(74 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on "semi-automatic" segmentation and calculation of metrics, which are typically rule-based or traditional image processing techniques, not necessarily AI/ML.
No.
The device is described as software that analyzes CT angiographic images to calculate and display cardiac functional parameters, assisting cardiologists and radiologists in assessment, rather than directly treating or diagnosing patients.
Yes
The device is described as assisting cardiologists and radiologists in assessing heart function and producing cardiac evaluations by calculating various global and regional metrics. This assessment of function indicates a diagnostic purpose.
Yes
The device is explicitly described as a "software application" and a "licensable software preset" that runs on existing "Vitrea Platforms." The description focuses solely on the software's functionality for image processing and analysis, with no mention of accompanying hardware components developed or included as part of this specific submission.
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. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The Vitrea CT Multi-Chamber CFA option is a software application that processes medical images (CT scans) of the heart. It analyzes the structure and function of the heart based on these images.
- No Sample Analysis: The device does not analyze biological samples taken from the patient. Its input is image data, not biological material.
Therefore, while it is a medical device used for diagnosis and assessment, it falls under the category of medical image processing software rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vitrea® CT Multi-Chamber CFA option is intended to be used with CT studies of the heart to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The CT Multi-Chamber CFA option includes semi-automatic heart segmentation including three chambers (left ventricle, right ventricle, and left atrium) segmentation, including identification of long axis and mitral valve boundaries across multiple phases; calculation of global metrics, including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, stroke index, and myocardial mass; and calculation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots.
Product codes
LLZ
Device Description
The Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) software application is a new post processing licensable software preset available on the Cardiac Functional CT protocol for the Vitrea Platforms. This product can be used in the analysis of CT angiographic images to calculate and display several functional cardiac parameters. The software has the ability to select the chambers of the heart and diastolic and/or systolic phases to evaluate the heart's function. The Vitrea CT Multi-Chamber CFA software application contains both graphic and text report capabilities with predefined templates for ease of use.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Heart, Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Cardiologists and radiologists. Medical facility.
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
The software was designed, developed and tested according to written procedures that included applying risk management. Software testing was completed to ensure the new feature operates according to its requirements. Testing included verification, validation, and evaluation of previously acquired medical images.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this traditional 510(k) notification, Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) software application, did not require clinical studies to support safety and effectiveness of the software.
Summary of Non-Clinical Tests:
The software was designed, developed and tested according to written procedures that included applying risk management. Software testing was completed to ensure the new feature operates according to its requirements. Testing included verification, validation, and evaluation of previously acquired medical images.
The following quality assurance measures were applied to the development of Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) software application:
- Risk Management
- Requirements reviews
- Developer testing
- Code reviews
- Design reviews
- Verification of the software - that included performance and safety testing
- Validation of the software – that included simulated usability testing by independent experienced medical professionals.
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.
External Validation:
During external validation of Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) software application, experienced cardiologists evaluated the application. Each user felt that the Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) software application can be used successfully with CT studies of the heart to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation.
Key results:
"The above noted additional seven characteristics either do not carry hazardous risks or are not critical to the risk profile based on an "Improbable" probability of occurrence of harm after applied mitigations. The above noted additional seven characteristics have been mitigated by design, labeling, and performed verification and validation tests and therefore do not raise new safety and effectiveness concerns when used as labeled."
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
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1. 2014
VITAL IMAGES, INC. PARTHIV SHAH SR. REGULATORY AFFAIRS SPECIALIST 5850 OPUS PARKWAY SUITE 300 MINNETONKA MN 55343
Re: K141302
Trade/Device Name: Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 2, 2014 Received: July 7, 2014
Dear Mr. Shah:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
Smh.P)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Vitrea® CT Multi-Chamber Cardiac Functional Analysis (CFA)
Indications for Use (Describe)
The Vitrea® CT Multi-Chamber CFA option is intended to be used with CT studies of the heart to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The CT Multi-Chamber CFA option includes semi-automatic heart segmentation including three chambers (left ventricle, and left atrium) segmentation, including identification of long axis and mitral valve boundaries across multiple phases; calculation of global metrics, including end diastolic volume, end systolic volume, ejection fraction, cardiac output, cardiac index, stroke index, and myocardial mass; and calculation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots.
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)
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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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 Officen 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."
