(87 days)
No
The summary describes standard image processing techniques and calculations based on Hounsfield units, with "semi-automated" segmentation, but does not mention AI, ML, or related concepts.
No
The device is post-processing software intended to assist with the visualization and analysis of medical images to assess disease state, not to provide therapy.
Yes
The device is intended to assist a trained user in visualizing hypo/hyper dense areas to assess disease state and treatment, aid in the identification of myocardial enhancement defects, and track findings, which clearly points to a diagnostic purpose.
Yes
The device is described as a "post-processing software option" for an existing software platform and its description focuses entirely on software functionalities for visualization and analysis of CT data. There is no mention of any accompanying hardware components being part of this specific submission.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of Vitrea CT Myocardial Perfusion clearly states it is a post-processing software for cardiac CT studies. CT studies involve imaging the patient directly, not analyzing a specimen taken from the patient.
- The intended use is to assist in the visualization and analysis of images. The software processes CT images to help trained users visualize and assess hypo/hyper dense areas in the myocardium. This is image analysis, not the analysis of a biological specimen.
- The device description focuses on image processing tools and measurements derived from image data. It mentions segmentation, color overlays, polar maps based on Hounsfield units, and ratios calculated from CT values. These are all related to the analysis of the CT images themselves.
Therefore, Vitrea CT Myocardial Perfusion falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Vitrea® CT Myocardial Perfusion is intended to assist a trained user for the visualization of hypo/hyper dense areas in patients with angina or with a previous myocardial infarction to assess the disease state and treatment. This software provides semi-automated heart and left ventricle segmentation and color polar maps of the myocardial tissue.
The information provided is intended to be qualitative in nature and, when used by a qualified physician, may aid in the identification of myocardial enhancement defects and the follow up of such findings.
Product codes (comma separated list FDA assigned to the subject device)
JAK, LLZ
Device Description
Vitrea CT Myocardial Perfusion is a post-processing software option for the already cleared Vitrea software platform (K071331). It leverages the existing Vitrea platform functionalities such as Multi-Planar Reconstruction (MPR) images, Maximum Intensity Projections (MIP) and volume rendering.
Vitrea CT Myocardial Perfusion enables the visualization and analysis of perfusion defects in the myocardium. The software is intended for use with cardiac CT (Computed Tomography) studies to analyze cardiovascular anatomy and pathology and to assess the presence of hypo/hyper dense areas of myocardial tissue.
The software visualization tools provide semi-automated heart and Left Ventricle (LV) segmentation, and color overlay and polar maps of the myocardial tissue based on the Hounsfield attenuation (HU) values. The software displays the values associated with the generation of the Perfusion Index (PI) and Transmural Perfusion Ratio (TPR) maps. Perfusion Index (PI) is the ratio of the Mean Myocardial CT value to the LV blood pool CT value. Transmural Perfusion Ratio (TPR) is provided as a ratio per sector of the Endocardial CT value to the mean Epicardial CT value. The defect size scoring tool allows a user to delineate one or more contiguous 3D regions within the myocardium for independent size measurements. The user may observe the interpolated result as they are constructing the defect.
The software analysis tools include measurements and comparison ratios. The CT Myocardial Perfusion application allows users to load one or two volumes. In dual-volume cases, the volumes are displayed based on time. It also includes reporting tools for formatting findings and user selected areas of interest.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT (Computed Tomography)
Anatomical Site
Myocardium, Heart, Left Ventricle (LV)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists and Cardiologists
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this 510(k) notification, Vitrea CT Myocardial Perfusion software, did not require clinical studies to support safety and effectiveness of the software.
Summary of Non-Clinical Tests:
The changes to the Vitrea CT Myocardial Analysis (i.e. Vitrea CT Myocardial Perfusion) software were designed, developed, and tested according to written procedures that included risk management. Software testing was completed to ensure the new features operate according to defined requirements.
Internal Validation (Phantom Testing):
The software validation team provided internal validation of Vitrea CT Myocardial Perfusion software. Internal validation included internal user acceptance testing using various phantoms. Results of numerical quantities calculated by CT Myocardial Perfusion were verified using CT semi-synthetic phantoms and patient based CT datasets.
