(74 days)
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 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.
Here's a breakdown of the acceptance criteria and the study information for the Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria for the device's performance in terms of specific metrics (e.g., accuracy, precision for EDV, ESV, EF). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices and fulfilling general software development and risk management standards.
The "reported device performance" in this context refers to the successful completion of verification and validation tests, confirming the software operates according to its requirements and user needs.
| Category | Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|---|
| Functional Performance | Software operates according to its requirements (e.g., semi-automatic segmentation, calculation of cardiac parameters like EDV, ESV, EF, CO, etc., display of regional metrics, polar plots). | Test cases were executed against system features and requirements, and a Requirements Traceability Matrix (RTM) was used to ensure coverage. Workflow testing was conducted by experts. The device provides "Yes" for all listed characteristics comparable to predicate devices, indicating successful implementation. These characteristics include: - Semi-automatic segmentation of LV, RV, and LA chambers (for the new features). - Calculation of various global and regional cardiac metrics. - Image viewing, editing, and reporting capabilities. |
| Usability/User Needs | Software conforms to user needs and intended use, assisting cardiologists and radiologists in assessing cardiac function from CT studies. | Experienced cardiologists evaluated the application and "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." |
| Safety & Effectiveness | No new safety and efficacy concerns raised, overall residual risk deemed acceptable after mitigations based on risk analysis and compliance with standards. | Risk analysis conducted (ISO 14971:2012), all identified risks reduced as low as possible. Software developed and tested according to written procedures including risk management. New features (RV/LA evaluation, additional metrics) were assessed to have the same risk profile as the predicate or mitigated through design, labeling, and V&V tests, not raising new safety/effectiveness concerns. |
| Regulatory Compliance | Compliance with applicable regulations and recognized consensus standards (e.g., DICOM, ISO 14971, IEC 62304). | The software complies with PS 3.1-3.20 (2011) NEMA DICOM Set, ISO 14971:2007, and IEC 62304:2006. |
| Cybersecurity/Information | Adherence to principles of Confidentiality, Integrity, Availability, and Accountability. | Relies on Windows Login for access control (Confidentiality). Complies with DICOM for data transfer and storage, marking and encoding data it produces (Integrity). Always available to logged-on user given Windows machine maintenance (Availability). Includes audit capability with time-stamped logs for user operations and information accessed (Accountability). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify an exact number of cases or studies used for the "verification of the software" or "validation of the software." It mentions "previously acquired medical images" and "workflow testing that provided evidence that the system requirements and features were implemented, reviewed and met."
- Data Provenance: The text states "previously acquired medical images" (for verification) and "CT studies of the heart" (for validation by cardiologists). The country of origin is not specified, and the data is retrospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: The document states that "experienced cardiologists evaluated the application" during external validation. It does not provide an exact number or a range for the "experienced cardiologists."
- Qualifications of Experts: They are described as "experienced cardiologists." No specific years of experience or sub-specialty details are provided beyond "cardiologists."
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth within the validation process. The "experienced cardiologists" "evaluated the application" and "felt that" it could be successfully used. This suggests a qualitative assessment of functionality and clinical utility rather than a quantitative comparison against an adjudicated ground truth for specific measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size (AI vs. without AI assistance)
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "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." The validation was focused on proving the software functions as intended and is perceived as useful by experts, rather than demonstrating an improvement in human reader performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is described as an "option" and "application" intended "to assist cardiologists and radiologists in assessing function." The external validation involved "experienced cardiologists" evaluating the application, confirming it "can be used successfully... to assist." This indicates the device is designed for human-in-the-loop use. The document doesn't explicitly describe a standalone performance evaluation where the algorithm's output is judged without any human intervention or review. The semi-automatic nature of the segmentation also implies human interaction.
7. The Type of Ground Truth Used
The ground truth for the device's functional correctness was established through:
- Software Requirements: Internal verification against predefined software requirements.
- Predicate Device Equivalence: The primary basis for equivalence, where the device's functionalities were compared to those of two legally marketed predicate devices, implying those devices' output represents a form of accepted clinical "ground truth."
- Expert Qualitative Assessment: During "External Validation," experienced cardiologists qualitatively assessed the application's utility and usability, essentially acting as a form of "expert consensus" on whether the tool correctly assists in cardiac evaluation, rather than providing exact numerical ground truth for calculations.
There is no mention of pathology or outcomes data being used for ground truth.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size used for training the algorithms within the Vitrea CT Multi-Chamber Cardiac Functional Analysis (CFA) software. Given the submission date (2014) and the description of the software as "semi-automatic heart segmentation," it's possible that traditional image processing and analysis algorithms were used, which might not rely on "training sets" in the same way modern deep learning AI models do.