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Image /page/3/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 smaller, red letters. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92.(c)
| Purpose of
Submission: | Vital Images, Inc. hereby submits this traditional 510(k) to provide a
notification submission of a new software application preset called "CT
Multi-Chamber Cardiac Functional Analysis (CFA)". This new application
has been added into the Cardiac Functional CT protocol available on the
Vitrea platforms to provide cardiac functions of Right Ventricle (RV) and
Left Atrium (LA) chambers of heart in addition to the previously cleared
cardiac evaluation of Left Ventricle (LV) chamber of heart. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | July 2, 2014 |
| Device Name
Trade Name: | Vitrea® CT Multi-Chamber Cardiac Functional Analysis (CFA) |
| Common Name: | System, Image Processing, Radiological |
| Classification Name: | System, Image Processing, Radiological (21 C.F.R. 892.2050, LLZ) |
| Regulatory Description: | Picture Archiving and Communications System |
Predicate Devices:
| Predicate Device | Manufacturer | FDA 510(k) number |
|---|---|---|
| Vitrea 2, version 3.7 Medical Image | ||
| Processing Software - Cardiac | ||
| Functional Analysis | ||
| (Legally Marketed Device) | Vital Images, Inc. | K043333 |
| CardIQ Function Xpress | ||
| (Legally Marketed Device) | GE Medical Systems SCS | K073153 |
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Image /page/4/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The letters in "VITAL" are all capitalized except for the "i", which is lowercase and has a dot above it.
Device Description:
The Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) software application is a new post processing licensable software preset available on the Cardiac Functional CT protocol for the Vitrea Platforms. This product can be used in the analysis of CT angiographic images to calculate and display several functional cardiac parameters. The software has the ability to select the chambers of the heart and diastolic and/or systolic phases to evaluate the heart's function. The Vitrea CT Multi-Chamber CFA software application contains both graphic and text report capabilities with predefined templates for ease of use.
Intended Use / Indications for Use:
The Vitrea® CT Multi-Chamber CFA option is intended to be used with CT studies of the heart to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The CT Multi-Chamber CFA option includes semi-automatic heart segmentation including three chambers (left ventricle, right ventricle, and left atrium) segmentation, including identification of long axis and mitral valve boundaries across multiple phases; calculation of global metrics, including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac index, stroke index, and myocardial mass; and calculation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots.
Intended for Disease / Condition / Patient Population:
The software assists cardiologists and radiologists during a cardiac evaluation to assess various cardiac functions of patients with suspected or known cardiac diseases.
Substantial Equivalence:
The Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) software application is substantial equivalent to a combination of the predicate Vital Images, Inc. Cardiac Functional Analysis (K043333) and GE Medical Systems SCS CardIQ Function Xpress (K073153) devices and is safe and effective for use.
Intended Use Comparison:
For Cardiac Evaluation of Left Ventricle (LV) Chamber:
| Vitrea CT Multi-Chamber Cardiac
Functional Analysis (CFA)
(K141302)
(Submission Subject) | Vitrea 2, version 3.7 Medical
Image Processing Software –
Cardiac Functional Analysis
(K043333)
(Predicate Device-1) | Differences | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------|
| Intended Use / Indications for Use: | | | |
| Vitrea CT Multi-Chamber Cardiac
Functional Analysis (CFA)
(K141302)
(Submission Subject) | Vitrea 2, version 3.7 Medical
Image Processing Software –
Cardiac Functional Analysis
(K043333)
(Predicate Device-1) | Differences | |
| The Vitrea® CT Multi-Chamber CFA
option is intended to be used with CT
studies of the heart to assist
cardiologists and radiologists in
assessing function when producing a
cardiac evaluation.
The CT Multi-Chamber CFA option
includes semi-automatic heart
segmentation including three
chambers (left ventricle, right
ventricle, and left atrium)
segmentation, including identification
of long axis and mitral valve
boundaries across multiple phases;
calculation of global metrics, including
end diastolic volume, end systolic
volume, stroke volume, ejection
fraction, cardiac output, cardiac index,
stroke index, and myocardial mass;
and calculation of regional metrics;
including wall motion, percentage of
wall thickening, regional ejection
fraction, and polar plots. | The CT CFA option is intended to
be used with CT studies of the heart
to assist cardiologists and
radiologists in assessing function
when producing a cardiac
evaluation.
