(261 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 for the visualization and analysis of cardiac images. 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.
ADAS 3D is not intended to identify regions for catheter ablation or treatment of arrhythmias.
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 cardiac chamber and the adjacent anatomy. After data processing, the data and images can be exported utilizing industry standard formats for viewing on other system, including Electrophysiology (EP) navigation system.
The provided document is a 510(k) summary for the ADAS 3D device. It identifies a predicate device (MR-CT VVA, K140587) and discusses the substantial equivalence of ADAS 3D based on intended use, indications for use, and performance, including non-clinical and clinical data.
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a direct performance table for ADAS 3D against such criteria. Instead, it relies on comparison to a predicate device and states that "clinical data was used to test and validate this software as described in section 18 of this submission to support this premarket notification and to establish the decision concerning adequate safety and performance of the predicate device." It concludes that ADAS 3D is "substantially equivalent to the listed legally marketed predicate devices."
Therefore, the reported device performance is implicitly considered to be equivalent to the predicate device, MR-CT VVA (K140587), and to generally meet the safety and performance standards for a radiological image processing system.
2. Sample size used for the test set and the data provenance
The document states that "Clinical data was used to test and validate this software as described in section 18 of this submission." However, Section 18 is not included in the provided text, so the specific sample size for the test set and the data provenance (e.g., country of origin, retrospective or prospective) cannot be determined from the given information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is also not present in the provided text. The document mentions that the device is "intended to be used by qualified medical professionals (cardiologists, electrophysiologists, radiologists or trained technicians)," but it does not specify how many or with what qualifications experts were involved in establishing ground truth for the validation studies.
4. Adjudication method
The adjudication method for the test set is not mentioned in the provided document.
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 indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted to measure human reader improvement with or without AI assistance. The focus is on the software's ability to provide visualization and quantification to support clinical decision-making, rather than directly improving human reader performance metrics.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document describes ADAS 3D as a "software-based image processing tool" for "calculation, quantification and visualization of 3D cardiac imaging data." It identifies specific functions like "Left Ventricle Layer Computation," "Enhancement Quantification algorithm," and "3D Corridor Detection Algorithm." These descriptions strongly suggest that standalone algorithm performance was evaluated, as the software performs these calculations and visualizations independently. The output then "supports" qualified medical professionals, implying the algorithm runs without a "human-in-the-loop" for its primary processing functions.
7. The type of ground truth used
The specific type of ground truth used for its clinical validation is not explicitly stated in the provided text. The device processes MR and CT images and focuses on identifying and quantifying myocardial scar and 3D corridors of border zone tissue. Therefore, the ground truth would likely involve expert consensus interpretations of complex cardiac imaging, potentially correlated with other clinical data or pathology where available, but this is not confirmed in the document.
8. The sample size for the training set
The document does not provide any information regarding the sample size used for the training set for the ADAS 3D algorithms.
9. How the ground truth for the training set was established
The document does not provide any information regarding how the ground truth for the training set was established.
{0}------------------------------------------------
January 15, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Galgo Medical S.L % Antoni Riu General Manager C/Comte d'Urgell, 143, 4B Barcelona, Barcelona 08036 SPAIN
Re: K191125
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: December 1, 2019 Received: December 12, 2019
Dear Antoni 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
{1}------------------------------------------------
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K191125
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 for the visualization and analysis of cardiac images. 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.
ADAS 3D is not intended to identify regions for catheter ablation or treatment of arrhythmias.
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) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for GalgoMedical. The logo consists of a stylized silhouette of a dog's head facing left, followed by the text "GALGOMEDICAL" in a sans-serif font. The logo is simple and modern, with a focus on the company's name and a visual representation of a galgo, a type of Spanish greyhound.
Section 5 - 510(k) Summary
| SUBMITTER NAME: | GALGO MEDICAL S.L |
|---|---|
| SUBMITTER ADDRESS: | C/Comte d'Urgell 143, 4-B08036 BarcelonaBARCELONASPAIN |
| CONTACT: | Antoni Riu |
| TELEPHONE: | +34 93 328 3964 |
| e-mail: | Antoni.riu@galgomedical.com |
| DEVICE TRADE NAME: | ADAS 3D |
| COMMON NAME: | Radiological Image Processing System |
Radiological Image Processing System (21 CFR 892.2050) CLASSIFICATION NAME: PRODUCT CODE: LLZ REGULATION DESCRIPTION: Picture archiving and communications system
PREDICATE DEVICE(S): MR-CT VVA (K140587)
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 cardiac chamber and the adjacent anatomy. After data processing, the data and images can be exported utilizing industry standard formats for viewing on other system, including Electrophysiology (EP) navigation system.
