(192 days)
No
The description focuses on post-processing algorithms based on material attenuation properties and image manipulation, with no mention of AI or ML techniques.
No.
The device is described as post-processing software that generates images and analyzes information about anatomical and pathological structures, but it does not directly perform any therapy or treatment.
No
The device is a post-processing software application that aids in visualizing and analyzing CT images; it does not directly diagnose but provides information for diagnostic interpretation by a trained professional.
Yes
The device is explicitly described as a "post-processing software application" that functions on a cleared platform. It processes existing CT images and does not include any hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a "post-processing software application" that works with "CT images acquired using different tube voltages and/or tube currents of the same anatomical location." It processes existing medical images.
- Lack of Biological Sample Analysis: There is no mention of analyzing biological samples from a patient. The input is imaging data, not biological material.
- Focus on Image Processing: The entire description revolves around manipulating and analyzing CT image data to visualize and analyze anatomical and pathological structures.
Therefore, this device falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The CT Dual Energy Image View application accepts CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The material composition of body regions may be determined using the energy dependence of the attenuation coefficients of different materials. This approach enables images to be generated at multiple energies within the available spectrum to visualize and analyze information about anatomical and pathological structures.
Product codes
JAK
Device Description
The Vitrea® CT Dual Energy Image View is a post-processing software application which functions on the Vitrea® Platform, cleared by K150258.This application allows you to load and combine two CT images, acquired from a Toshiba CT scanner with a Dual Energy protocol, of the same anatomical location; one obtained with low kV tube voltage and one obtained with high kV tube voltage. Vitrea® computes a Blended and an Enhanced image with adjustable virtual energy levels, a Virtual Non-Contrast (VNC) image, an lodine Map overlaid on one of the original or derived images, a CT graph, and a best Contrast-to-Noise Ratio (CNR) image. For the Raw Data Analysis workflow, Vitreally calculates a Monochromatic image.
The software supports Toshiba dual-energy studies containing image-based and projection-based reconstruction techniques.
- lmage-based reconstructed data consists of a standard image reconstruction of the two ● scans. Use the Dual Energy Image Domain (Two Volumes) workflow for these datasets.
- Projection-based reconstructed data consists of special material image reconstruction where . the two scans are combined to create two sets of images where a predefined material is defined, typically lodine/Water and/or Calcium/Water. Use the Dual Energy Raw Data Analysis (Four or Six Volumes) workflow for these datasets.
- NOTE: It is important that a description of the material is contained in the DICOM Image Comments tag (0020, 4000) for each dataset at the time of the scan. For lodine/Water projection-based reconstruction, the lodine material image should be labeled "I/H20," and the corresponding Water material image should be labeled "H20/1." For the Calcium/Water projection-based reconstruction, the Calcium material image should be labeled "Ca/H20," and the corresponding Water material image should be labeled "H20/Ca."
NOTE: The dual-energy datasets must be coincident with the same frame of reference UID.
NOTE: Available with Toshiba datasets only.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT /CTA
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained radiologists, clinicians or technologists.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Internal Validation (Phantom Testing):
The software validation team provided internal validation of Vitrea® CT Dual Energy Image View. Internal validation included internal user acceptance testing using various phantoms. Testing included side-by-side visual comparisons of dual energy algorithm outputs with Toshiba Display Console as the predicate device using phantom data. Details are included in Algorithm Verification and Validation.
External Validation:
During external validation, three experienced clinical experts evaluated the Vitrea CT Dual Energy Image View based on the following features: Iodine maps, Virtual non-contrast, monochromatic images, Best CNR, Blended images and Enhanced images at different energy levels. Two Radiological Technologists were provided a series of questions to obtain their feedback regarding performance and usability of each feature. In addition, a clinical radiologist evaluated multiple test cases comparing the Vitrea CT Dual Energy Image View to the Toshiba Dual Energy System Package (Predicate K132813). The radiologist was asked to rate the quality and performance of each feature to establish equivalence to the predicate device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests:
The Vitrea® CT Dual Energy Image View software was designed, 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 Dual Energy Image View 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 aqainst 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
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 Dual Energy Image View. Internal validation included internal user acceptance testing using various phantoms. Testing included side-by-side visual comparisons of dual energy algorithm outputs with Toshiba Display Console as the predicate device using phantom data. Details are included in Algorithm Verification and Validation.