External Validation:
During external validation of the Myocardial Perfusion software, experienced users evaluated the seven-up layout, six-up scoring layout and the classification of the Transmural Perfusion Ratio (TPR). Each user felt that the Vitrea CT Myocardial Perfusion software enables the user to assess and quantify myocardial perfusion abnormalities.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2015
Vital Images, Inc % Parthiv Shah Sr. Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343-4414
Re: K150104
Trade/Device Name: Vitrea CT Myocardial Perfusion Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: II Product Code: JAK, LLZ Dated: January 19, 2015 Received: January 20, 2015
Dear Parthiv 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.
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,
Robert A Ochs
Robert Ochs. Ph.D. Acting 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) K150104
Device Name Vitrea® CT Myocardial Perfusion
Indications for Use (Describe)
Vitrea® CT Myocardial Perfusion is intended to assist a trained user for the visualization of hypo/hyper dense areas in patients with angina or with a previous myocardial infarction to assess the disease state and treatment. This software provides semi-automated heart and left ventricle segmentation and color polar maps of the myocardial tissue.
The information provided is intended to be qualitative in nature and, when used by a qualified physician, may aid in the identification of myocardial enhancement defects and the follow up of such findings.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot on the "i" in "VITAL" is a circle.
510(k) 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: | Modifications to a legally marketed device which are not qualified for a
Special 510(k) notification |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Vital Images, Inc.
5850 Opus Parkway
Suite 300
Minnetonka, MN, 55343-4414 |
| Establishment
Registration: | 2134213 |
| Contact Person: | Parthiv Shah
Sr. Regulatory Affairs Specialist
Phone : 952—487—9574
Fax: 952-487-9510
E-mail: pshah@vitalimages.com |
| 510(k) Type: | Traditional |
| Summary Date: | March 31, 2015 |
| Device Trade Name: | Vitrea® CT Myocardial Perfusion Software |
| Device Common
Name / Regulatory
Description: | An accessory of Computed Tomography X-ray System |
| Device
Classification
Name: | System, X-ray, Tomography, Computed |
| Regulation Number: | 21 C.F.R. 892.1750 |
| Primary Product
Code: | JAK |
| Secondary Product
Code: | LLZ |
| Regulatory
Classification: | Class II |
| Device Panel: | Radiology |
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Image /page/4/Picture/0 description: The image shows the word "VITAL" in black, with a red tagline underneath that reads "A Toshiba Medical Systems Group Company". The font is sans-serif and modern. The dot on the "i" in "VITAL" is a perfect circle.
Predicate Devices:
| Predicate Device(s) | Predicate Type | Manufacturer | FDA 510(k)
number |
|-------------------------|----------------------------------|----------------------------------------|----------------------|
| MyoPerfusion, CSMP-001A | Primary
Predicate
Device | Toshiba Medical
Systems Corporation | K132523 |
| CT Myocardial Analysis | Secondary
Predicate
Device | Vital Images, Inc. | K112531 |
Device Description:
Vitrea CT Myocardial Perfusion is a post-processing software option for the already cleared Vitrea software platform (K071331). It leverages the existing Vitrea platform functionalities such as Multi-Planar Reconstruction (MPR) images, Maximum Intensity Projections (MIP) and volume rendering.
Vitrea CT Myocardial Perfusion enables the visualization and analysis of perfusion defects in the myocardium. The software is intended for use with cardiac CT (Computed Tomography) studies to analyze cardiovascular anatomy and pathology and to assess the presence of hypo/hyper dense areas of myocardial tissue.
The software visualization tools provide semi-automated heart and Left Ventricle (LV) segmentation, and color overlay and polar maps of the myocardial tissue based on the Hounsfield attenuation (HU) values. The software displays the values associated with the generation of the Perfusion Index (PI) and Transmural Perfusion Ratio (TPR) maps. Perfusion Index (PI) is the ratio of the Mean Myocardial CT value to the LV blood pool CT value. Transmural Perfusion Ratio (TPR) is provided as a ratio per sector of the Endocardial CT value to the mean Epicardial CT value. The defect size scoring tool allows a user to delineate one or more contiguous 3D regions within the myocardium for independent size measurements. The user may observe the interpolated result as they are constructing the defect.