| 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 or faster or Intel® orAMD 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 higher |
| Other | Rec. Microsoft® DirectX 11® or capable graphics card or higher (forexample GeForce GT 730)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 astandard for handling, storing, printing, and transmitting information inmedical imaging.-LIEBRE Study: A LIEBRE study is a set of files storing each processedcase.- Navigation System File Format: Format for Navigation system.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 enhancement in a three-dimensional (3D) chamber of the heart• Quantification of the total volume of the enhancement within theLeft Ventricle (LV) and the visualization of the enhancement areain multiple layers through the cardiac structure• Calculation, quantification and visualization of corridors ofintermediate signal intensity enhancement in the LV• Quantification and visualization of the total area and distribution ofthe enhancement within the Left Atrium (LA)CTA images support:• Quantification of LV wall thickness• Identification and Visualization of other 3D anatomical structures- The ADAS 3D exports data into industry standard file formats supportedby catheter navigation systems |
| Data Storage | All analysis results can be saved and reloaded again for reviewing and/orexporting. The analysis results include the input DICOM image, 3Dmodels, 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 |
The following table lists the principal characteristics and features of the software:
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for GalgoMedical. The logo consists of a stylized silhouette of a dog's head facing left, followed by the word "GALGOMEDICAL" in all capital letters. The font is sans-serif and the color is black against a white background.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for GalgoMedical. The logo consists of a stylized silhouette of a dog's head on the left, followed by the text "GALGOMEDICAL" in a sans-serif font. The dog's head is facing left and has pointed ears.
3D corridors module 1.1.
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
1.1.1. Precautions
- The software is not intended to identify regions for catheter ablation or treatment of . arrhythmias.
- . This software is a tool to support clinicians for better visualization of cardiac images from MR and CTA. It is up to the clinicians to make their own interpretations of the information that is presented.
- The intermediate signal intensity "3D Corridor" detection tool is not intended for clinical patient management and its use has not been validated clinically.
- . The results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis.
1.2. SUMMARY OF COMPARISON WITH PREDICATE DEVICE
In the establishment of substantial equivalence, the Software ADAS 3D is compared with the following previously cleared device:
- MR-CT VVA (K140587)
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for GalgoMedical. The logo consists of a stylized black silhouette of a dog's head facing left, followed by the word "GALGOMEDICAL" in a sans-serif font. The text is also in black, creating a clean and professional look.
Comparison of the proposed devices with the predicate device is summarized in the following table
| Elements ofComparison | Proposed DeviceADAS 3D(GALGO MEDICAL S.L) | Predicate DeviceMR-CT VVA(Medis Medical Imaging Systems, b.v.) | ||
|---|---|---|---|---|
| Regulatory Data | ||||
| RegulatoryClass | Class II | Class II | Identical | |
| Classification name | Radiological Image processing system | Radiological Image processing system | Identical | |
| RegulationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | Identical | |
| ProductCode | LLZ | LLZ | Identical | |
| FDAClearance | Pending | 510(k) cleared: K140587 | - | |
| Use | ||||
| Indicationfor Use | ADAS 3D is indicated for use in theclinical setting to support thevisualization and analysis of cardiacMR and CTA images for patients withcardiovascular disease.ADAS 3D is indicated for patients withmyocardial scar produced by ischemicor non-ischemic heart disease. ADAS3D processes MR and CTA images.The quality and the resolution of theoriginal images determines thequality and the accuracy of the dataproduced by ADAS 3D.ADAS 3D is indicated to be used byqualified medical professionals(cardiologists, electrophysiologists,radiologists or trained technicians)for the calculation, quantification andvisualization of cardiac images. Thedata produced by ADAS 3D isindicated to be used to supportclinical decision making and shouldnot be used on an irrefutable basis oras the sole source of information for | MR-CT VVA is indicated for use inclinical settings where morereproducible than manually derivedquantified results are needed tosupport the visualization andanalysis of MR and CT images of theheart and blood vessels for use onindividual patients withcardiovascular disease. Further, MR-CT VVA allows the quantification ofcerebral spinal fluid in MR velocity-encoded flow images.When the quantified resultsprovided by MR-CT VVA are used ina clinical setting on MR and CTimages of an individual patient, theycan be used to support the clinicaldecision making for the diagnosis ofthe patient. In this case, the resultsare explicitly not to be regarded asthe sole, irrefutable basis for clinicaldiagnosis, and they are onlyintended for use by the responsibleclinicians. | Similar topredicatedevice | |