The CFA option includes semi-
automatic heart and left ventricle
segmentation, including
identification of long axis and mitral
valve boundaries across multiple
phases; calculation of global
metrics, including end diastolic
volume, end systolic volume, stroke
volume, ejection fraction, cardiac
output, cardiac index, stroke index,
and myocardial mass; and
calculation of regional metrics;
including wall motion, percentage of
wall thickening, regional ejection
fraction, and polar plots. | The predicate device-1
does not provide
cardiac evaluation of
right ventricle and left
atrium compared to the
subject device. | |
| Intended Users: | | | |
| Cardiologists and radiologists. | Cardiologists and radiologists. | None | |
| Modality Support: | | | |
| CT | CT | None | |
| For Cardiac Evaluation of Right Ventricle (RV) and Left Atrium (LA) Chambers: | | | |
| Vitrea® CT Multi-Chamber Cardiac
Functional Analysis (CFA)
(K141302)
(Submission Subject) | CardIQ Function Xpress
(K073153)
(Predicate Device-2) | Differences | |
| Intended Use / Indications for Use: | | | |
| The Vitrea® CT Multi-Chamber CFA
option is intended to be used with CT
studies of the heart to assist
cardiologists and radiologists in
assessing function when producing a
cardiac evaluation.
The CT Multi-Chamber CFA option
includes semi-automatic heart
segmentation including three
chambers (left ventricle, right
ventricle, and left atrium )
segmentation, including identification
of long axis and mitral valve
boundaries across multiple phases;
calculation of global metrics, including
end diastolic volume, end systolic
volume, stroke volume, ejection
fraction, cardiac output, cardiac index,
stroke index, and myocardial mass;
and calculation of regional metrics;
including wall motion, percentage of
wall thickening, regional ejection
fraction, and polar plots. | CardIQ Function Xpress is intended
to provide an optimized noninvasive
application to analyze
cardiovascular anatomy and
pathology and aid in determining
treatment paths from a set of
Computed Tomography (CT)
Angiographic images.
CardIQ Function Xpress in
conjunction with CT cardiac images
to automatically calculate and
display various left ventricular and
right ventricular functional
parameters as ejection fraction,
end systolic and end diastolic
volumes, stroke volumes, wall
motion, wall thickening, cardiac
output, myocardial mass, systemic
and pulmonary vascular resistance.
Volume measurement of each
chamber of the heart is also
available. With CardIQ Function
Xpress atrium volumes may be
used to determine volume
assessment of atrial disease to
include but not limited to atrial
fibrillation. CardIQ Function Xpress
is a CT, non-invasive image
analysis software package, which
aids in the assessment of cardiac
function and in determination of
cardiovascular disease diagnosis
and management.
CardIQ Function Xpress is for use
on the Advantage Workstation (AW)
platform, CT Scanner, PAC or
Centricity stations, which can be
used in the analysis of 2D or 3D CT
angiography images/data derived
from DICOM 3.0 CT scans. | None | |
| Vitrea CT Multi-Chamber Cardiac
Functional Analysis (CFA)
(K141302)
(Submission Subject) | CardIQ Function Xpress
(K073153)
(Predicate Device-2) | Differences | |
| Intended Users: | Cardiologists and radiologists. | Cardiologists and radiologists. | None |
| Modality Support: | CT | CT | None |
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Image /page/5/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word, in smaller, red letters, is the phrase "A Toshiba Medical Systems Group Company." The text is centered in the image.
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Image /page/6/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 text is centered and the background is white.
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Image /page/7/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, lighter font. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.
