(261 days)
Not Found
No
The summary describes image processing and quantification but does not mention AI, ML, or related terms like deep learning or neural networks. The description of testing focuses on non-clinical and clinical data validation without mentioning training or test sets typical for ML model development.
No.
ADAS 3D is a software tool for visualization and analysis of medical images, supporting clinical decision-making, but it is explicitly stated that the data it produces "must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment," and it is "not intended to identify regions for catheter ablation or treatment of arrhythmias." This indicates it is a diagnostic or image processing tool, not a therapeutic one.
Yes
The device aids in the visualization and analysis of medical images to support clinical decision-making for patients with cardiovascular disease, which directly contributes to diagnosis. Although it states the data must not be an "irrefutable basis or a source of medical advice for clinical diagnosis," it is intended to "support qualified medical professionals for clinical decision making."
Yes
The device description explicitly states that ADAS 3D is a "software-based image processing tool" and focuses solely on the processing, calculation, quantification, and visualization of existing medical images (MR and CT). There is no mention of any accompanying hardware component that is part of the device itself.
Based on the provided information, ADAS 3D is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ADAS 3D's Function: ADAS 3D processes medical images (MR and CT) of the heart. It does not analyze biological specimens taken from the patient's body.
- Intended Use: The intended use clearly states it supports the visualization and analysis of MR and CT images. It is a post-processing tool for existing medical images.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR, CT
Anatomical Site
Left Ventricle and Left Atrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified medical professionals (cardiologists, electrophysiologists, 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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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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) | ☐ |
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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-B |
| 08036 Barcelona | |
| BARCELONA | |
| SPAIN | |
| 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 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 |
| Other | Rec. Microsoft® DirectX 11® or capable graphics card or higher (for |
| example 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 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 |
The following table lists the principal characteristics and features of the software:
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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)
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Comparison of the proposed devices with the predicate device is summarized in the following table
| Elements of
Comparison | Proposed Device
ADAS 3D
(GALGO MEDICAL S.L) | Predicate Device
MR-CT VVA
(Medis Medical Imaging Systems, b.v.) | | |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Regulatory Data | | | | |
| Regulatory
Class | Class II | Class II | Identical | |
| Classification name | Radiological Image processing system | Radiological Image processing system | Identical | |
| Regulation
Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Identical | |
| Product
Code | LLZ | LLZ | Identical | |
| FDA
Clearance | Pending | 510(k) cleared: K140587 | - | |
| Use | | | | |
| Indication
for Use | 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 trained technicians)
for the calculation, quantification and
visualization of cardiac images. The
data produced by ADAS 3D is
indicated to be used to support
clinical decision making and should
not be used on an irrefutable basis or
as the sole source of information for | MR-CT VVA is indicated for use in
clinical settings where more
reproducible than manually derived
quantified results are needed to
support the visualization and
analysis of MR and CT images of the
heart and blood vessels for use on
individual patients with
cardiovascular disease. Further, MR-
CT VVA allows the quantification of
cerebral spinal fluid in MR velocity-
encoded flow images.
When the quantified results
provided by MR-CT VVA are used in
a clinical setting on MR and CT
images of an individual patient, they
can be used to support the clinical
decision making for the diagnosis of
the patient. In this case, the results
are explicitly not to be regarded as
the sole, irrefutable basis for clinical
diagnosis, and they are only
intended for use by the responsible
clinicians. | Similar to
predicate
device | |
| Elements of
Comparison | Proposed Device
ADAS 3D
(GALGO MEDICAL S.L) | Predicate Device
MR-CT VVA
(Medis Medical Imaging Systems,
b.v.) | | |
| | clinical diagnosis or patient
treatment.
ADAS 3D is not intended to identify
regions for catheter ablation or
treatment of arrhythmias. | | | |
| 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. | QMass® MR is software intended to
be used for the visualization and
analysis of MR and CT images of the
heart and blood vessels.
QMass® MR is intended to support
the following visualization
functionalities:
- cine loop and 2D review
- performing caliper measurements
QMass® MR is also intended to
support the following analyses:
- cardiac function quantification
- anatomy and tissue segmentation
- signal intensity analysis for the
myocardium and infarct sizing - MR parametric maps (such as T1,
T2, T2* relaxation)
QMass® MR is also intended to be
used for:
- quantification of T2* results in MR
images that can be used to
characterize iron loading in the
heart and the liver
These analyses are based on
contours that are either manually
drawn by the clinician or trained
medical technician who is operating
the software, or automatically
detected by the software and
subsequently presented for review
and manual editing. The results
obtained are displayed on top of the
images and provided in reports.
