(111 days)
Not Found
Yes
The document explicitly states that "Both the predicate and the subject device use deep-learning algorithms to identify the presence of ● calcification and estimate calcification." Deep learning is a subset of machine learning.
No.
Explanation: The device is intended to assist physicians by providing information and quantification of aortic valve calcification from CT images. It does not provide any form of therapy or direct treatment. Its outputs are for informational purposes only and are not intended to be used on a stand-alone basis for treatment decisions.
Yes
The device detects, localizes, and quantifies aortic valve calcification, providing information that aids physicians in reviewing a patient's case and making diagnostic assessments.
Yes
The device description explicitly states that Bunkerhill AVC is a "software as a medical device (SaMD) product".
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: Bunkerhill AVC analyzes non-gated, non-contrast chest computed tomography (CT) images. These are medical images, not biological samples.
The device falls under the category of medical imaging software or a Software as a Medical Device (SaMD) that processes and analyzes medical images to provide information to a physician.
No
The input explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found", indicating that the FDA clearance letter does not mention the approval or clearance of a PCCP for this device.
Intended Use / Indications for Use
Bunkerhill AVC is a software device intended for use in detecting presence and estimating quantity of aortic valve calcification for adult patients aged 40 years and above. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during clinical care and outputs the region of interest (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 region of interest in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original non-gated, non-contrast 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 AVC is a software as a medical device (SaMD) product that interfaces with compatible and commercially available computed tomography (CT) systems. Bunkerhill AVC detects, localizes, and quantifies aortic valve calcification in non-gated, non-contrast chest CT studies. The core features of the product are:
- Detection of aortic valve calcification at an Agatston-equivalent score threshold of 0 AU.
- Estimation of the overall aortic valve calcification burden in the form of an estimated Agatston-equivalent Score.
- Localization of estimated calcium burden in the form of AVC region of interest applied to a copy of the original CT scan.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Both the predicate and the subject device use deep-learning algorithms to identify the presence and estimate calcification.
Input Imaging Modality
Computed tomography (CT)
Anatomical Site
Chest (Aortic Valve)
Indicated Patient Age Range
adult patients aged 40 years and above
Intended User / Care Setting
Qualified medical professionals such as cardiologists or radiologists / 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 dataset was curated from thirty-three (33) sites across three geographical regions in the United States.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Bunkerhill AVC performance was validated in a stand-alone retrospective study for localization and agreement of the device output compared to the established ground truth. The pivotal dataset was curated from thirty-three (33) sites across three geographical regions in the United States. The primary endpoint was a Bland Altman agreement analysis and the secondary endpoint was Precision and Recall of the circular ROI. The acceptance criteria were derived from the performance of the predicate device and clinical literature in high impact journals that inter-reader agreement of manual segmentation.
The observed bias in the pivotal study was -5.15 AU and lower and upper limits agreements were -200.96 AU and 190.65 AU, respectively. As result, Bunkerhill AVC met the mean difference and limits of agreement acceptance criteria, thus satisfying the endpoints of the pivotal testing study. The low mean difference demonstrates that Bunkerhill AVC has a bias of low magnitude. The observed Precision was 0.826 (0.784, 0.863) and the observed Recall was 0.855 (0.818, 0.890). As a result, Bunkerhill AVC met the secondary endpoint acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Primary endpoint: Bland Altman agreement analysis with observed bias -5.15 AU, lower limit -200.96 AU, upper limit 190.65 AU.
Secondary endpoint: Precision 0.826 (0.784, 0.863), Recall 0.855 (0.818, 0.890).
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
January 27, 2025
BunkerHill Health % Nitya Narayanan Director, Regulatory Affairs 436 Bryant Street SAN FRANCISCO, CA 94107
Re: K243229
Trade/Device Name: Bunkerhill AVC Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: December 18, 2024 Received: December 23, 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)
Device Name
Bunkerhill AVC
Indications for Use (Describe)
Bunkerhill AVC is a software device intended for use in detecting presence and estimating quantity of aortic valve calcification for adult patients aged 40 years and above. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during clinical care and outputs the region of interest (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 region of interest in a diagnostic image viewer. The subject device output in no wav replaces the original patient report or the original non-gated, non-contrast 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
K243229
510(K) SUMMARY
Bunkerhilll AVC
BunkerHill Health Inc. 436 Bryant Street San Francisco CA 94107
Phone: (408) 8028146 Contact Person: Nitya Narayanan
Date Prepared: January 27, 2025
Proposed Device
| Proprietary Name | Bunkerhill AVC |
|---|---|
| Classification Name | Computed tomography x-ray system |
| Regulation Number | 21 CFR 892.1750 |
| Product Code | JAK |
| Regulatory Class | II |
Predicate Device
| 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 AVC is a software as a medical device (SaMD) product that interfaces with compatible and commercially available computed tomography (CT) systems. Bunkerhill AVC detects, localizes, and quantifies aortic valve calcification in non-gated, non-contrast chest CT studies. The core features of the product are:
- Detection of aortic valve calcification at an Agatston-equivalent score threshold of 0 AU. •
- . Estimation of the overall aortic valve calcification burden in the form of an estimated Agatston-equivalent Score.
