iCAC Device

{0}------------------------------------------------ April 25, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that. Bunkerhill, Inc. % John J. Smith Partner Hogan Lovells LLP 555 Thirteenth Street, NW WASHINGTON DC 20004 Re: K230223 Trade/Device Name: iCAC Device Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: April 7, 2022 Received: April 7, 2023 Dear John Smith: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) K230223 Device Name iCAC Device #### Indications for Use (Describe) iCAC is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above during routine care. The device automatically analyzes non-contrast chest computed tomography (CT) images collected during routine care and outputs a visual representation of estimated coronary artery calcium segmentation (intended for informational purposes only) and both exact and four-category quantitative estimates of the patient warery calcium burden in Agatston units. The output of the subject device is made available to the physician on-demand workflow. The devicegenerated calcium score or score group can be viewed in the patient report at the discretion of the physician also has the option of viewing the device-generated calcium segmentation in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original chest CT scan: both are still available to be viewed and used at the discretion of the physician. The device is intended to provide information to the physician to provide assistance during review of the patient's case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing the patient's results. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov " An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. ' {3}------------------------------------------------ ### 510(k) SUMMARY Bunkerhill's iCAC Device K230223 Submitter Bunkerhill, Inc. 428 El Verano Ave Palo Alto, CA 94306 Phone: (650) 842-0198 Contact Person: Nishith Khandwala Date Prepared: February 10, 2023 ## Proposed Device | Proprietary Name | iCAC Device | |---------------------|----------------------------------| | Classification Name | Computed tomography x-ray system | | Regulation Number | 21 CFR 892.1750 | | Product Code | JAK | | Regulatory Class | II | ### Predicate Device | Proprietary Name | HealthCCSng Manufactured by Zebra Health | |------------------------|------------------------------------------| | Premarket Notification | K210085 | | Classification Name | Computed tomography x-ray system | | Regulation Number | 21 CFR 892.1750 | | Product Code | JAK | | Regulatory Class | II | ### Device Description The iCAC Device (or the "subject device") is a standalone software as a medical device (SaMD) that provides adjunctive information to a radiologist for an estimate assessment of the presence and quantity of coronary artery calcium (CAC) from routine, non-contrast, non-gated chest computed tomography (CT) scans. The device can be used to leverage the high utilization of nongated chest CT scans (from lung cancer screening programs, routine exams, etc.) to opportunistically identify and quantify coronary artery calcium in patients. The iCAC Device takes as an input non-contrast, non-gated chest CT scans via DICOM transfer from the clinicians imaging database such as PACS or DICOM router. The device uses a deeplearning-based computer vision algorithm for its assessment. It estimates the presence and quantity of coronary artery calcium (CAC) from routine, non-contrast, non-gated chest computed {4}------------------------------------------------ tomography (CT) scans. iCAC Device can be used to leverage the high utilization of non-gated chest CT scans (from lung cancer screening programs, routine exams, etc.) to opportunistically identify and quantify coronary artery calcium in patients. # Intended Use / Indications for Use iCAC is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above during routine care. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during routine care and outputs a visual representation of estimated coronary artery calcium segmentation (intended for informational purposes only) and both exact and four-category quantitative estimates of the patient's coronary artery calcium burden in Agatston units. The output of the subject device is made available to the physician on-demand as part of his or her standard workflow. The device-generated calcium score group can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device-generated calcium segmentation in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original chest CT scan: both are still available to be viewed and used at the discretion of the physician. The device is intended to provide information to the physician to provide assistance during review of the patient's case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing the patient's results. # Summary of Technological Characteristics At a high level, the subject and predicate devices are based on the following same technological elements: - Both the predicate and the subject device use deep-learning algorithms to identify the o presence of coronary artery calcium deposits and quantify calcium burden in individuals of age 30 years and up. - Both devices analyze non-gated, non-contrast chest computed tomography (CT) images . that are sent to the software in DICOM format. - Both the predicate and the subject device quantify the calcium burden of the coronary ● arteries. - Both devices serve as support tools to provide information to the physician. However, they 0 do not replace clinical evaluation and do not alter the standard of care. - Both devices segment the calcium area on an image and generate a report. ● {5}------------------------------------------------ The following technological differences exist between the subject and predicate devices: - The predicate device defines three (3) detection categories for reporting the calcium score o whereas the subject device defines four (4) detection categories. The subject and predicated devices differ in that the subject device reports a detection category for calcium scores of zero, while the predicate device does not explicitly distinguish zero from nonzero calcium scores. - The predicate device does not output an exact calcium score, whereas the subject device . reports an exact calcium score. | Characteristic | Proposed Device: iCAC | Predicate Device:<br>HealthCCSng<br>Manufactured by Zebra<br>Medical<br>(K210085) | Summary | |--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use /<br>Indications for Use | iCAC is a software device<br>intended for use in<br>estimating presence and<br>quantity of coronary<br>artery calcium for patients<br>aged 30 years and above<br>during routine care. The<br>device automatically<br>analyzes non-gated, non-<br>contrast chest computed<br>tomography (CT) images<br>collected during routine<br>care and outputs a visual<br>representation of<br>estimated coronary artery<br>calcium segmentation<br>(intended for<br>informational purposes<br>only) and both exact and<br>four-category quantitative<br>estimates of the patient's<br>coronary artery calcium<br>burden in Agatston units.