Bunkerhill MAC

K250662 · BunkerHill Health · JAK · Oct 3, 2025 · Radiology

Device Facts

• Record ID: K250662
• Device Name: Bunkerhill MAC
• Applicant: BunkerHill Health
• Product Code: JAK · Radiology
• Decision Date: Oct 3, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

Bunkerhill MAC is a software device intended for use in detecting presence and estimating quantity of mitral annulus 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 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.

Device Story

Bunkerhill MAC is a SaMD that processes non-gated, non-contrast chest CT images (DICOM format) to detect and quantify mitral annulus calcification. Using deep-learning algorithms, it identifies calcification, estimates an Agatston-equivalent score (up to 5000 units), and generates a circular region of interest (ROI) for visualization. Used in medical facilities by cardiologists or radiologists, the device provides adjunctive information to assist in clinical case review. The output is presented as a secondary capture or visual overlay in a diagnostic image viewer. The physician retains the original CT scan and report for final clinical decision-making. The device does not provide a definitive diagnosis; it serves as a support tool to aid in the assessment of calcification burden, potentially streamlining the review process for clinicians.

Clinical Evidence

Bench testing and retrospective study. Pivotal study used multi-site US dataset. Primary endpoints: Positive Agreement Rate, Negative Agreement Rate, Precision (0.885; 95% CI: 0.848-0.919), Recall (0.867; 95% CI: 0.834-0.895), and Bland-Altman agreement. Mean bias -6.47 AU; limits of agreement -399.57 to 386.64 AU. Met all acceptance criteria derived from predicate performance and literature.

Technological Characteristics

SaMD; deep-learning algorithm; inputs DICOM non-gated, non-contrast chest CT (up to 5mm slice thickness). Outputs Agatston-equivalent score and ROI visualization. Standalone software; interoperable with PACS via DICOM secondary capture. No hardware components.

Indications for Use

Indicated for adult patients aged 40 years and above to detect and estimate the quantity of mitral annulus calcification using non-gated, non-contrast chest CT images.

Regulatory Classification

Identification

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

Predicate Devices

• Bunkerhill AVC (K243229)
• iCAC Device (K230223)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

October 3, 2025

BunkerHill Health
% John Smith
Partner
Hogan Lovells LLP
555 Thirteenth Street, NW
WASHINGTON, DC 20004

Re: K250662
Trade/Device Name: Bunkerhill MAC
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed tomography x-ray system
Regulatory Class: Class II
Product Code: JAK
Dated: February 18, 2025
Received: September 2, 2025

Dear John Smith:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250662 - John Smith
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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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250662 - John Smith
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,


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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K250662

Device Name
Bunkerhill MAC

Indications for Use (Describe)
Bunkerhill MAC is a software device intended for use in detecting presence and estimating quantity of mitral annulus 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 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.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
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Office of Chief Information Officer
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[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]

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510(K) SUMMARY
Bunkerhill MAC
K250662

BunkerHill Health Inc.
436 Bryant Street
San Francisco CA 94107
Phone: [phone]
Contact Person: Eren Alkan
Date Prepared: September 29, 2025

## Proposed Device

| Proprietary Name | Bunkerhill MAC |
| --- | --- |
| Classification Name | Computed tomography x-ray system |
| Regulation Number | 21 CFR 892.1750 |
| Product Code | JAK |
| Regulatory Class | II |

## Primary Predicate Device

| Proprietary Name | Bunkerhill AVC |
| --- | --- |
| Premarket Notification | K243229 |
| Classification Name | Computed tomography x-ray system |
| Regulation Number | 21 CFR 892.1750 |
| Product Code | JAK |
| Regulatory Class | II |

## Secondary 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 MAC is a software as a medical device (SaMD) product that interfaces with compatible and commercially available computed tomography (CT) systems. Bunkerhill MAC detects, localizes, and quantifies mitral annulus calcification in non-gated, non-contrast chest CT studies. The core features of the product are:

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- Detection of mitral annulus calcification at an Agatston-equivalent score threshold of 0 AU.
- Quantification of the overall mitral annulus calcification burden in the form of an estimated Agatston Score up to 5000 Agatston-equivalent units
- Localization of estimated calcium burden in the form of circular region of interest applied to a copy of the original CT scan.

# Intended Use / Indications for Use

Bunkerhill MAC is a software device intended for use in detecting presence and estimating quantity of mitral annulus 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 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 primary predicate device is that while predicate device is used in aortic valve calcification, subject device is used to estimate calcification of the mitral annulus. The only difference in intended use between subject and secondary predicate device is that while predicate device is used in coronary artery calcification, subject device is used to estimate calcification in mitral annulus. Given the identical principles of operation and technological characteristics, the differences in anatomical area do not raise any new questions of safety and effectiveness. Both subject and predicate 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

| | Proposed Device: Bunkerhill MAC | Predicate Device: Bunkerhill AVC (K243229) | Predicate Device: iCAC (K230223) |
| --- | --- | --- | --- |
| Intended use / Indications for use | Bunkerhill MAC is a software device intended for use in detecting presence and estimating quantity of mitral annulus calcification for adult patients aged 40 years and above. The device automatically analyzes non-gated, non- | 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- | 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 |

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| | Proposed Device: Bunkerhill MAC | Predicate Device: Bunkerhill AVC (K243229) | Predicate Device: iCAC (K230223) |
| --- | --- | --- | --- |
| | 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 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 | 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 | automatically analyzes non- gated, non-contrast chest computed tomography (CT) images collected during routine care and outputs a visual representation of estimated coronary artery calcium segmentation (intended for informational purposes only) and both exact and four-category quantitative estimates of the patient’s coronary artery calcium burden in Agatston units.

