(14 days)
Not Found
No
The summary describes image processing and visualization software but does not mention AI, ML, or related terms.
No
The device is a software-based image processing tool intended for visualization and analysis of medical images to support clinical decision-making, not to provide treatment or directly affect the patient's health outcomes. It explicitly states that "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."
Yes
The "Intended Use / Indications for Use" states that ADAS 3D is for "visualization and analysis of MR and CT images of the heart" for patients with cardiovascular disease, and that "The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making." This indicates its role in aiding diagnosis.
Yes
The device description explicitly states that ADAS 3D is a "software-based image processing tool." It processes existing medical images (MR and CT) and outputs data and images for visualization and export, without mentioning any accompanying hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). ADAS 3D processes images of the human body (MR and CT scans).
- IVDs provide information about a patient's health status based on the analysis of these samples. ADAS 3D provides tools for visualizing and analyzing existing medical images to support clinical decision-making, but it doesn't directly analyze biological samples.
- The intended use and device description clearly state that ADAS 3D processes MR and CT images. There is no mention of analyzing biological specimens.
Therefore, ADAS 3D falls under the category of medical image processing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
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 10 Rec. 64-bit Microsoft® Windows® 10 |
| CPU Type | Min. Intel® Pentium® 4 or AMD AthlonTM 64, 3 GHz or faster or Intel® or AMD dual core 2 GHz or faster Rec. Intel® Core i74790 K or equivalent |
| Memory | Min. 8 GB RAM Rec. 16 GB RAM |
| Disk Space | Min. 100 GB free disk space for local study database Rec. 250 GB free disk space or more for local study database |
| Graphics | Min. Microsoft® DirectX 10® capable graphics card or higher Rec. Microsoft® DirectX 11® or capable graphics card or higher (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, and transmitting information in medical imaging. -LIEBRE Study: A LIEBRE study is a set of files storing each processed case. - 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 format MRI 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 the Left Ventricle (LV) and the visualization of the enhancement area in multiple layers through the cardiac structure • Calculation, quantification and visualization of corridors of intermediate signal intensity enhancement in the LV • Quantification and visualization of the total area and distribution of the 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 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 |
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR and CT images
Anatomical Site
Heart, Left Ventricle, Left Atrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified medical professionals ( cardiologists, radiologists, radiologists, radiologists, or trained technicians) / Clinical settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The submission states "This is a Special 510(k) submission where the modifications are limited to changes to the Indications for Use (IFU) and Precautions. The device remains identical in design, materials, function, and intended use as the predicate device (K191125), to which substantial equivalence was established, and these changes do not affect, nor do they raise new questions of safety or effectiveness." Therefore, no performance studies were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
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
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.
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
2
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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3
510(K) SUMMARY
| SUBMITTER NAME: | ADAS3D MEDICAL S.L |
|---|---|
| SUBMITTER ADDRESS: | C/ Paris 179, 2°-2° |
| 08036 Barcelona | |
| BARCELONA | |
| SPAIN | |
| 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 10 |
| Rec. 64-bit Microsoft® Windows® 10 | |
| CPU Type | Min. Intel® Pentium® 4 or AMD Athlon™ 64, 3 GHz or |
| faster or Intel® or AMD dual core 2 GHz or faster | |
| Rec. Intel® Core i74790 K or equivalent | |
| Memory | Min. 8 GB RAM |
| Rec. 16 GB RAM | |
| Disk Space | Min. 100 GB free disk space for local study database |
| Rec. 250 GB free disk space or more for local study database | |
| Graphics | Min. Microsoft® DirectX 10® capable graphics card or higher |
| Rec. Microsoft® DirectX 11® or capable graphics card or | |
| higher (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, and | |
| transmitting information in medical imaging. | |
| -LIEBRE Study: A LIEBRE study is a set of files storing each | |
| processed case. |
- 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 format
MRI 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 the Left Ventricle (LV) and the visualization of
the enhancement area in multiple layers through the
cardiac structure
• Calculation, quantification and visualization of
corridors of intermediate signal intensity
enhancement in the LV
• Quantification and visualization of the total area and
distribution of the 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 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 of
Comparison | Predicate Device
ADAS 3D
(ADAS3D MEDICAL S.L)
K191125 | Modified Device
ADAS 3D
(ADAS3D MEDICAL S.L) |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Data | | |
| Regulatory
Class | Class II | Class II |
| Classification
name | Radiological Image processing system | Radiological Image processing system |
| Regulation
Number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Product Code | LLZ | LLZ |
| 510(k)
Number | K191125 | To be assigned |
| Use | | |
| Indication for
Use | 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
non-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 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
non-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, 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 |
| Elements of
Comparison | Predicate Device
ADAS 3D
(ADAS3D MEDICAL S.L)
K191125 | Modified Device
ADAS 3D
(ADAS3D MEDICAL S.L) |
| | ADAS 3D is not intended to identify regions
for catheter ablation or treatment of
arrhythmias. | 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.