9. How the Ground Truth for the Training Set Was Established
Since the document does not mention a training set or the type of algorithms used (beyond "semi-automatic segmentation"), there is no information on how ground truth for a training set (if one existed for elements like segmentation) would have been established.
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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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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
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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:
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This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92.(c)
| Purpose ofSubmission: | Vital Images, Inc. hereby submits this traditional 510(k) to provide anotification submission of a new software application preset called "CTMulti-Chamber Cardiac Functional Analysis (CFA)". This new applicationhas been added into the Cardiac Functional CT protocol available on theVitrea platforms to provide cardiac functions of Right Ventricle (RV) andLeft Atrium (LA) chambers of heart in addition to the previously clearedcardiac evaluation of Left Ventricle (LV) chamber of heart. |
|---|---|
| Submitter: | Vital Images, Inc.5850 Opus ParkwaySuite 300Minnetonka, MN 55343-4414 |
| EstablishmentRegistration: | 2134213 |
| Contact Person: | Parthiv ShahSr. Regulatory Affairs SpecialistPhone : 952-487-9574Fax: 952-487-9510E-mail: pshah@vitalimages.com |
| 510(k) Type: | Traditional |
| Summary Date: | July 2, 2014 |
| Device NameTrade 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 ImageProcessing Software - CardiacFunctional Analysis(Legally Marketed Device) | Vital Images, Inc. | K043333 |
| CardIQ Function Xpress(Legally Marketed Device) | GE Medical Systems SCS | K073153 |
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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 CardiacFunctional Analysis (CFA)(K141302)(Submission Subject) | Vitrea 2, version 3.7 MedicalImage Processing Software –Cardiac Functional Analysis(K043333)(Predicate Device-1) | Differences | |
|---|---|---|---|
| Intended Use / Indications for Use: | |||
| Vitrea CT Multi-Chamber CardiacFunctional Analysis (CFA)(K141302)(Submission Subject) | Vitrea 2, version 3.7 MedicalImage Processing Software –Cardiac Functional Analysis(K043333)(Predicate Device-1) | Differences | |
| The Vitrea® CT Multi-Chamber CFAoption is intended to be used with CTstudies of the heart to assistcardiologists and radiologists inassessing function when producing acardiac evaluation.The CT Multi-Chamber CFA optionincludes semi-automatic heartsegmentation including threechambers (left ventricle, rightventricle, and left atrium)segmentation, including identificationof long axis and mitral valveboundaries across multiple phases;calculation of global metrics, includingend diastolic volume, end systolicvolume, stroke volume, ejectionfraction, cardiac output, cardiac index,stroke index, and myocardial mass;and calculation of regional metrics;including wall motion, percentage ofwall thickening, regional ejectionfraction, and polar plots. | The CT CFA option is intended tobe used with CT studies of the heartto assist cardiologists andradiologists in assessing functionwhen producing a cardiacevaluation.The CFA option includes semi-automatic heart and left ventriclesegmentation, includingidentification of long axis and mitralvalve boundaries across multiplephases; calculation of globalmetrics, including end diastolicvolume, end systolic volume, strokevolume, ejection fraction, cardiacoutput, cardiac index, stroke index,and myocardial mass; andcalculation of regional metrics;including wall motion, percentage ofwall thickening, regional ejectionfraction, and polar plots. | The predicate device-1does not providecardiac evaluation ofright ventricle and leftatrium compared to thesubject 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 CardiacFunctional Analysis (CFA)(K141302)(Submission Subject) | CardIQ Function Xpress(K073153)(Predicate Device-2) | Differences | |
| Intended Use / Indications for Use: | |||