<br><br>The output of the subject<br>device is made available | The HealthCCSng device<br>is intended for use as a<br>non-invasive post-<br>processing software to<br>evaluate calcified plaques<br>in the coronary arteries,<br>which present a risk for<br>coronary artery disease.<br>The software generates an<br>estimated coronary artery<br>calcium detection<br>category. The<br>HealthCCSng device<br>analyzes existing non-<br>cardiac-gated CT studies<br>that include the heart of<br>adult patients above the<br>age of 30. The device<br>generates a three-category<br>output representing the<br>estimated quantity of<br>calcium detected together<br>with preview axial images<br>of the detected calcium<br>meant for informational<br>purposes only. The device | Primary difference is in<br>calcium score<br>quantification for each<br>case | | Characteristic | Proposed Device: iCAC | Predicate Device:<br>HealthCCSng<br>Manufactured by Zebra Medical<br>(K210085) | Summary | | | to the physician on-<br>demand as part of his or<br>her standard workflow.<br>The device-generated<br>calcium score or score<br>group can be viewed in<br>the patient report at the<br>discretion of the<br>physician, and the<br>physician also has the<br>option of viewing the<br>device-generated calcium<br>segmentation in a<br>diagnostic image viewer.<br>The subject device output<br>in no way replaces the<br>original patient report or<br>the original chest CT<br>scan; both are still<br>available to be viewed<br>and used at the discretion<br>of the physician. | output will be available to<br>the physician as part of<br>their standard workflow.<br>The HealthCCSng results<br>are not intended to be<br>used on a stand-alone<br>basis for risk attribution,<br>clinical decision-making<br>or otherwise preclude<br>clinical assessment of CT<br>studies. | | | | The device is intended to<br>provide information to the<br>physician to provide<br>assistance during review<br>of the patient's case.<br>Results of the subject<br>device are not intended to<br>be used on a stand-alone<br>basis and are solely<br>intended to aid and<br>provide information to the<br>physician. In all cases,<br>further action taken on a<br>patient should only come<br>at the recommendation of<br>the physician after further | | | | Characteristic | Proposed Device: iCAC | Predicate Device:<br>HealthCCSng<br>Manufactured by Zebra<br>Medical<br>(K210085) | Summary | | | reviewing the patient's<br>results. | | | | Type of<br>Interpretation | Adjunctive information | Adjunctive information | Same | | Intended User | Interpreting physicians | Interpreting physicians | Same | | Patient population | Patients aged 30 years<br>and above | Patients above the age of<br>30 | Similar | | Anatomical location | Chest | Chest | Same | | Intended location | Medical facility | Medical facility | Same | | Rx or OTC | Rx | Rx | Same | | Measurement scale | Agatston units | Agatston units | Same | | Product code | JAK | JAK | Same | | Regulation number | 21 CFR §892.1750 | 21 CFR §892.1750 | Same | | Modality | Computed tomography<br>(CT) | Computed tomography<br>(CT) | Same | | Image format | DICOM | DICOM | Same | | Contrast | Non-contrast | Non-contrast | Same | | Supported CT scan | Non-cardiac-gated CT<br>scan | Non-cardiac-gated CT<br>scan | Same | | Slice thickness | Up to 5mm | Up to 3mm | Similar, iCAC can<br>support a wider variety of<br>scans | | Calcification<br>detection | Automatic | Automatic | Same | | Characteristic | Proposed Device: iCAC | Predicate Device:<br>HealthCCSng<br>Manufactured by Zebra<br>Medical<br>(K210085) | Summary | | Default threshold of<br>calcium | 130 HU (Hounsfield<br>Units) | 130 HU (Hounsfield<br>Units) | Same | | Coronary artery<br>calcification<br>quantification<br>method | CAC detection category<br>(based on Agatston<br>score), exact Agatston<br>score | CAC detection category<br>(based on Agatston score) | Similar, iCAC provides a<br>more precise<br>representation of coronary<br>calcium burden | | Main image quality | DICOM | DICOM | Same | | Annotation of<br>detected calcium | Yes | Yes | Same | | Generate patient<br>report | Optional to copy result to<br>clipboard, insert in report,<br>DICOM Secondary<br>Capture | Optional to copy result to<br>clipboard, insert in report,<br>DICOM Secondary<br>Capture | Same | | Report of the<br>calcium score | Yes, Coronary Calcium<br>Detection Category and<br>exact Agatston score<br>4 categories (for detection<br>category):<br>• 0<br>• 1-99<br>• 100-399<br>• ≥400 | Yes, Coronary Calcium<br>Detection Category<br>3 categories:<br>• 0-99<br>• 10-399<br>• >400 | Similar, iCAC provides a<br>more precise<br>representation of coronary<br>calcium burden by<br>separating the category 0<br>from the other categories. | A table comparing the key features of the subject and predicate devices is provided below. {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # Performance Data Safety and performance of the iCAC Device has been evaluated and verified in accordance with software specifications and applicable performance standards through Software Development and Validation & Verification Process to ensure performance according to specifications, User {9}------------------------------------------------ Requirements and Federal Regulations and Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The iCAC Device performance was validated in a stand-alone retrospective study for overall agreement of the device output compared to the established ground truth. The pivotal testing dataset consisted of 762 paired CT studies (one non-gated, non-contrast chest CT and one gated coronary CT in each pair) from nine (9) geographically diverse sites. The sample included adequate representation from each coronary calcium detection category. The iCAC Device's overall agreement was determined by comparing the device output coronary calcium detection category to the ground truth coronary calcium detection category. Primary acceptance criteria for the pivotal testing study were defined as 73% overall alignment between device output calcium score groups and ground truth calcium score groups and at least 65% positive predictive value (PPV) for each of the four possible calcium score groupings. The iCAC device demonstrated an overall alignment rate of 79.7% and calcium-score-group level positive predictive values of 68.1% to 90.1%, thus satisfying both the primary acceptance criteria for the pivotal testing study. # Conclusions The iCAC Device is as safe and effective as the predicate HealthCCSng device (K210085). The iCAC Device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended diagnostic use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the iCAC Device and its predicate devices raise no new issues of safety or effectiveness.