Lung Analysis Software
Device Facts
| Record ID | K151283 |
|---|---|
| Device Name | Lung Analysis Software |
| Applicant | Vital Images, Inc. |
| Product Code | JAK · Radiology |
| Decision Date | Oct 30, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K151283 · Oct 30, 2015 | Lung Analysis Software | Vital Images, Inc. | Patient-based clinical datasets | Retrospective patient-based datasets were used to assess the intra-reader and inter-reader variability of the software's GGO volume measurements. | Retrospective; Patient-based dataset; Variability assessment |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Intra-reader and inter-reader variability evaluation; Retrospective analysis of patient-based datasets | Patients with GGO nodules | Not applicable for this study | Intra-reader and inter-reader agreement (Concordance Correlation Coefficient, Total Deviation Index, Coverage Probability) |
Indications for Use
The separately-licensed Lung Analysis option is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.
Device Story
Lung Analysis software processes thoracic CT images to assist radiologists and technologists in characterizing lung nodules. Input consists of thoracic CT scans; the device provides automated segmentation and measurement tools for solid and GGO nodules. Users identify nodules and specify type (solid/GGO); the system calculates volume, mean/max diameter, and density (HU). It supports temporal analysis by tracking nodules across multiple studies, calculating doubling time and volume growth. Used in clinical settings, the software aids in nodule management, reporting (L-RADS/Fleischner criteria), and comparative review. Output is displayed on the workstation for clinical decision-making, enabling standardized reporting and longitudinal monitoring of potential malignancies.
Clinical Evidence
No clinical studies were required. Evidence consists of bench testing, including phantom studies using anthropomorphic lung phantoms with synthetic nodules to verify GGO volume, diameter, and density measurement accuracy/precision. Intra-reader and inter-reader variability were assessed using patient-based datasets. All tests passed within acceptable ranges.
Technological Characteristics
Radiological image processing software; DICOM compliant; operates on Windows-based platforms. Features automated segmentation, multi-planar reformatting (MPR), and quantitative analysis tools. Complies with ISO 14971:2007 (risk management) and IEC 62304:2006 (software lifecycle).
Indications for Use
Indicated for radiologists and technologists to locate, identify, segment, measure, and report on solid and ground glass opacity (GGO) lung nodules in thoracic CT images for single or longitudinal studies.
Regulatory Classification
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.
Predicate Devices
- Lung Analysis (K043333)
Reference Devices
- LungCARE CT (K033374)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2015
Vital Images, Inc. % Mr. Parthiv Shah Sr. Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343
Re: K151283
Trade/Device Name: Lung Analysis Software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK, LLZ Dated: October 9, 2015 Received: October 13, 2015
Dear Mr. Shah:
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.
Michael O'Hara For
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) K151283
Device Name Lung Analysis
### Indications for Use (Describe)
The separately-licensed Lung Analysis option is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c)
| Purpose of Submission: | Vital Images, Inc. hereby submits this traditional 510(k) for changes that do not qualify for a Special 510(k) notification. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Vital Images, Inc.<br>5850 Opus Parkway<br>Suite 300<br>Minnetonka, MN, 55343-4414 |
| Establishment Registration: | 2134213 |
| 510(k) Submitter: | Parthiv Shah<br>Sr. Regulatory Affairs Specialist<br>Phone : 952-487-9574<br>Fax: 952-487-9510<br>E-mail: pshah@vitalimages.com |
| FDA Contact: | Vince Swenson<br>Sr. Director Quality and Regulatory Affairs<br>Phone : 952-487-9548<br>Fax: 952-487-9510<br>E-mail: vswenson@vitalimages.com |
| 510(k) Type: | Traditional |
| Summary Date: | October 9, 2015 |
| Device Trade Name: | Lung Analysis Software |
| Device Common Name: | Radiological Image Processing Software |
| Device Classification Name: | System, Image Processing, Radiological |
| Regulatory Description: | Picture Archiving and Communications System |
| Regulation Number: | 21 CFR 892.1750 |
| Product Code: | JAK |
| Regulatory Classification: | Class II |
043_Updated_007_510k_Summary (21 CFR 807.92)
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# Predicate Device:
| Predicate Device | Manufacturer | FDA 510(k) number |
|--------------------------------------------|--------------------|-------------------|
| Lung Analysis<br>(Legally Marketed Device) | Vital Images, Inc. | K043333 |
### Reference Device:
| Reference Device | Manufacturer | FDA 510(k) number |
|------------------------------------------|------------------------------------|-------------------|
| LungCARE CT<br>(Legally Marketed Device) | Siemens Medical Solutions,<br>Inc. | K033374 |
# Device Description:
Lung Analysis aids in measuring and characterizing lung nodules. The interface and automated tools help to efficiently determine growth patterns and compose comparative reviews. Lung Analysis is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed. The Lung Analysis Software requires the user to identify a nodule and to determine whether it is a GGO or solid nodule in order to use the appropriate characterization tool.