| The Vitrea® CT Multi-Chamber CFAoption is intended to be used with CTstudies of the heart to assistcardiologists and radiologists inassessing function when producing acardiac evaluation.The CT Multi-Chamber CFA optionincludes semi-automatic heartsegmentation including threechambers (left ventricle, rightventricle, and left atrium )segmentation, including identificationof long axis and mitral valveboundaries across multiple phases;calculation of global metrics, includingend diastolic volume, end systolicvolume, stroke volume, ejectionfraction, cardiac output, cardiac index,stroke index, and myocardial mass;and calculation of regional metrics;including wall motion, percentage ofwall thickening, regional ejectionfraction, and polar plots. | CardIQ Function Xpress is intendedto provide an optimized noninvasiveapplication to analyzecardiovascular anatomy andpathology and aid in determiningtreatment paths from a set ofComputed Tomography (CT)Angiographic images.CardIQ Function Xpress inconjunction with CT cardiac imagesto automatically calculate anddisplay various left ventricular andright ventricular functionalparameters as ejection fraction,end systolic and end diastolicvolumes, stroke volumes, wallmotion, wall thickening, cardiacoutput, myocardial mass, systemicand pulmonary vascular resistance.Volume measurement of eachchamber of the heart is alsoavailable. With CardIQ FunctionXpress atrium volumes may beused to determine volumeassessment of atrial disease toinclude but not limited to atrialfibrillation. CardIQ Function Xpressis a CT, non-invasive imageanalysis software package, whichaids in the assessment of cardiacfunction and in determination ofcardiovascular disease diagnosisand management.CardIQ Function Xpress is for useon the Advantage Workstation (AW)platform, CT Scanner, PAC orCentricity stations, which can beused in the analysis of 2D or 3D CTangiography images/data derivedfrom DICOM 3.0 CT scans. | None | |
| Vitrea CT Multi-Chamber CardiacFunctional 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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Technological Characteristics Comparison:
| (SubmissionSubject) | (PredicateDevice-1) | (PredicateDevice-2) | ||
|---|---|---|---|---|
| Characteristic | Vitrea CTMulti-ChamberCardiacFunctionalAnalysis(CFA) | Vitrea 2, version3.7 MedicalImageProcessingSoftware –CardiacFunctionalAnalysis | CardIQFunctionXpress | Differences |
| For CardiacEvaluation ofLeft Ventricle(LV) Chamber | For CardiacEvaluation ofRightVentricle (RV)and LeftAtrium (LA)Chambers | |||
| (K141302) | (K043333) | (K073153) | ||
| Device Description: | ||||
| Input Data: | ||||
| Characteristic | (SubmissionSubject) | (PredicateDevice-1) | (PredicateDevice-2) | Differences |
| Characteristic | Vitrea CTMulti-ChamberCardiacFunctionalAnalysis(CFA) | Vitrea 2, version3.7 MedicalImageProcessingSoftware –CardiacFunctionalAnalysis | CardIQFunctionXpress | Differences |
| For CardiacEvaluation ofLeft Ventricle(LV) Chamber | For CardiacEvaluation ofRightVentricle (RV)and LeftAtrium (LA)Chambers | |||
| (K141302) | (K043333) | (K073153) | ||
| Use in the analysis of CTangiographic images to calculate anddisplay analysis of several functionalcardiac 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 radiologyworkstation | Yes | Yes | Yes | None |
| Loading DICOM Datasets: | ||||
| Processes multi-phase, multi-slicecardiac CT images | Yes | Yes | Yes | None |
| Characteristic | (SubmissionSubject) | (PredicateDevice-1) | (PredicateDevice-2) | Differences |
| Vitrea CTMulti-ChamberCardiacFunctionalAnalysis(CFA) | Vitrea 2, version3.7 MedicalImageProcessingSoftware –CardiacFunctionalAnalysis | CardIQFunctionXpress | ||
| For CardiacEvaluation ofLeft Ventricle(LV) Chamber | For CardiacEvaluation ofRightVentricle (RV)and LeftAtrium (LA)Chambers | |||
| (K141302) | (K043333) | (K073153) | ||
| Provides ability to select Diastolicphase | Yes | Yes | Yes | None |
| Provides ability to select Systolicphase | Yes | Yes | Yes | None |
| Automatically identifies the long axisacross multiple phases | Yes | Yes | Yes | None |
| Automatically identifies the plane ofthe Mitral valve | Yes | Yes | Yes | None |
| Segmentation: | ||||
| Semi-automatic segmentation of LeftVentricle (LV) chamber | Yes | Yes | Yes | None |
| Semi-automatic segmentation ofMyocardium of Left Ventricle (LV)chamber | Yes | Yes | Yes | None |
| (SubmissionSubject) | (PredicateDevice-1) | (PredicateDevice-2) | ||
| Characteristic | Vitrea CTMulti-ChamberCardiacFunctionalAnalysis(CFA) | Vitrea 2, version3.7 MedicalImageProcessingSoftware –CardiacFunctionalAnalysis | CardIQFunctionXpress | Differences |
| For CardiacEvaluation ofLeft Ventricle(LV) Chamber | For CardiacEvaluation ofRightVentricle (RV)and LeftAtrium (LA)Chambers | |||
| (K141302) | (K043333) | (K073153) | ||
| Key Functions: | ||||
| Automatic determination of EndDiastolic (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 ofEpicardial 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 |
| (SubmissionSubject) | (PredicateDevice-1) | (PredicateDevice-2) | ||
| Characteristic | Vitrea CTMulti-ChamberCardiacFunctionalAnalysis(CFA) | Vitrea 2, version3.7 MedicalImageProcessingSoftware –CardiacFunctionalAnalysis | CardIQFunctionXpress | Differences |
