(14 days)
ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease.
ADAS 3D is indicated for patients with myocardial scar produced by ischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D.
ADAS 3D is indicated to be used only by qualified medical professionals ( cardiologists, radiologists, radiologists, radiologists, or trained technicians) for the calculation and visualization of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making.
The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arrhythmias ( e.g., ventricular tachycardia) or risk stratification has not been established.
ADAS 3D is a software-based image processing tool for post-processing cardiovascular enhanced Magnetic Resonance (MRI) images and Computed Tomography Angiography (CTA) images.
ADAS 3D is designed to process DICOM image databases to enable the calculation, quantification and visualization of 3D cardiac imaging data by displaying and quantifying the levels of enhancement. ADAS 3D also enables the visualization of the shape of the cardiac chamber and the adjacent anatomy. After data processing, the data and images can be exported utilizing industry standard for viewing on other systems, including Electrophysiology (EP) navigation systems.
The provided text describes a 510(k) submission for the ADAS 3D device, which is a software-based image processing tool for post-processing cardiovascular MRI and CTA images.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: The provided document is a 510(k) summary for a submission involving clarifications to Indications for Use and Precautions sections of a previously cleared device (ADAS 3D, K191125). It explicitly states: "The ADAS 3D device that is the subject of this Special 510(k) is identical to the ADAS 3D device cleared under (K191125). Only clarifications to the Indications for Use and Precautions sections have been made... These labelling changes do not impact the safety or effectiveness of the device."
This means the current document does not contain a new study demonstrating the device's performance against acceptance criteria. Instead, it relies on the substantial equivalence to the predicate device (K191125), implying that any performance studies were conducted and reviewed during the clearance of K191125.
Therefore, the following answers are based on what might be expected for a device like this, or what we can infer from the description of ADAS 3D's functionalities and the acceptance criteria mentioned for its 3D Corridors Module. The document does not explicitly detail a performance study for K210850 because it's a special 510(k) primarily for labeling changes.
1. Table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria for the overall device's performance in K210850, as this submission focuses on labeling changes.
However, for the "3D Corridors Module," the document defines the criteria for what the algorithm must identify as a 3D Corridor. If this were a performance study, these would be the ground truth definitions that the algorithm's output would be compared against. The document does not provide "reported device performance" against these criteria in a quantitative manner (e.g., sensitivity, specificity, accuracy).
| Acceptance Criteria (for 3D Corridors Module, implicitly defined) | Reported Device Performance (Not reported in K210850) |
|---|---|
| Must pass through a BZ region | Not reported |
| Must connect two HT regions | Not reported |
| Must be protected by the CS region (within its layer, on both sides and by minimum CS size, AND surrounding the layer) | Not reported |
| Must have a minimum length of 5 mm | Not reported |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document for K210850 does not describe a new performance study, thus no test set sample size or data provenance is provided. Any such information would have been part of the original K191125 submission.
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)
No new performance study in K210850, so this information is not provided. The definitions for the "3D Corridors Module" are given algorithmically, not as expert-established ground truth from a study within this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No new performance study in K210850, so this information is not provided.
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
The document does not describe an MRMC comparative effectiveness study for K210850. The device is a post-processing tool intended to "support the visualization and analysis" and "support qualified medical professionals for clinical decision making," implying assistance, but no comparative effectiveness study with human readers is detailed here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document does not describe a standalone performance study for K210850. The device itself is software-only (standalone software application), but performance evaluation of its outputs against a ground truth is not presented here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "3D Corridors Module," the ground truth definition is algorithmic based on specific criteria (BZ region, HT region, CS region, minimum length). If a performance study were done, the algorithm's output would be compared against these predefined algorithmic criteria or against expert delineations following these criteria. The document does not specify which type of ground truth was used in any prior studies, or if such studies specifically used expert consensus, pathology, or outcomes data to validate the clinical significance of these algorithmic definitions. Indeed, the Indications for Use state, "The clinical significance of using ADAS 3D to identify arrhythmia substrates... has not been established."
8. The sample size for the training set
No details on training set size are provided in K210850.