# Key features:
# General Viewing:
- . Automated segmentation of lung and airways
- Single click lung nodule segmentation tools to include solid nodules and ground glass opacity (GGO) nodules
- Restore previously segmented nodules from prior studies for comparison ●
- Evaluation of nodules with quantitative measurements .
- Dictation Table with Lung-RADS, Fleischner Criteria and option to export to Clipboard
- Structured reporting available for export in the Viewer tab as well as the Reporting tab .
- Load three studies concurrently for temporal measurements .
- . Select a nodule in a single time point and the tool will automatically find the nodule in the other studies loaded
- Automatic nodule tracking of all measurements
- Improved nodule management and numbering ●
- Ability to export snapshots, CSV and copy to Clipboard features
- Available in Viewer and Report page o
# General Image Display, Manipulation, and Analysis Tools:
- . Automatic software calculation of the following measurements for each segmented nodule:
- Volume (mm³) o
- Mean diameter (mm) O
043_Updated_007_510k_Summary (21 CFR 807.92)
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- Maximum diameter (mm) (RECIST) o
- O Short axis diameter (mm) (WHO)
- Average/minimum/maximum densities (HU) o
- Manual edit of the nodule segmentation contour lines with automatic recalculation of all measurements post-editing
- . Manual specification of the following characteristics for each nodule:
- o Lobe Location
- Shape o
- O Border
- . Comparison feature that allows establishing correspondence between nodules in two or three studies, and automatic calculation of the following temporal measurements between each follow-up scan and the previous scan:
- o Elapsed time in days
- Doubling time in days o
- Percent (%) growth in nodule volume O
# Intended Use / Indications for Use:
The separately-licensed Lung Analysis option is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.
# Changes from the last 510(k) clearance K043333:
| No. | Change(s) | Rationale for Changes |
|-----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Change-1: Support of Ground Glass Opacity<br>(GGO) Nodule<br>Provides the ability to probe and segment a<br>GGO type lung nodule. In addition, this feature<br>includes the ability to use 2nd Maximum<br>Diameter to measure the solid portion of a GGO<br>nodule and enabling solid nodules to be<br>segmented prior to GGO nodules. | Extend the capabilities and<br>functionality of the previously cleared<br>Lung Analysis software to provide<br>physicians the ability to examine and<br>report on GGO nodules which can<br>be cancerous. |
| 2 | Change-2: Lung Analysis Performance<br>Enhancements<br>Improvements to enhance the overall<br>performance of Lung Analysis. | Enhance performance to include<br>improved execution and workflow for<br>better user experience and function. |
| 3 | Change-3: Nodule Numbering Enhancement<br>Updated nodule numbering to automatically<br>update numbering to the next sequential<br>number, specifically after deletion of a previously<br>numbered nodule. | Provide continuous numbering<br>during probing and matching of<br>nodules for better user experience. |
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| No. | Change(s) | Rationale for Changes |
|-----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4 | <b>Change-4: Dictation Table Addition</b><br>Added a dictation table with the ability to enable<br>L-Rad and Fleischner criteria. | Add the functionality of dictation<br>table with L-RAD and Fleischner<br>criteria as these are standard criteria<br>for reporting on lung cancer<br>screenings and diagnosis. |
| 5 | <b>Change-5: Replaced Current Editing Feature</b><br>The previous editing configuration was replaced<br>with a Lung Region editing functionality. | Replaced with Region editing to<br>increase the lung field which is to be<br>examined for more precise nodule<br>segmentation. |
| 6 | <b>Change-6: Replaced Effective Diameter<br/>Measurement Function</b><br>The previous measurement function “effective<br>diameter” was replaced with “mean diameter.” | Replaced for enhanced performance<br>and usability as mean diameter<br>provides a more accurate<br>measurement. |
# Intended for Disease / Condition / Patient Population:
The software provides Radiologists, Technologist, with a robust application to locate, identify, segment, measure and create reports on solid and GGO nodules. This application allows for the preparation of nodule comparison studies.
