(89 days)
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.
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
Here's an analysis of the provided text to extract the acceptance criteria and study details. Please note that the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical trial report with specific acceptance criteria and performance metrics against those criteria. Therefore, some information, particularly quantitative acceptance criteria and specific performance measures, is not explicitly stated in this document.
The document primarily relies on demonstrating equivalence in intended use, technological characteristics, and safety and effectiveness management (design controls, risk management, software verification and validation).
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy thresholds for lung density measurements or segmentation). Instead, it implicitly defines "acceptance" as meeting functional requirements, user needs, and demonstrating substantial equivalence to the predicate device.
The reported device performance is largely qualitative, focusing on whether the software functions as designed and meets user expectations.
| Acceptance Criteria (Implicit from document) | Reported Device Performance |
|---|---|
| Functional Requirements Met | "Software testing was completed to ensure the new features operate according to defined requirements." |
| User Needs and Intended Use Conformance | "The validation team conducted workflow testing that provided evidence that the system requirements and features were implemented, reviewed and met." "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." |
| Safety and Risk Mitigation | "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.'" "The overall residual risk for the project is deemed acceptable." |
| Equivalence to Predicate Device | The entire "Substantial Equivalence Comparison" section details how the subject device is similar in regulatory classification, intended use (with one noted difference that is deemed not to raise new questions of safety/effectiveness), and numerous technological features for data loading, viewing, segmentation, lung volume analysis, lung density analysis, and data export. |
| Numerical Quantity Verification | For internal validation, "Results of numerical quantities calculated by CT Lung Density Analysis were verified using CT semi-synthetic phantoms and patient based CT datasets." (No specific metrics or thresholds are provided). |
Study Details:
The document combines internal and external validation for its non-clinical testing. It explicitly states that "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."
-
Sample size used for the test set and the data provenance:
- Internal Validation (Phantom Testing): "various phantoms and patient based CT datasets." No specific number is given for either the phantoms or patients.
- External Validation: No specific number of cases or datasets is explicitly mentioned. The focus is on user evaluation of features.
- Data Provenance: Not specified, but "patient based CT datasets" implies retrospective patient data. Given the company is US-based (Minnetonka, MN), it's likely US data or data from a similar regulated environment.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For Internal Validation: "Results of numerical quantities calculated by CT Lung Density Analysis were verified using CT semi-synthetic phantoms and patient based CT datasets." It doesn't explicitly state the number or qualifications of experts establishing ground truth for the patient datasets. For phantoms, the ground truth is often inherent in the phantom's design or known physical properties.
- For External Validation: "experienced users evaluated the visualization, axial plane location, quantification of density, and snapshots among other features." The number of experienced users is not specified, nor are their exact qualifications (e.g., "radiologist with X years of experience").
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. The document describes "verification" and "validation," including internal testing and external user acceptance, but does not detail a specific adjudication method for ground truth establishment.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The document explicitly states that "The subject of this 510(k) notification... did not require clinical studies to support safety and effectiveness of the software." Therefore, no MRMC study comparing human readers with and without AI assistance was conducted or reported.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies a standalone evaluation was performed during internal validation, where "Results of numerical quantities calculated by CT Lung Density Analysis were verified using CT semi-synthetic phantoms and patient based CT datasets." This focuses on the algorithmic output against a known or established truth without direct human interpretation as part of the primary performance metric. However, the subsequent "External Validation" involves human interaction with the software.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Internal Validation:
- Semi-synthetic phantoms: Ground truth is inherent in the phantom's known physical properties or generated data.
- Patient-based CT datasets: The type of ground truth is not explicitly stated (e.g., expert consensus on manual measurements, pathology reference standard). It mentions "verified," implying a reference standard was used, but not its nature.
- For the external validation, "ground truth" was more about user acceptance and functionality, rather than specific quantitative medical accuracy against a clinical reference.