9. How the ground truth for the training set was established
No details on training set ground truth establishment are provided in K210850.
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April 5, 2021
Image /page/0/Picture/1 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Adas3D Medical S.L. % Antonio Riu General Manager Paris 179, 2-2 Barcelona, Barcelona 08036 SPAIN
Re: K210850
Trade/Device Name: ADAS 3D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 17, 2021 Received: March 22, 2021
Dear Antonio Riu:
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.
Michael D. O'Hara
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) K210850
Device Name ADAS 3D
Indications for Use (Describe)
ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease.
ADAS 3D is indicated for patients with myocardial scar produced by ischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D.
ADAS 3D is indicated to be used only by qualified medical professionals ( cardiologists, radiologists, radiologists, radiologists, or trained technicians) for the calculation and visualization of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making.
The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arrhythmias ( e.g., ventricular tachycardia) or risk stratification has not been established.
| 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) |
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510(K) SUMMARY
| SUBMITTER NAME: | ADAS3D MEDICAL S.L |
|---|---|
| SUBMITTER ADDRESS: | C/ Paris 179, 2°-2°08036 BarcelonaBARCELONASPAIN |
| CONTACT: | Antoni Riu |
| TELEPHONE: | +34 93 328 3964 |
| e-mail: | Antoni.riu@adas3d.com |
| DEVICE TRADE NAME: | ADAS 3D |
| COMMON NAME: | Radiological Image Processing System |
CLASSIFICATION NAME: Radiological Image Processing System (21 CFR 892.2050) PRODUCT CODE: LLZ REGULATION DESCRIPTION: Picture archiving and communications system
O
PREDICATE DEVICE(S): ADAS 3D (K191125)
1. DEVICE DESCRIPTION
ADAS 3D is a software-based image processing tool for post-processing cardiovascular enhanced Magnetic Resonance (MRI) images and Computed Tomography Angiography (CTA) images.
ADAS 3D is designed to process DICOM image databases to enable the calculation, quantification and visualization of 3D cardiac imaging data by displaying and quantifying the levels of enhancement. ADAS 3D also enables the visualization of the shape of the cardiac chamber and the adjacent anatomy. After data processing, the data and images can be exported utilizing industry standard for viewing on other systems, including Electrophysiology (EP) navigation systems.
The following table lists the principal characteristics and features of the software:
| Characteristics / Feature | ADAS 3D |
|---|---|
| General Features | |
| Operation System | Min. 64-bit Microsoft Windows 10Rec. 64-bit Microsoft® Windows® 10 |
| CPU Type | Min. Intel® Pentium® 4 or AMD Athlon™ 64, 3 GHz orfaster or Intel® or AMD dual core 2 GHz or fasterRec. Intel® Core i74790 K or equivalent |
| Memory | Min. 8 GB RAMRec. 16 GB RAM |
| Disk Space | Min. 100 GB free disk space for local study databaseRec. 250 GB free disk space or more for local study database |
| Graphics | Min. Microsoft® DirectX 10® capable graphics card or higherRec. Microsoft® DirectX 11® or capable graphics card orhigher (for example GeForce GT 730) |
| Other | 1,280 x 1,024 or higher screen resolution |
| Input file formats | DICOM/DICOMDIR |
| System Interface | -DICOM: Digital Imaging and Communications in Medicine(DICOM) is a standard for handling, storing, printing, andtransmitting information in medical imaging.-LIEBRE Study: A LIEBRE study is a set of files storing eachprocessed case.- Navigation System File Format: Format for Navigationsystem.Snapshots: Snapshots in PNG format.-Videos: Videos in MPEG format and MPEG-1 video codec. |
| User Interface | -Application workflow navigation tool.-Toolbar.- Working area.-Toolbox. |
| Functional Features | |
| Functions | -Importing Cardiac Imaging (MRI/CTA) in DICOM formatMRI Images support:• Visualization of the distribution of the enhancementin a three-dimensional (3D) chamber of the heart• Quantification of the total volume of the enhancementwithin the Left Ventricle (LV) and the visualization ofthe enhancement area in multiple layers through thecardiac structure• Calculation, quantification and visualization ofcorridors of intermediate signal intensityenhancement in the LV• Quantification and visualization of the total area anddistribution of the enhancement within the LeftAtrium (LA)CTA images support:• Quantification of LV wall thickness• Identification and Visualization of other 3Danatomical structures- The ADAS 3D exports data into industry standard fileformats supported by catheter navigation systems |
| Data Storage | All analysis results can be saved and reloaded again for reviewing and/or exporting. The analysis results include the input DICOM image, 3D models, numerical values, snapshots and videos. |
| Software Algorithms | -Left Ventricle Layer Computation-Left Atrium Layer Computation Algorithm-Enhancement Quantification Algorithm-3D Corridor Detection Algorithm-Heart Anatomy Extraction Algorithm-From Binary image to surface mesh Algorithm-Left Ventricle Wall Thickness Algorithm |
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2. 3D CORRIDORS MODULE
The 3D Corridors Module is an automatic detection feature designed to help identify and visualize 3D corridors of border zone (BZ) tissue within the LV. The 3D Corridors algorithm generates visual representations of the corridors that may travel through multiple layers of the LV.