The analysis results obtained with
QMass® MR are intended for use by
cardiologists and radiologists to
support clinical decisions concerning
the heart and vessels. | Similar to
predicate
device |
| Elements of
Comparison | Proposed Device
ADAS 3D
(GALGO MEDICAL S.L) | Predicate Device
MR-CT VVA
(Medis Medical Imaging Systems,
b.v.) | | |
| | 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 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. | | | |
| Technical characteristics | | | | |
| General
description | Is a software solution for the
visualization and analysis of
cardiovascular MR and CT images. | Is software intended to be used for
the visualization and analysis of MR
and CT images of the heart and
blood vessels. | Identical to
predicate
device | |
| Mode of
action | Software Solution | Software Solution | Identical to
predicate
device | |
| Operating
System | Windows | Windows | Identical to
predicate
device | |
| Principles of
operation | Analysis of MR and CT images | Analysis of MR and CT images | Identical to
predicate
device | |
| User
Interface | Mouse, Keyboard | Mouse, Keyboard | Identical to
predicate
device | |
| Target
Population | Patients with myocardial scar. | Individual patients with
cardiovascular disease. | Similar to
predicate
device | |
| Anatomical | Left Ventricle and Left Atrium | Left ventricle and Right Ventricle | Similar to | |
| Elements of
Comparison | Proposed Device
ADAS 3D
(GALGO MEDICAL S.L) | Predicate Device
MR-CT VVA
(Medis Medical Imaging Systems,
b.v.) | predicate
device | |
| sites | | | predicate
device | |
| 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. | Must be used by Cardiologist,
radiologist or trained technicians
who are qualified to perform cardiac
analysis. | Identical to
predicate
device | |
| 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) | Vendor independent DICOM MR/CT
images (specific requirements
depend on type of analysis, but
imaging viewing is possible on all
MR/CT images) | Identical to
predicate
device | |
| Image Features | | | | |
| Image
assessment | By visualization and analysis of the
images | By visualization and analysis of the
images | Identical to
predicate
device | |
| Image
display and
manipulatio
n | - 2D slice review
- 3D Multiplanar reconstruction
- Pan/zoom; magnify; maximize and
minimize; scroll through slice stack;
adjust window level, contrast and
brightness. | - 2D slice review - 3D Multiplanar reconstruction
- Pan/zoom; magnify; maximize and
minimize; scroll through slice stack;
adjust window level, contrast and
brightness. - Cine loop
- Performing caliper measurements | Similar to
predicate
device | |
| Result
visualization | - Numerical - Graph
- 2D view
- 3D view | - Numerical
- Graph
- Bulls Eye View
- 2D view
- 3D view | Similar to
predicate
device | |
| Export
capabilities | - 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 in
various file formats or as DICOM
secondary captures - Reports can be exported in TXT,
PDF, HTML, XML and as DICOM SC
directly to PACS | Similar to
predicate
device | |
| Elements of
Comparison | Proposed Device
ADAS 3D
(GALGO MEDICAL S.L) | Predicate Device
MR-CT VVA
(Medis Medical Imaging Systems,
b.v.) | | |
| | - 3D surface meshes as VTK/DIF | - All analysis results can be saved
and reloaded again for reviewing
and/or exporting | | |
| Performing Function Analysis | - Quantification of LV wall thickness | Cardiac Function Quantification:
mass, wall motion, wall thickness
and wall thickening | Similar to
predicate
device | |
| | - Identification and Visualization of
other 3D anatomical structures | Anatomy and tissue segmentation | Similar to
predicate
device | |
| | - 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. | Signal intensity analysis for the
myocardium and infarct sizing. Also
referred as DSI (Delayed Signal
Intensity) | Similar to
predicate
device (see
detailed
comparison
in the
section
below) | |
| | None | MR parametric maps (such as T1,
T2, T2* relaxation) | N/A
(additional
specificatio
ns for the
predicate
device, not
included on
the
proposed
device) | |
| Elements of
Comparison | Proposed Device
ADAS 3D
(GALGO MEDICAL S.L) | Predicate Device
MR-CT VVA
(Medis Medical Imaging Systems,
b.v.) | | |
| | None | quantification of T2* results in MR
images that can be used to
characterize iron loading in the
heart and the liver | N/A
(additional
specifications for the
predicate
device, not
included on the
proposed
device) | |
| Performance function analysis of enhancement | | | | |
| | Visualization of the enhancement in
2D | Visualization of the DSI in 2D | Similar to
predicate
device | |
| | Visualization of the distribution of the
enhancement in a three-dimensional
(3D) chamber of the heart. | Visualization of the DSI in 3D | Similar to
predicate
device | |
| | - 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)
Measurements:
- Total Volume (g), BZ (g) and Core
(g) - For each layer: Total area (cm2), BZ
(cm2) and Core (cm2) - Calculation, quantification and
visualization of corridors of | Quantification of DSI
Measurements:
- Quantification of infarct size (%
and mass), infarct transmurality | Similar to
predicate
device | |
| | | Visualization of DSI | Similar to
predicate | |
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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.
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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.
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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.
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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.
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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.
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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.
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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 of
Comparison | Proposed Device
ADAS 3D
(GALGO MEDICAL S.L) | Predicate Device
MR-CT VVA
(Medis Medical Imaging Systems,
b.v.) |
|---------------------------|----------------------------------------------------------|---------------------------------------------------------------------------|
| | intermediate, signal intensity
enhancement in the LV. | device |
Table 5.1 Summary comparison of characteristics and features – proposed and predicate devices.
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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
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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.