- For Internal Validation:
-
The sample size for the training set:
- Not specified. The document details software development and testing, but not the specifics of algorithm training if machine learning was used (which is not explicitly stated but implied for segmentation/analysis).
-
How the ground truth for the training set was established:
- Not specified. As the sample size for the training set and the specific methods of AI/ML are not disclosed, the method for establishing ground truth for training data is also not provided.
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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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely 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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510K Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c).
| Basis for theSubmission: | To obtain 510k clearance for Vital's software preset Vitrea CT LungDensity Analysis which is substantially equivalent to the clearedVIDA Pulmonary Workstation 2 (PW2) manufactured by VIDADiagnostics. | |
|---|---|---|
| Submitter: | Vital Images, Inc.5850 Opus Parkway, Suite 300Minnetonka, MN, 55343-4414 | |
| EstablishmentRegistration: | 2134213 | |
| Contact Person: | Katie RyanRegulatory Affairs SpecialistPhone : 952-487-9793Fax: 952-487-9510E-mail: kryan@vitalimages.com | |
| 510(k) Type: | Traditional | |
| Summary Date: | July 20, 2015 | |
| Device Trade Name: | Vitrea® CT Lung Density Analysis Software | |
| Device CommonName/ RegulatoryDescription: | Computed Tomography X-ray System | |
| Device ClassificationName: | System, X-ray, Tomography, Computed | |
| Regulation Number: | 21 CFR 892.1750 | |
| Product Code: | JAK | |
| RegulatoryClassification: | Class II | |
| Device Panel: | Radiology |
Predicate Device(s):
| Predicate Device | Manufacturer | FDA 510(k) Number |
|---|---|---|
| VIDA PulmonaryWorkstation 2 (PW2) | VIDA Diagnostics100 Oakdale Campus, Suite 225 Ticlowa City, IA 55242 | K083227 |
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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 3.7Medical Image ProcessingSystem (Lung Analysis) | Vital Images, Inc.5850 Opus Parkway, Suite 300Minnetonka, 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.
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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 LungDensity AnalysisSoftware | VIDA PulmonaryWorkstation 2(PW2) | Comparison |
| Classification Name | ComputedTomography X-raySystem. | ComputedTomography X-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 8,2008 | Predicate andReferencedevices arecleared |
Intended Use Comparison with Predicate Device:
| Criteria | Subject DeviceVitrea CT LungDensity AnalysisSoftware | Predicate DeviceVIDA PulmonaryWorkstation 2 (PW2) | Comparison |
|---|---|---|---|
| Intended Use | The Vitrea LungDensity Analysissoftware provides CTvalues for thepulmonary tissue fromCT thoracic datasets.Three-dimensional (3D)segmentation of the leftlung and right lung,volumetric analysis,density evaluations andreporting tools areintegrated in a specificworkflow to offer thephysician a quantitativesupport for diagnosisand follow-upevaluation of lungtissue images. | The VIDA PulmonaryWorkstation 2 (PW2)software providesreproducible CT valuesfor pulmonary tissue,which is essential forproviding quantitativesupport for diagnosis andfollow up examinations.The PW2 can be used tosupport the physician inthe diagnosis anddocumentation ofpulmonary tissue images(e.g., abnormalities) fromCT thoracic datasets.Three-D segmentationand isolation of sub-compartments, volumetricanalysis, densityevaluations, low densitycluster analysis andreporting tools are | The support for lowdensity cluster analysisis not part of the subjectdevice's indications foruse. |
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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 DeviceVitrea CT LungDensity AnalysisSoftware | Predicate DeviceVIDA PulmonaryWorkstation 2 (PW2) | Comparison |
