(233 days)
Not Found
Yes
The "Mentions AI, DNN, or ML" section explicitly states that both the subject device and the predicate device use deep-learning algorithms and machine learning.
No
The device is a diagnostic tool that estimates the presence and quantity of coronary artery calcium and provides information to physicians; it does not directly treat or prevent a medical condition.
Yes
The device estimates the "presence and quantity of coronary artery calcium," provides "quantification of detected calcium," and helps the physician "during review of the patient's case." While it states the output is "not intended to be used on a stand-alone basis" and is for "informational purposes only," its role in assessing a medical condition makes it a diagnostic device, providing information for a diagnosis.
Yes
The device is explicitly described as "software as a medical device (SaMD)" and its function is to analyze existing CT images, producing software-based outputs (segmentation, quantification, categorization). It interfaces with commercially available CT systems but does not include or modify the hardware of those systems.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological specimens: IVDs are designed to examine samples taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The CAC (gated) device analyzes computed tomography (CT) images, which are medical images of the body, not biological specimens.
- The intended use is image analysis for diagnostic support: The intended use clearly states that the device analyzes CT images to estimate the presence and quantity of coronary artery calcium. This is a form of medical image analysis intended to aid the physician in their diagnostic process.
Therefore, while it is a medical device used in the diagnostic process, it falls under the category of medical imaging software rather than an In Vitro Diagnostic.
No
The input letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP)' section explicitly states 'Not Found'.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
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, 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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
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.
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.
Input Imaging Modality
Computed tomography (CT)
Anatomical Site
Cardiac
Indicated Patient Age Range
30 years and above
Intended User / Care Setting
Interpreting physicians / Medical facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cohen's weighted kappa of 0.972 (95%CI 0.958, 0.987)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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
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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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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 |
| | | | | 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 Category
5 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
9
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.