Vitrea CT Brain Perfusion
Device Facts
| Record ID | K181247 |
|---|---|
| Device Name | Vitrea CT Brain Perfusion |
| Applicant | Vital Images, Inc. |
| Product Code | LLZ · Radiology |
| Decision Date | Nov 20, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | AI/ML, Software as a Medical Device |
Indications for Use
Vitrea CT Brain Perfusion is a non-invasive post-processing application designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e., delay of tissue response, time to peak), and mean transit time (MTT) from dynamic CT image data acquired after the injection of contrast media. The package also allows the calculation of regions of interest and mirrored regions, as well as the visual inspection of time density curves. Vitrea CT Brain Perfusion supports the physician in visualizing the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed signal intensity (lower for both CBF and CBV and higher for time to peak and MTT).
Device Story
Vitrea CT Brain Perfusion is a non-invasive post-processing software application used by clinicians to analyze dynamic CT image data acquired after contrast media injection. It transforms raw CT data into quantitative perfusion maps, including cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), and time to peak (TTP). The device utilizes a Bayesian algorithm—or optionally an SVD+ algorithm—to perform motion correction, curve fitting, and noise reduction. It generates 2D/3D perfusion maps, summary maps, and time-density curves. Used in clinical settings, the software assists physicians in visualizing perfusion deficits associated with acute stroke. By providing objective quantification of blood flow, the device supports clinical decision-making regarding stroke management and patient intervention.
Clinical Evidence
No clinical studies were required. Safety and effectiveness were supported by bench testing, software verification, and validation. External validation involved physician evaluation comparing the Bayesian algorithm to the predicate's SVD+ algorithm, concluding the subject device is as safe and effective as the predicate.
Technological Characteristics
Post-processing software for CT imaging. Features Bayesian and SVD+ perfusion algorithms. Supports DICOM 3.0 standards. Operates on standard radiological workstations. Includes automated motion correction, vessel removal, and midline detection. Complies with IEC 62304 (software lifecycle) and ISO 14971 (risk management).
Indications for Use
Indicated for patients with suspected compromised or abnormal cerebral blood flow. Intended for use by qualified healthcare professionals including radiologists, non-radiology specialists, physicians, and technologists.
Regulatory Classification
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Predicate Devices
- Vitrea CT Brain Perfusion software (K121213)
Reference Devices
- Olea Sphere V3.0 (K152602)
Submission Summary (Full Text)
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November 20, 2018
Vital Images, Inc. Susan Atwood Principal Quality Engineer 5850 Opus Parkway, Suite 300 MINNETONKA, MN 55343-4414
Re: K181247
Trade/Device Name: Vitrea CT Brain Perfusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: October 23, 2018 Received: October 24, 2018
Dear Susan Atwood:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert A. 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) K181247
Device Name Vitrea CT Brain Perfusion
#### Indications for Use (Describe)
Vitrea CT Brain Perfusion is a non-invasive post-processing application designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e., delay of tissue response, time to peak), and mean transit time (MTT) from dynamic CT image data acquired after the injection of contrast media. The package also allows the calculation of regions of interest and mirrored regions, as well as the visual inspection of time density curves. Vitrea CT Brain Perfusion supports the physician in visualizing the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed signal intensity (lower for both CBF and CBV and higher for time to peak and MTT).
