4DM

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 10, 2026 INVIA, LLC % Harrison Emery Consultant Emergo by UL 2500 Bee Caves Rd. Bldg. 1, Suite 300 Austin, Texas 78746 Re: K260879 Trade/Device Name: 4DM Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: May 11, 2026 Received: May 11, 2026 Dear Harrison Emery: 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 (the 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 available 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 U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260879 - Harrison Emery Page 2 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn {2} K260879 - Harrison Emery Page 3 (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-devices/device-advice-comprehensive-regulatory-assistance/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, Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260879 | ? | | Please provide the device trade name(s). | | ? | | 4DM | | | | Please provide your Indications for Use below. | | ? | | 4DM is a software application used by medical professionals to analyze and report nuclear medicine, PET, CT, MR and hybrid patient studies to support their assessment of a patient's cardiac health. | | | | 4DM provides tools to process, review, quantify, and display static, whole body, dynamic, gated planar, standard ungated ECT images, ECG gated ECT images, and dynamic ECT images. | | | | 4DM software performs quantification and enables:Assessment of Cardiac Function with Nuclear Myocardial Perfusion ImagingQuantify ventricular function (e.g. volumes, ejection fraction, diastolic) from radiotracer appropriate (e.g. perfusion, metabolism) gated ECT volumetric images.Quantify regional ventricular function (e.g. wall motion, thickening, contractility) from radiotracer appropriate (e.g. perfusion, metabolism) gated ECT volumetric images.Assessment of Cardiac Function with Nuclear Gated Blood Pool ImagingQuantify ventricular volumes and the ejection fraction (EF) from gated ECT blood pool images.Quantify ejection fraction (EF) from planar gated blood pool images.Assessment of Myocardial Perfusion with Nuclear Myocardial Perfusion ImagingQuantify regional relative myocardial perfusion with comparison to normal limits for interpretation of perfusion abnormalities by the Clinician.Provide semi-quantitative segmental myocardial perfusion scoring using standard segmental overlay(s).Quantify transient ischemic dilation from stress-rest myocardial perfusion images.Assessment of Myocardial Blood Flow with Nuclear Cardiology ImagingQuantify and display myocardial blood flow and flow reserve from SPECT or PET dynamic sequences.Assessment of Myocardial Viability with Nuclear Cardiology ImagingQuantify regional perfusion and metabolic radiotracer uptake for the interpretation of viable myocardium by the Clinician.Assessment of Inflammation and Infection with Nuclear Cardiology ImagingQuantify regional radiotracer uptake for the review and interpretation of the presence of inflammation and infection in the heart and body by the Clinician.Assessment of Cardiac Coronary Calcium with CT ImagingQuantify the presence of calcium in the coronary vessels for review and interpretation by the Clinician.SPECT Image ReconstructionMotion correction of SPECT tomographic projection images for patient or organ motion.Image reconstruction of SPECT tomographic projection images with post reconstruction filtering and | | | {4} reorientation. 4DM shall be used by qualified medical professionals. It does not provide diagnoses or therapeutic recommendations but is instead a visual and quantitative aid. | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | --- | --- | --- | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {5} Page 1 of 13 # 510(k) Summary ## 4DM K260879 1. Submission Sponsor INVIA, LLC 8192 Jackson Road Ann Arbor, MI 48103 United States Contact: Edward Ficaro Email: edificaro@inviasolutions.com 2. Submission Correspondent Emergo by UL 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Contact: Harrison Emery Office Phone: (512) 327-9997 Email: LST.US.EmergoFDASubmissions@ul.com 3. Date Prepared September 9, 2026 4. Device Identification Trade/Proprietary Name: 4DM Common/Usual Name: Medical image management and processing system Regulation Number(s): 892.2050 Product Code(s): QIH, LLZ Class: Class 2 