(233 days)
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 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 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.
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, 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).
Acceptance Criteria and Study Details for BunkerHill Health's CAC (gated) Algorithm (K240369)
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cohen's weighted kappa for the 4-category score group assessment: At least 0.90 | Cohen's weighted kappa: 0.972 (95% CI 0.958, 0.987) |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The exact number of cases in the test set is not explicitly stated, but it included "adequate representation from each coronary calcium detection category."
- Data Provenance: Retrospective study involving gated CT studies from six (6) geographically diverse sites. The specific countries of origin are not mentioned.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications (e.g., years of experience as a radiologist). However, it mentions "established ground truth," implying expert review.
4. Adjudication Method for Test Set
The adjudication method used to establish the ground truth for the test set is not specified in the provided document.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was mentioned in the document. The study focused on the standalone performance of the AI algorithm against a ground truth.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The document states:
"The CAC (gated) Device performance was validated in a stand-alone retrospective study for overall agreement of the device output compared to the established ground truth."
7. Type of Ground Truth Used
The type of ground truth used was "ground truth coronary calcium detection category," which was established for each case in the test set. While not explicitly detailed, this typically implies a consensus among expert readers or a gold standard interpretation.
8. Sample Size for Training Set
The document does not provide information regarding the sample size used for the training set.
9. How Ground Truth for Training Set Was Established
The document does not specify how the ground truth for the training set was established.
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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.
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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
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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
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Indications for Use
Submission Number (if known)
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)
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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,
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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.
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- . 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 SWImbio Inc's(K230112) | Secondary PredicateDevice: iCAC (K230223) | Summary |
|---|---|---|---|---|
| Intended Use /Indications for Use | CAC (gated) is a softwaredevice intended for use inestimating presence andquantity of coronary arterycalcium for patients aged30 years and above. Thedevice automaticallyanalyzes non-contrastelectrocardiogram (ECG)gated chest computedtomography (CT) imagescollected and outputs thesegmentation (intended forinformational purposesonly) and quantification ofdetected calcium. | Imbio CAC Software isintended for use as a non-invasive post-processingsoftware to evaluatecalcified plaques in thecoronary arteries, whichpresent a risk for coronaryartery disease. Imbio CACSoftware uses machinelearning to analyze thoracicCT images and outputs asummary report containingAgatston score, arterialage, and calcified lesionmass and volume metricsof the calcification burdenfor the whole heart andindividual coronary arterylevel. Additionally, ImbioCAC Software outputsannotated imagespreviewing thesegmentation ofcalcifications forinformational purposesonly. Imbio CAC Softwareis limited to thequantification of detectedpossible calcifications inadult patients ≥ 29 years ofage. It does not diagnosecoronary artery disease.The device output will beavailable to the users aspart of the standard DICOMviewing workflow. TheImbio CAC Software resultsare not intended to be usedon a stand-alone basis for | iCAC is a software deviceintended for use inestimating presence andquantity of coronary arterycalcium for patients aged 30years and above duringroutine care. The deviceautomatically analyzes non-gated, chest computedtomography (CT) imagescollected during routinecare and outputs a visualrepresentation of estimatedcoronary artery calciumsegmentation (intended forinformational purposesonly) and both exact andfour-category quantitativeestimates of the patient'scoronary artery calciumburden in Agatston units.The output of the subjectdevice is made available tothe physician on-demand aspart of his or her standardworkflow. The device-generated calcium score orscore group can be viewedin the patient report at thediscretion of the physician,and the physician also hasthe option of viewing thedevice-generated calciumsegmentation in adiagnostic image viewer.The subject device output inno way replaces the originalpatient report or the original | Same: Both primary andsecondary predicates arenon-invasive post-processing SW to evaluatecalcified plaque in coronaryarteries. Both use CTimages. Similar to primarypredicate device, CAC(gated) outputs a summaryreport containing Agatstonscore, i.e. the calcificationburden for the whole heartand at individual coronaryartery level. Annotatedimages previewing thesegmentation ofcalcifications is provided forinformation purposes. Bothsubject and predicates arenot intended to be used ona stand-alone basis. |