The software analysis tools include measurements and comparison ratios. The CT Myocardial Perfusion application allows users to load one or two volumes. In dual-volume cases, the volumes are displayed based on time. It also includes reporting tools for formatting findings and user selected areas of interest.
Intended Use / Indications for Use:
Vitrea® CT Myocardial Perfusion is intended to assist a trained user for the visualization of hypo/hyper dense areas in patients with angina or with a previous myocardial infarction to assess the disease state and treatment. This software provides semi-automated heart and left ventricle segmentation and color polar maps of the myocardial tissue.
The information provided is intended to be qualitative in nature and, when used by a qualified physician, may aid in the identification of myocardial enhancement defects and the follow up of such findings.
5
Image /page/5/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image.
Intended for Disease / Condition / Patient Population:
The software provides Radiologists and Cardiologists with a robust dedicated suite of software tools to aid in the creation of evidence to support these physicians with their assessment of cardiac disease and functions for patients with angina or those who have had a previous myocardial infarction.
Substantial Equivalence Comparison:
. Regulatory Comparison
| Characteristic | Vitrea CT
Myocardial
Perfusion
software
(Submission
Subject) | MyoPerfusion,
CSMP-001A
(K132523)
(Predicate
Device-1)
Primary
Predicate Device | CT Myocardial
Analysis
(K112531)
(Predicate
Device-2)
Secondary
Predicate Device | Noted Differences |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Classification
Name | Computed
tomography
x-ray System | Computed
tomography
x-ray System | Picture Archiving
and
Communications
System | None
Note: The subject
device has both JAK
and LLZ product
codes. |
| Regulatory
Number | 892.1750 | 892.1750 | 892.2050 | None
Note: The subject
device has both JAK
and LLZ product
codes. |
| Product Code | Primary: JAK
Secondary:
LLZ | JAK | LLZ | None |
| Classification | Class II | Class II | Class II | None |
| Review Panel | Radiology | Radiology | Radiology | None |
| Decision Date | Under Review | December 12,
2013 | November 18,
2011 | Both predicates are
cleared. |
| Characteristic | Vitrea CT Myocardial
Perfusion software
(Submission Subject) | MyoPerfusion,
CSMP-001A (K132523)
(Predicate Device-1) | Noted Differences | |
| Intended Use | Vitrea® CT Myocardial
Perfusion is intended
to assist a trained user
for the visualization of
hypo/hyper dense
areas in patients with
angina or with a
previous myocardial
infarction to assess
the disease state and
treatment. This
software provides
semi-automated heart
and left ventricle
segmentation and
color polar maps of
the myocardial tissue.
The information
provided is intended to
be qualitative in nature
and, when used by a
qualified physician,
may aid in the
identification of
myocardial
enhancement defects
and the follow up of
such findings. | This software is
intended to be used for
the visualization of non-
reversible perfusion
defects (hypo/hyper
dense areas) in
patients with angina or
with a previous
myocardial infarct.
Included software tools
may aid a trained user
in monitoring the
disease state and
treatment over time.
This software provides
maps and the values
used to generate the
maps.
The information
provided is intended to
be qualitative in nature
and when used by a
qualified physician may
aid in the identification
of myocardial
enhancement defects
and the follow up of
such findings. | None | |
| Intended
Users | Radiologists and
Cardiologists | Radiologists and
Cardiologists | None | |
| Patient
Population | Patients with angina or
those who have had a
previous myocardial
infarction | Patients with angina or
those who have had a
previous myocardial
infarction | None | |
| Modality
Support | CT | CT | None | |
| Characteristic | Vitrea CT Myocardial
Perfusion software
(Submission Subject) | CT Myocardial Analysis
(K112531)
(Predicate Device-2) | Noted Differences | |
| Intended Use | Vitrea® CT Myocardial
Perfusion is intended
to assist a trained user
for the visualization of
hypo/hyper dense
areas in patients with
angina or with a
previous myocardial
infarction to assess
the disease state and
treatment. This
software provides
semi-automated heart
and left ventricle
segmentation and
color polar maps of
the myocardial tissue.