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# 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 Submission: | Vital Images, Inc. hereby submits this traditional 510(k) to provide a notification submission for proposed software changes in the already 510(k) cleared Vitrea CT Brain Perfusion software (K121213). | |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Vital Images, Inc.<br>5850 Opus Parkway, Suite 300<br>Minnetonka, MN, 55343-4414, USA | |
| Establishment Registration: | 2134213 | |
| Contact Person: | Susan Atwood<br>Principal Quality Engineer<br>Phone: 952-487-9759<br>Fax: 952-487-9510<br>E-mail: satwood@vitalimages.com | Alternate Contact Person:<br>Vince Swenson<br>Sr. Director of Quality and Regulatory<br>Phone: 952-487-9548<br>Fax: 952-487-9510<br>E-mail: vswenson@vitalimages.com |
| 510(k) Type: | Traditional | |
| Summary Date: | May 8, 2018 | |
| Device Trade Name: | Vitrea CT Brain Perfusion | |
| Device Common Name/ Regulatory Description: | Picture Archiving and Communications System | |
| Device Classification Name: | System, Image Processing, Radiological | |
| Regulation Number: | 21 CFR 892.2050 | |
| Product Code: | LLZ | |
| Regulatory Classification: | Class II | |
| Device Panel: | Radiology | |
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## Predicate Device
| Predicate Device | Manufacturer | FDA 510(k) Number |
|---------------------------------------|-----------------------------------------------------------------------------------|-------------------|
| Vitrea CT Brain Perfusion<br>software | Vital Images, Inc.<br>5850 Opus Parkway, Suite 300<br>Minnetonka, MN 55343<br>USA | K121213 |
#### Reference Device
| Reference Device | Manufacturer | FDA 510(k) Number |
|------------------|-----------------------------------------------------------------------------------|-------------------|
| Olea Sphere V3.0 | Olea Medical<br>93 Avenue Des Sorbiers,<br>Zone Athelia Iv<br>La Ciotat, FR 13600 | K152602 |
## Device Description
Vitrea CT Brain Perfusion is a noninvasive post-processing software that calculates cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e., delay of tissue response, time to peak), and mean transit time (MTT) from dynamic CT image data. It displays time density curves, perfusion characteristics in perfusion and summary maps, as well as regions of interest and mirrored regions.
#### Intended Use / Indications for Use
Vitrea CT Brain Perfusion is a non-invasive post-processing application designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e., delay of tissue response, time to peak), and mean transit time (MTT) from dynamic CT image data acquired after the injection of contrast media. The package also allows the calculation of regions of interest and mirrored regions, as well as the visual inspection of time density curves. Vitrea CT Brain Perfusion supports the physician in visualizing the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed signal intensity (lower for both CBF and CBV and higher for time to peak and MTT).
## Intended for Disease / Condition / Patient Population
Vitrea CT Brain Perfusion is intended for patients with suspected compromised or abnormal cerebral blood flow.
## Key Changes from last 510k clearance K121213
The following list contains the key changes since the last 510k. These changes were made to enhance user experience and performance:
- . Addition of Bayesian algorithm.
- Enhancements to Region-of-Interest tools (ROI) tools. ●
- Optimized layouts to include 4-up and 6-up views. .
- Support for loading variable time scans for multi-series studies in 2D. ●
- Support for Jog and Helical Shuttle Thin Slice Brain Perfusion datasets from Canon ● (formerly Toshiba) Aquilion Prime Scanners.
- . Support for Thick Slice "Jog Shuttle" from Philips Scanners (2D Perfusion).
- . Support of 2D perfusion for thick slice irregular helical Siemens & GE scans.
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- Increased the number of slices allowed per time series for GE & Siemens Helical Shuttle . Scans.
- Support for DSA for Jog and Helical datasets. .
- Enhancements to 4D thin slice to support axial and helical GE scans and helical Siemens scans.