External Validation:
During external validation, three experienced clinical experts evaluated the Vitrea CT Dual Energy Image View based on the following features: Iodine maps, Virtual non-contrast, monochromatic images, Best CNR, Blended images and Enhanced images at different energy levels. Two Radiological Technologists were provided a series of questions to obtain their feedback regarding performance and usability of each feature. In addition, a clinical radiologist evaluated multiple test cases comparing the Vitrea CT Dual Energy Image View to the Toshiba Dual Energy System Package (Predicate K132813). The radiologist was asked to rate the quality and performance of each feature to establish equivalence to the predicate device. All external validation testing passed with each expert confirming the Vitrea® CT Dual Energy Image View software fulfils the intended use and meets the needs of the user. Details of the external validation are included in the performance bench testing section.
Summary of Clinical Tests:
The subject of this 510(k) notification, Vitrea® CT Dual Energy Image View software, did not require clinical studies to support safety and effectiveness of the software.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized caduceus, which is a symbol of medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 3, 2016
Vital Images, Inc. % Mr. Vince Swenson Senior Director of Quality and Regulatory 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343
Re: K161157
Trade/Device Name: Vitrea® CT Dual Energy Image View Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 29, 2016 Received: September 30, 2016
Dear Mr. Swenson:
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.
1
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 D'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
2
Indications for Use
510(k) Number (if known) K161157
Device Name
Vitrea® CT Dual Energy Image View
Indications for Use (Describe)
The CT Dual Energy Image View application accepts CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The material composition of body regions may be energy dependence of the attenuation coefficients of different materials. This approach enables images to be generated at multiple energies within the available spectrum to visualize and analyze information about anatomical structures.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "ViTAL" in a sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and the word is horizontally aligned.
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: | To obtain 510k clearance for Vital's software application Vitrea® CT
Dual Energy Image View which is substantially equivalent to the
cleared K132813 Dual Energy System Package manufactured by
Toshiba Medical Systems Corporation. | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Submitter: | Vital Images, Inc.
5850 Opus Parkway, Suite 300
Minnetonka, MN, 55343-4414 | |
| Establishment
Registration: | 2134213 | |
| Contact Person: | Vince Swenson
Sr. Dir. of Quality and Regulatory Affairs
Phone: 952-487-9548
Fax: 952-487-9510
vswenson@vitalimages.com | |
| 510(k) Type: | Traditional | |
| Summary Date: | September 29, 2016 | |
| Device Trade Name: | Vitrea® CT Dual Energy Image View | |
| | Subject Device | Predicate Device |
| | Vitrea® CT Dual Energy Image
View | K132813 Dual Energy System
Package |
| Classification Name | Computed Tomography X-ray
System. | Computed Tomography X-ray
System. |
| Regulatory Number | 892.1750 | 892.1750 |
| Product Code | JAK | JAK |
| Classification | Class II | Class II |
| Review Panel | Radiology | |
| Decision Date | Under Review | February 6, 2014 |
4
Image /page/4/Picture/0 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it, resembling a candle flame. The font is sans-serif and the letters are evenly spaced.
Predicate Device(s):
| Predicate Device | Manufacturer | FDA 510(k) Number |
|---|---|---|
| Dual Energy System | ||
| Package | Toshiba Medical Systems Corporation | |
| 2441 Michelle Drive, | ||
| Tustin, CA 92780 | K132813 |
General Description of Dual Energy Technology:
Standard computed tomography (CT) scanners use normal X-rays to make cross-sectional pictures or images of the body. A dual energy CT scanner is a technology that uses both a normal X-ray and also a second less powerful X-ray to make the CT images. This can facilitate making some abnormalities in the body more clear on the images taken. lodine for example, is a commonly used substance in X-ray contrast agents, and using a dual energy CT can facilitate improved images of blood vessels which might allow the radiologist to obtain more accurate information about a patient's condition. Dual Energy images can be obtained using a single examination instead of two separate examinations.
In addition, dual energy CT allows for the decomposition of materials and thus the differentiation of materials with high atomic numbers such as iodine map image data set using dual energy methodology can display the distribution of iodine and thus differentiate regions of vascularity within the organ post scanned. The iodine enhancement map is usually a color over an anatomical image to emphasize the differences in vascularity and to allow anatomical localization.