Technological Characteristics Comparison:
| | (Submission
Subject) | (Predicate
Device-1) | (Predicate
Device-2) | |
|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------|
| Characteristic | Vitrea CT
Multi-Chamber
Cardiac
Functional
Analysis
(CFA) | Vitrea 2, version
3.7 Medical
Image
Processing
Software –
Cardiac
Functional
Analysis | CardIQ
Function
Xpress | Differences |
| | | For Cardiac
Evaluation of
Left Ventricle
(LV) Chamber | For Cardiac
Evaluation of
Right
Ventricle (RV)
and Left
Atrium (LA)
Chambers | |
| | (K141302) | (K043333) | (K073153) | |
| Device Description: | | | | |
| Input Data: | | | | |
| Characteristic | (Submission
Subject) | (Predicate
Device-1) | (Predicate
Device-2) | Differences |
| Characteristic | Vitrea CT
Multi-Chamber
Cardiac
Functional
Analysis
(CFA) | Vitrea 2, version
3.7 Medical
Image
Processing
Software –
Cardiac
Functional
Analysis | CardIQ
Function
Xpress | Differences |
| | | For Cardiac
Evaluation of
Left Ventricle
(LV) Chamber | For Cardiac
Evaluation of
Right
Ventricle (RV)
and Left
Atrium (LA)
Chambers | |
| | (K141302) | (K043333) | (K073153) | |
| Use in the analysis of CT
angiographic images to calculate and
display analysis of several functional
cardiac parameters | Yes | Yes | Yes | None |
| DICOM 3.0 compliant image data | Yes | Yes | Yes | None |
| Where Used: | | | | |
| Medical facility | Yes | Yes | Yes | None |
| User Interface: | | | | |
| Designed for use on a radiology
workstation | Yes | Yes | Yes | None |
| Loading DICOM Datasets: | | | | |
| Processes multi-phase, multi-slice
cardiac CT images | Yes | Yes | Yes | None |
| Characteristic | (Submission
Subject) | (Predicate
Device-1) | (Predicate
Device-2) | Differences |
| | Vitrea CT
Multi-Chamber
Cardiac
Functional
Analysis
(CFA) | Vitrea 2, version
3.7 Medical
Image
Processing
Software –
Cardiac
Functional
Analysis | CardIQ
Function
Xpress | |
| | | For Cardiac
Evaluation of
Left Ventricle
(LV) Chamber | For Cardiac
Evaluation of
Right
Ventricle (RV)
and Left
Atrium (LA)
Chambers | |
| | (K141302) | (K043333) | (K073153) | |
| Provides ability to select Diastolic
phase | Yes | Yes | Yes | None |
| Provides ability to select Systolic
phase | Yes | Yes | Yes | None |
| Automatically identifies the long axis
across multiple phases | Yes | Yes | Yes | None |
| Automatically identifies the plane of
the Mitral valve | Yes | Yes | Yes | None |
| Segmentation: | | | | |
| Semi-automatic segmentation of Left
Ventricle (LV) chamber | Yes | Yes | Yes | None |
| Semi-automatic segmentation of
Myocardium of Left Ventricle (LV)
chamber | Yes | Yes | Yes | None |
| | (Submission
Subject) | (Predicate
Device-1) | (Predicate
Device-2) | |
| Characteristic | Vitrea CT
Multi-Chamber
Cardiac
Functional
Analysis
(CFA) | Vitrea 2, version
3.7 Medical
Image
Processing
Software –
Cardiac
Functional
Analysis | CardIQ
Function
Xpress | Differences |
| | | For Cardiac
Evaluation of
Left Ventricle
(LV) Chamber | For Cardiac
Evaluation of
Right
Ventricle (RV)
and Left
Atrium (LA)
Chambers | |
| | (K141302) | (K043333) | (K073153) | |
| Key Functions: | | | | |
| Automatic determination of End
Diastolic (ED) and End Systolic (ES)
phases by volume | Yes | Yes | Yes | None |
| Volume Rendering | Yes | Yes | Yes | None |
| Phase Navigator | Yes | Yes | Yes | None |
| Semi-automatic determination of
Epicardial and Endocardial contours | Yes | Yes | Yes | None |
| Automated Calculation of Cardiac Parameters | | | | |
| End Diastolic Volume (EDV) | Yes | Yes | Yes | None |
| End Systolic Volume (ESV) | Yes | Yes | Yes | None |
| | (Submission
Subject) | (Predicate
Device-1) | (Predicate
Device-2) | |
| Characteristic | Vitrea CT
Multi-Chamber
Cardiac
Functional
Analysis
(CFA) | Vitrea 2, version
3.7 Medical
Image
Processing
Software –
Cardiac
Functional
Analysis | CardIQ
Function
Xpress | Differences |
| | | For Cardiac
Evaluation of
Left Ventricle
(LV) Chamber | For Cardiac
Evaluation of
Right
Ventricle (RV)
and Left
Atrium (LA)
Chambers | |
| | (K141302) | (K043333) | (K073153) | |
| Stroke Volume (SV) | Yes | Yes | Yes | None |
| Stroke Index (SI) | Yes | Yes | Yes | None |
| Ejection Fraction (EF) | Yes | Yes | Yes | None |
| Cardiac Output (CO) | Yes | Yes | Yes | None |
| Myocardial Mass | Yes | Yes | Yes | None |
| Wall Motion | Yes | Yes | Yes | None |
| Percent Wall Thickening | Yes | Yes | Yes | None |
| Myocardial Volume (MV) | Yes | Yes | Yes | None |
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Image /page/9/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. The phrase below it provides additional context about the company.