- . Addition of 3D Summary Map view
## Regulatory Comparison
| | Subject<br>Device | Predicate<br>Device | Reference<br>Device | |
|---------------------|---------------------------------------------------------------|----------------------------------------------|----------------------------------------------|-------------------------------------------------------|
| Characteristic | Vitrea CT<br>Brain<br>Perfusion<br>with Bayesian<br>Algorithm | Vitrea CT<br>Brain<br>Perfusion<br>(K121213) | Olea Sphere<br>V3.0 (K152602) | Comparison |
| Classification Name | System, Image<br>Processing,<br>Radiological | System, Image<br>Processing,<br>Radiological | System, Image<br>Processing,<br>Radiological | Same |
| Regulatory Number | 892.2050 | 892.2050 | 892.2050 | Same |
| Product Code | LLZ | LLZ | LLZ | Same |
| Classification | Class II | Class II | Class II | Same |
| Review Panel | Radiology | Radiology | Radiology | Same |
| Decision Date | Under Review | Nov. 02, 2012 | Mar. 03, 2016 | Predicate and<br>reference<br>devices are<br>cleared. |
## Indications for Use Comparison with the Predicate Device
| | Subject Device | Predicate Device | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Criteria | Vitrea CT Brain Perfusion<br>with Bayesian Algorithm | Vitrea CT Brain Perfusion<br>(K121213) | Comparison |
| Indications<br>for Use | Vitrea CT Brain Perfusion is a<br>non-invasive post-processing<br>application designed to<br>evaluate areas of brain<br>perfusion. The software can<br>calculate cerebral blood flow<br>(CBF), cerebral blood volume<br>(CBV), local bolus timing (i.e.,<br>delay of tissue response, time<br>to peak), and mean transit time<br>(MTT) from dynamic CT image<br>data acquired after the injection<br>of contrast media. The package<br>also allows the calculation of<br>regions of interest and mirrored<br>regions, as well as the visual<br>inspection of time density<br>curves. Vitrea CT Brain | Vitrea CT Brain Perfusion is a<br>non-invasive post-processing<br>application designed to<br>evaluate areas of brain<br>perfusion. The software can<br>calculate cerebral blood flow<br>(CBF), cerebral blood volume<br>(CBV), local bolus timing (i.e.,<br>delay of tissue response, time<br>to peak), and mean transit time<br>(MTT) from dynamic CT image<br>data acquired after the injection<br>of contrast media. The package<br>also allows the calculation of<br>regions of interest and mirrored<br>regions, as well as the visual<br>inspection of time density<br>curves. Vitrea CT Brain | Same |
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| Criteria | Subject Device | Predicate Device | Comparison |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | Vitrea CT Brain Perfusion<br>with Bayesian Algorithm | Vitrea CT Brain Perfusion<br>(K121213) | |
| | Perfusion supports the<br>physician in visualizing the<br>apparent blood perfusion in<br>brain tissue affected by acute<br>stroke. Areas of decreased<br>perfusion, as is observed in<br>acute cerebral infarcts, appear<br>as areas of changed signal<br>intensity (lower for both CBF<br>and CBV and higher for time to<br>peak and MTT). | Perfusion supports the<br>physician in visualizing the<br>apparent blood perfusion in<br>brain tissue affected by acute<br>stroke. Areas of decreased<br>perfusion, as is observed in<br>acute cerebral infarcts, appear<br>as areas of changed signal<br>intensity (lower for both CBF<br>and CBV and higher for time to<br>peak and MTT). | |
| Intended<br>Users | Qualified healthcare<br>professionals including, but not<br>restricted to, radiologists, non-<br>radiology specialists,<br>physicians and technologists. | Qualified healthcare<br>professionals including, but not<br>restricted to, radiologists, non-<br>radiology specialists,<br>physicians and technologists. | Same |
| Patient<br>Population | Patients with suspected<br>compromised or abnormal<br>cerebral blood flow. | Patients with suspected<br>compromised or abnormal<br>cerebral blood flow. | Same |
| Modality<br>Support | CT | CT | Same |
## Similarities in Technology with the Predicate Device
| | Subject Device | Predicate<br>Device | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software Functionality | Vitrea CT Brain<br>Perfusion with<br>Bayesian<br>Algorithm | Vitrea CT Brain<br>Perfusion<br>(K121213) | Comparison |
| Quantitative brain perfusion maps<br>for:<br>• Regional cerebral blood<br>volume (rCBV)<br>• Regional cerebral blood<br>flow (rCBV)<br>• Mean transit time (MTT)<br>• Time to peak of tissue<br>(TTP)<br>• Delay of tissue response<br>(Delay) | Yes | Yes | Same |
| Display:<br>• Region of interest (ROI)<br>• Mirrored regions<br>• Time density curves | Yes | Yes | Same |
| | Subject Device | Predicate<br>Device | |