A 3D Corridor is defined as a path of BZ tissue (or an area of intermediate intensity on the MRI) that starts and ends in healthy tissue (HT) and travels between areas of core scar (CS) tissue. A corridor is a three-dimensional path in the myocardium and has an associated volume. The ADAS 3D software distinguishes between protected and unprotected regions for a corridor.
- A protected region of BZ tissue is defined as the corridor that is embedded in an area . of CS.
- An unprotected region of BZ tissue is defined as BZ tissue that is not surrounded by . CS.
The ADAS 3D software only calculates 3D Corridors using the layers in between the endo and epicardium. The mitral value and the endo and epicardial surfaces define the boundaries for 3D Corridor detection, they are considered as CS tissue by the software.
To be automatically identified, by ADAS 3D, as a 3D Corridor, four criteria must be met in at least one layer:
-
- It must pass through a BZ region
-
- It must connect two HT regions
-
- It must be protected by the CS region both
- a. Within its layer, on both sides and by a minimum CS size
- b. AND surrounding the layer
-
- It must have a minimum length of 5 mm
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3. SUMMARY OF COMPARISON WITH PREDICATE DEVICE
The ADAS 3D device that is the subject of this Special 510(k) is identical to the ADAS 3D device cleared under (K191125). Only clarifications to the Indications for Use and Precautions sections have been made as noted with use of bold (added language) and strikethrough (deleted language) fonts in the following table. These labelling changes do not impact the safety or effectiveness of the device.
| Elements ofComparison | Predicate DeviceADAS 3D(ADAS3D MEDICAL S.L)K191125 | Modified DeviceADAS 3D(ADAS3D MEDICAL S.L) |
|---|---|---|
| Regulatory Data | ||
| RegulatoryClass | Class II | Class II |
| Classificationname | Radiological Image processing system | Radiological Image processing system |
| RegulationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Product Code | LLZ | LLZ |
| 510(k)Number | K191125 | To be assigned |
| Use | ||
| Indication forUse | ADAS 3D is indicated for use in clinicalsettings to support the visualization andanalysis of MR and CT images of the heartfor use on individual patients withcardiovascular disease.ADAS 3D is indicated for patients withmyocardial scar produced by ischemic ornon-ischemic heart disease. ADAS 3Dprocesses MR and CT images. The qualityand the resolution of the medical imagesdetermines the accuracy of the data producedby ADAS 3D.ADAS 3D is indicated to be used only byqualified medical professionals for thevisualization and analysis of cardiac images.The data produced by ADAS 3D must not beused as an irrefutable basis or a source ofmedical advice for clinical diagnosis orpatient treatment. The data produced byADAS 3D is intended to be used to supportqualified medical professionals for clinicaldecision making | ADAS 3D is indicated for use in clinicalsettings to support the visualization andanalysis of MR and CT images of the heartfor use on individual patients withcardiovascular disease.ADAS 3D is indicated for patients withmyocardial scar produced by ischemic ornon-ischemic heart disease. ADAS 3Dprocesses MR and CT images. The qualityand the resolution of the medical imagesdetermines the accuracy of the data producedby ADAS 3D.ADAS 3D is indicated to be used only byqualified medical professionals(cardiologists, electrophysiologists,radiologists or trained technicians) for thecalculation, quantification and visualizationof cardiac images and intended to be usedfor pre-planning and duringelectrophysiology procedures. The dataproduced by ADAS 3D must not be used asan irrefutable basis or a source of medical |
| Elements ofComparison | Predicate DeviceADAS 3D(ADAS3D MEDICAL S.L)K191125 | Modified DeviceADAS 3D(ADAS3D MEDICAL S.L) |
