(61 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. There is no information about training or test sets, which are typically associated with ML development.
No
The device is described as a software tool for visualization and analysis of medical images to support diagnostic decision-making, not for direct treatment or therapy.
Yes
The device aids in the visualization and analysis of medical images, provides calculations and quantifications of cardiac imaging data, and supports a comprehensive diagnostic decision-making process for understanding cardiovascular disease.
Yes
The device description explicitly states that ADAS 3D is a "software tool" and describes its function as post-processing and analyzing existing medical images (DICOM format). There is no mention of any accompanying hardware components or hardware-specific functions.
Based on the provided information, ADAS 3D is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- ADAS 3D Function: ADAS 3D is a software tool that processes and analyzes medical images (MR, CT, CTA, MRA) of the heart. It works with images acquired from the patient's body, not with biological specimens taken from the patient.
- Intended Use: The intended use clearly states it's for supporting the visualization and analysis of MR and CT images of the heart. It's used for image post-processing and analysis, not for testing biological samples.
Therefore, ADAS 3D falls under the category of medical imaging software or a medical image analysis device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease.
ADAS 3D is indicated for patients with myocardial scar produced by ischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D.
ADAS 3D is indicated to be used only by qualified medical professionals (cardiologists, radiologists, radiologists, radiologists or trained technicians) for the calculation and visualization of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making.
The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arthythmias (e.g., ventricular tachycardia) or risk stratification has not been established.
Product codes
LLZ
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.
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR, CT, MRA
Anatomical Site
Heart, cardiac structure, Left Ventricle (LV), Left Atrium (LA)
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)
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. The implemented design control activities demonstrate the safety and effectiveness of the modified device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
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 ) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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).