# Substantial Equivalence Comparison:
#### ● Regulatory Comparison with the Predicate Device
| Criteria | Predicate Device | Subject Device | Comparison |
|---------------------------------------|-------------------------------------------|-------------------------------------------------------|------------|
| | Lung Analysis (K043333) | Lung Analysis<br>(Modified Lung<br>Analysis Software) | |
| Device Type /<br>Classification Name | System, Image Processing,<br>Radiological | System, Image<br>Processing,<br>Radiological | Same |
| Common Name | Radiological Image Processing<br>Software | Radiological Image<br>Processing Software | Same |
| Regulation /<br>Classification Number | 21 CFR 892.2050 | 21 CFR 892.1750 | Similar |
| Product Code | LLZ | JAK | Similar |
| Classification | Class II | Class II | Same |
| Review Panel | Radiology | Radiology | Same |
043_Updated_007_510k_Summary (21 CFR 807.92)
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| Criteria | Predicate Device | Subject Device | Comparison |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | Lung Analysis<br>(K043333) | Lung Analysis<br>(Modified Lung<br>Analysis Software) | |
| Indications for Use | The separately-<br>licensed Lung<br>Analysis option is<br>intended for the<br>review and analysis<br>of thoracic CT<br>images for the<br>purposes of<br>characterizing<br>nodules in the lung in<br>a single study, or<br>over the time course<br>of several thoracic<br>studies.<br>Characterizations<br>include diameter,<br>volume and volume<br>over time. The<br>system automatically<br>performs the<br>measurements,<br>allowing lung nodules<br>and measurements to<br>be displayed. | The separately-<br>licensed Lung<br>Analysis option is<br>intended for the<br>review and analysis<br>of thoracic CT<br>images for the<br>purposes of<br>characterizing<br>nodules in the lung in<br>a single study, or<br>over the time course<br>of several thoracic<br>studies.<br>Characterizations<br>include diameter,<br>volume and volume<br>over time. The<br>system automatically<br>performs the<br>measurements,<br>allowing lung nodules<br>and measurements to<br>be displayed. | Same |
#### Intended Use Comparison with the Predicate Device ●
#### Technology Comparison with the Predicate Device ●
| Criteria | Predicate Device | Subject Device | Comparison |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------|
| | Lung Analysis<br>(K043333) | Lung Analysis<br>(Modified Lung<br>Analysis Software) | |
| Image<br>Communication<br>Standard: DICOM | Yes | Yes | Same |
| 2D Image Review | Yes | Yes | Same |
| 3D Image Review | Yes | Yes | Same |
| Criteria | Predicate Device | Subject Device | Comparison |
| | Lung Analysis<br>(K043333) | Lung Analysis<br>(Modified Lung<br>Analysis Software) | |
| 2D and 3D<br>Comparative Review | Yes | Yes | Same |
| 3D Lung map | Yes | Yes | Same |
| 2D Measurements | Line and ROI tools<br>with statistics<br>Area | Line and ROI tools<br>with statistics<br>Area | Same |
| Density<br>Measurements | Minimum, Maximum<br>and Average HU | Minimum, Maximum<br>and Average HU | Same |
| Temporal<br>Measurements | Elapsed Time<br>% Growth in Volume<br>Doubling Time | Elapsed Time<br>% Growth in Volume<br>Doubling Time | Same |
| Workflow | Point-and-click<br>detection<br>Automated contouring<br>Automated<br>measurements<br>Manual correction | Point-and-click<br>detection<br>Automated<br>contouring<br>Automated<br>measurements<br>Manual correction | Same |
| Multi-planar<br>reformatting | MPR in any user-<br>defined linear plane,<br>MIP and average | MPR in any user-<br>defined linear plane,<br>MIP and average | Same |
| Auto-cine | Yes | Yes | Same |
| Save workflow | Restorable state from<br>user snapshots | Restorable state from<br>user snapshots | Same |
| Reporting | Detailed tabular report<br>with auto-population of<br>user-defined key<br>images | Detailed tabular<br>report with auto-<br>population of user-<br>defined key images | Same |
