Who is the manufacturer of ADAS 3D?

Adas3D Medical S.L. filed the 510(k) submission for ADAS 3D (K230803).

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: Special).

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

K230803 · Adas3D Medical S.L. · LLZ · May 23, 2023 · Radiology

Device Facts

Record ID	K230803
Device Name	ADAS 3D
Applicant	Adas3D Medical S.L.
Product Code	LLZ · Radiology
Decision Date	May 23, 2023
Decision	SESE
Submission Type	Special
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 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 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.

Device Story

ADAS 3D is a software tool for post-processing cardiovascular MR, CTA, and MRA images in DICOM format. It performs non-invasive calculation, quantification, and 3D visualization of cardiac structures and myocardial fibrosis. Inputs include DICOM MR/CT/MRA images; outputs include 3D anatomical models and quantitative data exported to industry-standard formats compatible with catheter navigation systems (e.g., Stereotaxis Navigant, Boston Scientific Rhythmia HDx). Used in clinical settings by cardiologists, radiologists, or technicians to support diagnostic decision-making and pre-planning for electrophysiology procedures. The device provides automated identification of heart anatomy, coronaries, and left ventricle, and calculates wall thickness and fibrosis distribution. It does not provide medical advice; output supports clinical decision-making by qualified professionals.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by design controls, risk analysis, and software verification/validation testing.

Technological Characteristics

Software-based radiological image processing system. Operates on DICOM-compliant MR, CTA, and MRA images. Features include 3D segmentation, quantification of myocardial fibrosis, wall thickness measurement, and anatomical structure identification. Connectivity via DICOM import and export to standard file formats for catheter navigation systems. No hardware components; software-only device.

Indications for Use

Indicated for patients with myocardial scar from ischemic or non-ischemic heart disease. Used by cardiologists, electrophysiologists, radiologists, or trained technicians for cardiac image calculation, quantification, and visualization to support pre-planning and electrophysiology procedures.

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

ADAS 3D (K212421)