|---|---|---|---|
| combined with adedicated workflow. TheVIDA PulmonaryWorkstation 2 (PW2)software package is alsointended to be a real-timeinteractive evaluation inspace and time for CTvolume data sets thatprovides thereconstruction of two-dimensional images intoa three-dimensionalimage format. | |||
| Intended Users | Thoracic Radiologistsand Pulmonologists | Thoracic Radiologistsand Pulmonologists | None |
| PatientPopulation | Patients withpulmonary diseasesand abnormalities | Patients with chestdiseases, e.g. whenexamining the pulmonarytissue (i.e. lungparenchyma) in CTthoracic datasets | Similar |
| ModalitySupport | CT /CTA | CT /CTA | None |
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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
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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 DensityAnalysis Software | VIDA Pulmonary Workstation 2(PW2)which cannot be accomplished by atrained user utilizing manual tracingmethods; the intent of the software is tosave time and automate potential errorprone manual tasks.The software has functions for loading,analyzing, saving datasets and willgenerate screen displays, computationsand aggregate statistics. |
Similarities in Technology with Predicate Device:
| Criteria | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Vitrea CT LungDensity AnalysisSoftware | VIDA PulmonaryWorkstation 2(PW2) | ||
| Modality | |||
| CT | Yes | Yes | Same |
| Data Loading | |||
| DICOM | Yes | Yes | Same |
| Ability to load one or twoseries of chest CT exam | Yes | Yes | Same |
| Data Viewing Support | |||
| MPR | Yes | Yes | Same |
| 3D | Yes | Yes | Same |
| Segmentation | |||
| Provides 3D Segmentationtool | Yes | Yes | Same |
| Provide Left LungSegmentation | Yes | Yes | Same |
| Provides Right LungSegmentation | Yes | Yes | Same |
| Provides airwayssegmentation (trachea,main bronchi, and somelarger bronchioles) | Yes | Yes | Same |
| Criteria | Subject Device | Predicate Device | Comparison |
| Vitrea CT LungDensity AnalysisSoftware | VIDA PulmonaryWorkstation 2(PW2) | ||
| User can manually editsegmentation provided bythe software | Yes | Yes | Same |
| Lung Volume Analysis Support | |||
| Ability to measure andview Left Lung volume | Yes | Yes | Same |
| Ability to measure andview Right Lung volume | Yes | Yes | Same |
| Lung Density Analysis Support | |||
| Low (ml) Volume forRight Lung:Ability to measure volumeof Right lung voxels in thelowest HU density rangeas defined by the densitythresholds | Yes | Yes | Same |
| Low (ml) Volume for LeftLung:Ability to measure volumeof Left lung voxels in thelowest HU density rangeas defined by the densitythresholds | Yes | Yes | Same |
| Low (ml) Volume forBoth Lungs:Ability to measure additionof volumes of both lungsvoxels in the lowest HUdensity range as definedby the density thresholds | Yes | Yes | Same |
| Medium (ml) Volume forRight Lung:Ability to measure volumeof Right lung voxels in themiddle HU density rangeas defined by the densitythresholds | Yes | Yes | Same |
| Medium (ml) Volume forLeft Lung: | Yes | Yes | Same |
| Criteria | Subject Device | Predicate Device | Comparison |
| Vitrea CT LungDensity AnalysisSoftware | VIDA PulmonaryWorkstation 2(PW2) | ||
| Ability to measure volumeof Left lung voxels in themiddle HU density rangeas defined by the densitythresholds | Yes | ||
| Medium (ml) Volume forBoth Lungs:Ability to measure additionof volumes of both lungsvoxels in the middle HUdensity range as definedby the density thresholds | Yes | Yes | Same |
| High (ml) Volume forRight Lung:Ability to measure volumeof Right lung voxels in thehighest HU density range(such as vessels) asdefined by the densitythresholds | Yes | Yes | Same |
| High (ml) Volume forLeft Lung:Ability to measure volumeof Left lung voxels in thehighest HU density range(such as vessels) asdefined by the densitythresholds | Yes | Yes | Same |