Device Description:
The Vitrea® CT Dual Energy Image View is a post-processing software application which functions on the Vitrea® Platform, cleared by K150258.This application allows you to load and combine two CT images, acquired from a Toshiba CT scanner with a Dual Energy protocol, of the same anatomical location; one obtained with low kV tube voltage and one obtained with high kV tube voltage. Vitrea® computes a Blended and an Enhanced image with adjustable virtual energy levels, a Virtual Non-Contrast (VNC) image, an lodine Map overlaid on one of the original or derived images, a CT graph, and a best Contrast-to-Noise Ratio (CNR) image. For the Raw Data Analysis workflow, Vitreally calculates a Monochromatic image.
The software supports Toshiba dual-energy studies containing image-based and projection-based reconstruction techniques.
- lmage-based reconstructed data consists of a standard image reconstruction of the two ● scans. Use the Dual Energy Image Domain (Two Volumes) workflow for these datasets.
- Projection-based reconstructed data consists of special material image reconstruction where . the two scans are combined to create two sets of images where a predefined material is defined, typically lodine/Water and/or Calcium/Water. Use the Dual Energy Raw Data Analysis (Four or Six Volumes) workflow for these datasets.
- NOTE: It is important that a description of the material is contained in the DICOM Image Comments tag (0020, 4000) for each dataset at the time of the scan. For lodine/Water projection-based reconstruction, the lodine material image should be labeled "I/H20," and the corresponding Water material image should be labeled "H20/1." For the Calcium/Water projection-based reconstruction, the Calcium material image should be labeled "Ca/H20," and the corresponding Water material image should be labeled "H20/Ca."
NOTE: The dual-energy datasets must be coincident with the same frame of reference UID.
NOTE: Available with Toshiba datasets only.
5
Image /page/5/Picture/0 description: The image shows the word "ViTAL" in a bold, sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and the word is centered.
Intended Use / Indications for Use:
The CT Dual Energy Image View application accepts CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The material composition of body regions may be determined using the energy dependence of the attenuation coefficients of different materials. This approach enables images to be generated at multiple energies within the available spectrum to visualize and analyze information about anatomical and pathological structures.
Intended for Disease / Condition / Patient Population:
The CT Dual Energy Image View is a viewing option that allows users to combine different energy scans for the purpose of creating derived images. Specific information of intended for disease, condition, and patient population is not applicable as Dual Energy Image View can be used on variant diseases and conditions.
Substantial Equivalence Comparison:
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Criteria | Vitrea® CT Dual Energy | ||
| Image View | K132813 Dual Energy System | ||
| Package | Comparison | ||
| Indications | |||
| for Use | The CT Dual Energy | ||
| Image View application | |||
| accepts CT images | |||
| acquired using different | |||
| tube voltages and/or tube | |||
| currents of the same | |||
| anatomical location. The | |||
| material composition of | |||
| body regions may be | |||
| determined using the | |||
| energy dependence of the | |||
| attenuation coefficients of | |||
| different materials. This | |||
| approach enables images | |||
| to be generated at multiple | |||
| energies within the | |||
| available spectrum to | |||
| visualize and analyze | |||
| information about | |||
| anatomical and | |||
| pathological structures. | The Dual Energy System allows | ||
| the system to acquire two CT | |||
| images of the same anatomical | |||
| location using distinct tube | |||
| voltages and/or tube currents | |||
| during two tube rotations. The x-ray | |||
| dose will be the sum of the dose of | |||
| each tube rotation at its respective | |||
| tube voltage and current. | |||
| Information regarding the material | |||
| composition of various organs, | |||
| tissues, and contrast materials may | |||
| be gained from the differences in x- | |||
| ray attenuation between these | |||
| distinct energies. | |||
| This information may also be used | |||
| to reconstruct images at multiple | |||
| energies within the available | |||
| spectrum, and to reconstruct basis | |||
| images that allow the visualization | |||
| and analysis of anatomical and | |||
| pathological materials. | |||
| The visualization of the | |||
| differentiation between uric acid | |||
| and others is provided with the | |||
| Dual Energy system. When used | |||
| by a qualified physician, a potential | |||
| application is to determine the | |||
| course of treatment. | Similar | ||
| The subject | |||
| device does | |||
| not have the | |||
| capacity to | |||
| evaluate uric | |||
| acid. |
Intended Use Comparison with Predicate Device:
6
Image /page/6/Picture/0 description: The image shows the word "ViTAL" in a sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and the word is centered.