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Image /page/12/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The "i" in "VITAL" is lowercase. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, sans-serif font. The text is in red.
| | (Submission
Subject) | (Predicate
Device-1) | (Predicate
Device-2) | |
|----------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------|
| Characteristic | Vitrea CT
Multi-Chamber
Cardiac
Functional
Analysis
(CFA) | Vitrea 2, version
3.7 Medical
Image
Processing
Software –
Cardiac
Functional
Analysis | CardIQ
Function
Xpress | Differences |
| | | For Cardiac
Evaluation of
Left Ventricle
(LV) Chamber | For Cardiac
Evaluation of
Right
Ventricle (RV)
and Left
Atrium (LA)
Chambers | |
| | (K141302) | (K043333) | (K073153) | |
| Myocardial Mass Index | Yes | Yes | Yes | None |
| Regional Ejection Fraction (EF) | Yes | Yes | Yes | None |
| Outputs a Polar Map | Yes | Yes | Yes | None |
| Time/Volume Graph | Yes | Yes | Yes | None |
| Views: | | | | |
| 2D image viewing with real-time
Window/Level, Zoom, and Pan | Yes | Yes | Yes | None |
| 3D and Multi-Planar Reformatting
(MPR) view | Yes | Yes | Yes | None |
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| | (Submission
Subject) | (Predicate
Device-1) | (Predicate
Device-2) | |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------|
| Characteristic | Vitrea CT
Multi-Chamber
Cardiac
Functional
Analysis
(CFA) | Vitrea 2, version
3.7 Medical
Image
Processing
Software –
Cardiac
Functional
Analysis | CardIQ
Function
Xpress | Differences |
| | | For Cardiac
Evaluation of
Left Ventricle
(LV) Chamber | For Cardiac
Evaluation of
Right
Ventricle (RV)
and Left
Atrium (LA)
Chambers | |
| | (K141302) | (K043333) | (K073153) | |
| Automatic industry standard Oblique
views of the heart | Yes | Yes | Yes | None |
| Tools: | | | | |
| Provides image editing tools if
adjustments are needed | Yes | Yes | Yes | None |
| Visualization presets and automated
steps for typical image review
procedures | Yes | Yes | Yes | None |
| Report | Yes | Yes | Yes | None |
| Printing: | Yes | Yes | Yes | None |
| Printing to standard Windows or
DICOM printers | Yes | Yes | Yes | None |
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| Characteristic | (Submission
Subject) | (Predicate
Device-1) | (Predicate
Device-2) | Differences |
|---------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------|-------------|
| | Vitrea CT
Multi-Chamber
Cardiac
Functional
Analysis
(CFA) | Vitrea 2, version
3.7 Medical
Image
Processing
Software –
Cardiac
Functional
Analysis | CardIQ
Function
Xpress | |
| | For Cardiac
Evaluation of
Left Ventricle
(LV) Chamber | For Cardiac
Evaluation of
Right
Ventricle (RV)
and Left
Atrium (LA)
Chambers | | |
| | (K141302) | (K043333) | (K073153) | |
| Export / Restore Findings | Yes | Yes | Yes | None |
Additional Similarity with Predicate Device-1:
| Cardiac Parameter | Vitrea CT Multi-
Chamber Cardiac
Functional Analysis
(CFA)
(K141302)
(Submission Subject) | Vitrea 2, version 3.7
Medical Image
Processing Software -
Cardiac Functional
Analysis
(K043333)
(Predicate Device-1) | Differences |
|--------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Cardiac Index (CI) | Yes | Yes | None |
The above characteristic is the same characteristics as found in the available predicate device-1 (K04333).