Classification Panel: Radiology 5. Legally Marketed Predicate and Reference Devices The predicate device is Corridor4DM, and the subject device is an updated version of the predicate. Additionally, a reference device was utilized. These devices are summarized in the following table. Page 1 of 13 {6} Page 2 of 13 | Device | Type | 510(k) | Manufacturer | Product Code(s) | | --- | --- | --- | --- | --- | | Corridor4DM | Predicate | K101279 | INVIA, LLC | KPS, JAK, LLZ | | Cvi42 | Reference | K242781 | Circle Cardiovascular Imaging, Inc | QIH, LLZ | ## 6. Device Description 4DM is a software application (software as a medical device) that provides image review and clinical reporting of radiographic imaging data. It is used by trained medical professionals to support their assessment of cardiac health. The software does not provide any diagnoses or therapeutic recommendations. Rather, it serves only as a visual and quantitative aid to assist medical professionals in their diagnoses. 4DM is a comprehensive application designed to process, review, and quantitatively analyze nuclear medicine, PET, CT and MR patient studies. The application provides tools to process, quantify, and display static, whole body, dynamic, gated planar, standard ungated ECT images, ECG gated ECT images, and dynamic ECT images. It is used to allow a physician to assess cardiac health in patients. It does not provide any diagnoses or therapeutic recommendations but is instead a visual and quantitative aid. 4DM allows users to save and export findings in a variety of formats. The application generates DICOM multi-frame (MFSC) and secondary screen captures (SSC), in addition to producing static (JPEG, TIFF) and dynamic (WMV) image files. The user can export results to a relational database, XML, and text-formatted reports for data analysis. 4DM is not intended to provide diagnoses or therapeutic recommendations but is intended to be a visual and quantitative aid for use by trained medical professionals. The Clinician should never rely solely on the software in making diagnostic or therapeutic decisions, nor should the Clinician rely on the software to determine the presence or absence of a condition. Rather, the Clinician should interpret the entirety of the patient's clinical and diagnostic information before making a final diagnosis. The Clinician retains the ultimate responsibility for making a diagnosis. The 4DM application can be used to do the following: • Radiographic Image Review ○ Standard Nuclear Cardiology Image review for ■ Static, gated, and dynamic ECT (SPECT and PET) radiotracer (perfusion, metabolism, inflammation) studies of all types. ■ Quality control review of SPECT projection data (e.g. patient motion, ECG gating errors). ■ Gated blood pool SPECT studies. ■ Gated blood pool planar studies (MUGA). ○ Provide Standard Nuclear Medicine Image review for ■ Static, gated, and dynamic nuclear medicine ECT (SPECT and PET) images ■ Static, gated, and dynamic nuclear medicine planar images Page 2 of 13 {7} Page 3 of 13 - ○ Radiographic Review of CT Images - ○ Hybrid Image Review Screens • Fusion of volumetric radiographic images (NM, PET, CT, MR) - ○ Fusion of calcium and/or coronary vessels to volumetric rendered images. - ○ Review single and multi-frame DICOM screen capture files. - ○ Review of DICOM encapsulated PDF reports - ● Radiographic Image Quantification - ○ Assessment of Cardiac Function with Nuclear Myocardial Perfusion Imaging - ▪ Quantify ventricular function (e.g. volumes, ejection fraction, diastolic) from radiotracer appropriate (e.g. perfusion, metabolism) gated ECT volumetric images. - ▪ Quantify regional ventricular function (e.g. wall motion, thickening, contractility) from radiotracer appropriate (e.g. perfusion, metabolism) gated ECT volumetric images. - ○ Assessment of Cardiac Function with Nuclear Gated Blood Pool Imaging - ▪ Quantify ventricular volumes and the ejection fraction (EF) from gated ECT blood pool images. - ▪ Quantify ejection fraction (EF) from planar gated blood pool images. - ○ Assessment of Myocardial Perfusion with Nuclear Myocardial Perfusion Imaging - ▪ Quantify regional relative myocardial perfusion with comparison to normal limits for interpretation of perfusion abnormalities by the Clinician. - ▪ Provide semi-quantitative segmental myocardial perfusion scoring using standard