The information
provided is intended to
be qualitative in nature
and, when used by a
qualified physician,
may aid in the
identification of
myocardial
enhancement defects
and the follow up of
such findings. | Vitrea® CT Myocardial
Analysis is an image
analysis software
application for cardiac
Computer Tomography
(CT) studies to
visualize cardiovascular
anatomy and pathology
and to highlight and
color code the
presence of hypo/hyper
dense areas of
myocardial tissue. | None
The language of Intended
Use has been updated to
be similar with the 510(k)
cleared predicate products
available in the US market. | |
| Intended
Users | Radiologists and
Cardiologists | Radiologists and
Cardiologists | None | |
| Patient
Population | Patients with angina or
those who have had a
previous myocardial
infarction | Patients with angina or
those who have had a
previous myocardial
infarction | None | |
| Modality
Support | CT | CT | None | |
| Characteristic | Vitrea CT Myocardial
Perfusion software
(Submission Subject) | MyoPerfusion,
CSMP-001A (K132523)
(Predicate Device-1) | Noted Differences | |
| Device
Description | Vitrea CT Myocardial
Perfusion is a post-
processing software
option for the already
cleared Vitrea
software platform
(K071331).
It leverages existing
Vitrea® functionality
such as Multi-Planar
Reconstruction (MPR)
images, Maximum
Intensity Projections
(MIP) and volume
rendering.
Vitrea CT Myocardial
Perfusion enables the
visualization and
analysis of perfusion
deficits in the
myocardium. The
software is intended
for use with cardiac
CT (Computed
Tomography) studies
to analyze
cardiovascular
anatomy and
pathology and to
assess the presence
of hypo/hyper dense
areas of myocardial
tissue.
The software
visualization tools
provide semi-
automated heart and
left ventricle
segmentation, and
color overlay and polar
maps of the
myocardial tissue | This device processes
ECG-gated contrast
enhanced cardiac scan
data using MPR
generated images
according to the cardiac
axis.
The software generates
polar maps, perfusion
index (PI) map and
Transmural Perfusion
Ration (TPR) maps
based upon the
measured CT values of
the tissue within the
specified region of
interest.
The software displays
the values associated
with the generation of
the Perfusion Index and
TPR Maps.
PI is the ratio of the
Mean Myocardial CT
value to the LV blood
pool CT value.
TPR is provided as a
ratio per sector of the
Endocardial CT value
to the mean Epicardial
CT value. | None
Note:
The added key features,
except Defect Size Scoring
tool, are similar to those
which are available in the
510(k) cleared Predicate
Device-1. | |
| Characteristic | Vitrea CT Myocardial
Perfusion software
(Submission Subject) | MyoPerfusion,
CSMP-001A (K132523)
(Predicate Device-1) | Noted Differences | |
| | based on the
Hounsfield attenuation
(HU) values. | | | |
| | The software displays
the values associated
with the generation of
the Perfusion Index
(PI) and Transmural
Perfusion Ratio (TPR)
maps. | | | |
| | PI is the ratio of the
Mean Myocardial CT
value to the LV blood
pool CT value. | | | |
| | TPR is provided as a
ratio per sector of the
Endocardial CT value
to the mean Epicardial
CT value. | | | |
| | The software analysis
tools include
measurements and
comparison ratios. | | | |
| | The CT Myocardial
Perfusion application
allows to load one or
two volumes. In dual-
volume cases, the
volumes are displayed
based on time. Vitrea
labels the volumes as
Series1 (earlier
acquisition time) and
Series2 (later
acquisition time). | | | |
| | It also includes
reporting tools for
formatting findings and
user selected areas of
interest. | | | |
| | | | | |
| Characteristic | Vitrea CT Myocardial
Perfusion software
(Submission Subject) | CT Myocardial Analysis
(K112531)
(Predicate Device-2) | Noted Differences | |
| Device
Description | Vitrea CT Myocardial
Perfusion is a post-
processing software
option for the already
cleared Vitrea
software platform
(K071331).