| Software Functionality | Vitrea CT Brain<br>Perfusion with<br>Bayesian<br>Algorithm | Vitrea CT Brain<br>Perfusion<br>(K121213) | Comparison |
| Display of Perfusion Maps in:<br>MPR orientations<br>•<br>2D<br>•<br>3D | Yes | Yes | Same |
| 4D-DSA (digital subtraction<br>angiography) view for visualizing<br>flow of contrast through the vessels | Yes | Yes | Same |
| Perfusion maps in MPR orientations<br>and 2D | Yes | Yes | Same |
| Automatic motion correction and<br>curve fitting | Yes | Yes | Same |
| Region of interest (ROI) templates | Yes | Yes | Same |
| Midline identification and display | Yes | Yes | Same |
| Manual and automatic detection of<br>artery and vein locations | Yes | Yes | Same |
| Automatic calculation of<br>quantitative brain perfusion<br>results | Yes | Yes | Same |
| Window leveling, edit mid-plane<br>line, display mirrored ROIs,<br>snapshots, time-series batch,<br>movies for physician reporting | Yes | Yes | Same |
| Report generation for the Brain<br>Perfusion patient study | Yes | Yes | Same |
| Perfusion measurement averages<br>for multiple ROIs with ability to<br>mirror an ROI from one hemisphere<br>to the other | Yes | Yes | Same |
| Window leveling, edit mid-plane<br>line, display mirrored ROIs,<br>snapshots, time-series batch,<br>movies for physician reporting | Yes | Yes | Same |
| Color coded Summary maps | Yes | Yes | Same |
| | Subject Device | Predicate<br>Device | |
| Software<br>Functionality | Vitrea CT Brain<br>Perfusion with<br>Bayesian<br>Algorithm | Vitrea CT<br>Brain<br>Perfusion<br>(K121213) | Comparison |
| Bayesian Perfusion<br>Algorithm | Yes | No | Subject device provides user<br>with choice to use either the<br>Bayesian algorithm or SVD+<br>algorithm.<br><br>Predicate device can use the<br>SVD+ algorithm.<br><br>Note: The added Bayesian<br>algorithm in the subject device is<br>similar to the Bayesian algorithm<br>in the reference device, Olea<br>Sphere 3.0, which was cleared<br>by the FDA under K152602.<br>Therefore, this added algorithm<br>does not raise different<br>questions of safety and<br>effectiveness. |
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## Differences in Technology with the Predicate Device
## Similarities in Technology with the Reference Device
| | Subject Device | Reference<br>Device | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-------------------------------|------------|
| Software Functionality | Vitrea CT Brain<br>Perfusion with<br>Bayesian<br>Algorithm | Olea Sphere<br>V3.0 (K152602) | Comparison |
| Bayesian Algorithm:<br>The Bayesian estimation of the<br>hemodynamical parameters<br>integrates a model-based<br>approach especially robust to<br>image noise and fast analytical<br>integration techniques to compute<br>the posterior probabilities of the<br>estimated blood flow, delay, MTT<br>and time concentration curves<br>(residue functions). | Yes | Yes | Same |
| Motion correction | Yes | Yes | Same |
| Automatic Arterial Input function<br>and Vein Output function | Yes | Yes | Same |
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| | Subject Device | Reference<br>Device | |
|----------------------------------------------------------------|------------------------------------------------------------|-------------------------------|------------|
| Software Functionality | Vitrea CT Brain<br>Perfusion with<br>Bayesian<br>Algorithm | Olea Sphere<br>V3.0 (K152602) | Comparison |
| Automatic vessel removal | Yes | Yes | Same |
| Automatic Brain Midline detection | Yes | Yes | Same |
| Noise reduction is applied before<br>the Bayesian computation. | Yes | Yes | Same |
| Model based Bayesian estimation<br>of perfusion parameters. | Yes | Yes | Same |
| Delay insensitive method. | Yes | Yes | Same |
# Summary of Non-Clinical Tests
The changes to the Vitrea CT Brain Perfusion software were designed, developed, and tested according to written procedures that included risk management. Software verification 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 Brain Perfusion software:
- . Risk Management
- Requirements Reviews ●
- Code Designs ●
- Code Development Testing ●
- Code Reviews ●
- Design Reviews ●
- Verification of the software
- . Validation of the software
# Risk Management
Each risk pertaining to the modifications to the Vitrea CT Brain Perfusion software 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 "Improbable." All risks for these modifications were collectively reviewed to determine if the benefits outweigh the risk. Based on Post Market information and because of the risk control measures included in these modifications, it is believed that the risk for these modifications as a whole are extremely low. Considering all risks against the benefits, it has been assessed that the benefits do outweigh the risks for these modifications.
