(61 days)
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.
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.
The provided text is a 510(k) summary for the ADAS 3D device. It outlines changes from a previous version (K212421) but does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, especially in the context of clinical performance or accuracy metrics of the AI algorithms. The summary focuses on comparing the modified device to its predicate and describing the changes.
Therefore, much of the requested information cannot be extracted from this document regarding a study proving the device meets acceptance criteria. However, I can provide what is mentioned about the modifications and the general statement about testing.
Here's an attempt to answer based on the limited information available in the provided text:
Acceptance Criteria and Study for ADAS 3D (K230803)
The provided 510(k) summary details modifications to an existing device (ADAS 3D, K212421) and states that "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."
However, this document does not provide a specific table of detailed acceptance criteria with numerical performance targets or the results of a specific study demonstrating that the device explicitly meets these criteria for its AI-powered functionalities beyond a general statement of design verification and validation.
Without a dedicated section detailing specific performance metrics and a corresponding study, the table below represents what can be inferred or is missing from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred/Missing from document) | Reported Device Performance (Inferred/Missing from document) |
|---|---|
| Accuracy of initial identification of coronaries (Change 1) | Not specified. Stated "improved with an option to provide an initial identification." |
| Accuracy of initial identification of Left Ventricle (Change 1) | Not specified. Stated "improved with an option to provide an initial identification." |
| Accuracy of initial identification of left chambers and aorta (Change 1) | Not specified. Stated "improved with an option to provide an initial identification." |
| Preservation of tissue type transition in DIF-5.0 export (Change 2) | Not specified. Stated "optimized to preserve the transition." |
| Compatibility/functionality with Navigant and Rhythmia HDx systems (Change 2) | Not specified beyond "improved to add support." |
| Accuracy of generic distance measurements (Change 3) | Not specified. Stated "A generic Measurement Module has been added to allow computing distances between points." |
| Accuracy/detail of LV wall thickness segmentation for CTA (Change 4) | Not specified. Stated "improved to obtain a more detailed segmentation... and a better visualization." |
| Robustness of 3D corridor detection for special cases (Change 5) | Not specified. Stated "improved to handle special cases." |
| Successful import of MRA DICOM images (Change 6) | Not specified. Stated "improved to add support for the MRA image modality." |
| Functionality of Exclude Image Region Tool (Change 7) | Not specified. Stated "improved by adding an Exclude Image Region Tool." |
| Overall safety and effectiveness of modified device | "The implemented design control activities demonstrate the safety and effectiveness of the modified device." (General statement, no specific metrics) |
2. Sample size used for the test set and the data provenance
The document states that the modifications were "assessed using well-established methods to validate that the software fully satisfies system requirements." However, it does not specify the sample size used for any test sets, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective) for any specific performance evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the 510(k) summary. The document mentions that the device is intended for use by "qualified medical professionals (cardiologists, electrophysiologists, radiologists or trained technicians)." However, it does not detail how ground truth was established for any specific test set related to the modifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size for human reader improvement with AI assistance. The Indications for Use explicitly state: "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." This indicates the device is for decision support rather than a standalone diagnostic tool, but no human-in-the-loop performance study is detailed here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
While the document implies some level of algorithm performance validation through "design verification / validation testing," it does not explicitly describe a standalone performance study with specific metrics for any of the modified functionalities (e.g., accuracy of coronary identification, LV segmentation, or corridor detection).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used for any validation testing of the modified functionalities.
8. The sample size for the training set
The document does not provide any information regarding the sample size used for training the algorithms, nor does it explicitly state that the modifications involved retraining existing AI models or developing new ones from scratch (though "improvements" to existing tools could imply model updates).
9. How the ground truth for the training set was established
As no training set information is provided, how its ground truth was established is also not mentioned in this document.
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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
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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
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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-H08036 BarcelonaBARCELONASPAIN |
| 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.
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- 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.