| Printing | Printing to standard<br>windows printers | Printing to standard<br>windows printers | Same |
| Criteria | Predicate Device | Subject Device | Comparison |
| | Lung Analysis<br>(K043333) | Lung Analysis<br>(Modified Lung<br>Analysis Software) | |
| Ease of Use | Visualization presets<br>and semi-automated<br>steps for typical image<br>review procedures | Visualization presets<br>and semi-automated<br>steps for typical<br>image review<br>procedures | Same |
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#### . Technology Comparison with the Reference Device
| Criteria | Reference Device | Subject Device | Comparison |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | LungCARE CT<br>(K033374) | Lung Analysis<br>(Modified Lung<br>Analysis Software) | |
| Feature: Support of<br>GGO lung nodule<br><br>The GGO lung<br>nodule feature<br>allows for detection,<br>segmentation and<br>tracking over time of<br>GGO nodules. | Yes | Yes | Same<br><br><b>Note:</b> The added<br>GGO lung nodule<br>feature is similar to<br>the feature on the<br>already cleared<br>Siemens Medical<br>Solutions, Inc.,<br>LungCARE CT<br>("Reference Device")<br>software package by<br>K033374. Therefore,<br>the added feature<br>does not raise new<br>questions of safety<br>and effectiveness. |
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| Criteria | Predicate Device | Subject Device | Comparison |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Lung Analysis<br>(K043333) | Lung Analysis<br>(Modified Lung Analysis Software) | |
| Feature: Support<br>of Ground Glass<br>Opacity (GGO)<br>Nodule and 2nd<br>Maximum<br>Diameter Rulers<br>Provides the ability<br>to probe and<br>segment a GGO<br>type lung nodule. In<br>addition, this<br>feature includes the<br>ability to use 2nd<br>Maximum Diameter<br>to measure the<br>solid portion of a<br>GGO nodule and<br>enabling solid<br>nodules to be<br>segmented prior to<br>GGO nodules. | No | Yes | The added features<br>do not affect the<br>intended use or<br>fundamental scientific<br>technology of the<br>already cleared Lung<br>Analysis software<br>(K043333).<br><br><b>Note:</b> The added<br>GGO lung nodule<br>feature is similar to<br>the feature on the<br>already cleared<br>Siemens Medical<br>Solutions, Inc.,<br>LungCARE CT<br>("Reference Device")<br>software package by<br>K033374. Therefore,<br>the added feature<br>does not raise new<br>questions of safety<br>and effectiveness. |
| Enhancement:<br>Lung Analysis<br>Performance<br>Improvements to<br>enhance the overall<br>performance of<br>Lung Analysis. | No | Yes | The added<br>performance<br>enhancements do not<br>affect the intended<br>use or fundamental<br>scientific technology<br>of the already cleared<br>Lung Analysis<br>software (K043333). |
| Criteria | Predicate Device | Subject Device | Comparison |
| | Lung Analysis<br>(K043333) | Lung Analysis<br>(Modified Lung<br>Analysis Software) | |
| Enhancement:<br>Nodule<br>Numbering<br>Updated nodule<br>numbering to<br>automatically<br>update numbering<br>to the next<br>sequential number,<br>specifically after<br>deletion of a<br>previously<br>numbered nodule. | No | Yes | This enhancement<br>does not affect the<br>intended use or<br>fundamental scientific<br>technology of the<br>already cleared Lung<br>Analysis software<br>(K043333). |
| Enhancement:<br>Dictation Table<br>Added a dictation<br>table with the ability<br>to enable L-Rad<br>and Fleischner<br>criteria. | No | Yes | This enhancement<br>does not affect the<br>intended use or<br>fundamental scientific<br>technology of the<br>already cleared Lung<br>Analysis software<br>(K043333). |
| Change: Replaced<br>Current Editing<br>Feature<br>The previous<br>editing<br>configuration was<br>replaced with a<br>Lung Region<br>editing functionality. | No | Yes | This change does not<br>affect the intended<br>use or fundamental<br>scientific technology<br>of the already cleared<br>Lung Analysis<br>software (K043333). |
