Who is the manufacturer of CAC (gated) Algorithm?

BunkerHill Health filed the 510(k) submission for CAC (gated) Algorithm (K240369).

What is the FDA product code for CAC (gated) Algorithm?

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

What is the regulatory pathway for CAC (gated) Algorithm?

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

Does CAC (gated) Algorithm use AI or machine learning?

Yes. CAC (gated) Algorithm (K240369) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for CAC (gated) Algorithm?

Imbio's CAC Software (K230112); iCAC Device (K230223).

Who can help prepare an FDA 510(k) submission like CAC (gated) Algorithm?

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 CAC (gated) Algorithm 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.

CAC (gated) Algorithm

K240369 · BunkerHill Health · JAK · Sep 27, 2024 · Radiology

Device Facts

Record ID	K240369
Device Name	CAC (gated) Algorithm
Applicant	BunkerHill Health
Product Code	JAK · Radiology
Decision Date	Sep 27, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

CAC (gated) is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above. The device automatically analyzes non-contrast electrocardiogram (ECG) gated cardiac computed tomography (CT) images collected and outputs the segmentation (intended for informational purposes only) and quantification of detected calcium. The output of the subiect device is made available to the physician on-demand as part of his or her standard workflow. The device-generated quantification 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 cardiac 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

Software as a Medical Device (SaMD) for coronary artery calcium (CAC) assessment; inputs non-contrast ECG-gated cardiac CT images in DICOM format. Uses deep-learning algorithms to automatically localize, segment, and quantify calcium burden. Outputs include exact Agatston scores for the whole heart and individual coronary arteries (LCA, LAD, LCX, RCA), plus categorization into four Agatston ranges (0, 1-99, 100-399, 400+). Used in medical facilities by interpreting physicians; output provided on-demand within standard clinical workflow. Physician reviews device-generated segmentation and quantification alongside original CT scans to assist in clinical case review. Does not replace standard of care or diagnostic reports; intended to aid clinical decision-making.

Clinical Evidence

Retrospective study using gated CT studies from six geographically diverse sites. Primary endpoint: agreement of cardiovascular disease risk category between device and ground truth. Metric: Cohen's weighted kappa for 4-category assessment. Result: 0.972 (95% CI 0.958, 0.987), exceeding the 0.90 acceptance criterion.

Technological Characteristics

SaMD; deep-learning algorithm for image analysis. Inputs: DICOM format non-contrast ECG-gated cardiac CT images (slice thickness up to 3mm). Threshold: 130 HU. Outputs: Agatston scores and calcium segmentation. Connectivity: interfaces with standard CT systems/diagnostic viewers. No hardware components.

Indications for Use

Indicated for estimating presence and quantity of coronary artery calcium in patients aged 30 years and above using non-contrast ECG-gated cardiac CT images. Not for stand-alone diagnostic use; intended as an adjunctive tool 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

Imbio's CAC Software (K230112)
iCAC Device (K230223)

