitrea platform (K071331) relies on built in Windows Login security to limit access to the system. The Vitrea platform can only be installed and configured by an administrator of the Windows machine. #### Integrity The Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances. New DICOM produced by Vitrea is identified as such with the appropriate manufacturer tags per the DICOM standard. #### Availability The Vitrea platform is always available to the logged on user as long as the Windows machine itself is properly maintained. # Accountability The Vitrea platform includes an audit capability that enables accountability by tracking authenticated and authorized user operations along with information accessed. Vitrea audit logs are time stamped, enabling correlation with Windows system logging to track information accessed by a user. # Performance Standards: The FDA has not established mandatory performance standards and no special controls exist for this device. General software verification and validation tests were conducted to confirm proper function of the device's features. | Standard No. | Standards<br>Organization | Standard Title | Version | Date | |-------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------|---------|------------| | PS 3.1- 3.20 (2011)<br>(Recognition<br>Number 12-238) | NEMA | Digital Imaging and<br>Communications in Medicine<br>(DICOM) Set (Radiology) | 3 | 03/16/2012 | | ISO 14971:2007<br>(Recognition<br>Number 5-70) | AAMI / ANSI<br>/ ISO | Medical Devices -<br>Applications of Risk<br>Management to Medical<br>Devices | 2007 | 03/16/2012 | | IEC 62304:2006<br>(Recognition<br>Number 13-32) | AAMI / ANSI<br>/ IEC | Medical Device Software -<br>Software Life Cycle<br>Processes (Software /<br>Informatics) | 2006 | 08/20/2012 | The Vitrea software complies with the following voluntary recognized consensus standards: {16}------------------------------------------------ Image /page/16/Picture/0 description: The image shows the word "VITAL" in all capital letters. The letters are black and bolded. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. # Substantial Equivalence Analysis Conclusion: Vital Images believes the CT Lung Density Analysis software application has a similar intended use, indications for use, principle of operation, and technological characteristics as the legally marketed VIDA Pulmonary Workstation 2 software (K083227). In addition, the segmentation algorithm is similar to the algorithm available on already cleared CT Lung Analysis software (K043333). Any noted minor differences have been explained and do not raise any different questions of safety or effectiveness when used as labeled. The implemented design controls, risk management activities, labeling, and performed tests demonstrate the safety and efficacy of the subject device. Based on the comparison information provided above, Vital Images believes the subject device should be found substantially equivalent to the predicate device.