Who is the manufacturer of Autoplaque?

Cedars-Sinai Medical Center: Aim filed the 510(k) submission for Autoplaque (K212758).

What is the FDA product code for Autoplaque?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Autoplaque?

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

Does Autoplaque use AI or machine learning?

Yes. Autoplaque (K212758) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Autoplaque?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Autoplaque get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Autoplaque

Q: What are the predicate devices for Autoplaque?

Autoplaque add-on ORS Visual (K122429).

K212758 · Cedars-Sinai Medical Center: Aim · LLZ · May 19, 2023 · Radiology

Device Facts

Record ID	K212758
Device Name	Autoplaque
Applicant	Cedars-Sinai Medical Center: Aim
Product Code	LLZ · Radiology
Decision Date	May 19, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

Autoplaque is intended to provide an optimized non-invasive application to analyze coronary anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. Autoplaque is a workstation-based post processing application. It is a non-invasive diagnostic reading software intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques and luminal stenoses. The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present. Autoplaque must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Typical users of Autoplaque are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Device Story

Autoplaque 3.0 is a standalone workstation-based software for post-processing coronary CT angiography (CTA) images. It ingests DICOM image data from local storage. The device utilizes deep learning-based algorithms to perform automated segmentation of coronary vessels, plaque, and lumen. It provides clinicians with visualization tools including multiplanar reformatting (MPR), curved MPR, straightened MPR, and 3D views. The software calculates quantitative metrics such as vessel/lumen diameter and area, plaque volume (calcified, non-calcified, low-density), plaque burden, and stenosis severity. Clinicians review and may manually edit the automated segmentations. The output aids cardiologists and radiologists in assessing coronary pathology and determining treatment paths. It is intended for use by trained medical professionals in clinical settings. The device offers faster analysis times compared to manual expert review and the predicate device, potentially improving clinical workflow efficiency.

Clinical Evidence

Clinical validation included three studies. 1) US multicenter study (n=201 patients, 781 lesions) showed excellent agreement between Autoplaque 3.0 and expert readers for plaque volumes and diameter stenosis. 2) Non-US study (n=175 patients, 1081 lesions) confirmed excellent agreement with expert readers and demonstrated a mean analysis time of 5.7 seconds per patient. 3) Comparative study (n=27 patients, 30 lesions) showed excellent correlation and intraclass correlation agreement between Autoplaque 3.0 and the predicate device, with Autoplaque 3.0 performing significantly faster (2 seconds/lesion vs 30 seconds/lesion).

Technological Characteristics

Standalone software for Windows and Mac OS. Uses deep learning-based segmentation for vessels, plaque, and lumen. Supports DICOM 3.1. Features include 2D/3D visualization, MPR, curved/straightened MPR, and quantitative analysis of plaque/lumen parameters. Software is user-editable. No specific hardware materials; runs on commercial computer platforms.

Indications for Use

Indicated for cardiologists and radiologists to analyze coronary anatomy and pathology, determine presence/extent of coronary plaques and luminal stenoses, and aid in treatment planning using cardiac CT angiographic images.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

Autoplaque add-on ORS Visual (K122429)