| ADAS 3D is not intended to identify regionsfor catheter ablation or treatment ofarrhythmias. | advice for clinical diagnosis or patienttreatment. The data produced by ADAS 3Dis intended to be used to support qualifiedmedical professionals for clinical decisionmaking.ADAS 3D is not intended to identify regionsfor catheter ablation or treatment ofarrhythmias.The clinical significance of using ADAS3D to identify arrhythmia substrates forthe treatment of cardiac arrhythmias (e.g.,ventricular tachycardia) or riskstratification has not been established. | |
| Precautions | The software is not intended to identifyregions for catheter ablation or treatmentof arrhythmias.This software is a tool to supportclinicians for better visualization ofcardiac images from MR and CTA. It isup to the clinicians to make their owninterpretations of the information that ispresented.The intermediate signal intensity “3DCorridor” detection tool is not intendedfor clinical patient management and itsuse has not been validated clinically.The results are explicitly not to beregarded as the sole, irrefutable basis forclinical diagnosis. | The software is not intended to identifyregions for catheter ablation or treatmentof arrhythmias.This software is a tool to supportclinicians for better visualization ofcardiac images from MR and CTA. It isup to the clinicians to make their owninterpretations of the information that ispresented.The intermediate signal intensity “3DCorridor” detection tool is not intendedfor clinical patient management and itsuse has not been validated clinically.The results are explicitly not to beregarded as the sole, irrefutable basis forclinical diagnosis.The software has not been validatedfor identifying arrhythmia substratesand should not be used as the solesource of information for treatmentplanning.The clinical significance of using the |
| Elements ofComparison | Predicate DeviceADAS 3D(ADAS3D MEDICAL S.L)K191125 | Modified DeviceADAS 3D(ADAS3D MEDICAL S.L) |
| Intended use | ADAS 3D is intended to be used for post-processing cardiovascular enhanced MagneticResonance (MR) images and ComputedTomography Angiography (CTA) images thatare formatted in Digital Imaging andCommunication in Medicine (DICOM)standard. ADAS 3D is intended for the non-invasive calculation, quantification andvisualization of cardiac imaging data tosupport a comprehensive diagnostic decision-making process for understandingcardiovascular disease.ADAS 3D analyzes the enhancement ofmyocardial fibrosis from DICOM MR imagesto support:• Visualization of the distribution of theenhancement in a three-dimensional (3D)chamber of the heart.• Quantification of the total volume of theenhancement within the left Ventricle(LV) and the visualization of theenhancement area in multiple layersthrough the cardiac structure.• Calculation, quantification andvisualization of corridors of intermediatesignal intensity enhancement in the LV.• Quantification and visualization of thetotal area and distribution of theenhancement within the Left Atrium(LA).Additionally, ADAS 3D imports DICOMCTA images to support:• Quantification of the wall thicknessof the LV.• Identification and visualization ofother 3D anatomical structures.ADAS-3D exports information to multipleindustry standard file formats suitable fordocumentation and information sharingpurposes. The 3D data is exported into | No change |
| tachycardia) or risk stratification hasnot been established. | ||
| Elements ofComparison | Predicate DeviceADAS 3D(ADAS3D MEDICAL S.L)K191125 | Modified DeviceADAS 3D(ADAS3D MEDICAL S.L) |
| industry standard file formats supported bycatheter navigation systems. It is intended tobe used by qualified medical professionals(cardiologists, electrophysiologists,radiologists or trained technicians) experienced in examining and evaluatingcardiovascular MR and CTA images as part ofthe comprehensive diagnostic decision-making process. ADAS-3D is a standalonesoftware application. The target population ofthe use of ADAS-3D is not restricted | ||
| Technical characteristics | ||