| Change: Replaced<br>Effective Diameter<br>Measurement<br>Function<br>The previous<br>measurement<br>function "effective<br>diameter" was<br>replaced with<br>"mean diameter." | No | Yes | This change does not<br>affect the intended<br>use or fundamental<br>scientific technology<br>of the already cleared<br>Lung Analysis<br>software (K043333). |
#### ● Differences in Technology with the Predicate Device
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#### . Substantial Equivalence Analysis
The enhancements in the software do not affect the intended use or alter the fundamental scientific technology of the legally marketed Lung Analysis software (K043333). The modified Lung Analysis software has the same indications for use, principle of operation, and performs the same technological functions as the already cleared Lung Analysis software - K043333 (Predicate Device). The added GGO lung nodule feature is similar to the already cleared Siemens Medical Solutions, Inc., LungCARE CT (K033374) (Reference Device). The modifications are not consequential from the standpoint of device operation, safety, effectiveness or intended use. Any minor differences noted have been explained and do not raise any new questions of safety or effectiveness when used as labeled. The implemented design controls, risk management activities, and the performed verification and validation tests demonstrate the safety and efficacy of the device is equivalent to the predicate device. Based on the comparison data and test data, Vital Images believes the subject device should be found substantially equivalent to the predicate device.
### Summary of Non-Clinical Tests:
The changes to the software were designed, developed and tested according to written procedures that included applying risk management. Software testing was completed to ensure the new features operate according to their requirements.
Testing included verification, validation, and evaluation on previously acquired medical images. The following quality assurance measures were applied to the development:
- Risk Management ●
- . Requirements reviews
- Code designs .
- Code reviews
- . Design reviews
- . Verification of the software - that included performance and safety testing
- . Validation of the software – that included simulated usability testing by independent experienced medical professionals.
# Risk Management:
Each risk pertaining to this feature has 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 at least "Remote". All risks for this feature were collectively reviewed to determine if the benefits outweigh the risk. Based on the post market information contained in our Clinical Evaluation Report, injury or death is very rare for our product and products similar to ours. Because of this history and 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:
- All risks were reduced as low as possible ●
- 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
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# 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.
# Phantom Testing:
The phantom tests were performed is to verify that the Lung Analysis application generates reliable volumes and related linear and CT attenuation measurements of pulmonary ground glass opacifications (GGOs). The validation of the GGO measurements is based on anthropomorphic lung phantoms with synthetic nodules. Moreover, accuracy, intra-reader variability and interreader variability are assessed using patient-based datasets. In summary the following tests were performed:
- 1. GGO volume accuracy and precision: the accuracy and the precision of the GGO volume measurements after semi-automatic segmentation and before manual editing are within acceptable.
- 2. GGO volume reproducibility: the intra-reader and inter-reader agreement for the GGO volume measurements (patient-based dataset - after manual editing) are within acceptable ranges.
- GGO diameters accuracy and precision: the accuracy and the precision of the GGO 3. longest nodule diameter measurements after semi-automatic segmentation and before manual editing are within acceptable ranges.
