(30 days)
Not Found
No
The document describes image processing and quantification but does not mention AI, ML, or related terms like deep learning or neural networks. The performance studies mentioned are based on synthetic phantoms, not clinical data typically used for training or testing AI/ML models.
No
The device is described as a software tool for visualization and analysis of medical images to aid in diagnostic decision-making, pre-planning, and during electrophysiology procedures. It explicitly states that the data produced "must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment," and that its clinical significance for treatment has "not been established." This indicates it's a diagnostic/planning tool, not a therapeutic one.
Yes
The device description states that "ADAS 3D software aids in the non-invasive calculation, quantification and visualization of cardiac imaging data to support a comprehensive diagnostic decisionmaking process for understanding cardiovascular disease." It is also indicated to "support qualified medical professionals for clinical decision making."
Yes
The device description explicitly states that ADAS 3D is a "stand-alone software tool" designed for post-processing medical images. There is no mention of accompanying hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: The core function of an IVD is to examine biological specimens (like blood, urine, tissue, etc.) to provide information about a patient's health.
- ADAS 3D analyzes medical images: ADAS 3D processes and analyzes MR and CT images, which are generated by medical imaging equipment, not directly from biological samples.
- The intended use is image analysis and visualization: The description clearly states that ADAS 3D is a software tool for post-processing and analyzing cardiovascular images to support clinical decision-making. It does not perform tests on biological materials.
Therefore, ADAS 3D falls under the category of medical image analysis software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease.
ADAS 3D is indicated for patients with myocardial scar produced by ischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D.
ADAS 3D is indicated to be used only by qualified medical professionals (cardiologists, radiologists, radiologists, or trained technicians) for the calculation quantification of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making.
The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arrhythmias (e.g., ventricular tachycardia) or risk stratification has not been established.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
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 decisionmaking 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.
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, CTA
Anatomical Site
Heart (Left Ventricle, Left Atrium)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified medical professionals (cardiologists, electrophysiologists, radiologists or trained technicians) in 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 two new features (Left Atrial wall thickness and Left Atrial distances measurements) were assessed using synthetic phantoms to validate that the software fully satisfies system requirements.
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).
0
Image /page/0/Picture/0 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 and 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.
Adas3D Medical S.L % Antonio Riu General Manager c/ Paris 179, 2°-2° Barcelona, Barcelona 08036 SPAIN
September 3, 2021
Re: K212421
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: July 30, 2021 Received: August 4, 2021
Dear Antonio Riu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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
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Indications for Use
510(k) Number (if known)
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, or trained technicians) for the calculation quantification of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making.
The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arrhythmias (e.g., ventricular tachycardia) or risk stratification has not been established.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K212421
510(K) SUMMARY
| DATE PREPARED: | July 30, 2021 |
|---|---|
| SUBMITTER NAME: | ADAS3D MEDICAL S.L |
| SUBMITTER ADDRESS: | C/ Paris 179, 2°-2° |
| 08036 Barcelona | |
| BARCELONA | |
| SPAIN | |
| CONTACT: | Antoni Riu |
| TELEPHONE: | +34 93 328 3964 |
| e-mail: | Antoni.riu@adas3d.com |
| DEVICE TRADE NAME: | ADAS 3D |
| COMMON NAME: | Radiological Image Processing System |
| CLASSIFICATION NAME: | Radiological Image Processing System (21 CFR 892.2050) |
| PRODUCT CODE: | LLZ |
| REGULATION DESCRIPTION: | Picture archiving and communications system |
Medical image management and processing system
PREDICATE DEVICE: ADAS 3D (K210850)
- DEVICE DESCRIPTION
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 decisionmaking 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.
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.
3. COMPARISON WITH PREDICATE DEVICE
The ADAS 3D device that is the subject of this Special 510(k) contains two new functional features compared to the previous version of the ADAS 3D cleared under K210850. The two
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new functional features are denoted in bold text in the right-hand column in the table below.
| Elements of
Comparison | Predicate Device
ADAS 3D
(ADAS3D MEDICAL S.L)
K210850 | Modified Device
ADAS 3D
(ADAS3D MEDICAL S.L) |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Data | | |
| Regulatory
Class | Class II | Class II |
| Classification
name | Radiological Image processing system | Radiological Image processing system |
| Regulation
Number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Product Code | LLZ | LLZ |
| 510(k)
Number | K210850 | To be assigned |
| 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
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 | No change |
| Elements of
Comparison | Predicate Device
ADAS 3D
(ADAS3D MEDICAL S.L)
K210850 | Modified Device
ADAS 3D
(ADAS3D MEDICAL S.L) |
| | 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 (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 | 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 (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 |
| Elements of
Comparison | Predicate Device | Modified Device |
| | ADAS 3D | ADAS 3D |
| | (ADAS3D MEDICAL S.L) | (ADAS3D MEDICAL S.L) |
| | K210850 | |
| | - 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. | - 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 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 | 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 |
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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 two new features (Left Atrial wall thickness and Left Atrial distances measurements) were assessed using synthetic phantoms to validate that the software fully satisfies system requirements.
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5. CONCLUSION
The implemented design control activities demonstrate the safety and effectiveness of the modified device. Therefore, Adas3D Medical believes the modified ADAS 3D software device should be found substantially equivalent to the predicate ADAS 3D device (K210850).