- Localization of estimated calcium burden in the form of AVC region of interest applied . to a copy of the original CT scan.
5
Intended Use / Indications for Use
Bunkerhill AVC is a software device intended for use in detecting presence and estimating quantity of aortic valve calcification for adult patients aged 40 years and above. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during clinical care and outputs the region of interest (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 region of interest in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original non-gated, non-contrast 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.
Note: The only difference in intended use between subject and predicate device is that while predicate device is used in coronary artery calcification, subject device is used to estimate calcification in aortic valve. The differences in anatomical area do not raise any new questions of safety and effectiveness. Both devices assist the medical professionals in detecting presence and location of calcifications. Both subject and predicate devices are to aid medical professionals in viewing and analyzing cardiac computed tomography (CT) data to determine presence and extent of calcification.
| | Proposed Device: Bunkerhill AVC | Predicate Device: iCAC Device
(K230223) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use /
Indications for
use | Bunkerhill AVC is a software device
intended for use in detecting presence
and estimating quantity of aortic valve
calcification for adult patients aged 40
years and above. The device
automatically analyzes non-gated, non-
contrast chest computed tomography
(CT) images collected during clinical
care and outputs the region of interest
(intended for informational purposes
only) and quantification of detected
calcium. | iCAC is a software device intended for
use in estimating presence and quantity
of coronary artery calcium for patients
aged 30 years and above during routine
care. The device automatically analyzes
non-gated, non-contrast chest computed
tomography (CT) images collected
during routine care and outputs a visual
representation of estimated coronary
artery calcium segmentation (intended
for informational purposes only) and
both exact and four-category quantitative
estimates of the patient's coronary artery
calcium burden in Agatston units. |
A table comparing the intended use of the subject and predicate devices is provided below.
6
| Proposed Device: Bunkerhill AVC | Predicate Device: iCAC Device
(K230223) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 region of
interest in a diagnostic image viewer.
The subject device output in no way
replaces the original patient report or the
original non-gated, non-contrast CT
scan; both are still available to be viewed
and used at the discretion of the
physician. | 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 chest CT scan; both are
still available to be viewed and used at
the discretion of the physician. |
| The device is intended to provide
information to the physician to provide
assistance during review of the patient's
case. Results of the subject device are
not intended to be used on a stand-alone
basis and are solely intended to aid and
provide information to the physician. In
all cases, further action taken on a patient
should only come at the recommendation
of the physician after further reviewing
the patient's results. | 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
- Both the predicate and the subject device use deep-learning algorithms to identify the presence of ● calcification and estimate calcification.
- Both devices analyze non-gated chest computed tomography (CT) images that are sent to the . software in DICOM format.
- Both the predicate and the subject device quantify the calcification by generating a metric (an estimated score). These metrics are both based on the Agatston-equivalent score.
- Both devices serve as support tools to provide information to the physician. Both can be used ondemand or optionally by the physician and do not provide a definitive diagnosis. Both devices do not replace clinical evaluation and do not alter the standard of care. Both require the physician to use this information to decide next steps and/or additional diagnostic work up.
- Both devices provide a visual representation of the detected calcification for better ● explainability and for the physician to confirm the device output.
