(59 days)
Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis.
TOMTEC-ARENA (TTA2) is a clinical software package for reviewing, quantifying and reporting digital medical data. The software is compatible with different IMAGE-ARENA platforms and third party platforms.
Platforms enhance the workflow by providing the database, import, export and other services. All analyzed data and images will be transferred to the platform for archiving, reporting and statistical quantification purposes.
TTA2 consists of the following optional modules:
- TOMTEC-ARENA SERVER & CLIENT .
- . IMAGE-COM/ECHO-COM
- REPORTING ●
- AutoStrain (LV, LA, RV) ●
- . 2D CARDIAC-PERFORMANCE ANALYSIS (Adult and Fetal)
- . 4D LV-ANALYSIS
- 4D RV-FUNCTION
- . 4D CARDIO-VIEW
- 4D MV-ASSESSMENT
- 4D SONO-SCAN .
The provided text is a 510(k) summary for the TOMTEC-ARENA software. It details the device's substantial equivalence to predicate devices and outlines non-clinical performance data. However, it explicitly states "No clinical testing conducted in support of substantial equivalence when compared to the predicate devices."
Therefore, I cannot provide information on acceptance criteria or a study that proves the device meets those criteria from the given text as no clinical study was performed.
Here's a breakdown of what can be extracted or inferred based on the document's content:
1. A table of acceptance criteria and the reported device performance:
Not applicable, as no clinical performance data or acceptance criteria for clinical performance are reported in this document. The document states that the device was tested to meet design and performance requirements through non-clinical methods.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable, as no clinical test set was used. Non-clinical software verification was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no clinical test set requiring expert ground truth was mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring adjudication was mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was done, as explicitly stated: "No clinical testing conducted in support of substantial equivalence". The device is a "Picture archiving and communications system" and advanced analysis tools; the document does not indicate it's an AI-assisted diagnostic tool that would typically undergo such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
While the document describes various "Auto" modules (AutoStrain, Auto LV, Auto LA) which imply algorithmic processing, it does not detail standalone performance studies for these algorithms. The context is generally about reviewing, quantifying, and reporting digital medical data to support physicians, not to replace interpretation. The comparison tables highlight that for certain features (e.g., 4D RV-Function, 4D MV-Assessment), the subject device uses machine learning algorithms for 3D surface model creation, with the user able to edit, accept, or reject the contours/landmarks. This indicates a human-in-the-loop design rather than a standalone algorithm for final diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable for clinical ground truth, as no clinical studies were performed. For the software verification, the "ground truth" would be the predefined design and performance requirements.
8. The sample size for the training set:
Not applicable for clinical training data, as no clinical studies were performed. While some modules utilize "machine learning algorithms" (e.g., for 3D surface model creation), the document does not disclose the training set size or its characteristics.
9. How the ground truth for the training set was established:
Not applicable for clinical training data. The document mentions machine learning algorithms are used (e.g., in 4D RV-FUNCTION and 4D MV-ASSESSMENT for creating 3D surface models), but it does not describe how the training data for these algorithms, or their ground truth, was established.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 14, 2020
TOMTEC Imaging Systems GmbH % Mr. Marc Bergenthal Manager Regulatory Affairs Edisonstrasse 6 Unterschleissheim, Bavaria 85716 GERMANY
Re: K201632
Trade/Device Name: TOMTEC-ARENA Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 12, 2020 Received: June 16, 2020
Dear Mr. Bergenthal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201632
Device Name TOMTEC-ARENA
Indications for Use (Describe)
Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis.
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) |
|---|---|
iption 06c (Part 21 CFR 801 Subpart D)
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of a stylized "T" followed by the word "TOMTEC" in a bold, sans-serif font. The "T" is formed by two thick, intersecting lines, creating a modern and geometric design.
510(K) SUMMARY
This 510(k) summary is provided as part of the Premarket Notification in compliance with 21CFR, Part 807, Subpart E, Section 807.92.
1) SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON
| Primary Contact: | Marc BergenthalEmail: marc.bergenthal@tomtec.deTel: (+49) 89 32175 555Fax: (+49) 89 32175 750 |
|---|---|
| Sponsor: | TOMTEC Imaging Systems GmbHEdisonstrasse 685716 UnterschleissheimGermany |
- NAME OF THE DEVICE, INCLUDING THE TRADE OR PROPRIETARY NAME IF APPLICABLE, THE COMMON OR USUAL NAME, AND THE CLASSIFICATION
June 12, 2020
NAME, IF KNOWN
Date prepared:
| Common Name: | Picture archiving and communications system |
|---|---|
| Proprietary Name: | TOMTEC-ARENA |
| Classification Name: | 21 CFR 892.2050,System, Image Processing, Radiological |
| Product code: | QIH, Class II |
3) INDICATIONS FOR USE
Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis.
4) DEVICE DESCRIPTION
TOMTEC-ARENA (TTA2) is a clinical software package for reviewing, quantifying and reporting digital medical data. The software is compatible with different IMAGE-ARENA platforms and third party platforms.
Platforms enhance the workflow by providing the database, import, export and other services. All analyzed data and images will be transferred to the platform for archiving, reporting and statistical quantification purposes.
TTA2 consists of the following optional modules:
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Image /page/4/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of a stylized "T" symbol on the left, followed by the word "TOMTEC" in a bold, sans-serif font. The entire logo is in black and white.
- TOMTEC-ARENA SERVER & CLIENT .
- . IMAGE-COM/ECHO-COM
- REPORTING ●
- AutoStrain (LV, LA, RV) ●
- . 2D CARDIAC-PERFORMANCE ANALYSIS (Adult and Fetal)
- . 4D LV-ANALYSIS
- 4D RV-FUNCTION
- . 4D CARDIO-VIEW
- 4D MV-ASSESSMENT
- 4D SONO-SCAN .
5) SUBSTANTIALLY EQUIVALENT DEVICES
Primary Predicate Device: TomTec-Arena TTA2 K150122 (February 13, 2015) Secondary Predicate Device: QLAB Advanced Quantification Software K200974 (June 03, 2020)
TOMTEC Imaging Systems GmbH believes that the TOMTEC-ARENA modifications that are the subject of this 510(k) are substantially equivalent to TomTec-Arena TTA2 (K150122).
6) TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES
The TOMTEC-ARENA software with the modified modules has the same intended use and technological characteristics as the legally marketed predicate devices. A comparison of the proposed TOMTEC-ARENA application to the currently marketed primary predicate device (TomTec-Arena TTA2) and secondary predicate device (QLAB Advanced Quantification Software) are provided in the tables below:
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| Feature | Primary Predicate DeviceTomTec-Arena(K150122) | Secondary Predicate DeviceQLAB(K200974) | Subject DeviceTOMTEC-ARENEA | Discussion / Comment |
|---|---|---|---|---|
| GENERAL COMPARISONIntended Use | TomTec-Arena software is a clinicalsoftware package designed forreview, quantification and reporting ofstructures and function based onmulti-dimensional digital medical dataacquired with different modalities.TomTec-Arena is not intended to beused for reading of mammographyimages. | QLAB Quantification software is asoftware application package. It isdesigned to view and quantify imagedata acquired on Philips ultrasoundsystems. | TOMTEC-ARENA software is aclinical software package designedfor review, quantification andreporting of structures and functionbased on multi-dimensional digitalmedical data acquired with differentmodalities.TOMTEC-ARENA is notintended to be used for reading ofmammography images. | Intended Use of primary and subjectdevice are identical(unchanged)Intended Use/Indicationsfor use of secondary predicate andsubject device are comparable andconsidered equivalent. |
| Indications forUse | Indications for use of TomTec-ArenaTTA2 software are quantification andreporting of cardiovascular, fetal,abdominal structures and function ofpatients with suspected disease tosupport the physicians in thediagnosis | QLAB Quantification software is asoftware application package. It isdesigned to view and quantify imagedata acquired on Philips ultrasoundsystems. | Indications for use of TOMTEC-ARENA TTA2 software arequantification and reporting ofcardiovascular, fetal, abdominalstructures and function of patientswith suspected disease to support thephysicians in the diagnosis | Indications for use of primary andsubject device are identical(unchanged).Intended Use/Indications for use ofsecondary predicate and subjectdevice are comparable andconsidered equivalent. |