It leverages existing
Vitrea® functionality
such as Multi-Planar
Reconstruction (MPR)
images, Maximum
Intensity Projections
(MIP) and volume
rendering.
Vitrea CT Myocardial
Perfusion enables the
visualization and
analysis of perfusion
deficits in the
myocardium. The
software is intended
for use with cardiac
CT (Computed
Tomography) studies
to analyze
cardiovascular
anatomy and
pathology and to
assess the presence
of hypo/hyper dense
areas of myocardial
tissue.
The software
visualization tools
provide semi-
automated heart and
left ventricle
segmentation, and
color overlay and polar
maps of the
myocardial tissue | Vitrea® CT Myocardial
Analysis is a post-
processing software
option for the Vitrea®
software platform.
It leverages existing
Vitrea® functionality
such as Multi Planar
Reconstruction (MPR)
images, Maximum
Intensity Projections
(MIP) and volume
rendering.
Vitrea® CT Myocardial
Analysis enables the
visualization and
analysis of the
myocardium. It assists
in analyzing the
hyper/hypo dense
areas of myocardial
tissue. Its visualization
tools include
segmentation, color
coding, and polar
maps. Its analysis tools
include measurements
and comparison ratios.
It also includes
reporting tools for
formatting findings and
user selected areas of
interest. | ● Two polar map plots i.e.
TPR and Pl are added
in the already cleared
Myocardial Analysis
software (K112531)
● Additional 3D Fusion
overlay feature is
provided for better
viewing of cardiac
vessels over colored
attenuation data
● Additional Defect Size
Scoring tool is provided
for quantifying size of
individual defects within
the myocardium
● The software now
automatically segments
the Left Ventricle (LV)
Blood Pool in all loaded
volumes
● The software allows to
edit automatically
generated LV Blood
Pool attenuation value
(LV HU) for each
loaded volume
Note:
The added key features,
except Defect Size Scoring
tool, are similar to those
which are available in the
510(k) cleared Predicate
Device-1. | |
| Characteristic | Vitrea CT Myocardial
Perfusion software
(Submission Subject) | CT Myocardial Analysis
(K112531)
(Predicate Device-2) | Noted Differences | |
| | based on the
Hounsfield attenuation
(HU) values. | | | |
| | The software displays
the values associated
with the generation of
the Perfusion Index
(PI) and Transmural
Perfusion Ratio (TPR)
maps. | | | |
| | PI is the ratio of the
Mean Myocardial CT
value to the LV blood
pool CT value. | | | |
| | TPR is provided as a
ratio per sector of the
Endocardial CT value
to the mean Epicardial
CT value. | | | |
| | The software analysis
tools include
measurements and
comparison ratios.