7
The following technological difference exists between the subject and predicate devices:
- The predicate device estimates presence and quantity of coronary artery calcium and additionally defines 4 detection categories for reporting the coronary artery calcium score whereas the subject device only provides a binary output (presence/absence of calcification) and an estimated Agatston-equivalent score for aortic valve calcium. The predicate device provides a segmentation output, whereas the subject device provides a circular region of interest (ROI) around detected calcification.
| | Proposed Device:
Bunkerhill AVC | Predicate Device: iCAC
Device (K230223) | Summary |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | JAK | JAK | Same |
| Regulation number | 21 CFR §892.1750 | 21 CFR §892.1750 | Same |
| Modality | Computed tomography
(CT) | Computed tomography
(CT) | Same |
| Image format | DICOM | DICOM | Same |
| Contrast | Non-contrast | Non-contrast | Same |
| Supported CT scan | Non-cardiac-gated CT scan | Non-cardiac-gated CT scan | Same |
| Slice thickness | Up to 5 mm | Up to 5 mm | Same |
| Calcification
detection | Automatic | Automatic | Same |
| Main image quality | DICOM | DICOM | Same |
| Annotation of
detected calcium | Yes | Yes | Same |
| Visual
Output
format | Visual output in the form
a Circular Region of
Interest (ROI) around
detected calcification
(intended for
informational purposes
only). The estimated
visual output can be
viewed by the physician
in a | Outputs a visual
representation of
estimated coronary
artery calcium
segmentation
(intended for
informational
purposes only). The | Predicate device shows
estimated segmentation
as one of the device
outputs whereas subject
device shows a ROI, no
segmentation. |
| | diagnostic image viewer.
The physician's standard
method for viewing
unaltered chest CT scans
in PACS will remain
available to them even if
the subject device is
being used. However, the
physician will also have
an option to view the
visual output estimated
by the subject device as a
separate series within
PACS. | estimated calcium
segmentation can be
viewed by the
physician in a
diagnostic image
viewer. The
physician's standard
method for viewing
unaltered chest CT
scans in PACS will
remain available to
them even if the
subject device is being
used.
However, the
physician will also
have an option to view
the calcium
segmentation
estimated by the
subject device as a
separate series within
PACS. | Both are for information
only. |
| Generate patient
report | Optional to copy result
to clipboard, insert in
report, DICOM
Secondary Capture | Optional to copy result to
clipboard, insert in report,
DICOM Secondary Capture | Same |
8
9
| Report
of
the
calcium score | Yes, estimated
Agatston-equivalent
score and binary
output
(presence/absence) | Yes, Coronary Calcium
Detection Category and
estimated Agatston score
4 detection categories | iCAC provides
estimation of coronary
calcium burden
whereas subject device
provides estimation of
calcification on aortic
valve. |
|--------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of
Interpretation | Adjunctive information | Adjunctive information | Same |
| Intended User | Qualified medical
professionals such as
cardiologists or
radiologists | Interpreting physicians | Similar |
| Patient population | Patients aged 40 years
and above | Patients above the age of 30 | Similar |
| Anatomical
location | Chest | Chest | Same |
| Intended location | Medical facility | Medical facility | Same |
| Rx or OTC | Rx | Rx | Same |
| Measurement scale | Agatston-equivalent units | Agatston-equivalent units | Same |
Performance Data
Safety and performance of Bunkerhill AVC 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".
The Bunkerhill AVC performance was validated in a stand-alone retrospective study for localization and agreement of the device output compared to the established ground truth. The pivotal dataset was curated from thirty-three (33) sites across three geographical regions in the United States. The primary endpoint was a Bland Altman agreement analysis and the secondary endpoint was Precision and Recall of the circular ROI. The acceptance criteria were derived from the performance of the predicate device and clinical literature in high impact journals that inter-reader agreement of manual segmentation.
The observed bias in the pivotal study was -5.15 AU and lower and upper limits agreements were -200.96 AU and 190.65 AU, respectively. As result, Bunkerhill AVC met the mean difference and limits of agreement acceptance criteria, thus satisfying the endpoints of the pivotal testing study. The low mean difference demonstrates that Bunkerhill AVC has a bias of low magnitude. The observed Precision was 0.826 (0.784, 0.863) and the observed Recall was 0.855 (0.818, 0.890). As a result, Bunkerhill AVC met the secondary endpoint acceptance criteria.
10
The testing demonstrates that the device is substantially equivalent to the predicate as required by 21 CFR 807.92(b)(3) since both the predicate and subject device demonstrated that with the cited mean difference and limits of agreement, the primary endpoint for calcium score was met.
Conclusions
Bunkerhill AVC is substantially equivalent to the predicate iCAC Device (K230223). The subject 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 summary, any minor differences between Bunkerhill AVC and the iCAC Device do not raise any issues of safety or effectiveness.