Related Devices

K242338 — Cleerly LABS (v2.0) · Cleerly, Inc. · Mar 7, 2025
K251027 — cvi42 Coronary Plaque Software Application · Circle Cardiovascular Imaging, Inc. · Oct 27, 2025
K222662 — Vitrea CT Cardiac Analysis · Canon Medical Informatics, Inc. · Oct 14, 2022
K122429 — VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL · Object Research Systems (Ors), Inc. · Nov 28, 2012
K202280 — Cleerly Labs v2.0 · Cleerly, Inc. · Oct 2, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Cedars-Sinai Medical Center % Philip Won Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street NW, Suite 1200 WASHINGTON DC 20005 Re: K212758 May 19, 2023 Trade/Device Name: Autoplaque 3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ Dated: April 24, 2023 Received: April 25, 2023 Dear Philip Won: 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 (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 located 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. 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 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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-regulatoryassistance/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, Jessica Lamb Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212758 Device Name Autoplaque 3.0 ### Indications for Use (Describe) Autoplaque is intended to provide an optimized non-invasive application to analyze coronary and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. Autoplaque is a workstation-based post processing application. It is a non-invasive diagnostic reading software intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques and luminal stenoses. The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present. Autoplaque must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Typical users of Autoplaque are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) SUMMARY ## Cedars-Sinai Medical Center's Autoplaque 3.0 In accordance with 21 CFR § 807.92 the following summary of information is provided: #### I. Submitter Cedars-Sinai Medical Center 8700 Beverly Blvd. Los Angeles, CA 90048 Contact Person: Damini Dey, Ph.D. Title: Director, Quantitative Image Analysis Program, Biomedical Imaging Research Institute (BIRI), Department of Biomedical Sciences, Cedars Sinai Medical Center Cedars-Sinai Medical Center Phone: 310-423-1517 Fax: 310-423-8396 #### Date of 510(k) Summary Preparation: II. May 2, 2023 #### III. Device | Device Proprietary Name: | Autoplaque 3.0 | |--------------------------|--------------------------------------------------------------------------------------------| | Common or Usual Name: | Image Processing System, Radiological | | Classification Name: | Automated Radiological Image Processing Software Radiological Imaging Processing System | | Regulation Number: | 21 CFR § 892.2050 | | Product Code: | QIH, LLZ | | Device Classification | II | #### IV. Predicate Device Primary Predicate Device: - Autoplaque add-on ORS Visual, K122429, Object Research Systems (ORS) Inc. . {4}------------------------------------------------ #### V. Device Description Autoplaque 3.0. a stand-alone software, performs post-processing of coronary Computed Tomography Angiography (CTA) images and measurements of components of images using computerized algorithms. Autoplaque 3.0 aids the physician with measurement of coronary artery stenosis and provides measurements for coronary plaque and coronary artery remodeling. Autoplaque 3.0 does not replace standard clinical practice or clinician decision making. Autoplaque 3.0 allows for standardized characterization of plaque and stenosis from DICOM image data (loaded from the local computer hard drive) and includes the following features: - Review of heart and coronary vessels in Multiplanar Reformatting (MPR), curved MPR, . and straightened MPR views: - Measurement of vessel diameter and area; . - Characterization and measurement of plaque parameters; and - . Measurement of lumen diameter, area, and luminal stenosis. Autoplaque 3.0 includes automated vessel, plaque and lumen segmentation, which is reviewed and can be edited, if necessary, by the clinician. Autoplaque 3.0 can run on Windows or Mac computer platforms. The minimum hardware specifications are specified in the user manual. #### VI. Indications for Use Autoplaque is intended to provide an optimized non-invasive application to analyze coronary anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. Autoplaque is a workstation-based post processing application. It is a non-invasive diagnostic reading software intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques and luminal stenoses. The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present. {5}------------------------------------------------ Autoplaque must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Typical users of Autoplaque are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others. #### VII. Comparison of Technological Characteristics Autoplaque 3.0 and the predicate device are identical with respect to intended use and technological characteristics with the exception of the following: - Compatibility of the subject device with Mac operating system (OS); - Provision of the subject device as stand-alone software versus an add-on; and ● - . Deep learning-based vessel, plaque and lumen segmentation, which is reviewed and can be edited, if necessary, by the clinician. The table below compares the key technological features between the subject and predicate devices. | Parameter | Subject Device: Autoplaque 3.0 (K212758) | Predicate Device: Autoplaque add-on ORS Visual (K122429) | | | | | | | | | | | | | | | | |--------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------|-----|------|---------------------------------------|-----|------|--------------------------------------------------------------|-----|------|---------------------|-----|------|---------------|-----|------| | Computer operating system | Windows OS Mac OS | Windows OS only | | | | | | | | | | | | | | | | | Stand-alone software | Yes | No, ORS Visual add-on | | | | | | | | | | | | | | | | | DICOM compliance | DICOM 3.1 | Same | | | | | | | | | | | | | | | | | 2D Imaging | Review of coronary vessels in 2D MPR, curved