The output of the subject device is made available to the physician on-demand as part of his or her standard workflow. The device generated calcium score 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. |

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| | Proposed Device: Bunkerhill MAC | Predicate Device: Bunkerhill AVC (K243229) | Predicate Device: iCAC (K230223) |
| --- | --- | --- | --- |
| | physician after further reviewing the patient’s results. | 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(s) 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 on-demand 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 region of the detected calcification for better explainability and for the physician to confirm the device output.

The following technological difference exists between the subject and predicate devices:

- There are no technological differences between subject device and primary predicate device(s). The primary predicate device outputs an estimated Agatston-equivalent Score, visual output for reporting the aortic valve calcium score, whereas the subject device outputs an estimated Agatston-equivalent Score, visual output for reporting the mitral annulus calcium score. The only difference between the two devices lies in their anatomical focus. The technology behind both the AI algorithms is well-established and there

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are no new types of risks involved since the underlying mechanism for detecting and quantifying calcium does not differ between the aortic valve and the mitral valve.

- A minor difference between subject device and secondary predicate device in the information-only device output is that while the predicate device displays estimated calcium segmentation, the subject device shows a visual output in the form of a Region of Interest (ROI). The rationale behind this was to ensure that the interpreting physician is able to visualize the underlying calcification. The user has the option to delete the visual outputs if they do not agree with the results in both the subject and predicate device.

| | Proposed Device: Bunkerhill MAC | Predicate Device: Bunkerhill AVC (K243229) | Predicate Device: iCAC (K230223) | Summary |
| --- | --- | --- | --- | --- |
| 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 |
| Contrast | Non-contrast | Non-contrast | Non-contrast | Same |
| Supported CT scan | Non-cardiac-gated CT scan | Non-cardiac-gated CT scan | Non-cardiac-gated CT scan | Same |
| Slice thickness | Up to 5 mm | Up to 5 mm | Up to 5 mm | Same |
| Calcification detection | Automatic | Automatic | Automatic | Same |
| Main image quality | DICOM | DICOM | DICOM | Same |
| Annotation of detected calcium | Yes | Yes | Yes | Same |
| Visual Output format | Visual output in the form a Region of Interest or ROI (intended for informational purposes only). The estimated visual output 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 visual output estimated by the subject device as a | Visual output in the form a Region of Interest or ROI (intended for informational purposes only). The estimated visual output 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 visual output estimated by the subject device as a | Outputs a visual representation of estimated coronary artery calcium segmentation (intended for informational purposes only). The 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 | Same |

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| | Proposed Device: Bunkerhill MAC | Predicate Device: Bunkerhill AVC (K243229) | Predicate Device: iCAC (K230223) | Summary |
| --- | --- | --- | --- | --- |
| | by the subject device as a separate series within PACS. | separate series within PACS. | 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. | |
| 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, estimated exact Agatston-equivalent score and binary output (presence/absence) | Yes, estimated exact Agatston-equivalent score and binary output (presence/absence) | Yes, Coronary Calcium Detection Category and exact Agatston score 4 detection categories | Same |
| Type of Interpretation | Adjunctive information | Adjunctive information | Adjunctive information | Same |
| Intended User | Qualified medical professionals such as cardiologists or radiologists | Qualified medical professionals such as cardiologists or radiologists | Interpreting physicians | Same |
| Patient population | Patients aged 40 years and above | Patients above the age of 40 | Patients above the age of 30 | Same |
| Anatomical location | Chest (mitral annulus) | Chest (aortic valve) | Chest | Similar |
| Intended location | Medical facility | Medical facility | Medical facility | Same |
| Rx or OTC | Rx | Rx | Rx | Same |
| Measurement scale | Agatston-equivalent units | Agatston-equivalent units | Agatston units | Same |

# Performance Data

Safety and performance of Bunkerhill MAC 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 MAC performance was validated in a stand-alone retrospective study for detection, localization and agreement of the device output compared to the established reference standard. The pivotal dataset was curated from multiple sites across three geographical regions in the United States. The co-primary endpoints of Positive Agreement Rate, Negative Agreement Rate, Precision and Recall of the circular ROI, Bland Altman agreement analysis and correlation coefficient were met successfully. The

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acceptance criteria were derived from the performance of the predicate device and clinical literature in high impact journals that investigate the inter-reader agreement of manual segmentation. The observed bias in the pivotal study was $-6.47$ AU and lower and upper limits agreements were $-399.57$ AU and $386.64$ AU, respectively. As result, Bunkerhill MAC met the mean difference and limits of agreement acceptance criteria, thus satisfying all the endpoints of the pivotal testing study. The low mean difference demonstrates that Bunkerhill MAC has a bias of low magnitude. The observed Precision was 0.885 (0.848, 0.919) and the observed Recall was 0.867 (0.834, 0.895). As a result, Bunkerhill MAC met all study acceptance criteria.

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.

Please note performance metrics represent agreement between the device and non-gated CT reference measurements. Non-gated CT may be subject to motion artifacts and scoring variability. Clinical interpretation should account for these methodological considerations.

## Conclusions

Bunkerhill MAC is substantially equivalent to the primary predicate Bunkerhill AVC (K243229) and secondary predicate iCAC Device (K230223). The subject device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. 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 MAC and the predicate devices do not raise any issues of safety or effectiveness.

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