| High (ml) Volume forBoth Lungs:Ability to measure additionof volumes of both lungsvoxels in the highest HUdensity range (such asvessels) as defined by thedensity thresholds | Yes | Yes | Same |
| Right Lung (ml) Volume:Ability to provide Rightlung volume including onlythe voxels designated asLow and Medium Right | Yes | Yes | Same |
| Criteria | Subject Device | Predicate Device | Comparison |
| Vitrea CT LungDensity AnalysisSoftware | VIDA PulmonaryWorkstation 2(PW2) | ||
| lung tissues | |||
| Left Lung (ml) Volume:Ability to provide Left lungvolume including only thevoxels designated as Lowand Medium Left lungtissues | Yes | Yes | Same |
| Lung (ml) Volume:Ability to provide additionof both lungs volumesincluding only the voxelsdesignated as Low andMedium Right and Leftlung tissues | Yes | Yes | Same |
| Low Density (LD) Index(%) for Right Lung:$Low RightLung volume(Low RightLung volume+Medium RightLung volume)$ | Yes | Yes | Same |
| Low Density (LD) Index(%) for Left Lung:$Low LeftLung volume(Low LeftLung volume+Medium LeftLung volume)$ | Yes | Yes | Same |
| Low Density (LD) Index(%) for Both Lungs: | Yes | Yes | Same |
| Criteria | Subject DeviceVitrea CT LungDensity AnalysisSoftware | Predicate DeviceVIDA PulmonaryWorkstation 2(PW2) | Comparison |
| Addition of Leftand Right LungsLow volumes(Addition of Leftand Right LungsLow volumes+Addition of Leftand Right LungsMedium volumes) | |||
| PD15 (g/l) measurementfor Right Lung:The HU value which acertain percentage (15%)of the voxels in thecumulative frequencydistribution histogramhave a lower density inRight Lung | Yes | Yes | Same |
| PD15 (g/l) measurementfor Left Lung:The HU value which acertain percentage (15%)of the voxels in thecumulative frequencydistribution histogramhave a lower density inLeft Lung | Yes | Yes | Same |
| PD15 (g/l) measurementfor Both Lungs:The HU value which acertain percentage (15%)of the voxels in thefrequency distributionhistogram have a lowerdensity in both Lungs | Yes | Yes | Same |
| Ability to generate Densitygraphs | Yes | Yes | Same |
| Criteria | Subject Device | Predicate Device | Comparison |
| Vitrea CT LungDensity AnalysisSoftware | VIDA PulmonaryWorkstation 2(PW2) | ||
| Analyzed Data Export | |||
| Ability to take snapshot | Yes | Yes | Same |
| Ability to generate report | Yes | Yes | Same |
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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 densitycluster analysis | No | Yes | The support for lowdensity clusteranalysis is not part ofthe subject device. |
Similarities in Technology with the Reference Device:
| Subject Device | Reference Device | Comparison | |
|---|---|---|---|
| Criteria | Vitrea CT LungDensity AnalysisSoftware | VITREA2, Version 3.7Medical ImageProcessing System(Lung Analysis) | |
| Segmentation | Yes | Yes | SimilarNote: 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. |
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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.
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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. | StandardsOrganization | Standard Title | Version | Date |
|---|---|---|---|---|
| PS 3.1- 3.20 (2011)(RecognitionNumber 12-238) | NEMA | Digital Imaging andCommunications in Medicine(DICOM) Set (Radiology) | 3 | 03/16/2012 |
| ISO 14971:2007(RecognitionNumber 5-70) | AAMI / ANSI/ ISO | Medical Devices -Applications of RiskManagement to MedicalDevices | 2007 | 03/16/2012 |
| IEC 62304:2006(RecognitionNumber 13-32) | AAMI / ANSI/ IEC | Medical Device Software -Software Life CycleProcesses (Software /Informatics) | 2006 | 08/20/2012 |
The Vitrea software complies with the following voluntary recognized consensus standards:
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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.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.