| Elements ofComparison | Proposed DeviceADAS 3D(GALGO MEDICAL S.L) | Predicate DeviceMR-CT VVA(Medis Medical Imaging Systems,b.v.) | ||
| clinical diagnosis or patienttreatment.ADAS 3D is not intended to identifyregions for catheter ablation ortreatment of arrhythmias. | ||||
| Intendeduse | ADAS 3D is intended to be used forpost-processing cardiovascularenhanced Magnetic Resonance (MR)images and Computed TomographyAngiography (CTA) images that areformatted in Digital Imaging andCommunication in Medicine (DICOM)standard. ADAS 3D is intended for thenon-invasive calculation,quantification and visualization ofcardiac imaging data to support acomprehensive diagnostic decision-making process for understandingcardiovascular disease.ADAS 3D analyzes the enhancementof myocardial fibrosis from DICOMMR images to support:• Visualization of the distribution ofthe enhancement in a three-dimensional (3D) chamber of theheart.• Quantification of the totalvolume of the enhancementwithin the left Ventricle (LV) andthe visualization of theenhancement area in multiplelayers through the cardiacstructure.• Calculation, quantification andvisualization of corridors ofintermediate signal intensityenhancement in the LV.• Quantification and visualizationof the total area and distributionof the enhancement within theLeft Atrium (LA).Additionally, ADAS 3D importsDICOM CTA images to support:• Quantification of the wallthickness of the LV. | QMass® MR is software intended tobe used for the visualization andanalysis of MR and CT images of theheart and blood vessels.QMass® MR is intended to supportthe following visualizationfunctionalities:- cine loop and 2D review- performing caliper measurementsQMass® MR is also intended tosupport the following analyses:- cardiac function quantification- anatomy and tissue segmentation- signal intensity analysis for themyocardium and infarct sizing- MR parametric maps (such as T1,T2, T2* relaxation)QMass® MR is also intended to beused for:- quantification of T2* results in MRimages that can be used tocharacterize iron loading in theheart and the liverThese analyses are based oncontours that are either manuallydrawn by the clinician or trainedmedical technician who is operatingthe software, or automaticallydetected by the software andsubsequently presented for reviewand manual editing. The resultsobtained are displayed on top of theimages and provided in reports.The analysis results obtained withQMass® MR are intended for use bycardiologists and radiologists tosupport clinical decisions concerningthe heart and vessels. | Similar topredicatedevice | |
| Elements ofComparison | Proposed DeviceADAS 3D(GALGO MEDICAL S.L) | Predicate DeviceMR-CT VVA(Medis Medical Imaging Systems,b.v.) | ||
| Identification andvisualization of other 3Danatomical structures. ADAS-3D exports information tomultiple industry standard fileformats suitable for documentationand information sharing purposes.The 3D data is exported into industrystandard file formats supported bycatheter navigation systems. It isintended to be used by qualifiedmedical professionals (cardiologists,electrophysiologists, radiologists ortrained technicians) experienced inexamining and evaluatingcardiovascular MR and CTA images aspart of the comprehensive diagnosticdecision-making process. ADAS-3D isa standalone software application. | ||||
| Technical characteristics | ||||
| Generaldescription | Is a software solution for thevisualization and analysis ofcardiovascular MR and CT images. | Is software intended to be used forthe visualization and analysis of MRand CT images of the heart andblood vessels. | Identical topredicatedevice | |
| Mode ofaction | Software Solution | Software Solution | Identical topredicatedevice | |
| OperatingSystem | Windows | Windows | Identical topredicatedevice | |
| Principles ofoperation | Analysis of MR and CT images | Analysis of MR and CT images | Identical topredicatedevice | |
| UserInterface | Mouse, Keyboard | Mouse, Keyboard | Identical topredicatedevice | |
| TargetPopulation | Patients with myocardial scar. | Individual patients withcardiovascular disease. | Similar topredicatedevice | |
| Anatomical | Left Ventricle and Left Atrium | Left ventricle and Right Ventricle | Similar to | |
| Elements ofComparison | Proposed DeviceADAS 3D(GALGO MEDICAL S.L) | Predicate DeviceMR-CT VVA(Medis Medical Imaging Systems,b.v.) | predicatedevice | |
| sites | predicatedevice | |||
| Conditionsof use | It is intended to be used by qualifiedmedical professionals (cardiologists,radiologists or trained technicians)experienced in examining andevaluating cardiovascular MR andCTA images as part of thecomprehensive diagnostic decision-making process. | Must be used by Cardiologist,radiologist or trained technicianswho are qualified to perform cardiacanalysis. | Identical topredicatedevice | |