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. |
| 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. | 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.
The software has not been validated
for identifying arrhythmia substrates
and should not be used as the sole
source of information for treatment
planning.
The clinical significance of using the |
| Elements of
Comparison | Predicate Device
ADAS 3D
(ADAS3D MEDICAL S.L)
K191125 | Modified Device
ADAS 3D
(ADAS3D MEDICAL S.L) |
| Intended use | ADAS 3D is intended to be used for post-
processing cardiovascular enhanced Magnetic
Resonance (MR) images and Computed
Tomography Angiography (CTA) images that
are formatted in Digital Imaging and
Communication in Medicine (DICOM)
standard. ADAS 3D is intended for the non-
invasive calculation, quantification and
visualization of cardiac imaging data to
support a comprehensive diagnostic decision-
making process for understanding
cardiovascular disease.
ADAS 3D analyzes the enhancement of
myocardial fibrosis from DICOM MR images
to 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 the left Ventricle
(LV) and the visualization of the
enhancement area in multiple layers
through the cardiac structure.
• Calculation, quantification and
visualization of corridors of intermediate
signal intensity enhancement in the LV.
• Quantification and visualization of the
total area and distribution of the
enhancement within the Left Atrium
(LA).
Additionally, ADAS 3D imports DICOM
CTA images to support:
• Quantification of the wall thickness
of the LV.
• Identification and visualization of
other 3D anatomical structures.
ADAS-3D exports information to multiple
industry standard file formats suitable for
documentation and information sharing
purposes. The 3D data is exported into | No change |
| | | tachycardia) or risk stratification has
not been established. |
| Elements of
Comparison | Predicate Device
ADAS 3D
(ADAS3D MEDICAL S.L)
K191125 | Modified Device
ADAS 3D
(ADAS3D MEDICAL S.L) |
| | industry standard file formats supported by
catheter navigation systems. It is intended to
be used by qualified medical professionals
(cardiologists, electrophysiologists,
radiologists or trained technicians) experienced in examining and evaluating
cardiovascular MR and CTA images as part of
the comprehensive diagnostic decision-
making process. ADAS-3D is a standalone
software application. The target population of
the use of ADAS-3D is not restricted | |
| Technical characteristics | | |
| General
description | Is a software solution for the visualization
and analysis of cardiovascular MR and CT
images. | No change |
| Mode of
action | Software Solution | No change |
| Operating
System | Windows | No change |
| Principles of
operation | Analysis of MR and CT images | No change |
| User Interface | Mouse, Keyboard | No change |
| Target
Population | Patients with myocardial scar. | No change |
| Anatomical
sites | Left Ventricle and Left Atrium | No change |
| Conditions of
use | It is intended to be used by qualified medical
professionals (cardiologists, radiologists or
trained technicians) experienced in
examining and evaluating cardiovascular MR
and CTA images as part of the
comprehensive diagnostic decision-making
process. | No change |
| Images
supported | Vendor independent DICOM MR/CT images
(specific requirements depends on type of
analysis, but imaging viewing is possible on
all MR/CT images) | No change |
| Image Features | | |
| Image
assessment | By visualization and analysis of the images | No change |
| Elements of
Comparison | Predicate Device
ADAS 3D
(ADAS3D MEDICAL S.L)
K191125 | Modified Device
ADAS 3D
(ADAS3D MEDICAL S.L) |
| Image display
and
manipulation | - 2D slice review
- 3D Multiplanar reconstruction
- Pan/zoom; magnify; maximize and
minimize; scroll through slice stack; adjust
window level, contrast and brightness. | No change |
| Result
visualization | - Numerical - Graph
- 2D view
- 3D view | No change |
| Export
capabilities | - 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 3D
anatomical structures - 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 the Left Ventricle
(LV) and the visualization of the
enhancement area in multiple layers
through the cardiac structure. - Calculation, quantification and
visualization of corridors of intermediate,
signal intensity enhancement in the LV. | No change |
| Performance function analysis of enhancement | Visualization of the enhancement in 2D
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 the Left Ventricle
(LV) and the visualization of the
enhancement area in multiple layers
through the cardiac structure. - Quantification and visualization of the total
area and distribution of the enhancement
within the left Atrium (LA) | No change |
| | Measurements: - Total Volume (g), BZ (g) and Core (g) | |
| Elements of
Comparison | Predicate Device | Modified Device |
| | ADAS 3D | ADAS 3D |
| | (ADAS3D MEDICAL S.L) | (ADAS3D MEDICAL S.L) |
| | K191125 | |
| | and Core (cm2) | |
| | - Calculation, quantification and
visualization 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.