Who is the manufacturer of iCAC Device?

Bunkerhill, Inc. filed the 510(k) submission for iCAC Device (K230223).

What is the FDA product code for iCAC Device?

JAK. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for iCAC Device?

510(k) clearance (submission type: Traditional).

Does iCAC Device use AI or machine learning?

Yes. iCAC Device (K230223) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like iCAC Device?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like iCAC Device get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

iCAC Device

K230223 · Bunkerhill, Inc. · JAK · Apr 25, 2023 · Radiology

Device Facts

Record ID	K230223
Device Name	iCAC Device
Applicant	Bunkerhill, Inc.
Product Code	JAK · Radiology
Decision Date	Apr 25, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended 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-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.

Device Story

Standalone SaMD; analyzes non-contrast, non-gated chest CT images (DICOM) from routine clinical care (e.g., lung cancer screening). Uses deep-learning computer vision to segment coronary artery calcium and calculate Agatston scores. Outputs visual segmentation and quantitative estimates (exact score and four-category burden) to physician on-demand via PACS/DICOM router. Physician reviews output in patient report or diagnostic viewer as adjunctive information. Does not replace original CT scan or radiologist report. Aids clinical decision-making by providing opportunistic calcium assessment; benefits patient through early identification of potential coronary artery disease risk.

Clinical Evidence

Retrospective study of 762 paired CT studies (non-gated chest CT vs. gated coronary CT) from 9 sites. Primary endpoints: overall alignment between device output and ground truth, and PPV per category. Results: 79.7% overall alignment (criteria >73%); PPV 68.1%–90.1% (criteria >65%).

Technological Characteristics

Standalone SaMD; deep-learning computer vision algorithm. Inputs: DICOM non-contrast, non-gated chest CT (up to 5mm slice thickness). Outputs: Agatston score, 4-category burden, calcium segmentation. Threshold: 130 HU. Connectivity: DICOM transfer from PACS/router.

Indications for Use

Indicated for patients aged 30+ undergoing routine non-contrast, non-gated chest CT scans to estimate coronary artery calcium presence and quantity. Not for stand-alone use; intended as adjunctive information for physicians.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

HealthCCSng (K210085)

Related Devices

K260166 — Bunkerhill Contrast CAC · BunkerHill Health · Mar 6, 2026
K240369 — CAC (gated) Algorithm · BunkerHill Health · Sep 27, 2024
K252217 — CT VScore+ · Canon Medical Informatics, Inc. · Nov 28, 2025
K230112 — CAC Software · Imbio, Inc. · Jun 13, 2023
K231631 — BriefCase-Quantification · Aidoc Medical , Ltd. · Nov 28, 2023

Submission Summary (Full Text)

{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: HealthCCSng Manufactured by Zebra Medical (K210085) | Summary | |--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 | The 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 preview axial images of the detected calcium meant for informational purposes only. The device | Primary difference is in calcium score quantification for each case | | Characteristic | Proposed Device: iCAC | Predicate Device: HealthCCSng Manufactured by Zebra Medical (K210085) | Summary | | | to the physician on- demand as part of his or her standard workflow. The device-generated calcium score or 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. | output will be available to the physician 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. | | | | 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 | | | | Characteristic | Proposed Device: iCAC | Predicate Device: HealthCCSng Manufactured by Zebra Medical (K210085) | Summary | | | reviewing the patient's results. | | | | Type of Interpretation | Adjunctive information | Adjunctive information | Same | | Intended User | Interpreting physicians | Interpreting physicians | Same | | Patient population | Patients aged 30 years and above | Patients above the age of 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 (CT) | Computed tomography (CT) | Same | | Image format | DICOM | DICOM | Same | | Contrast | Non-contrast | Non-contrast | Same | | Supported CT scan | Non-cardiac-gated CT scan | Non-cardiac-gated CT scan | Same | | Slice thickness | Up to 5mm | Up to 3mm | Similar, iCAC can support a wider variety of scans | | Calcification detection | Automatic | Automatic | Same | | Characteristic | Proposed Device: iCAC | Predicate Device: HealthCCSng Manufactured by Zebra Medical (K210085) | Summary | | Default threshold of calcium | 130 HU (Hounsfield Units) | 130 HU (Hounsfield Units) | Same | | Coronary artery calcification quantification method | CAC detection category (based on Agatston score), exact Agatston score | CAC detection category (based on Agatston score) | Similar, iCAC provides a more precise representation of coronary calcium burden | | Main image quality | DICOM | DICOM | Same | | Annotation of detected calcium | Yes | Yes | Same | | Generate patient report | Optional to copy result to clipboard, insert in report, DICOM Secondary Capture | Optional to copy result to clipboard, insert in report, DICOM Secondary Capture | Same | | Report of the calcium score | Yes, Coronary Calcium Detection Category and exact Agatston score 4 categories (for detection category): • 0 • 1-99 • 100-399 • ≥400 | Yes, Coronary Calcium Detection Category 3 categories: • 0-99 • 10-399 • >400 | Similar, iCAC provides a more precise representation of coronary calcium burden by separating the category 0 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.