The CT Myocardial
Perfusion application
allows to load one or
two volumes. In dual-
volume cases, the
volumes are displayed
based on time. Vitrea
labels the volumes as
Series1 (earlier
acquisition time) and
Series2 (later
acquisition time). | | | |
| | It also includes
reporting tools for
formatting findings and
user selected areas of
interest. | | | |
| Characteristic | Vitrea CT
Myocardial
Perfusion
software
(Submission
Subject) | MyoPerfusion,
CSMP-001A
(K132523)
(Predicate
Device-1)
Primary
Predicate
Device | CT Myocardial
Analysis
(K112531)
(Predicate
Device-2)
Secondary
Predicate
Device | Noted
Differences |
| Post-processing analysis software | ✓ | ✓ | ✓ | None |
| 2D or 3D CT angiography images/
data derived from DICOM 3.0 CT
scans | ✓ | ✓ | ✓ | None |
| Support for single or dual volume
exams | ✓ | ✓ | ✓ | None |
| Conventional navigation on 2D and 3D
views, change of layouts, adapt
window level values for CT
angiography images | ✓ | ✓ | ✓ | None |
| Segment heart structures | ✓ | ✓ | ✓ | None |
| Edit and correct segmented regions | ✓ | ✓ | ✓ | None |
| Semi-Automatic segmentation of
myocardium | ✓ | ✓ | ✓ | None |
| Support for single or dual volume
exams | ✓ | ✓ | ✓ | None |
| Characteristic | Vitrea CT
Myocardial
Perfusion
software
(Submission
Subject) | MyoPerfusion,
CSMP-001A
(K132523)
(Predicate
Device-1)
Primary
Predicate
Device | CT Myocardial
Analysis
(K112531)
(Predicate
Device-2)
Secondary
Predicate
Device | Noted
Differences |
| View: | | | | |
| Cardiac views:
Multi-Planar Reconstruction (MPR)
planes to short/long axis, Maximum
Intensity Projection (MIP) formats | ✓ | ✓ | ✓ | None |
| Ability to view cardiac vessels over
colored attenuation data | ✓ | ✓ | ✓ | None |
| Functional Parameters: | | | | |
| Provides automatic quantified values (HU values) of perfusion results for: | | | | |
| Comparison Ratios | ✓ | ✓ | ✓ | None |
| Myocardial Mass | ✓ | ✓ | ✓ | None |
| Myocardial Volume | ✓ | ✓ | ✓ | None |
| Hypo-attenuated Volume | ✓ | ✓ | ✓ | None |
| Color Overlay:
Color codes the myocardial tissue to
show hypo/hyper dense areas in the
myocardial tissue of the heart onto
MPR and 3D images | ✓ | ✓ | ✓ | None |
| Polar Maps:
17-segment or detailed bulls-eye plots
for display of myocardial parameters | ✓ | ✓ | ✓ | None |
| Reporting Tools:
Functionality for editing values of
clinical findings such as location,
characteristics, pathology, user | ✓ | ✓ | ✓ | None |
| Characteristic | Vitrea CT
Myocardial
Perfusion
software
(Submission
Subject) | MyoPerfusion,
CSMP-001A
(K132523)
(Predicate
Device-1)
Primary
Predicate
Device | CT Myocardial
Analysis
(K112531)
(Predicate
Device-2)
Secondary
Predicate
Device | Noted
Differences |
| assigned classifications to simplify
report population, and report | | | | |
| Templates for summarization of
findings etc | | | | |
| Ability to take Snapshots | V | V | V | None |
| Ability to export image to a PACS
device | V | V | V | None |
| Ability to save images to local
computer | V | V | V | None |
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Intended Use Comparison with the Predicate Device-1 (Primary Predicate Device) ●
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● Intended Use Comparison with the Predicate Device-2 (Secondary Predicate Device)
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● Device Description Comparison with the Predicate Device-1 (Primary Predicate Device)
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Image /page/9/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.
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Device Description Comparison with the Predicate Device-2 (Secondary Predicate ● Device)
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● Similarities in Technology
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Image /page/14/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.
| Characteristic | Vitrea CT
Myocardial
Perfusion
software
(Submission
Subject) | MyoPerfusion,
CSMP-001A
(K132523)
(Predicate
Device-1)
Primary
Predicate
Device | CT Myocardial
Analysis
(K112531)
(Predicate
Device-2)
Secondary
Predicate
Device | Noted
Differences | |
|-----------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Perfusion Index (PI) map | ✓ | ✓ | x | The added | |
| Transmural Perfusion Ratio (TPR)
map | ✓ | ✓ | x | key features,
except Defect
Size Scoring
tool, are
similar to
those which
are available
in the 510(k)
cleared
Predicate | |
| LV Blood Pool to Region | ✓ | ✓ | x | | |
| LV HU | ✓ | ✓ | x | | |
| 3D Fusion view | ✓ | ✓ | x | | |
| Defect Size Scoring tool | ✓ | x | x | Device-1. | |
Differences .