| Imagessupported | Vendor independent DICOM MR/CTimages (specific requirementsdepends on type of analysis, butimaging viewing is possible on allMR/CT images) | Vendor independent DICOM MR/CTimages (specific requirementsdepend on type of analysis, butimaging viewing is possible on allMR/CT images) | Identical topredicatedevice | |
| Image Features | ||||
| Imageassessment | By visualization and analysis of theimages | By visualization and analysis of theimages | Identical topredicatedevice | |
| Imagedisplay andmanipulation | - 2D slice review- 3D Multiplanar reconstruction- Pan/zoom; magnify; maximize andminimize; scroll through slice stack;adjust window level, contrast andbrightness. | - 2D slice review- 3D Multiplanar reconstruction- Pan/zoom; magnify; maximize andminimize; scroll through slice stack;adjust window level, contrast andbrightness.- Cine loop- Performing caliper measurements | Similar topredicatedevice | |
| Resultvisualization | - Numerical- Graph- 2D view- 3D view | - Numerical- Graph- Bulls Eye View- 2D view- 3D view | Similar topredicatedevice | |
| Exportcapabilities | - Snapshots as PNG- Videos as MPEG- Numerical data as TXT- Study data as an internal file format | - Images, movie frames, movies,graphs, snapshots and reports invarious file formats or as DICOMsecondary captures- Reports can be exported in TXT,PDF, HTML, XML and as DICOM SCdirectly to PACS | Similar topredicatedevice | |
| Elements ofComparison | Proposed DeviceADAS 3D(GALGO MEDICAL S.L) | Predicate DeviceMR-CT VVA(Medis Medical Imaging Systems,b.v.) | ||
| - 3D surface meshes as VTK/DIF | - All analysis results can be savedand reloaded again for reviewingand/or exporting | |||
| Performing Function Analysis | - Quantification of LV wall thickness | Cardiac Function Quantification:mass, wall motion, wall thicknessand wall thickening | Similar topredicatedevice | |
| - Identification and Visualization ofother 3D anatomical structures | Anatomy and tissue segmentation | Similar topredicatedevice | ||
| - Visualization of the distribution ofthe enhancement in a three-dimensional (3D) chamber of theheart.- Quantification of the total volumeof the enhancement within the LeftVentricle (LV) and the visualizationof the enhancement area inmultiple layers through the cardiacstructure.- Calculation, quantification andvisualization of corridors ofintermediate, signal intensityenhancement in the LV. | Signal intensity analysis for themyocardium and infarct sizing. Alsoreferred as DSI (Delayed SignalIntensity) | Similar topredicatedevice (seedetailedcomparisonin thesectionbelow) | ||
| None | MR parametric maps (such as T1,T2, T2* relaxation) | N/A(additionalspecifications for thepredicatedevice, notincluded ontheproposeddevice) | ||
| Elements ofComparison | Proposed DeviceADAS 3D(GALGO MEDICAL S.L) | Predicate DeviceMR-CT VVA(Medis Medical Imaging Systems,b.v.) | ||
| None | quantification of T2* results in MRimages that can be used tocharacterize iron loading in theheart and the liver | N/A(additionalspecifications for thepredicatedevice, notincluded on theproposeddevice) | ||
| Performance function analysis of enhancement | ||||
| Visualization of the enhancement in2D | Visualization of the DSI in 2D | Similar topredicatedevice | ||
| Visualization of the distribution of theenhancement in a three-dimensional(3D) chamber of the heart. | Visualization of the DSI in 3D | Similar topredicatedevice | ||
| - Quantification of the total volumeof the enhancement within the LeftVentricle (LV) and the visualizationof the enhancement area inmultiple layers through the cardiacstructure.- Quantification and visualization ofthe total area and distribution ofthe enhancement within the leftAtrium (LA)Measurements:- Total Volume (g), BZ (g) and Core(g)- For each layer: Total area (cm2), BZ(cm2) and Core (cm2)- Calculation, quantification andvisualization of corridors of | Quantification of DSIMeasurements:- Quantification of infarct size (%and mass), infarct transmurality | Similar topredicatedevice | ||
| Visualization of DSI | Similar topredicate |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for GalgoMedical. The logo consists of a stylized black silhouette of a dog's head facing left, with pointed ears and a sharp snout. To the right of the dog's head is the word "GALGOMEDICAL" in a bold, sans-serif font, with each letter clearly defined and spaced.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for GalgoMedical. The logo consists of a stylized silhouette of a dog's head facing left, followed by the text "GALGOMEDICAL" in a sans-serif font. The entire logo is in black and white.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for GalgoMedical. The logo consists of a stylized silhouette of a dog's head on the left, followed by the word "GALGOMEDICAL" in capital letters. The text is in a simple, sans-serif font and is aligned horizontally with the dog's head.