| Anatomical Site | Quantification and reporting ofcardiovascular, fetal, and abdominalstructures and function. | Quantification of imaging dataacquired from ultrasound machines ofvarious anatomical structures andfunction. | Quantification and reporting ofcardiovascular, fetal, and abdominalstructures and function. | Identical to primary and secondarypredicate. |
| where used(hospital, home,ambulance, etc.) | Hospitals, clinics, and physician'soffices. | Hospitals, clinics, and physician'soffices. | Hospitals, clinics, and physician'soffices. | Identical to primary and secondarypredicate. |
| Design | Software as a medical device | Software as a medical device | Software as a medical device | Identical to primary and secondarypredicate. |
| 4D RV-FUNCTION | ||||
| ApplicationDescription | 4D RV-Function provides acomprehensive evaluation of the rightventricle including volumes and strainanalysis. It provides EDV, ESV,RVEF, SV, RVLS, TAPSE and FAC.Distance measurements can also beanalyzed. This softwaredelivers a quick and reproducibleanalysis of the right ventricle, thus | The 3D Auto RV Q-App is anintegration of the segmentationengine of the QLAB HeartModel andthe TOMTEC-ARENA 4D RV-Function thereby providing a dynamicRight Ventricle clinical functionality. | The 4D RV-Function is a rightventricular quantification tool forroutine clinical work, pulmonaryhypertension, and right-sided heartfailure. The application helps toovercome complexity of right-ventricle analysis by calculatingstandard values based on a semi- | Revised for clarity. Consideredequivalent to primary predicate. Noimpact to the safety or effectivenessof the device.Comparable and consideredequivalent to secondary predicate.This modification to QLAB wascleared by K191647. |
| increasing your diagnostic confidenceby visualizing the complexity of theRV shape in 3D. | automatically generated 3D surfacemodel. | |||
| SW Version | 2.0 | 15.0 | 3.0 | Updated due to changes to SW code.Integrates HeartModel auto-segmentation technology with 4D RV-Function algorithm for RV borderplacement. |
| Measurements | Volume and function of RightVentricle | EDVIESVI | Added:EDVIESVI | Added measurements are identical tosecondary predicate device. |
| Export Formats: | As cleared | Beutel value export into .stl and .objformat | Added:Beutel value export into .stl and .objformat | Identical to secondary predicate.Workflow improvements for userconvenience.No impact to the safety oreffectiveness of the device. |
| ContourGeneration | 3D surface model is created basedon user defined anatomicallandmarks. User is able to edit thecontour of the surface model. | 3D surface model is createdautomatically using machine learningalgorithms without user interaction.User is able to edit, accept or rejectthe contours or the anatomicallandmarks. | 3D surface model is createdautomatically using machine learningalgorithms without user interaction.User is able to edit, accept or rejectthe contours or the anatomicallandmarks. | Identical to secondary predicate.Workflow improvements for userconvenience.No impact to the safety oreffectiveness of the device. |
| 4D MV-ASSESSMENT | ||||
| ApplicationDescription | 4D MV-Assessment is used forcomprehensive morphological andfunctional assessment of the mitralvalve. Based on an easy and intuitiveworkflow the application packagegenerates models of anatomicalstructures such as MV annulus,leaflet and the closure line.Automatically derived parametersallow quantification of pre- and post-operative valvular function andcomparison of morphology. 4D MV-Assessment improves thepresentation of anatomy and findingsand visualizes the complexmorphology and dynamics of themitral valve. | The 3D Auto MV Q-App is a semi-automatic tool that essentially is anintegration of the machine-learningderived segmentation engine of theQLAB HeartModel and the TOMTEC-Arena TTA2 4D MV-Assessmentapplication thereby providing adynamic Mitral Valve clinicalquantification tool. | 4D MV-ASSESSMENT provides amorphological and functional analysisof the mitral valve (MV) using 3D/4Dechocardiography data. Models ofanatomical structures such as MVannulus, leaflets and the closure lineare generated. The derivedparameters allow quantification ofpre- and post-operative valvularfunction and a comparison ofmorphology. | Revised for clarity. Consideredequivalent to primary predicate. Noimpact to the safety or effectivenessof the device.Comparable and consideredequivalent to secondary predicate.This modification to QLAB wascleared by K200974- |