segmental overlay(s). - ▪ Quantify transient ischemic dilation from stress-rest myocardial perfusion images. - ○ Assessment of Myocardial Blood Flow with Nuclear Cardiology Imaging - ▪ Quantify and display myocardial blood flow and flow reserve from SPECT or PET dynamic sequences. - ○ Assessment of Myocardial Viability with Nuclear Cardiology Imaging - ▪ Quantify regional perfusion and metabolic radiotracer uptake for the interpretation of viable myocardium by the Clinician. - ○ Assessment of Inflammation and Infection with Nuclear Cardiology Imaging - ▪ Quantify regional radiotracer uptake for the review and interpretation of the presence of inflammation and infection in the heart and body by the Clinician. - ○ Assessment of Cardiac Coronary Calcium with CT Imaging - ▪ Quantify the presence of calcium in the coronary vessels for review and interpretation by the Clinician. - ○ SPECT Image Reconstruction Page 3 of 13 {8} Page 4 of 13 - Motion correction of SPECT tomographic projection images for patient or organ motion. - Image reconstruction of SPECT tomographic projection images with post reconstruction filtering and reorientation. - Clinical Reporting - Provide a reporting interface to enter clinical information specific to the patient's exam. - Provide the ability to create custom formatted reports based on clinical information and imaging findings. - Export imaging results and/or patient information in various formats (e.g. screen capture, saved result files, HL7 elements) for archive or use by other 3rd party applications (e.g. EMR, PACS). 4DM introduces optional deep learning functionalities, specifically: - Deep learning (DL) attenuation correction algorithm for SPECT myocardial perfusion imaging (DLAC) - DL estimation of attenuation corrected SPECT perfusion polar maps from uncorrected (no attenuation correction) relative perfusion polar maps. - DL left ventricular segmentation algorithm for cardiac PET metabolic imaging (Sarcoid-DL) - DL estimation of LV surfaces from metabolic images, e.g. sarcoidosis, for the co-registration of perfusion and metabolic images, the automated transfer of LV surfaces from perfusion to metabolic images, and the estimation of SUV based on DL-LV surfaces. - DL algorithm for isolation of the heart from CT images (CT-DL) - DL algorithm to isolate the heart from non-cardiac anatomical structures in a CT exam of the chest. - DL Volumetric Blood Flow Images (MBF-DL) - DL kinetic modeling using PET dynamic sequences to estimate blood flow at the pixel level to provide volumetric blood flow images of the heart. - Construction of regional blood flow in 4DM's established polar map format for quantitative analysis and review. # 7. Indication for Use Statement 4DM is a software application used by medical professionals to analyze and report nuclear medicine, PET, CT, MR and hybrid patient studies to support their assessment of a patient's cardiac health. 4DM provides tools to process, review, quantify, and display static, whole body, dynamic, gated planar, standard ungated ECT images, ECG gated ECT images, and dynamic ECT images. 4DM software performs quantification and enables: - Assessment of Cardiac Function with Nuclear Myocardial Perfusion Imaging Page 4 of 13 {9} Page 5 of 13 - ○ Quantify ventricular function (e.g. volumes, ejection fraction, diastolic) from radiotracer appropriate (e.g. perfusion, metabolism) gated ECT volumetric images. - ○ Quantify regional ventricular function (e.g. wall motion, thickening, contractility) from radiotracer appropriate (e.g. perfusion, metabolism) gated ECT volumetric images. - • Assessment of Cardiac Function with Nuclear Gated Blood Pool Imaging - ○ Quantify ventricular volumes and the ejection fraction (EF) from gated ECT blood pool images. - ○ Quantify ejection fraction (EF) from planar gated blood pool images. - • Assessment of Myocardial Perfusion with Nuclear Myocardial Perfusion Imaging - ○ Quantify regional relative myocardial perfusion with comparison to normal limits for interpretation of perfusion abnormalities by the Clinician. - ○ Provide semi-quantitative segmental myocardial perfusion scoring using standard segmental overlay(s). - ○ Quantify transient ischemic dilation from stress-rest myocardial perfusion images. - • Assessment of Myocardial Blood Flow with Nuclear Cardiology Imaging - ○ Quantify and display myocardial