| Criteria | Subject Device
Vitrea® CT Dual Energy
Image View | Predicate Device
K132813 Dual Energy System
Package | Comparison |
|---------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|------------|
| Intended
Users | Trained radiologists,
clinicians or technologists. | Radiologic technologists or other
medical personnel who are
qualified to operate X-ray CT
scanners | Similar |
| Modality
Support | CT /CTA | CT /CTA | Same |
Device Description Comparison with Predicate Device:
| Subject Device | Predicate Device | Comparison |
|---|---|---|
| Vitrea® CT Dual Energy Image View | K132813 Dual Energy System | |
| Package | ||
| CT Dual Energy Image View software | ||
| allows you to load and combine two | ||
| Toshiba CT volumes, one obtained with | ||
| low kV tube voltage and one obtained | ||
| with high kV tube voltage. Vitrea | ||
| computes a Blended and an Enhanced | ||
| image with adjustable virtual energy | ||
| levels, a virtual non-contrast (VNC) | ||
| image, an Iodine map overlaid on one | ||
| of the original or derived images, a CT | ||
| graph, and a best contrast-to-noise | ||
| ratio (CNR) image. For the Raw Data | ||
| Analysis workflow, Vitrea calculates a | ||
| monochromatic image. | ||
| The software supports Toshiba dual- | ||
| energy studies containing image- and | Dual Energy System Package, | |
| CSDP-001A, consists of three | ||
| software packages intended to be | ||
| used on Toshiba CT systems which | ||
| allows for the acquisition of two CT | ||
| images of the same anatomical | ||
| location using different tube | ||
| voltages and/or tube currents | ||
| during two tube rotations. | ||
| CSDP-001A/1 (Dual Energy | ||
| System) allows the same region to | ||
| be scanned at two different tube | ||
| voltages and tube currents and | ||
| permits the CT values and ratio in | ||
| the selected region to be measured | ||
| based on the two image data sets | Similar | |
| The subject | ||
| device is a post- | ||
| processing | ||
| software | ||
| application and | ||
| only has a subset | ||
| of capabilities of | ||
| the predicate | ||
| device. The | ||
| subject device is | ||
| able to display | ||
| iodine maps and | ||
| monochromatic | ||
| images. However, | ||
| it does not | ||
| projection- based reconstruction | ||
| techniques. | obtained, providing information that | |
| is useful for identifying materials. | evaluate uric acid | |
| studies or have | ||
| CT scanner | ||
| capabilities. | ||
| • Image-based reconstructed data | ||
| consists of a standard image | ||
| reconstruction of the two scans. | ||
| Use the Dual Energy Image | ||
| Domain (Two Volumes) workflow | ||
| for these datasets. | ||
| • Projection-based reconstructed | ||
| data consists of special material | ||
| image reconstruction where the two | CSDP-001A/2 (Dual Energy Raw | |
| Data Analysis) allows | ||
| monochromatic images to be | ||
| generated and permits images in | ||
| which contrast enhancement is | ||
| visualized to be generated based | ||
| on the datasets acquired by | ||
| scanning the same positions with | ||
| different tube voltages, making it | ||
| possible to perform analysis. | ||
| scans are combined to create two | ||
| sets of images where a predefined | ||
| material is defined, typically | ||
| Iodine/Water and/or | CSDP-001A/3 (Dual Energy | |
| Composition Analysis) reads data | ||
| acquired by scanning the same |
7
Image /page/7/Picture/0 description: The image shows the word "ViTAL" in a bold, sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and the word is centered.
| Subject Device | Predicate Device | |
|---|---|---|
| Vitrea® CT Dual Energy Image View | K132813 Dual Energy System Package | Comparison |
| Calcium/Water. Use the Dual Energy Raw Data Analysis (Four or Six Volumes) workflow for these datasets. | positions with different tube voltages and extracts suspected uric acids from the acquired images. |
Similarities in Technology with Predicate Device:
| Criteria | Description of Feature | Subject
Device | Predicate
K132813 | Comparison |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|----------------------|------------|
| Modality | | | | |
| CT | Computed Tomography | Yes | Yes | Same |
| Data Loading | | | | |
| DICOM | Digital Imaging and
Communications in Medicine | Yes | Yes | Same |
| Function(s) | | | | |
| Iodine Map/ Iodine
Map Generation | Description:
A color scale of iodine regions
generated using the high kV and
low kV scans. The map is overlaid
on one of the original or derived
volumes.