| SW Version | 2.3 | 15.0 | 2.5 | Updated due to changes to SW code. |
| Measurements | As cleared | Prolapse HeightOpen Coaptation GapOpen Coaptation WidthOpen Coaptation Area 3DC-shaped AnnulusDistal Anterior Leaflet Angle | Added:Prolapse HeightOpen Coaptation GapOpen Coaptation WidthOpen Coaptation Area 3DC-shaped AnnulusDistal Anterior Leaflet Angle | Identical to secondary predicate. |
| ContourGeneration | 3D surface model is created basedon user defined anatomicallandmarks.User is able to edit the contour of thesurface model before proceeding withthe workflow. | 3D surface model is created semi-automatically using machine learningalgorithm without user interaction.User is able to edit, accept, or rejectthe initial landmark proposals of themitral valve anatomical locations. | 3D surface model is created semi-automatically using machine learningalgorithm without user interaction.User is able to edit, accept, or rejectthe initial landmark proposals of themitral valve anatomical locations. | Identical to secondary predicate.Workflow improvements for userconvenience in initial model displayand landmark proposal.User is still able to edit, accept orreject the contours.No impact to the safety oreffectiveness of the device. |
| 4D LV-ANALYSIS | ||||
| ApplicationDescription | Volume quantification and functionanalysis of the left ventricle based on3D data has proven to be moreaccurate and reproducible than using2D clips. 4D LV-Analysis is a vendorindependent offline solution for 3Dspeckle tracking. It provides anautomated workflow for quantitativeand reproducible analysis of leftventricular deformation and globalstrain values. 4D LV Function is abasic application for the assessmentof left ventricular volumes, EF andGLS while 4D LV Analysis allows foradvanced investigations includingtwist, regional strain and deformationanalysis. Results are mapped ontothe LV Beutel surface for clearvisualization. All results can be storedand exported. | The Dynamic HeartModel (DHM)provides automatic 3D anatomicalborders and left ventricle (LV) and leftatrium (LA) border tracking across allframes of the cardiac cycle or cycles. | 4D LV-ANALYSIS providesmorphological and functionalanalyses of the left ventricle. Basedon 3D echo datasets a 4D model(Beutel) is generated that representsthe cavity of the LV and optionallyalso the LA. Volumes, Strain andDisplacement are quantified on aglobal and segmental level. | Revised for clarity. Consideredequivalent to primary predicate. Noimpact to the safety or effectivenessof the device.Comparable and consideredequivalent to secondary predicate. |
| SW Version | 3.1 | 15.0 | 3.2 | Updated due to changes to SW code. |
| Measurements | As cleared | Same technology extended to Atrium(LA Option in 4D LV-Analysis). | ||
| LAVminLAVmax | Added:LA EDV (LA EDVI)LA ESV (LA ESVI)LA PreAV (LA PreAVI) | LA EDV corresponds to LAVmin, andLA ESV corresponds to LAVmax.LA PreAV is based on the samedynamic quantification as LA volumecurve (prior to contraction). | ||
| LA EF | LA trueEFLA EFLA GLS | LA trueEF uses the same formula asLA EF but different volume values(LA PreAV instead of LAVmax).LA GLS is a well-known parameterand described in clinical literature.Identical to secondary predicate (see"4D RV-Function"). | ||
| Export formats: | As cleared | Beutel value export into .stl and .obj format | Added:Beutel value export into .stl and .obj format | |
| Enhancements: | As cleared | n/a | Adapted Bullseye based an ASE2015guideline.Workflow improvements by removedBeutel revision step & contourproposal and retracking withintracking revision step. | Workflow improvements for userconvenience. No impact to the safetyor effectiveness of the device. |
