CAC Software

{0}------------------------------------------------ June 13, 2023 Image /page/0/Picture/1 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. Imbio, Inc. % Lauren Keith Director of Engineering 1015 Glenwood Avenue, Floor 4 MINNEAPOLIS MN 55405 Re: K230112 Trade/Device Name: CAC Software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: May 9, 2023 Received: May 9, 2023 Dear Lauren Keith: 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. 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Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 | |----------------------------------| | Expiration Date: 06/30/2020 | | See PRA Statement below. | | 510(k) Number (if known) | K230112 | |--------------------------|---------| |--------------------------|---------| | Device Name | CAC Software | |-------------|--------------| |-------------|--------------| Imbio CAC Software is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. Imbio CAC Software uses machine learning to analyze non-contrast thoracic CT images and outputs a summary report containing Agatston score, arterial age, and calcified lesion mass and volume metrics of the calcification burden for the whole heart and individual coronary artery level. Additionally, Imbio CAC Software outputs annotated images previewing the segmentation of calcifications for informational purposes only. Imbio CAC Software is limited to the quantification of detected possible calcifications in adult patients ≥ 29 years of age. It does not diagnose coronary artery disease. The device output will be available to the users as part of the standard DICOM viewing workflow. The Imbio CAC Software results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CT images. | Type of Use ( <i>Select one or both, as applicable</i> ) | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <table style="border:none"><tr><td><div style="display:inline-block; vertical-align:middle;"> <div style="display:inline-block; vertical-align:middle;"> <input checked="true" type="checkbox"/> </div> <div style="display:inline-block; vertical-align:middle;">Prescription Use (Part 21 CFR 801 Subpart D)</div> </div></td><td><div style="display:inline-block; vertical-align:middle;"> <div style="display:inline-block; vertical-align:middle;"> <input type="checkbox"/> </div> <div style="display:inline-block; vertical-align:middle;">Over-The-Counter Use (21 CFR 801 Subpart C)</div> </div></td></tr></table> | <div style="display:inline-block; vertical-align:middle;"> <div style="display:inline-block; vertical-align:middle;"> <input checked="true" type="checkbox"/> </div> <div style="display:inline-block; vertical-align:middle;">Prescription Use (Part 21 CFR 801 Subpart D)</div> </div> | <div style="display:inline-block; vertical-align:middle;"> <div style="display:inline-block; vertical-align:middle;"> <input type="checkbox"/> </div> <div style="display:inline-block; vertical-align:middle;">Over-The-Counter Use (21 CFR 801 Subpart C)</div> </div> | | <div style="display:inline-block; vertical-align:middle;"> <div style="display:inline-block; vertical-align:middle;"> <input checked="true" type="checkbox"/> </div> <div style="display:inline-block; vertical-align:middle;">Prescription Use (Part 21 CFR 801 Subpart D)</div> </div> | <div style="display:inline-block; vertical-align:middle;"> <div style="display:inline-block; vertical-align:middle;"> <input type="checkbox"/> </div> <div style="display:inline-block; vertical-align:middle;">Over-The-Counter Use (21 CFR 801 Subpart C)</div> </div> | | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Classified as Class 2 at 21 CFR 892.1750, product code JAK. ## 1.6 Legally Marketed Device To Which The Device Is Substantially Equivalent The CAC Software is substantially equivalent to the Zebra Medical Vision HealthCCSng cleared under K210085. {4}------------------------------------------------ ## Description of the Device 1.7 The Imbio CAC Software is a set of medical image post-processing computer algorithms that together performs automated coronary artery calcification segmentation and reports a total Agatston score, calcified lesion mass and volume, and arterial age from thoracic computed tomography (CT) images. The Agatston score, calcified lesion mass and volume are reported both as a total and for each of the following individual coronary arteries: right coronary artery (RCA), left anterior descending (LAD), left circumflex (LCx). The Imbio CAC Software is a single command-line executable program that may be run directly from the command-line or through scripting and thus the user interface is minimal. Imbio CAC Software is a Software and Medical Device (SaMD) intended to provide annotated DICOM-formatted images and a PDF report that will be read most typically at a PACS workstation. Imbio CAC Software is an aid only used to support a physician in the analysis of CT images. The Imbio CAC Software program reads in thoracic CT DICOM datasets, processes the data, then writes output DICOM files and summary reports to a specified directory. Imbio CAC Software outputs DICOMs of the original input DICOM CT images overlaid with color-codings representing the coronary artery calcification segmentations. Additionally, a summary PDF report is output. Imbio CAC Software does not interface directly with any CT scanner or data collection equipment; instead the software imports data previously generated by such equipment and is integrated as part of the radiological workflow, reducing the risk of use errors. ## 1.8 Indication for Use Imbio CAC Software is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. Imbio CAC Software uses machine learning to analyze non-contrast CT images and outputs a summary report containing Agatston score, arterial age, and calcified lesion mass and volume metrics of the calcification burden for the whole heart and individual coronary artery level. Additionally, Imbio CAC Software outputs annotated images previewing the segmentation of calcifications for informational purposes only. Imbio CAC Software is limited to the quantification of detected possible calcifications in adult patients > 29 years of age. It does not diagnose coronary artery disease. The device output will be available to the users as part of the standard DICOM viewing workflow. The Imbio CAC Software results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CT images. ## 1.9 Technological Characteristics Table 1.1 compares the technological characteristics between the proposed CAC Software and the predicate Zebra Medical Vision HealthCCSng. Table 1.1: Technological