- GGO mean CT attenuation accuracy and precision: the accuracy and the precision of 4. the GGO mean CT attenuation (HU) measurements after semi-automatic segmentation and before manual editing are within acceptable ranges.
| ID | Test Case Name | Parameters | Type | Status |
|----------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------|
| Test 1.a | Evaluate the accuracy and<br>precision of the GGO volume<br>measurement for Siemens 64-CT<br>scanner. | GGO volume<br><b>Bias:</b> Absolute error (mm3)<br>Absolute percentage normalized<br>error %(APNE)<br><br><b>Precision:</b> Percent Repeatability<br>Coefficient (PRC) | Phantom<br>dataset | Passed |
| ID | Test Case Name | Parameters | Type | Status |
| Test 1.b | Evaluate the accuracy and<br>precision of the GGO volume<br>measurement for Philips 16-CT<br>scanner. | GGO volume<br>Bias: Absolute error (mm3)<br>Absolute percentage normalized<br>error %(APNE)<br>Precision: Percent Repeatability<br>Coefficient (PRC) | Phantom<br>dataset | Passed |
| Test 1.c | Evaluate the accuracy and<br>precision of the GGO volume<br>measurement for Toshiba AQ1<br>320-CT scanner | GGO volume<br>Bias: Absolute error (mm3)<br>Absolute percentage normalized<br>error %(APNE)<br>Precision: Percent Repeatability<br>Coefficient (PRC) | Phantom<br>dataset | Passed |
| Test 2 | Evaluate the intra-reader and<br>inter-reader variability of GGO<br>volume measurements on<br>patient-based datasets. | Intra-reader agreement and<br>Inter-reader agreement:<br>Concordance Correlation<br>Coefficient (CCCinter, Total<br>Deviation Index (TDI), Coverage<br>Probability (CV) | Patient-<br>based<br>dataset<br>User-edited<br>GGOs | Passed |
| Test 3 | Evaluate the accuracy and<br>precision of the GGO longest<br>diameter measurement for<br>Toshiba AQ1 320-CT scanner. | Longest diameter (mm)<br>Bias: Absolute error (mm)<br>Absolute percentage normalized<br>error %(APNE)<br>Precision: within-nodule standard<br>deviation (wSD). | Phantom<br>dataset | Passed |
| Test 4 | Evaluate the accuracy and<br>precision of the GGO mean<br>attenuation measurement for<br>Toshiba AQ-One CT scanner. | Mean attenuation (HU)<br>Bias: Absolute error (HU) Absolute<br>percentage normalized error<br>%(APNE)<br>Precision: within-nodule standard<br>deviation (wSD). | Phantom<br>dataset | Passed |
The following table summarize the performed phantom tests:
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# Measurement Accuracy:
The following table summarize accuracy i.e. average bias (APE %) and precision (PRC %) for lung GGO volume measurement performed on Toshiba scanner with 100mAs exposure.
| GGO Ref. diameter | Bias APE% | Precision PRC% |
|-------------------|-----------|----------------|
| 5mm | 15.04% | 24.74% |
| 8mm | 16.15% | 11.85% |
| 10mm | 5.49% | 3.24% |
| 12mm | 2.98% | 3.38% |
The accuracy and precision results of the GGO volume measurements may vary for other CT scanner types or CT manufacturers and for other acquisition conditions involving tube current, slice thickness, reconstruction filters, etc.
### External Validation:
During external validation of Lung Analysis software, experienced medical professionals evaluated the application. All validators confirmed that the Lung Analysis software fulfills its intended uses.
### Summary of Clinical Tests:
The subject of this traditional 510(k) notification, Lung Analysis software, did not require clinical studies to support safety and effectiveness of the software.
# Cyber and Information Security:
- Confidentiality ●
The Vitrea platform (K150258) 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.
#### ● Intearity
The Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances.
#### ● 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 tracks authenticated and authorized user operations along with information on what data was 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.
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Image /page/16/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.
The Lung Analysis software complies with the following voluntary recognized consensus standards:
| Standard No. | Standards<br>Organization | Standard Title | Version | Date |
|---------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------|---------|------------|
| PS 3.1-3.20<br>(2011)<br>(Recognition<br>Number 12-238) | NEMA | Digital Imaging and<br>Communications in<br>Medicine (DICOM) Set<br>(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 |
# Conclusion:
Vital Images believes that the Lung Analysis software application has the same intended use and indications and similar principle of operation, and technological characteristics as the predicate and reference devices. Any minor differences noted have been explained and do not raise any new 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 device in comparison to the predicate device. Based on the comparison data and test data, Vital Images believes the subject device should be found substantially equivalent to the predicate device. The Lung Analysis software device is as safe and effective as the predicate device.