| AUTOSTRAIN | ||||
| ApplicationDescription | n/a - features and functionality werepart of IMAGE-COM (AutoSTRAINAddins) and 2D CPA | AutoStrain LV, LA, RV included | AutoStrain is a quantification tool ofglobal and regional function based oncontour detection and tracking. Itsupports a bull's eye display of Timeto Peak Longitudinal Strain and End-Systolic Longitudinal Strain. Further,this CAP provides the calculation ofGLS (Global Peak LongitudinalStrain). | Based on cleared Addins of IMAGE-COM and 2D CPA, a dedicatedmodule (CAP) was released.This CAP only includes features andmeasurements that were alreadyavailable in IMAGE-COM (andrespective Addins), 2D CPA or havebeen cleared by QLAB. Theintegration "on cart" requiresdedicated CAPs (e.g. for theapplication layout). This CAP is usedin the same clinical context andworkflows. No impact to the safety oreffectiveness of the device. |
| SW Version | n/a - features and functionality werepart of IMAGE-COM (AutoSTRAINAddins) and 2D CPA | 15.0 | 2.1 | No previous SW version as featuresand functionality were included inIMAGE-COM and/or 2D CPA |
| Measurements | n/a - features and functionality werepart of IMAGE-COM (AutoSTRAINAddins) and 2D CPA | Added: | Measurements available within thisCAP were already available inIMAGE-COM/2D CPA or are identicalto the secondary predicate (QLAB).No impact to the safety oreffectiveness of the device. | |
| LASr ED | LASr ED | |||
| LAScd ED | LAScd ED | |||
| LASct ED | LASct ED | |||
| LASr AC | LASr AC | |||
| LAScd AC | LAScd AC | |||
| LASct AC | LASct AC |
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Image /page/6/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of a stylized "T" followed by the word "TOMTEC" in a sans-serif font. The "T" is made up of two thick, black bars, one vertical and one angled, creating a modern and geometric design.
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ТГтомтес
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| Feature | Primary Predicate DeviceTomTec-Arena(K150122) | Subject DeviceTOMTEC-ARENEA | Discussion / Comment |
|---|---|---|---|
| IMAGE-COM | |||
| Applicationdescription | Image-Com is a dedicated DICOM viewer forcardiovascular ultrasound and Cath Labexaminations. Easy and quickimage review is supported by a variety of timesaving features. Prior studies can easily becompared with currentexaminations and the simultaneous display of CathLab, echo or nuclear medicine examinationsprovides additionalclinical information. | IMAGE-COM is a basic module for reviewing andmeasuring digital medical data. It supports routineworkflows for loading, analyzing and savingmedical studies, e.g. for the purpose of creatingreports. IMAGE-COM is where basicmeasurements can be performed and the entrypoint for advanced analysis modules. Study relatedroutine measurements can be imported, displayed,edited and exported to accompanying reportingsystems. | Revised for clarity. Considered equivalent toprimary predicate. No impact to the safety oreffectiveness of the device. |
| SW Version | 5.4 | 5.5 | Updated due to changes to SW code. |
| Measurements | ECHO | Added:Annulus dminAnnulus dmaxAnnulus dmeanAnnulus AreaAnnulus PerimeterAnnulus d(area)Ann-Ost left diamAnn-Ost right diamMV E ValsalvaMV A ValsalvaMV E/A Valsalva | Existing ECHO measurements have beenextended. No impact to the safety or effectivenessof the device. |
| Measurements(continued) | Vascular | Renal (AT & AI) | Existing Vascular measurements have beenextended. No impact to the safety or effectivenessof the device. |
| Exam Types | |||
| ECHO and Vascular | Added:PediatricCath | ECHO and Vascular were extended to Pediatric.Extension of existing measurement methods toCath. | |
| Deployment | Application based (FAT) | Browser support added | IMAGE-COM is available as a zero footprintsolution (TOMTEC ZERO). No change in intendeduse or use environment. No impact to the safety oreffectiveness of the device. |
| Auto LV | AutoLV enables IMAGE-COM to quantify leftventricular function based on 4-chamber and 2-chamber views of the left ventricle (biplaneSimpson) with a single mouse click per view | Unchanged | Identical to primary predicate. |