| Generaldescription | Is a software solution for the visualizationand analysis of cardiovascular MR and CTimages. | No change |
| Mode ofaction | Software Solution | No change |
| OperatingSystem | Windows | No change |
| Principles ofoperation | Analysis of MR and CT images | No change |
| User Interface | Mouse, Keyboard | No change |
| TargetPopulation | Patients with myocardial scar. | No change |
| Anatomicalsites | Left Ventricle and Left Atrium | No change |
| Conditions ofuse | It is intended to be used by qualified medicalprofessionals (cardiologists, radiologists ortrained technicians) experienced inexamining and evaluating cardiovascular MRand CTA images as part of thecomprehensive diagnostic decision-makingprocess. | No change |
| Imagessupported | Vendor independent DICOM MR/CT images(specific requirements depends on type ofanalysis, but imaging viewing is possible onall MR/CT images) | No change |
| Image Features | ||
| Imageassessment | By visualization and analysis of the images | No change |
| Elements ofComparison | Predicate DeviceADAS 3D(ADAS3D MEDICAL S.L)K191125 | Modified DeviceADAS 3D(ADAS3D MEDICAL S.L) |
| Image displayandmanipulation | - 2D slice review- 3D Multiplanar reconstruction- Pan/zoom; magnify; maximize andminimize; scroll through slice stack; adjustwindow level, contrast and brightness. | No change |
| Resultvisualization | - Numerical- Graph- 2D view- 3D view | No change |
| Exportcapabilities | - Snapshots as PNG- Videos as MPEG- Numerical data as TXT- Study data as an internal file format- 3D surface meshes as VTK/DIF | No change |
| Performing Function Analysis | - Quantification of LV wall thickness- Identification and Visualization of other 3Danatomical structures- Visualization of the distribution of theenhancement in a three-dimensional (3D)chamber of the heart.- Quantification of the total volume of theenhancement within the Left Ventricle(LV) and the visualization of theenhancement area in multiple layersthrough the cardiac structure.- Calculation, quantification andvisualization of corridors of intermediate,signal intensity enhancement in the LV. | No change |
| Performance function analysis of enhancement | Visualization of the enhancement in 2DVisualization of the distribution of theenhancement in a three-dimensional (3D)chamber of the heart.- Quantification of the total volume of theenhancement within the Left Ventricle(LV) and the visualization of theenhancement area in multiple layersthrough the cardiac structure.- Quantification and visualization of the totalarea and distribution of the enhancementwithin the left Atrium (LA) | No change |
| Measurements:- Total Volume (g), BZ (g) and Core (g) | ||
| Elements ofComparison | Predicate Device | Modified Device |
| ADAS 3D | ADAS 3D | |
| (ADAS3D MEDICAL S.L) | (ADAS3D MEDICAL S.L) | |
| K191125 | ||
| and Core (cm2) | ||
| - Calculation, quantification andvisualization of corridors of intermediate,signal intensity enhancement in the LV. | No change |
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4. INDICATIONS FOR USE
The revised Indications for Use are as follows:
ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease.
ADAS 3D is indicated for patients with myocardial scar produced by ischemic or nonischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D.
ADAS 3D is indicated to be used only by qualified medical professionals (cardiologists, electrophysiologists, radiologists or trained technicians) for the calculation, quantification and visualization of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making.
The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arrhythmias (e.g., ventricular tachycardia) or risk stratification has not been established.
5. CONCLUSIONS
The clarifications to the Indications for Use and Precautions sections of the labelling do not impact the safety or effectiveness of the device. Therefore, the subject ADAS 3D software device is substantially equivalent to the ADAS 3D device cleared in K191125.
§ 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).