Related Devices

K241440 — HealthCCSng · Nano-X AI , Ltd. · Aug 19, 2024
K260166 — Bunkerhill Contrast CAC · BunkerHill Health · Mar 6, 2026
K230112 — CAC Software · Imbio, Inc. · Jun 13, 2023
K252217 — CT VScore+ · Canon Medical Informatics, Inc. · Nov 28, 2025
K231631 — BriefCase-Quantification · Aidoc Medical , Ltd. · Nov 28, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. September 27, 2024 BunkerHill Health % Nitva Naravanan Director of Regulatory Affairs 436 Bryant Street SAN FRANCISCO, CA 94107 Re: K240369 Trade/Device Name: CAC (gated) Algorithm Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: August 23, 2024 Received: August 26, 2024 Dear Nitya Narayanan: 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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-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 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/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-regulatory {2}------------------------------------------------ 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, Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use Submission Number (if known) K240369 Device Name CAC (gated) Algorithm ### Indications for Use (Describe) CAC (gated) is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above. The device automatically analyzes noncontrast electrocardiogram (ECG) gated cardiac computed tomography (CT) images collected and outputs the segmentation (intended for informational purposes only) and quantification of detected calcium. The output of the subiect device is made available to the physician on-demand as part of his or her standard workflow. The device-generated quantification 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 cardiac 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) 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." {4}------------------------------------------------ # 510(K) SUMMARY ## BunkerHill Health Inc.'s CAC (gated) Device BunkerHill Health Inc. 436 Bryant Street San Francisco CA 94107 Phone: (650) 842-0198 Contact Person: Nishith Khandwala Date Prepared: September 18, 2024 ### Proposed Device | Proprietary Name | CAC (gated) Device | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification Name | Computed tomography x-ray system | | Regulation Number | 21 CFR 892.1750 | | Product Code | JAK | | Requlatory Class | ============================================================================================================================================================================== | # Predicate Device(s) | Proprietary Name | Imbio's CAC Software | |------------------------|----------------------------------| | Premarket Notification | K230112 | | Classification Name | Computed tomography x-ray system | | Regulation Number | 21 CFR 892.1750 | | Product Code | JAK | | Regulatory Class | II | | Proprietary Name | iCAC Device | |------------------------|----------------------------------| | Premarket Notification | K230223 | | Classification Name | Computed tomography x-ray system | | Regulation Number | 21 CFR 892.1750 | | Product Code | JAK | | Regulatory Class | II | ### Device Description Bunkerhill CAC (gated) is a software as a medical device (SaMD) product that interfaces with compatible and commercially available CT systems. Bunkerhill CAC (gated) localizes, quantifies, {5}------------------------------------------------ and categorizes coronary artery calcification in non-contrast, electrocardiogram (ECG) gated, chest CT studies. The core features of the product are: - Categorization of the coronary artery calcium burden in the form of a range of Agatston ● scores. Calcium score groupings are defined as one of the four following ranges of Agatston units: - a. Group 1: 0 Agatston units - b. Group 2: 1-99 Agatston units - Group 3: 100-399 Agatston units C. - d. Group 4: 400+ Agatston units - Quantification of the overall coronary artery calcium burden in the form of an exact Agatston Score. - o Quantification of each coronary artery's (left main (LCA), left anterior descending (LAD), left circumflex (LCX), and right coronary artery (RCA)) calcium burden in the form of an exact Agatston score. - Localization of estimated calcium burden in the form of a CAC segmentation applied to a ● copy of the original CT scan (intended for informational purposes only). ### Intended Use / Indications for Use CAC (gated) is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above. The device automatically analyzes non-contrast electrocardiogram (ECG) gated chest computed tomography (CT) images collected and outputs the seqmentation (intended for informational purposes only) and quantification of detected calcium. 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 quantification 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 ECG-gated cardiac 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 presence of coronary artery calcium deposits and quantify calcium burden in adult patients. - Both devices analyze computed tomography (CT) imaqes that are sent to the software in o DICOM format. - Both the predicate and the subject device quantify the calcium burden of the coronary arteries. {6}------------------------------------------------ - . Both devices serve as support tools to provide information to the physician. However, they 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. A table comparing the key features of the subject and predicate devices is provided below. | Characteristic | Subject Device (gated) algorithm | Primary Predicate Device: CAC SW Imbio Inc's (K230112) | Secondary Predicate Device: iCAC (K230223) | Summary | |-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use / Indications for Use | CAC (gated) is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above. The device automatically analyzes non-contrast electrocardiogram (ECG) gated chest computed tomography (CT) images collected and outputs the segmentation (intended for informational purposes only) and quantification of detected calcium. | 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 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 | 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, 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 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 | Same: Both primary and secondary predicates are non-invasive post- processing SW to evaluate calcified plaque in coronary arteries. Both use CT images. Similar to primary predicate device, CAC (gated) outputs a summary report containing Agatston score, i.e. the calcification burden for the whole heart and at individual coronary artery level. Annotated images previewing the segmentation of calcifications is provided for information purposes. Both subject and predicates are not intended to be used on a stand-alone basis. | | | 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 quantification 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 ECG-gated cardiac CT scan; both are still available to be viewed and | | | | | Characteristic | Subject Device (gated) algorithm | Primary Predicate Device: Imbio Inc's CAC SW (K230112) | Secondary Predicate Device: iCAC (K230223) | Summary | | | 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. | clinical decision-making or otherwise preclude clinical assessment of CT images. | ECG-gated cardiac 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 Interpretation | Adjunctive information | Adjunctive information | Adjunctive information | Same | | Intended User | Interpreting physicians | Interpreting physicians | Interpreting physicians | Same | | Patient population | Patients aged 30 years and above | Patients above the age of 29 | Patients aged 30 years and above | Same | | Anatomical location | Cardiac | Thoracic, Chest, cardiac | Chest | Same | | Intended location | Medical facility | Medical facility | Medical facility | Same | | Rx or OTC | Rx | Rx | Rx | Same | | Measurement scale | Agatston units | Agatston units | Agatston units | Same | | Product code | JAK | JAK | JAK | Same | | Regulation number | 21 CFR §892.1750 | 21 CFR §892.1750 | 21 CFR §892.1750 | Same | | Modality | Computed tomography (CT) | Computed tomography (CT) | Computed tomography (CT) | Same | | Image format | DICOM | DICOM | DICOM | Same | | Supported CT scan | Cardiac gated CT scan | Non-cardiac-gated and cardiac gated CT scan | Non-cardiac-gated CT scan | Similar. Primary predicate is for both gated and non- gated scans therefore | | Characteristic | Subject Device -CAC (gated) algorithm | Primary Predicate Device: Imbio Inc's CAC SW (K230112) | Secondary Predicate Device: iCAC (K230223) | Summary | | |…