blood flow and flow reserve from SPECT or PET dynamic sequences. - • Assessment of Myocardial Viability with Nuclear Cardiology Imaging - ○ Quantify regional perfusion and metabolic radiotracer uptake for the interpretation of viable myocardium by the Clinician. - • Assessment of Inflammation and Infection with Nuclear Cardiology Imaging - ○ Quantify regional radiotracer uptake for the review and interpretation of the presence of inflammation and infection in the heart and body by the Clinician. - • Assessment of Cardiac Coronary Calcium with CT Imaging - ○ Quantify the presence of calcium in the coronary vessels for review and interpretation by the Clinician. - • SPECT Image Reconstruction - ○ Motion correction of SPECT tomographic projection images for patient or organ motion. - ○ Image reconstruction of SPECT tomographic projection images with post reconstruction filtering and reorientation. 4DM shall be used by qualified medical professionals. It does not provide diagnoses or therapeutic recommendations but is instead a visual and quantitative aid. ## 8. Substantial Equivalence Discussion The following table compares the 4DM to the predicate device with respect to indications for use. The second table compares the 4DM to the predicate and reference device in terms of principles of operation, technological characteristics, and performance. Note that materials are not applicable as all these devices Page 5 of 13 {10} Page 6 of 13 are software as a medical device (SaMD). This comparison forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device. Where relevant, reference device information is also provided. Note that some items were not assessed for the reference device as they are the same between the subject and predicate device. Page 6 of 13 {11} Page 7 of 13 | Attribute | Subject: 4DM | Predicate: Corridor4DM K101279 | Comparison | | --- | --- | --- | --- | | **Indications for Use** | 4DM is a software application used by medical professionals to analyze and report nuclear medicine, PET, CT, MR, and hybrid patient studies to support their assessment of a patient’s cardiac health. 4DM provides tools to process, review, quantify, and display static, whole body, dynamic, gated planar, standard ungated ECT images, ECG gated ECT images, and dynamic ECT images. 4DM software performs quantification and enables: - Assessment of Cardiac Function with Nuclear Myocardial Perfusion Imaging - Quantify ventricular systolic function (volumes, ejection fraction) from radiotracer appropriate (e.g. perfusion, metabolism) gated ECT volumetric images. - Quantify ventricular diastolic function (e.g. filling and emptying rates) from radiotracer appropriate (e.g. perfusion, metabolism) gated ECT volumetric images. - Quantify regional ventricular wall motion and wall thickening from radiotracer appropriate (e.g. perfusion, metabolism) gated ECT volumetric images. - Quantify regional ventricular contractile function for the assessment of regional synchrony. - Assessment of Cardiac Function with Nuclear Gated Blood Pool Imaging - Quantify ventricular volumes and the ejection fraction (EF) from gated ECT blood pool images. - Quantify ejection fraction (EF) from planar gated blood pool images. - Assessment of Myocardial Perfusion with Nuclear Myocardial Perfusion Imaging - Quantify regional relative myocardial perfusion with comparison to normal limits for interpretation of perfusion abnormalities by the Clinician. - Provide semi-quantitative segmental myocardial perfusion scoring | INVIA’s Corridor4DM application is intended to provide processing, quantification, and multidimensional review of the biodistribution of radionuclides in the body using planar and tomographic images. The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion emission tomographic images. Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT). The calcium scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, a risk factor for coronary artery disease. Co-registration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation. | Similar The variation between indications for use between devices cleared in this product code indicates that if certain basic information is provided, variations are acceptable. The requested indications for use provide additional information related to potential diseases that may be relevant to the imaging, but remains about reviewing, processing, quantification, and multidimensional review. Therefore, there is no difference in safety or effectiveness. | Page 7 of 13 {12} Page 8 of 13 | Attribute | Subject: 4DM | Predicate: Corridor4DM K101279 | Comparison | | --- | --- | --- | --- | | | using standard segmental overlay(s). - ○ Quantify transient ischemic dilation from stress-rest myocardial perfusion images. - ● Assessment of Myocardial Blood Flow with Nuclear Cardiology Imaging - ○ Quantify and display myocardial blood flow and flow reserve from SPECT or PET dynamic sequences. - ● Assessment of Myocardial Viability with Nuclear Cardiology Imaging - ○ Quantify regional perfusion and metabolic radiotracer uptake for the interpretation of viable myocardium by the Clinician. - ● Assessment of Inflammatory Processes with Nuclear Cardiology Imaging - ○ Quantify regional radiotracer uptake for the review and interpretation of the presence of inflammation and infection in the heart and body by the Clinician. - ● Assessment of Cardiac Coronary Calcium with CT Imaging - ○ Quantify the presence of calcium in the coronary vessels for review and interpretation by the Clinician. - ● SPECT Image Reconstruction - ○ Motion correction of SPECT tomographic projection images for patient or organ motion. - ○ Image reconstruction of SPECT tomographic projection images with post reconstruction filtering and reorientation. 4DM shall be used by qualified medical professionals. It does not provide diagnoses or therapeutic recommendations but is instead a visual and quantitative aid. | | | | Attribute | Subject: 4DM | Predicate: Corridor4DM K101279 | Reference: Cvi42 K242781 | Comparison | | --- | --- | --- | --- | --- | | Product Code | QIH, LLZ | KPS, JAK, LLZ | QIH, LLZ | Equivalent QIH has been added to cover optional ML functionalities. QIH is included in the reference device. | Page 8 of 13 {13} Page 9 of 13 | Attribute | Subject: 4DM | Predicate: Corridor4DM K101279 | Reference: Cvi42 K242781 | Comparison | | --- | --- | --- | --- | --- | | Regulation Number | 892.2050 | 892.2050, 892.1750, and 892.1200 | 892.2050 | Same | | Intended Use | Software providing viewing, processing, quantification, and multidimensional review to aid in the interpretation of radiographic images. | Software providing viewing, processing, quantification, and multidimensional review to aid in the interpretation of radiographic images. | Software providing viewing, processing, quantification, and multidimensional review to aid in the interpretation of radiographic images. | Same | | Imaging Modalities | MR and CT | CT | MR and/or CT | Same | | 2D Imaging | Yes | Yes | Not assessed | Same | | 3D Imaging | Yes | No | Yes | Different from the predicate. Same as Reference. No new questions related to safety or effectiveness. | | Multiplanar Reformat (MPR) | Yes | No | Yes | Different from the predicate. Same as Reference. No new questions related to safety or effectiveness. | | DICOM Compliant | Yes | Yes | Yes | Same | | Navigation Tools | Panning, Windowing, Zooming, Series / Slices and Phases | Panning, Windowing, Zooming, Series / Slices and Phases | Panning, Windowing, Zooming, Series / Slices and Phases | Same | | Reconstruction of tomographic datasets | Yes Standard algorithm | Yes Standard algorithm | Not assessed | Same | | Processing of planar images | Yes Standard algorithm | Yes Standard algorithm | Not assessed | Same | | Tracer uptake over time | Yes Standard algorithm | Yes Standard algorithm | Not assessed | Same | | Estimates of cardiac function | Yes Standard algorithm | Yes Standard algorithm | Not assessed | Same | Page 9 of 13 {14} Page 10 of 13 | Attribute | Subject: 4DM | Predicate: Corridor4DM K101279 | Reference: Cvi42 K242781 | Comparison | | --- | --- | --- | --- | --- | | Estimates of cardiac perfusion | Yes Standard algorithm | Yes Standard algorithm | Not assessed | Same | | Attenuation correction | Yes Standard algorithm and optional Deep learning (DL) estimation | Yes Standard algorithm | Yes All reference devices include attenuation correction. It is not clear if they utilize standard or DL algorithms for this feature. | Similar to predicate. While the algorithms have been generated differently, all software algorithms are generated in a somewhat different manner by different teams and using different techniques. Algorithms