| Auto Strain | The AutoStrain application yields cardiac functionanalysis based on a workflow. After selecting viewsto analyze, and starting the application results areshown directly for user's review. | Unchanged | Identical to primary predicate. |
| AutoSTRAINMeasurements(continued) | As cleared | Added:LVLd (A4C)LVLs (A4C)LVLd (A2C)LVLs (A2C)AVC | Length measurements/values added because ofuser needs:User is able to double check if LV axis is acquiredwithout foreshortening. In this case both Diastolicand Systolic Major Axis should be similar. |
| AutoSTRAINEnhancements | Bullseye (16 segments) | Bullseye (18 segments) | Adapted Bullseye based on ASE2015 guideline. |
| Auto LA | AutoLA* is a fast and intuitive automation ofSimpson's biplane method.By selecting apical 4- and 2-chamber views,AutoLA finds end-systole and proposes tracings ofthe left atrial blood tissue interface | Unchanged | Identical to primary predicate. |
| Auto LAMeasurements | LA Vol (Simpson) | Extension of existing left atrium LA volume(Simpson) measurements with contour proposalstep | Improvement for user convenience. No impact tothe safety or effectiveness of the device. |
| Cath-QCA | Cath QCA is a calculation of stenosis diameter andarea, obstruction and reference diameters andobstruction length | Unchanged | Identical to primary predicate. |
| Cath-QVLAMeasurements | Cath-QVLA is a calculation of EDV and ESV, EF,SV, CO of the Left ventricle | Unchanged | Identical to primary predicate. |
| 4D CARDIO-VIEW | |||
| ApplicationDescription | 4D Cardio-View is a vendor independent offlinesolution to review and analyze 3D echo data. Itoffers an easy and fast navigation to get the perfect3D view with just two clicks by using the unique | 4D CARDIO-VIEW is an advanced analysis tool for3D/4D echocardiography data. Anatomicalstructure visualization, volume measurements (LVand/or generic), and specified or manual | Revised for clarity. Considered equivalent toprimary predicate. No impact to the safety oreffectiveness of the device. |
| D'Art tool. Features like the multi-slice D'Art(multiple 2D slices), basic measurements andworkflow based volume measurements make 4DCardio-View an all-purpose solution for any cardiacstructure. All measurements and views can bestored as bookmarks for easy retrieval at any time. | measurements are possible. Various tools areavailable for rendering that display 2- and 3-dimensional morphology and function for definedstructures. | ||
| SW Version | 3.0 | 3.1 | Updated due to changes to SW code. |
| Measurements | as cleared | Unchanged | Identical to primary predicate. |
| Export formats: | as cleared | Added:Beutel value export into .stl and .obj format | Identical to secondary predicate (see "4D RV-Function"). |
| 2D CARDIAC-PERFORMANCE ANALYSIS (Adult and Fetal) | |||
| Application | 2D Cardiac Performance Analysis is a vendorindependent offline solution for thequantification of left ventricular deformation.Detailed analysis of myocardial velocity,displacement, strain and strain rate isperformed based on 2D speckle tracking inlong or short axis views. Basic parameterassessment and comprehensive result exportoptions make 2D CPA suitable for researchand routine use. | 2D CARDIAC PERFORMANCE ANALYSIS(2D CPA) provides parameters for myocardialfunction and deformation analysis. Based ontwo dimensional echo B-Mode datasets aspeckle tracking algorithm supports thecalculation of 2D-contour models of theendocardial and epicardial border.Corresponding velocities, displacements,strains, strain rates and functional parameterscan be derived. The results are displayed asfigures, in charts or they are available asnumerical values.FETAL 2D CARDIAC PERFORMANCEANALYSIS (FETAL 2D CPA) is a vendorindependent, offline solution for thequantification of cardiac deformation of thefetal heart. Detailed analysis of myocardialvelocity, displacement, strain and strain rate isperformed based on 2D speckle tracking inthe long axis views of the left ventricle andright ventricle. Basic parameter assessmentas well as advanced quantifications, togetherwith comprehensive result export