Who is the manufacturer of ADAS 3D?

Galgo Medical S.L filed the 510(k) submission for ADAS 3D (K191125).

What is the FDA product code for ADAS 3D?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for ADAS 3D?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ADAS 3D?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ADAS 3D

K191125 · Galgo Medical S.L · LLZ · Jan 15, 2020 · Radiology

Device Facts

Record ID	K191125
Device Name	ADAS 3D
Applicant	Galgo Medical S.L
Product Code	LLZ · Radiology
Decision Date	Jan 15, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended 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.

Device Story

ADAS 3D is a software-based image processing tool for post-processing cardiovascular enhanced MRI and CTA images. It imports DICOM image databases to enable 3D cardiac visualization and quantification of enhancement levels. The device calculates and visualizes myocardial scar distribution, LV wall thickness, and 3D corridors of intermediate signal intensity enhancement. It is used in clinical settings by qualified medical professionals (cardiologists, electrophysiologists, radiologists, technicians) to support clinical decision-making. The software exports data in industry-standard formats for use in external systems, including EP navigation systems. It does not provide medical advice or irrefutable diagnostic results; it serves as a visualization and analysis aid. The device benefits patients by providing detailed anatomical and tissue characterization data to assist clinicians in evaluating cardiovascular disease.

Clinical Evidence

The submission states that clinical data was used to test and validate the software, alongside non-clinical testing with synthetic and phantom data. No specific clinical study metrics (e.g., sensitivity, specificity, AUC) are provided in the summary document.

Technological Characteristics

Standalone software application for Windows 10 (64-bit). Processes DICOM MR/CT images. Features include 3D multiplanar reconstruction, enhancement quantification, and 3D corridor detection. Developed per ISO 14971 (risk management) and ISO 62304 (software lifecycle). Connectivity via standard DICOM/DICOMDIR and export to industry-standard formats (VTK/DIF, MPEG, PNG).

Indications for Use

Indicated for patients with myocardial scar produced by ischemic heart disease. Used by qualified medical professionals (cardiologists, electrophysiologists, radiologists, or trained technicians) to support visualization and analysis of cardiac MR and CT images. Not intended to identify regions for catheter ablation or treatment of arrhythmias.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

MR-CT VVA (K140587)

Related Devices

K212421 — ADAS 3D · Adas3D Medical S.L. · Sep 3, 2021
K210850 — ADAS 3D · Adas3D Medical S.L. · Apr 5, 2021
K230803 — ADAS 3D · Adas3D Medical S.L. · May 23, 2023
K240791 — ADAS 3D · Adas3D Medical S.L. · Sep 9, 2024
K163076 — Segment CMR · Medviso AB · Apr 5, 2017

Submission Summary (Full Text)

{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 K191125 | 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: {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: - 1. It must pass through a BZ region - 2. It must connect two HT regions - 3. 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 - 4. 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 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. |…