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Additional Similarity with Predicate Device-2:
| Characteristic | Vitrea CT Multi-
Chamber Cardiac
Functional Analysis
(CFA)
(K141302)
(Submission Subject) | CardIQ Function Xpress
(K073153)
(Predicate Device-2) | Differences |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------|
| Semi-automatic segmentation of
Right Ventricle (RV) chamber | Yes | Yes | None |
| Semi-automatic segmentation of Left
Atrium (LA) chamber | Yes | Yes | None |
| Maximum Volume | Yes | Yes | None |
| Review Heart in Motion | Yes | Yes | None |
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Differences from the Predicate Devices:
| Cardiac Parameter | (Submission
Subject)
(K141302) | (Predicate
Device-1)
(K043333) | (Predicate
Device-2)
(K073153) | Test |
|------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| | Vitrea CT
Multi-Chamber
Cardiac
Functional
Analysis
(CFA) | Vitrea 2, version
3.7 Medical
Image
Processing
Software –
Cardiac
Functional
Analysis | CardIQ
Function
Xpress
For Cardiac
Evaluation of
Right
Ventricle (RV)
and Left
Atrium (LA)
Chambers | |
| | | For Cardiac
Evaluation of
Left Ventricle
(LV) Chamber | | |
| Regurgitation Fraction | Yes | No | Information
not available | The additional
measurement is
verified by an
internal test. |
| Cyclic Volume Change | Yes | No | Information
not available | The additional
measurement is
verified by an
internal test. |
| Reservoir Volume | Yes | No | Information
not available | The additional
measurement is
verified by
internal tests. |
Description of the added features to the Predicate Device-1 (K043333):
The new features added to the predicate device-1 (K043333) since the clearance are defined as follows:
- The predicate device-1 (K043333) provides cardiac evaluation for the Left Ventricle (LV) chamber of O heart. The subject device is an extension of the predicate device-1 (K043333) with additional support for cardiac evaluation of the Right Ventricle (RV) and Left Atrium (LA) chambers of the heart.
17
-
The technical characteristics for the predicate device-1 (K043333), which are defined in the technical O characteristics comparison table, are the same characteristics which now have been added in the subject device for the Right Ventricle (RV) and Left Atrium (LA) chambers of the heart.
The technical characteristics that have been added for the Right Ventricle (RV) and Left Atrium (LA) chambers of the heart are the same characteristics currently available for the Left Ventricle (LV) and carry the same risk profile as the predicate device-1 (K043333). Therefore, these additions do not raise new safety and efficacy concerns when used as labeled. -
o In addition, there are seven (7) characteristics which have been added. These additions are:
- Semi-automatic segmentation of Right Ventricle (RV) chamber ●
- Semi-automatic segmentation of Left Atrium (LA) chamber .
- . Maximum Volume
- Review Heart in Motion ●
- . Requrgitation Fraction
- . Cyclic Volume Change
- Reservoir Volume o
The above noted additional seven characteristics either do not carry hazardous risks or are not critical to the risk profile based on an "Improbable" probability of occurrence of harm after applied mitigations. The above noted additional seven characteristics have been mitigated by design, labeling, and performed verification and validation tests and therefore do not raise new safety and effectiveness concerns when used as labeled.
Summary of Non-Clinical Tests:
The software was designed, developed and tested according to written procedures that included applying risk management. Software testing was completed to ensure the new feature operates according to its requirements. Testing included verification, validation, and evaluation of previously acquired medical images.
The following quality assurance measures were applied to the development of Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) software application:
- Risk Management ●
- Requirements reviews
- Developer testing
- Code reviews
- o Desian reviews
- Verification of the software - that included performance and safety testing
- Validation of the software – that included simulated usability testing by independent experienced medical professionals.
Risk Management:
Vital Images performed a risk analysis, refering to software hazards associated with the intended use, including severity assessment and mitigation. The analysis was based upon the application of ISO 14971:2012 Risk Management to Medical Devices, in compliance with medical device ISO 13485:2012 and IEC 62304:2006 requirements.
All identified risks were reduced as low as possible. The medical benefits of the residual risk for each individual risk and all risks together. The overall residual risk for the software was 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
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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.
External Validation:
During external validation of Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) software application, experienced cardiologists evaluated the application. Each user felt that the Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) software application can be used successfully with CT studies of the heart to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation.
Summary of Clinical Tests:
The subject of this traditional 510(k) notification, Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) software application, did not require clinical studies to support safety and effectiveness of the software.
Cyber and Information Security:
. Confidentiality
The Vitrea platform relies on built in Windows Login security to limit access to the Vitrea platform can only be installed and configured by an administrator of the Windows machine.
● Integritv
The Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances. The Vitrea platform identifies the data it produces, marking and encoding the appropriate DICOM fields.
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.
The Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) software application complies with the following voluntary recognized consensus standards:
| 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 |
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| Standard No. | Standards
Organization | Standard Title | Version | Date |
|-------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------|---------|------------|
| 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 |
Conclusion:
Vital Images believes that Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) 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 when used as labeled. The implemented design mitigations, labeling, and the performed verification and validation tests demonstrate the safety and efficacy of the device is equivalent to the 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.