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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 ofComparison | Modified DeviceADAS 3D(ADAS3D MEDICAL S.L) | Predicate DeviceADAS 3D(ADAS3D MEDICAL S.L)K212421 |
|---|---|---|
| Regulatory Data | ||
| RegulatoryClass | Class II | Class II |
| Classificationname | Radiological Image processing system | Radiological Image processing system |
| RegulationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Product Code | LLZ | LLZ |
| 510(k)Number | To be assigned | K212421 |
| Use | ||
| Indicationsfor Use | ADAS 3D is indicated for use in clinicalsettings to support the visualization andanalysis of MR and CT images of the heartfor use on individual patients withcardiovascular disease.ADAS 3D is indicated for patients withmyocardial scar produced by ischemic ornon-ischemic heart disease. ADAS 3Dprocesses MR and CT images. The qualityand the resolution of the medical imagesdetermines the accuracy of the data producedby ADAS 3D.ADAS 3D is indicated to be used only byqualified medical professionals(cardiologists, electrophysiologists,radiologists or trained technicians) for thecalculation, quantification and visualizationof cardiac images and intended to be used forpre-planning and during electrophysiology | No change |
| Elements ofComparison | Modified DeviceADAS 3D(ADAS3D MEDICAL S.L) | Predicate DeviceADAS 3D(ADAS3D MEDICAL S.L)K212421 |
| procedures. The data produced by ADAS 3Dmust not be used as an irrefutable basis or asource of medical advice for clinicaldiagnosis or patient treatment. The dataproduced by ADAS 3D is intended to be usedto support qualified medical professionals forclinical decision making.The clinical significance of using ADAS 3Dto identify arrhythmia substrates for thetreatment of cardiac arrhythmias (e.g.,ventricular tachycardia) or risk stratificationhas not been established. | ||
| DeviceDescriptionIncludingFunctional andTechnologicalCharacteristics | ADAS 3D is a software tool intended to beused for post-processing cardiovascularenhanced Magnetic Resonance (MR) imagesand Computed Tomography Angiography(CTA) images that are formatted in theDigital Imaging and Communication inMedicine (DICOM) standard. ADAS 3D isintended for the non-invasive calculation,quantification and visualization of cardiacimaging data to support a comprehensivediagnostic decision-making process forunderstanding cardiovascular disease.ADAS 3D exports information to multipleindustry standard file formats suitable fordocumentation and information sharingpurposes. The 3D data is exported intoindustry standard file formats supported bycatheter navigation systems.ADAS 3D analyses the enhancement ofmyocardial fibrosis from DICOM MRimages to support:- Visualization of the distribution of theenhancement in a three-dimensional | ADAS 3D is a stand-alone software tooldesigned for post-processing cardiovascularenhanced Magnetic Resonance (MR) imagesand Computed Tomography Angiography(CTA) images that are formatted in the DigitalImaging and Communication in Medicine(DICOM) standard. ADAS 3D software aidsin the non-invasive calculation, quantificationand visualization of cardiac imaging data tosupport a comprehensive diagnostic decision-making process for understandingcardiovascular disease.ADAS 3D exports information to multipleindustry standard file formats suitable fordocumentation and information sharingpurposes. The 3D data is exported intoindustry standard file formats supported bycatheter navigation systems.ADAS 3D analyses the enhancement ofmyocardial fibrosis from DICOM MR imagesto support:- Visualization of the distribution of theenhancement in a three-dimensional |
| Elements ofComparison | Modified DeviceADAS 3D(ADAS3D MEDICAL S.L) | Predicate DeviceADAS 3D(ADAS3D MEDICAL S.L)K212421 |
| (3D) chamber of the heart.- Quantification of the total volume ofthe enhancement within the LeftVentricle (LV) and the visualizationof the enhancement area in multiplelayers through the cardiac structure.- Calculation, quantification andvisualization of corridors ofintermediate, signal intensityenhancement in the LV.- Quantification and visualization ofthe total area and distribution of theenhancement within the left Atrium(LA).Additionally, ADAS 3D imports DICOMCTA images to support:- Quantification of LV wall thickness.- Identification and Visualization ofother 3D anatomical structures.- Quantification and visualization ofLA wall thickness.- Quantification and visualization ofdistances from the LA epicardium toother 3D anatomical structures.Additionally, ADAS 3D imports DICOMMagnetic Resonance Angiography (MRA)images to support:- Identification and Visualization of3D anatomical structures. | (3D) chamber of the heart.- Quantification of the total volume ofthe enhancement within the LeftVentricle (LV) and the visualizationof the enhancement area in multiplelayers through the cardiac structure.- Calculation, quantification andvisualization of corridors ofintermediate, signal intensityenhancement in the LV.- Quantification and visualization ofthe total area and distribution of theenhancement within the left Atrium(LA).Additionally, ADAS 3D imports DICOMCTA images to support:- Quantification of LV wall thickness.- Identification and Visualization ofother 3D anatomical structures.- Quantification and visualization ofLA wall thickness.- Quantification and visualization ofdistances from the LA epicardium toother 3D anatomical structures.It is designed to be used by qualified medicalprofessionals (cardiologists, radiologists ortrained technicians) experienced in examiningand evaluating cardiovascular MR and CTAimages as part of the comprehensivediagnostic decision-making process | |
| It is intended to be used by qualified medicalprofessionals (cardiologists, radiologists ortrained technicians) experienced inexamining and evaluating cardiovascular MRand CTA images as part of thecomprehensive diagnostic decision-makingprocess |
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| 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 toolsA 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 detectionThe 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 imagesThe DICOM import tool has been improved to add support for the MRA image modality. |
| 7. | Change 7: Exclude image regionThe 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
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modified device. Therefore, Adas3D Medical believes the modified ADAS 3D software device should be found substantially equivalent to the predicate ADAS 3D device (K212421).
§ 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).