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Image /page/15/Picture/0 description: The image shows the word "VITAL" in black, with a red subtitle that reads "A Toshiba Medical Systems Group Company". The letters of the word "VITAL" are large and bold, with a dot above the "i". The subtitle is in a smaller font and is located directly below the word "VITAL".
Summary of Non-Clinical Tests:
The changes to the Vitrea CT Myocardial Analysis (i.e. Vitrea CT Myocardial Perfusion) software were designed, developed, and tested according to written procedures that included risk management. Software testing was completed to ensure the new features operate according to defined requirements.
The following design control measures were applied to the development of the Vitrea CT Myocardial Perfusion software:
- Risk Management ●
- Requirements Reviews ●
- Code Designs ●
- Code Development Testing ●
- . Code Reviews
- Design Reviews ●
- Verification of the software that included performance and safety testing ●
- Validation of the software that included phantom testing and simulated usability testing . by experienced professionals.
Risk Management:
Each risk pertaining to these features have been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of "Improbable." All risks for this feature were collectively reviewed to determine if the benefits outweigh the risk. Because of the risk control measures included in this feature, it is believed that the risk for the feature as a whole is extremely low. Taking into account all risks against the benefits of this feature, it has been assessed that the benefits do outweigh the risks for this feature.
During the design review, the following conclusions were reached:
- 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 Myocardial Perfusion software. Internal validation included internal user acceptance testing using various phantoms. Results of numerical quantities calculated by CT Myocardial Perfusion were verified using CT semi-synthetic phantoms and patient based CT datasets.
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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 dot on the "i" in "VITAL" is a solid black circle.
External Validation:
During external validation of the Myocardial Perfusion software, experienced users evaluated the seven-up layout, six-up scoring layout and the classification of the Transmural Perfusion Ratio (TPR). Each user felt that the Vitrea CT Myocardial Perfusion software enables the user to assess and quantify myocardial perfusion abnormalities.
Summary of Clinical Tests:
The subject of this 510(k) notification, Vitrea CT Myocardial Perfusion software, did not require clinical studies to support safety and effectiveness of the software.
Cyber and Information Security:
- Confidentiality .
The Vitrea platform (K071331) relies on built in Windows Login security to limit access to the system. The Vitrea platform can only be installed and configured by an administrator of the Windows machine.
. Integrity
The Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances. New DICOM produced by Vitrea is identified as such with the appropriate manufacturer tags per the DICOM standard.
Availability ●
The Vitrea platform is always available to the logged on user as long as the Windows machine itself is properly maintained.
● Accountability
The Vitrea platform includes an audit capability that enables accountability by tracking authenticated and authorized user operations along with information accessed. Vitrea audit logs are time stamped, enabling correlation with Windows system logging to track information accessed by a user.
Performance Standards:
The FDA has not established mandatory performance standards and no special controls exist for this device. General software verification and validation tests were conducted to confirm proper function of the device's features.
| Standard No. | Standards
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 |
The Vitrea software complies with the following voluntary recognized consensus standards:
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Image /page/17/Picture/0 description: The image shows the word "VITAL" in black font. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in red font. The dot above the "i" in "VITAL" is a circle.
| Standard No. | Standards
Organization | Standard Title | Version | Date |
|-------------------------------------------------|---------------------------|----------------------------------------------------------------------------------------------|---------|------------|
| IEC 62304:2006
(Recognition
Number 13-32) | AAMI / ANSI
/ IEC | Medical Device Software
Software Life Cycle
Processes (Software /
Informatics) | 2006 | 08/20/2012 |
Substantial Equivalence Analysis Conclusion:
Vital Images believes that Vitrea CT Myocardial Perfusion software application has a substantially equivalent intended use, indications for use and technological characteristics as the predicate devices. Any minor differences noted have been explained and do not raise any new questions of safety or effectiveness as the predicate devices. The implemented design controls, risk management and performed testing demonstrate the Vitrea CT Myocardial Perfusion software device is as safe and effective as both predicate devices. Based on the comparison data and test data Vital Images believes, the subject device should be found substantially equivalent to the predicate devices.