| For CardiacEvaluation ofLeft Ventricle(LV) Chamber | For CardiacEvaluation ofRightVentricle (RV)and LeftAtrium (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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| (SubmissionSubject) | (PredicateDevice-1) | (PredicateDevice-2) | ||
|---|---|---|---|---|
| Characteristic | Vitrea CTMulti-ChamberCardiacFunctionalAnalysis(CFA) | Vitrea 2, version3.7 MedicalImageProcessingSoftware –CardiacFunctionalAnalysis | CardIQFunctionXpress | Differences |
| For CardiacEvaluation ofLeft Ventricle(LV) Chamber | For CardiacEvaluation ofRightVentricle (RV)and LeftAtrium (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-timeWindow/Level, Zoom, and Pan | Yes | Yes | Yes | None |
| 3D and Multi-Planar Reformatting(MPR) view | Yes | Yes | Yes | None |
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| (SubmissionSubject) | (PredicateDevice-1) | (PredicateDevice-2) | ||
|---|---|---|---|---|
| Characteristic | Vitrea CTMulti-ChamberCardiacFunctionalAnalysis(CFA) | Vitrea 2, version3.7 MedicalImageProcessingSoftware –CardiacFunctionalAnalysis | CardIQFunctionXpress | Differences |
| For CardiacEvaluation ofLeft Ventricle(LV) Chamber | For CardiacEvaluation ofRightVentricle (RV)and LeftAtrium (LA)Chambers | |||
| (K141302) | (K043333) | (K073153) | ||
| Automatic industry standard Obliqueviews of the heart | Yes | Yes | Yes | None |
| Tools: | ||||
| Provides image editing tools ifadjustments are needed | Yes | Yes | Yes | None |
| Visualization presets and automatedsteps for typical image reviewprocedures | Yes | Yes | Yes | None |
| Report | Yes | Yes | Yes | None |
| Printing: | Yes | Yes | Yes | None |
| Printing to standard Windows orDICOM printers | Yes | Yes | Yes | None |
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| Characteristic | (SubmissionSubject) | (PredicateDevice-1) | (PredicateDevice-2) | Differences |
|---|---|---|---|---|
| Vitrea CTMulti-ChamberCardiacFunctionalAnalysis(CFA) | Vitrea 2, version3.7 MedicalImageProcessingSoftware –CardiacFunctionalAnalysis | CardIQFunctionXpress | ||
| For CardiacEvaluation ofLeft Ventricle(LV) Chamber | For CardiacEvaluation ofRightVentricle (RV)and LeftAtrium (LA)Chambers | |||
| (K141302) | (K043333) | (K073153) | ||
| Export / Restore Findings | Yes | Yes | Yes | None |
Additional Similarity with Predicate Device-1:
| Cardiac Parameter | Vitrea CT Multi-Chamber CardiacFunctional Analysis(CFA)(K141302)(Submission Subject) | Vitrea 2, version 3.7Medical ImageProcessing Software -Cardiac FunctionalAnalysis(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 CardiacFunctional Analysis(CFA)(K141302)(Submission Subject) | CardIQ Function Xpress(K073153)(Predicate Device-2) | Differences |
|---|---|---|---|
| Semi-automatic segmentation ofRight Ventricle (RV) chamber | Yes | Yes | None |
| Semi-automatic segmentation of LeftAtrium (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 | (SubmissionSubject)(K141302) | (PredicateDevice-1)(K043333) | (PredicateDevice-2)(K073153) | Test |
|---|---|---|---|---|
| Vitrea CTMulti-ChamberCardiacFunctionalAnalysis(CFA) | Vitrea 2, version3.7 MedicalImageProcessingSoftware –CardiacFunctionalAnalysis | CardIQFunctionXpressFor CardiacEvaluation ofRightVentricle (RV)and LeftAtrium (LA)Chambers | ||
| For CardiacEvaluation ofLeft Ventricle(LV) Chamber | ||||
| Regurgitation Fraction | Yes | No | Informationnot available | The additionalmeasurement isverified by aninternal test. |
| Cyclic Volume Change | Yes | No | Informationnot available | The additionalmeasurement isverified by aninternal test. |
| Reservoir Volume | Yes | No | Informationnot available | The additionalmeasurement isverified byinternal 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.
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-
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. | StandardsOrganization | Standard Title | Version | Date |
|---|---|---|---|---|
| PS 3.1- 3.20(2011)(RecognitionNumber 12-238) | NEMA | Digital Imaging andCommunications inMedicine (DICOM) Set(Radiology) | 3 | 03/16/2012 |
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| Standard No. | StandardsOrganization | Standard Title | Version | Date |
|---|---|---|---|---|
| ISO 14971:2007(RecognitionNumber 5-70) | AAMI / ANSI/ ISO | Medical Devices -Applications of RiskManagement to MedicalDevices | 2007 | 03/16/2012 |
| IEC 62304:2006(RecognitionNumber 13-32) | AAMI /ANSI / IEC | Medical Device Software- Software Life CycleProcesses (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.
§ 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).