options,make FETAL 2D CPA suitable for researchand routine use. | Revised for clarity. Considered equivalent toprimary predicate. No impact to the safety oreffectiveness of the device.Analysis of the fetal heart can be performedbased on the cleared implementation ofspeckle tracking that is available in 2D CPA.Quantification of fetal structures is part of thecleared Indications for Use. Technologyalready available is applied within theIntended Use/Indications for Use of thedevice. Substantial evidence for thismodification is available.Optimized workflow (exclusively for 4CH clips)to analyze both ventricles in the same 4CHclip and within the same application session.Same algorithm for contour detection is used. |
| SW Version | 1.2 | 1.4 | Updated due to changes to SW code. |
| Measurements | Left ventricle strain calculation | Extended to right ventricle strain and atriumstrain (e.g. GLS and segmental strain/strainrate values).- MAPSE (lateral and septal)- Basal ventricle diameter at ES and ED of RVand LV- Ventricle length at ES and ED of RV and LV- Myocardial area at ED of LV and RV | Existing measurements were extended toright ventricle strain and atrium strain (similarto LA Option). |
| REPORTING | |||
| ApplicationDescription | Dedicated module for Ultrasound Reporting. | REPORTING provides various workspaces whichare dedicated to different clinical applications andsupports the workflow within clinical institutions.Measurements can be imported, modified andexported in order to support connected reportingsystems. | Revised for clarity. Considered equivalent toprimary predicate. No impact to the safety oreffectiveness of the device. |
| SW Version | 2.01 | 2.40 | SW version is identical and correspond to theTOMTEC-ARENA version, due to releasedependencies. |
| Workspaces /Areas | Echo | Added:VascularStress EchoPediatricFetalTEE Pre/Post OP | Based on existing and extended measurements,new workspaces were added in order to displayand structure those measurements in a dedicatedworkspace (view) for easy clinical reporting. Noimpact to the safety or effectiveness of the device. |
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7) NON-CLINICAL PERFORMANCE DATA
The proposed modifications were tested in accordance with TOMTEC's internal processes. Design Control activities to assure the safe and effective performance of the modified TOMTEC-ARENA include but are not limited to the following:
- I Product Specifications
- . Design Review
- . Risk Analysis
- Software Verification
TOMTEC-ARENA is considered a Moderate Level of Concern. Software verification was performed according to the standard IEC 62304 "Medical device software - Software lifecycle processes".
A Summative Usability Evaluation was performed considering FDA's Guidance for Industry and FDA Staff "Applying Human Factors and Usability Engineering to Medical Devices" and according to the standard IEC 62366-1 "Medical devices - Part 1: Application of usability engineering to medical devices". TOMTEC-ARENA has been found to be safe and effective for the intended users, uses, and use environments.
Completion of all verification activities demonstrated that the subject device meets all design and performance requirements. Verification activities performed that the differences in the design did not adversely affect the safety and effectiveness of the subject device.
8) SUMMARY OF CLINICAL TESTS:
No clinical testing conducted in support of substantial equivalence when compared to the predicate devices.
9) CONCLUSION
Verification and validation activities required to establish the performance, functionality, and reliability characteristics of the modified TOMTEC-ARENA software with respect to the predicate device(s) were performed successfully. Testing performed demonstrated that the proposed TOMTEC-ARENA (TTA2.40) meets defined requirements and performance claims.
Based on the conformance to standards, development under TOMTEC's Quality Management System, and the successful verification and validation testing, TOMTEC believes that the proposed TOMTEC-ARENA (TTA2.40) is substantially equivalent to the legally marketed predicate device(s).
§ 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).