Characteristics Comparison with Predicate Device | Indications for Use | Due to the length of the<br>statement, see below. | Due to the length of the<br>statement, see below. | Different but does not<br>introduce questions of<br>safety and effectiveness. | |---------------------|---------------------------------------------------|---------------------------------------------------|-------------------------------------------------------------------------------| |---------------------|---------------------------------------------------|---------------------------------------------------|-------------------------------------------------------------------------------| {5}------------------------------------------------ | Characteristic | Proposed Device CAC Software | Predicate Device Zebra Medical Vision HealthCCSng | Comparison | |------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Regulatory | | | | | FDA Clearance | TBD | K210085 (9/9/2021) | | | Product Code | JAK | JAK | Same | | Class | II | II | Same | | Regulation | 21 CFR 892.1750 | 21 CFR 892.1750 | Same | | Software | Device is software only | Device is software only | Same | | Level of Concern | Moderate | Moderate | Same | | General | | | | | Modality | CT | CT | Same | | Anatomical Site | Thoracic, Chest, Cardiac | Thoracic, Chest, Cardiac | Same | | Support Input CT Scan | Low and standard dose. Cardiac-gated and non-cardiac-gated. Up to 3mm slice thickness. | Low and standard dose. Non-cardiac-gated. Up to 3mm slice thickness. | Different - Predicate is not labeled for use in cardiac-gated scans. | | Image Format | DICOM | DICOM | Same | | Use Environment | Hospitals and Clinics including Inpatient and outpatient, and lung cancer screening programs. | Hospitals and Clinics including Inpatient and outpatient, and lung cancer screening programs. | Same | | Quantification | | | | | Calcium Detection | Automatic | Automatic | Same | | Default Threshold | 130 (HU) | 130 (HU) | Same | | Calcium Reporting | CAC score and reference 5 category CAC risk | 3 category CAC risk | Different - Predicate does not report CAC score and combines lower risk categories. | | Display and Outputs | | | | | Outputs | DICOM Report and CAC annotated DICOM images. | DICOM Report and CAC annotated DICOM images. | Same | | Alteration of original image | No | No | Same | | Image Viewing | Images viewed on existing viewing workstation. | Images viewed on existing viewing workstation. | Same | | Characteristic | Proposed Device<br>CAC Software | Predicate Device<br>Zebra Medical Vision<br>HealthCCSng | Comparison | | Communication with Patient | Does not communicate<br>with patients. | Does not communicate<br>with patients. | Same | {6}------------------------------------------------ {7}------------------------------------------------ Proposed Device CAC Software Indication for Use: Imbio CAC Software is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. Imbio CAC Software uses machine learning to analyze non-contrast thoracic CT images and outputs a summary report containing Agatston score, arterial age, and calcified lesion mass and volume metrics of the calcification burden for the whole heart and individual coronary artery level. Additionally, Imbio CAC Software outputs annotated images previewing the segmentation of calcifications for informational purposes only. Imbio CAC Software is limited to the quantification of detected possible calcifications in adult patients ≥ 29 years of age. It does not diagnose coronary artery disease. The device output will be available to the users as part of the standard DICOM viewing workflow. The Imbio CAC Software results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CT images. Predicate Device Zebra Medical Vision HealthCCSng Indications for Use: HealthCCSng device is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery disease. The software generates an estimated coronary artery calcium detection category. The HealthCCSng device analyzes existing non-cardiac-gated CT studies that include the heart of adult patients above the age of 30. The device generates a three-category output representing the estimated quantity of calcium detected together with the preview axial images of the detected calcium meant for informational purposes only. The device output will be available to the radiologist as part of their standard workflow. The HealthCCSng results are not intended to be used on a stand-alone basis for risk attribution, clinical decision-making or otherwise preclude clinical assessment of CT studies. ## 1.10 Clinical Study Non-clinical testing was conducted in the form of a retrospective, multi-center, standalone device performance assessment. 500 anonymized chest CT series meeting the input requirements for Imbio CAC Software were curated from a variety of sources including large publically available databases and private imaging data brokers. Exclusion criteria included: - · CTs from pediatric patients (< 22 years old) - · Contrast-enhanced acquisitions - · Scans with significant respiratory motion - · Scans with severe metal artifacts - · Scans containing non-thoracic anatomy The mean age of patients whose scans were included in the performance assessment was 64.3 years with a standard deviation of 10 years with the oldest and youngest patient being 90+ (not listed above 90 years old) and 29 years old, respectively. Gender distrubution was 41.7% male and 42.5 % female with 15.6% of the data having no gender information. Images originated from GE Medical Systems (65.1%), Siemens (19.4%), Imatron (15.2%), and Philips (0.2%) scanners. There was an equal split of ECG-gated and non-gated acquisitions. All chest CT series were annotated by experienced 3D Image Post-Processing Technologists using an FDA-cleared semi-automated CAC scoring software program. These images and the corresponding CAC scores were used as ground truth for Imbio CAC Software validation. {8}------------------------------------------------ The primary endpoint was to evaluate the cardiovaclar disease risk category across all cases between Imbio CAC Software and the ground truth. For a 5-category risk assessment, the Cohen's kappa between Imbio CAC Software and the ground truth was 0.907 (95% CI 0.895, 0.920), which met the acceptance criteria of kappa > 0.859. ## 1.11 Biocompatibility Biocompatibility testing is not applicable for the CAC Software. ## Conclusions 1.12 The results of the comparison of design, intended use and technological characteristics demonstrate that the device is as safe and effective as the legally marketed predicate device.