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for GalgoMedical. The logo consists of a stylized silhouette of a dog's head facing left, with pointed ears and a sharp snout. To the right of the dog's head is the text "GALGOMEDICAL" in a bold, sans-serif font. The logo is simple and modern, with a focus on the company's name and a memorable visual element.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for GalgoMedical. The logo consists of a stylized silhouette of a dog's head facing left, followed by the word "GALGOMEDICAL" in all capital letters. The font used for the text is sans-serif, and the overall design is clean and modern.
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for GalgoMedical. The logo consists of a stylized black silhouette of a dog's head facing left, with pointed ears and a sharp snout. To the right of the dog's head is the word "GALGOMEDICAL" in a bold, sans-serif font, with each letter clearly defined and spaced.
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for GalgoMedical. The logo consists of a stylized black silhouette of a dog's head with pointed ears, facing left. To the right of the dog's head is the company name, "GALGOMEDICAL," written in a bold, sans-serif font, with each letter clearly defined.
Section 5 – 510(k) Summary
| Elements ofComparison | Proposed DeviceADAS 3D(GALGO MEDICAL S.L) | Predicate DeviceMR-CT VVA(Medis Medical Imaging Systems,b.v.) |
|---|---|---|
| intermediate, signal intensityenhancement in the LV. | device |
Table 5.1 Summary comparison of characteristics and features – proposed and predicate devices.
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the logo for GalgoMedical. The logo consists of a stylized black silhouette of a dog's head facing left, followed by the text "GALGOMEDICAL" in a sans-serif font. The text is all in uppercase letters and is also black.
INTENDED USE 1.3.
As established in the Indications for Use Statement:
ADAS 3D is indicated for use in the clinical setting to support the visualization and analysis of cardiac MR and CTA images for patients with cardiovascular disease.
ADAS 3D is indicated for patients with myocardial scar produced by ischemic or non-ischemic heart disease.
ADAS 3D processes MR and CTA images. The quality and the resolution of the original images determines the quality and the accuracy of the data produced by ADAS 3D.
ADAS 3D is indicated to be used by qualified medical professionals (cardiologists, electrophysiologists, radiologists or technicians) for the calculation, quantification and visualization of cardiac images. The data produced by ADAS 3D is indicated to support clinical decision making and should not be used on an irrefutable basis or as the sole source of information 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.
ADAS 3D is not intended to identify regions for catheter ablation or treatment of arrhythmias.
ADAS 3D has similar intended uses as the predicate devices and has very similar technological characteristics. However, subject and predicate devices have some minor different technical characteristics as described in Section 12 of this submission.
1.4. SUMMARY DISCUSSION OF NON-CLINICAL DATA
The proposed device has been designed, developed, tested, verified and validated according to documented procedures and specific protocols in line with the FDA guidance documents.
Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the predicate device. It was tested and validated with synthetic and phantom data. The results of these non-clinical data testing and validation is included in this submission in section 18.
The FDA guidance documents used are the following:
- . Guidance for the Submission of Premarket Notifications for Medical Imaging Management Devices
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- Guidance for Off-The-Shelf Software Use in Medical Devices – September 9, 1999
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff – January
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the logo for GalgoMedical. The logo consists of a stylized silhouette of a greyhound's head facing left, followed by the word "GALGOMEDICAL" in all caps. The font is sans-serif and the color is black. The logo is simple and modern.
11, 2002.
- Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - September 6, 2017
- . Design and development included identification, evaluation and control of potential hazards as per standard ISO 14971. Integration, verification and validation testing have been successfully completed following standard ISO 62304.
SUMMARY DISCUSSION OF CLINICAL DATA 1.5.
Clinical data was used to test and validate this software as described in section 18 of this submission to support this premarket notification and to establish the decision concerning adequate safety and performance of the predicate device.
CONCLUSIONS 1.6.
We believe the intended use, the indications for use and performance of the ADAS 3D software is substantially equivalent to the intended use, indications for use and performance of the predicate device. We also believe that the ADAS 3D software does not pose any new or increased risk compared with the predicate device. Based on the information included in this submission, we conclude that ADAS 3D is substantially equivalent to the listed legally marketed 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).