009 510(k) Summary
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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
- . All risks have been reduced as low as possible
- . The overall residual risk for the software product 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, requirements and risk mitigations. Verification testing confirmed the software functions according to its requirements and all risk mitigations are functioning properly.
# Validation
The software validation team's primary qoal was to assure that 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 properly to conform to the intended use.
# Alqorithm Testing
Algorithm testing was performed to validate the proper function of the Bayesian algorithms within Vitrea CT Brain Perfusion. The Vitrea CT Brain Perfusion Bavesian algorithm has passed all the verification and validation and is therefore considered validated and acceptable.
# External Validation
During the external validation of the Vitrea CT Brain Perfusion software, physicians evaluated if the Brain Perfusion with Bayesian algorithm (subject device) was substantially equivalent with the Brain Perfusion with SVD+ algorithm (K121213, predicate device). Based on the scores provided by the physicians, Vital concluded the Brain Perfusion with Bayesian algorithm is as safe and effective as the already cleared Brain Perfusion with SVD+ algorithm and fulfills its intended use.
# Summary of Clinical Tests
The subject of this 510(k) notification, Vitrea CT Brain Perfusion software, did not require clinical studies to support safety and effectiveness of the software.
# Cyber and Information Security
The Vitrea CT Brain Perfusion software follows internal documentation which includes information based on the FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
Internal documentation covers the following:
- 1. Hazard analysis, mitigations, and design considerations pertaining to intentional and unintentional cybersecurity risks associated with the device, including:
- A specific list of all cybersecurity risks that were considered in the design of the . device;
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- . A specific list and justification for all cybersecurity controls that were established for the device.
- A traceability matrix that links the actual cybersecurity controls to the cybersecurity risks 2. that were considered;
- 3. A summary describing the plan for providing validated software updates and patches as needed throughout the lifecycle of the medical device to continue to assure its safety and effectiveness. The FDA typically will not need to review or approve medical device software changes made solely to strengthen cybersecurity.
- A summary describing controls that are in place to assure that the medical device 4. software will maintain its integrity (e.g. remain free of malware) from the point of origin to the point at which that device leaves the control of the manufacturer; and
- 5. Device instructions for use and product specifications related to recommended cybersecurity controls appropriate for the intended use environment (e.g. anti-virus software, use of firewall).
# 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 (2016)<br>(Recognition<br>Number 12-300) | NEMA | Digital Imaging and<br>Communications in Medicine<br>(DICOM) Set (Radiology) | 3 | 06/27/2016 |
| ISO 14971:2007<br>/(R)2010<br>(Recognition<br>Number 5-70) | AAMI / ANSI<br>/ ISO | Medical Devices -<br>Applications of Risk<br>Management to Medical<br>Devices | 2007 | 06/27/2016 |
| 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 CT Brain Perfusion software complies with the following voluntary recognized consensus standards:
# Substantial Equivalence Analysis Conclusion
Vital Images, Inc. believes the Vitrea CT Brain Perfusion software with Bayesian algorithm has a similar intended use, indications for use, principle of operation, and technological characteristics as the legally marketed, predicate device Vitrea CT Brain Perfusion with SVD+ algorithm (K121213). In addition, the Bayesian perfusion algorithm added to the Vitrea CT Brain Perfusion software is similar to the Bayesian perfusion algorithm in the reference device, Olea Sphere V3.0, which was cleared by the FDA under K152602.
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Furthermore, the verification and validation testing performed demonstrates the subject device is as safe and effective as the predicate device and does not raise any different questions of safety and effectiveness. Therefore, Vital believes the enhancements in the Vitrea CT Brain Perfusion software do not alter the fundamental scientific technology, safety or intended use of the device.
Each change was evaluated for the impact to the safety and effectiveness of the software. It was concluded that the changes do not raise any different questions of safety or effectiveness when used as labeled. The implemented design controls, risk management activities, labeling, and performed verification and validation tests demonstrate the safety and efficacy of the subject device. Based on the comparison information provided above, Vital Images, Inc. believes the subject device should be found substantially equivalent to the predicate device.