are validated to ensure appropriate outputs. Therefore, there are no new questions related to safety or effectiveness. | | Segmentation | Yes Standard algorithm and optional DL estimation | Yes Standard algorithm | Yes Standard algorithm and optional DL estimation | Similar to predicate. Same as Reference. No new questions related to safety or effectiveness. | | Volumetric Blood Flow Estimation | Yes Standard algorithm and optional DL estimation | Yes Standard algorithm | Yes Include volumetric blood flow estimation. It is not clear if they use standard or DL algorithms for this feature. | Similar to predicate. While the algorithms have been generated differently, all software algorithms are generated in a somewhat different manner by different teams and using different techniques. Algorithms are validated to ensure appropriate outputs. Therefore, there are no new questions related to safety or effectiveness. | Page 10 of 13 {15} Page 11 of 13 ## 9. Non-Clinical Training and Performance Data The DL aspects of 4DM were trained using various databases as summarized in the following table. All training data were separate from the validation data. To demonstrate the safety and effectiveness of 4DM and to show substantial equivalence to the predicate device, INVIA completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. 4DM passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device: - Risk management per ISO 14971 - Software verification and validation per IEC 62304 - Usability / Human factors per IEC 62366-1 - Verification and validation testing were conducted in alignment with FDA guidance “Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions” from 2022. Outputs were validated using retrospective analysis of human image data that was obtained as part of standard clinical patient care data, quantitative and qualitative analysis, and visual / manual evaluation. A summary of the validation testing is provided below. Page 11 of 13 {16} Page 12 of 13 | Feature / Module | Training | Tuning | Validation Sample Description / Size | Test Method / Applicable Standards | Acceptance Criteria | Test Results | | --- | --- | --- | --- | --- | --- | --- | | DLAC | 5,593 patient studies | 1,865 patient studies | 4,074 patient studies in two evaluations | Quantitative performance comparison (ROC area under curve [AUC], sensitivity, specificity) of DLAC polar maps versus standard-of-care NAC polar maps and conventional measured CTAC polar maps | Equivalent or better than conventional analysis | Pass | | Sarcoid-DL | 189 patient studies | 63 patient studies | 341 patient studies in two evaluations | Quantitative comparison of volumes and Dice scores for DL LV segmentations on sarcoid images vs the standard-of-care LV segmentations on perfusion images | Equivalent or better than conventional analysis | Pass | | CT-DL | 1,221 patient studies | None. Justification provided. | 332 patient studies in two evaluations | Quantitative comparison of the VOI derived from the CT-DL heart mask vs the standard-of-care manually defined VOI | Equivalent or better than conventional analysis | Pass | | MBF-DL | 4,487 patient studies | 1,122 patient studies | 4,305 patient studies in three evaluations | Quantitative comparison of regional blood flow and quantitative comparison of relevant and absolute perfusion images using established polar map tools | Equivalent or better than conventional analysis | Pass | Page 12 of 13 {17} Page 13 of 13 # **10. Clinical Performance Data** No clinical data was necessary to determine the substantial equivalence of this device. # **11. Statement of Substantial Equivalence** 4DM has the same intended use as the predicate device and similar indications for use. All differences between the subject device when compared to the predicate device have been successfully evaluated through appropriate safety and performance testing which demonstrates that the subject device does not raise any new questions of safety and effectiveness. Based on the results of the risk assessment and all applicable testing, the 4DM is determined to perform as intended during normal anticipated usage and is at least as safe, as effective, and performs as well as or better than the legally marketed predicate device and therefore can be determined to be substantially equivalent to the predicate device. Page 13 of 13