| The output of the subjectdevice is made available tothe physician on-demandas part of his or herstandard workflow. Thedevice-generatedquantification can beviewed in the patient reportat the discretion of thephysician, and thephysician also has theoption of viewing thedevice-generated calciumsegmentation in adiagnostic image viewer.The subject device outputin no way replaces theoriginal patient report or theoriginal ECG-gated cardiacCT scan; both are stillavailable 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 provideassistance during review of the patient's case. Resultsof the subject device arenot intended to be used ona stand-alone basis and aresolely intended to aid andprovide information to thephysician. In all cases,further action taken on apatient should only come atthe recommendation of thephysician after furtherreviewing the patient'sresults. | clinical decision-making orotherwise preclude clinicalassessment of CT images. | ECG-gated cardiac CTscan; both are still availableto be viewed and used atthe discretion of thephysician.The device is intended toprovide information to thephysician to provideassistance during review ofthe patient's case. Resultsof the subject device arenot intended to be used ona stand-alone basis and aresolely intended to aid andprovide information to thephysician. In all cases,further action taken on apatient should only come atthe recommendation of thephysician after furtherreviewing the patient'sresults. | ||
| 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 andcardiac gated CT scan | Non-cardiac-gated CT scan | Similar. Primary predicateis 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 |
| subject device which works on gated scans is a subset. Note: Secondary predicate iCAC clearance (K230223) works on non-gated scans. | ||||
| Slice thickness | Up to 3mm | Up to 3mm | Up to 5mm | Same |
| Calcification detection | Automatic | Automatic | Automatic | Same |
| Default threshold of calcium | 130 HU (Hounsfield Units) | 130 HU (Hounsfield Units) | 130 HU (Hounsfield Units) | Same |
| Coronary artery calcification quantification method | CAC detection category (based on Agatston score), exact Agatston score including vessel specific Agatston scores. | CAC detection category (based on Agatston score), including vessel specific Agatston scores | CAC detection category (based on Agatston score), exact Agatston score | Same |
| Main image quality | DICOM | DICOM | DICOM | Same |
| Annotation of detected calcium | Yes | 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 | 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 Category5 categories | Yes, Coronary Calcium Detection Category and exact Agatston score.4 categories (for detection category):• 0• 1-99• 100-399• ≥400 | Similar, CAC (gated) provides 4-category estimates whereas primary predicate provides 5 categories. Currently cleared iCAC (secondary predicate) has 4-categories similar to the subject device. |
Substantial Equivalence Comparison Table
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Figure 1: SE Table
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Performance Data
Safety and performance of the CAC (gated) 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 Requirements and Federal Regulations and Guidance documents, "Content of Premarket Submissions for Device Software Functions"-June 2023.
The CAC (gated) 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 gated CT studies from six (6) geographically diverse sites. The sample included adequate representation from each coronary calcium detection category. The CAC (gated) Device's overall agreement was determined by comparing the device output coronary calcium detection category to the ground truth coronary calcium detection category.
The primary endpoint was to evaluate the cardiovascular disease risk category across all cases between the subject device and the ground truth. Primary acceptance criteria for the pivotal testing study was defined as Cohen's weighted kappa for the 4-category score group assessment of at least 0.90. The BunkerHill device demonstrated a Cohen's weighted kappa of 0.972 (95%CI 0.958, 0.987) thus exceeding the primary acceptance criteria for the pivotal testing study.
Conclusions
The CAC (gated) Device is as safe and effective as the predicate devices (Imbio's CAC Software K230112 and iCAC device K230223). The CAC (gated) 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 CAC (gated) Device and its predicate devices raise no new issues of safety or effectiveness.
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.