Purpose:
Iodine map images indicate whether
or not the contrast-enhanced
regions are present. Iodine Mapping
is intended to visualize the
presence of contrast enhancement,
more specifically, the uptake of
iodine.
Input Data:
Low and High kVp acquisition data. | Yes | Yes | Same |
| Criteria | Description of Feature | Subject
Device | Predicate
K132813 | Comparison |
| Virtual-Non-
Contrast | Description:
An estimation of a comparable
image if no contrast agent was
administered. The image is
generated by replacing the iodine
HU enhancement with an estimation
of the original soft tissue texture.
Purpose:
Virtual-Non-Contrast images
attempt to estimate a comparable
image as if no contrast agent was
administered.
Input Data:
Low and High kVp acquisition data. | Yes | Yes | Same |
| Monochromatic | Description:
Image created by combining the
material pair volumes to simulate
the appearance of a single energy
level.
The image initially displays at a
virtual energy level of 66 keV. The
virtual energy level is adjustable.
Purpose:
Monochromatic images simulate the
appearance of a single energy level.
Input Data:
Material reconstruction of Low and
High kVp acquisition data. | Yes | Yes | Same |
| Best CNR | Description:
An image that displays the best
contrast-to-noise ratio of all energy
levels.
Purpose:
Best CNR images are used to
minimize the trade-off between
contrast and noise.
Input Data:
Low and High kVp data. | Yes | Yes | Same |
| Display Blended
Image | Description:
Image created by combining the
high kV and low kV images to
simulate the appearance of a single
energy scan. | Yes | Yes | Same |
| Criteria | Description of Feature | Subject
Device | Predicate
K132813 | Comparison |
| | The image initially displays at a
virtual energy level of 120 kVp. The
virtual energy level is adjustable.
Purpose:
Blended images are intended to
simulate the appearance of a
single-energy scan at a user-
specified kVp value
Input Data: | | | |
| | Low and High kVp acquisition data. | | | |
| Display Enhanced
Image | Description:
Image created using a weighted
averaging for the estimated
contrast-enhanced regions relative
to the Blended image.
The image initially displays at a
virtual energy level of 120 kVp. The
virtual energy level is adjustable.
Purpose:
Enhance the previously blended
images which simulate the
appearance of a single-energy scan
at a user-specified kVp value
Input Data:
Low and High kVp acquisition data. | Yes | Yes | Same |
| Material
composition of
body regions | Description:
The software exploits the energy
dependence of the attenuation
coefficients of different materials to
perform a decomposition into basis
materials. This fundamental
technique is used to generate the
iodine map and virtual non-contrast
(VNC) images.
Purpose:
A graph of Hounsfield unit
attenuation vs. energy level is
provided within a user-defined
region of interest (ROI). The shape
characteristics of the energy
response curve can provide
additional information about the
material composition within the ROI. | Yes | Yes | Same |
| Criteria | Description of Feature | Subject
Device | Predicate
K132813 | Comparison |
| | Low and High kVp data. | | | |
8
Image /page/8/Picture/0 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it, resembling a candle flame. The font is sans-serif and the letters are evenly spaced.
9
Image /page/9/Picture/0 description: The image shows the word "ViTAL" in all caps. The letters are black except for the dot above the "i", which is red. The font is sans-serif and the letters are evenly spaced.
10
Image /page/10/Picture/0 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The letters are bold and sans-serif. The background is white.
Differences in Technology with the Predicate Device:
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Criteria | Vitrea® CT Dual | ||
| Energy Image | |||
| View | K132813 Dual | ||
| Energy System | |||
| Package | Comparison | ||
| Differentiation between | |||
| Uric Acid and other | |||
| materials | No | Yes | The subject device |
| contains a subset of | |||
| the Dual Energy | |||
| System Package | |||
| features which does | |||
| not include these | |||
| features. | |||
| Dose | N/A | Yes | Vital is not making |
| any claims for these | |||
| features. | |||
| Kidney Stone | |||
| Characterization | No | Yes | |
| Uric Acid Characterization | No | Yes | |
| Acquisition of Images | N/A | Yes |
Currently, the Vitrea Dual Energy Image View application does not have the capability to differentiate between Uric Acid and other materials, it does not perform Kidney Stone Characterization and/or Uric Acid Characterization. As Vitrea Dual Energy image View is a post-processing software application and not a scanner, dosage and acquisition of images is not an applicable function. Furthermore, the acquisition of images is based on the scanner parameters, which are determined by the manufactures' protocol. The manufacturers' protocols would determine parameters such as scan extent, slice thickness, scan field of view, and the low and high kVp values.