Related Devices

K212421 — ADAS 3D · Adas3D Medical S.L. · Sep 3, 2021
K210850 — ADAS 3D · Adas3D Medical S.L. · Apr 5, 2021
K191125 — ADAS 3D · Galgo Medical S.L · Jan 15, 2020
K240791 — ADAS 3D · Adas3D Medical S.L. · Sep 9, 2024
K220727 — inHEART MODELS · Inheart, Sas · May 10, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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. Adas3D Medical S.L Antoni Riu General Manager Rambla Catalunya 53, 4H Barcelona. Barcelona 08007 Spain May 23, 2023 Re: K230803 Trade/Device Name: Adas 3d Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: May 12, 2023 Received: May 12, 2023 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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, Jessica Lamb Jessica Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230803 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 arthythmias (e.g., ventricular tachycardia) or risk stratification has not been established. | Type of Use ( Select one or both, as applicable ) | |-------------------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | 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}------------------------------------------------ # 510(K) SUMMARY | SUBMITTER NAME: | ADAS3D MEDICAL S.L | |----------------------|-------------------------------------------------------------------| | SUBMITTER ADDRESS: | Rambla Catalunya 53, 4-H 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 89) | ર 892.2050) ological Image Processing System (21 CFF PRODUCT CODE: LLZ REGULATION DESCRIPTION: Picture archiving and communications system PREDICATE DEVICE: ADAS 3D (K212421) ## 1. DEVICE DESCRIPTION ADAS 3D is a software tool intended to be used for post-processing cardiovascular enhanced Magnetic Resonance (MR) images and Computed Tomography (CTA) images that are formatted in the Digital Imaging and Communication in Medicine (DICOM) standard. ADAS 3D is intended for the non-invasive calculation, quantification of cardiac imaging data to support a comprehensive diagnostic decision-making process for understanding cardiovascular disease. 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. ADAS 3D analyses 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. {4}------------------------------------------------ - 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 LV wall thickness. - - -Identification and Visualization of other 3D anatomical structures. - -Quantification and visualization of LA wall thickness. - Quantification and visualization of distances from the LA epicardium to other 3D anatomical structures. Additionally, ADAS 3D imports DICOM Magnetic Resonance Angiography (MRA) images to support: - Identification and Visualization of other 3D anatomical structures. - It is designed 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. ## 2. 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 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}------------------------------------------------ ## 3. COMPARISON WITH PREDICATE DEVICE The ADAS 3D device that is the subject of this Special 510(k) contains seven modifications compared to the previous version of the ADAS 3D cleared under K212421. Only one of the seven modifications impacts the existing device description denoted in bold text in the left column in the table below. | Elements of Comparison | Modified Device ADAS 3D (ADAS3D MEDICAL S.L) | Predicate Device ADAS 3D (ADAS3D MEDICAL S.L) K212421 | |------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 | To be assigned | K212421 | | 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 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 | No change | | Elements of Comparison | Modified Device ADAS 3D (ADAS3D MEDICAL S.L) | Predicate Device ADAS 3D (ADAS3D MEDICAL S.L) K212421 | | | 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. | | | Device Description Including Functional and Technological Characteristics | ADAS 3D is a software tool intended to be used for post-processing cardiovascular enhanced Magnetic Resonance (MR) images and Computed Tomography Angiography (CTA) images that are formatted in the 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 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. ADAS 3D analyses the enhancement of myocardial fibrosis from DICOM MR images to support: - Visualization of the distribution of the enhancement in a three-dimensional | ADAS 3D is a stand-alone software tool designed for post-processing cardiovascular enhanced Magnetic Resonance (MR) images and Computed Tomography Angiography (CTA) images that are formatted in the Digital Imaging and Communication in Medicine (DICOM) standard. ADAS 3D software aids in 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 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. ADAS 3D analyses the enhancement of myocardial fibrosis from DICOM MR images to support: - Visualization of the distribution of the enhancement in a three-dimensional | | Elements of Comparison | Modified Device ADAS 3D (ADAS3D MEDICAL S.L) | Predicate Device ADAS 3D (ADAS3D MEDICAL S.L) K212421 | | | (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 LV wall thickness. - Identification and Visualization of other 3D anatomical structures. - Quantification and visualization of LA wall thickness. - Quantification and visualization of distances from the LA epicardium to other 3D anatomical structures. Additionally, ADAS 3D imports DICOM Magnetic Resonance Angiography (MRA) images to support: - Identification and Visualization of 3D anatomical structures. | (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 LV wall thickness. - Identification and Visualization of other 3D anatomical structures. - Quantification and visualization of LA wall thickness. - Quantification and visualization of distances from the LA epicardium to other 3D anatomical structures. It is designed 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 | | | 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 | | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ | No. | Changes(s) | |-----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | Change-1: Initial identification of structures - The Heart Anatomy Extraction tool has been improved with an option to provide an initial identification of the coronaries. - The Left Ventricle Enhancement analysis has been improved with an option to provide an initial identification of the Left Ventricle. - The Heart Anatomy Extraction tool has been improved with an option to provide an initial identification of the left chambers and aorta. | | 2. | Change 2: Improved Export Formats - The export to the DIF-5.0 file format has been optimized to preserve the transition of the three tissue types for the exported layers. - The functionality to export to catheter navigation systems has been improved to add support to the Navigant navigation system from the manufacturer Stereotaxis Inc. (St Louis, MO, USA) and the Rhythmia HDx navigation system from the manufacturer Boston Scientific Corporation (Minneapolis, MN, USA). | | 3. | Change 3: Addition of measurements tools A generic Measurement Module has been added to allow computing distances between points. | | 4. | Change 4: Improved left ventricle Wall Thickness Workflow for CTA. The Left Ventricle Wall Thickness analysis has been improved to obtain a more detailed segmentation of the patient anatomy and a better visualization of the thickness for CTA images. | | 5. | Change 5: Improve in corridor detection The 3D Corridors detection module has been improved to handle special cases for the treatment of the Healthy Tissue (HT) region. | | 6. | Change 6: Import of MRA DICOM images The DICOM import tool has been improved to add support for the MRA image modality. | | 7. | Change 7: Exclude image region The calculation, quantification and visualization of cardiac imaging data has been improved by adding an Exclude Image Region Tool to allow excluding a region from analysis. | ## Changes from the last 510(k) clearance K212421: ## 4. SUMMARY OF NON-CLINICAL TESTING The modified ADAS 3D device has been subject to design controls including design review, risk analyses, design verification / validation testing in order to ensure its safety and effectiveness. The modifications were assessed using well-established methods to validate that the software fully satisfies system requirements. ## 5. CONCLUSION The implemented design control activities demonstrate the safety and effectiveness of the {9}------------------------------------------------ modified device. Therefore, Adas3D Medical believes the modified ADAS 3D software device should be found substantially equivalent to the predicate ADAS 3D device (K212421).