Summary of Non-Clinical Tests:
The Vitrea® CT Dual Energy Image View software was designed, 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 Dual Energy Image View software:
- Risk Management ●
- . Requirements Reviews
- Code Designs
- Code Development Testing .
- Code Reviews
- Design Reviews ●
- Verification of the software that included performance and safety testing ●
11
Image /page/11/Picture/0 description: The image shows the word "VITAL" in black font. The "i" in "VITAL" has a red dot above it. The font is sans-serif and the letters are evenly spaced. The background is white.
- 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 aqainst 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
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 Dual Energy Image View. Internal validation included internal user acceptance testing using various phantoms. Testing included side-by-side visual comparisons of dual energy algorithm outputs with Toshiba Display Console as the predicate device using phantom data. Details are included in Algorithm Verification and Validation.
External Validation:
During external validation, three experienced clinical experts evaluated the Vitrea CT Dual Energy Image View based on the following features: Iodine maps, Virtual non-contrast, monochromatic images, Best CNR, Blended images and Enhanced images at different energy levels. Two Radiological Technologists were provided a series of questions to obtain their feedback regarding performance and usability of each feature. In addition, a clinical radiologist evaluated multiple test cases comparing the Vitrea CT Dual Energy Image View to the Toshiba Dual Energy System Package (Predicate K132813). The radiologist was asked to rate the quality and performance of each feature to establish equivalence to the predicate device. All external validation testing passed with each expert confirming the Vitrea® CT Dual Energy Image View software fulfils the intended use and meets the needs of the user. Details of the external validation are included in the performance bench testing section.
Summary of Clinical Tests:
The subject of this 510(k) notification, Vitrea® CT Dual Energy Image View software, did not require clinical studies to support safety and effectiveness of the software.
12
Image /page/12/Picture/0 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The letters are spaced evenly apart and are in a simple, sans-serif font.
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.
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.
Accountabilitv
The Vitrea® platform includes an audit capability that enables accountability by tracking authenticated and authorized user operations along with information accessed. Vitrea® audit logs are time stamped, enabling correlation with Windows system logging to track information accessed by a user.
Performance Standards:
The FDA has not established mandatory performance standards and no special controls exist for this device. General software verification and validation tests were conducted to confirm proper function of the device's features.
| Standard No. | Standards
Organization | Standard Title | Version | Date |
|-------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------|---------|------------|
| PS 3.1- 3.20 (2011)
(Recognition
Number 12-238) | NEMA | Digital Imaging and
Communications in Medicine
(DICOM) Set (Radiology) | 3 | 03/16/2012 |
| ISO 14971:2007
(Recognition
Number 5-70) | AAMI / ANSI
/ ISO | Medical Devices -
Applications of Risk
Management to Medical
Devices | 2007 | 03/16/2012 |
| IEC 62304:2006
(Recognition
Number 13-32) | AAMI / ANSI
/ IEC | Medical Device Software -
Software Life Cycle
Processes (Software /
Informatics) | 2006 | 08/20/2012 |
The Vitrea® software complies with the following voluntary recognized consensus standards:
Substantial Equivalence Analysis Conclusion:
Vital Images believes that the Vitrea® CT Dual Energy Image View software is substantially equivalent to the legally marketed Dual Energy System Package (K132813) based on a comparison of its features and its performance. The Vitrea® CT Dual Energy Image View accepts CT images acquired using different tube voltages and/or tube currents of the same anatomical location as does the Dual Energy System Package. Both predicate and subject devices are able to provide users with Monochromatic views and lodine Maps to allow for evaluation of images produced by low and high kV tube voltage.
13
Image /page/13/Picture/0 description: The image shows the word "ViTAL" in black letters. The "i" in "ViTAL" has a red dot above it. The font is sans-serif and the letters are evenly spaced.
In addition, the verification and validation testing performed by Vital Images demonstrated the subject device is as safe and effective as the predicate device and does not raise different questions of safety and efficacy than the predicate device.
In conclusion, Vital Images believes the Vitrea® CT Dual Energy Image View software application has a similar intended use, indications for use, principle of operation, and technological characteristics as the legally marketed Dual Energy System Package (K132813).
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.