MPR, and straightened view. | Same | | | | | | | | | | | | | | | | | 2D Measurement | 2D measurement tools of vessel diameter and contour | Same | | | | | | | | | | | | | | | | | 3D Imaging | Review of structures in 3D | Same | | | | | | | | | | | | | | | | | Maximum intensity projection (MIP) | MIP with interactive control | Same | | | | | | | | | | | | | | | | | Multiplanar reformatting (MPR) | MPR with oblique slicing and variable slab thickness | Same | | | | | | | | | | | | | | | | | Quantitative Measurements | | | NCP volume: non-calcified plaque volume | Yes | Same | CP volume: calcified plaque volume | Yes | Same | LD-NCP volume: low- density noncalcified plaque volume | Yes | Same | Total plaque volume | Yes | Same | Vessel volume | Yes | Same | | Quantitative Measurements | | | | | | | | | | | | | | | | | | | NCP volume: non-calcified plaque volume | Yes | Same | | | | | | | | | | | | | | | | | CP volume: calcified plaque volume | Yes | Same | | | | | | | | | | | | | | | | | LD-NCP volume: low- density noncalcified plaque volume | Yes | Same | | | | | | | | | | | | | | | | | Total plaque volume | Yes | Same | | | | | | | | | | | | | | | | | Vessel volume | Yes | Same | | | | | | | | | | | | | | | | {6}------------------------------------------------ | Parameter | Subject Device: Autoplaque 3.0 (K212758) | Predicate Device: Autoplaque add-on ORS Visual (K122429) | |------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | NCP burden: noncalcified plaque volume/analyzed vessel volume | Yes | Same | | LD-NCP burden: low-density noncalcified plaque volume/analyzed vessel volume | Yes | Same | | CP burden: calcified plaque volume/analyzed vessel volume | Yes | Same | | Total plaque burden: total plaque volume/analyzed vessel volume | Yes | Same | | Plaque composition NCP: Noncalcified plaque composition (NCP volume /total plaque volume) | Yes | Same | | Plaque composition CP: Calcified plaque composition (CP volume/total plaque volume) | Yes | Same | | Plaque composition LD-NCP: low-density noncalcified plaque composition (LD-NCP volume/ NCP volume) | Yes | Same | | Diameter stenosis: maximal diameter stenosis, with respect to proximal and distal references | Yes | Same | | QCAD: Maximal diameter stenosis, with respect to proximal and distal references | Yes | Same | | Remodeling index: ratio of maximum vessel area/proximal and distal references | Yes | Same | | Area stenosis: maximum area stenosis, with respect to proximal and distal references | Yes | Same | | Plaque length: diseased vessel length | Yes | Same | | Contrast density difference: maximum difference in contrast density over lesion with respect to proximal | Yes | Same | | MLD: minimal luminal diameter over lesion | Yes | Same | | Parameter | Subject Device: Autoplaque 3.0 (K212758) | Predicate Device: Autoplaque add-on ORS Visual (K122429) | | MLA: minimum luminal area over lesion | Yes | Same | | Vessel profile: Area, maximum diameter, minimum diameter measured from selected vessel cross section | Yes | Same | | Lumen profile: Area, maximum diameter, minimum diameter measured from selected lumen cross section | Yes | Same | | Vessel, plaque, and lumen segmentation | Deep learning based, validated with ground truth by clinician expert readers, with full option to edit. | Algorithm based, validated with ground truth by clinician expert readers, with full option to edit. | {7}------------------------------------------------ Discussion: As shown above, there are slight technological differences between the subject and predicate devices with respect to computer operating system, provision of the product as standalone software, and vessel, plaque, and lumen segmentation method; however, these differences do not raise new questions of safety and effectiveness, and the differences are addressed through software verification and validation as well as clinical performance studies. # VIII. Performance Data Software verification and validation were conducted on the subject device to demonstrate that the subject device meets specifications and works as intended. In addition, clinical validation studies were undertaken to verify and validate that Autoplaque 3.0 performs as intended. A summary of these studies is provided below. # 1. Comparison with Expert Reader Measurements in a Multicenter US Patient Population Performance data was collected on a data set of clinically indicated coronary computed tomography angiography (CCTA) images from multiple U.S. sites. The patient population consisted of 201 patients (53% men, 47% women) with a mean age of 60 ± 12 years. A total of 781 lesions from 201 patients were analyzed. Ethnicity available in 80 patients was as follows: White alone (not Hispanic or Latino) 18%, Black 19%, Hispanic or Latino 61%, and American Indian and Alaska native alone 1%. The CT scanners to collect images included commercial CT scanners from Siemens, Philips and GE. Ground truthing was performed by a board-certified imaging cardiologist. This study established concordance and agreement between clinician expert reader and Autoplaque 3.0 measurements for total plaque volume, calcified plaque volume, non-calcified plaque volume, and diameter stenosis using the acceptance criteria of an intraclass correlation coefficient and correlation coefficient. An excellent agreement was {8}------------------------------------------------ shown between the subject device and expert reader measurements for total plaque volume, noncalcified plaque volume, calcified plaque volume, and diameter stenosis. ### 2. Comparison with Expert Reader Measurements in a Non-US Patient Population Performance data was collected on clinically indicated coronary computed tomography angiography (CCTA) images from multiple non-U.S. external sites. The patient population consisted of 175 patients (53% men, 47% women) with a mean age of age 56 ± 9 years. A total of 1081 lesions from 175 patients were analyzed. The CT scanners to collect images included commercial CT scanners from Siemens, Philips and Canon. Ground truthing was performed by two cardiologists with one additional highly experienced radiologist to resolve discrepancies. This study established concordance and agreement between clinician expert reader and Autoplaque 3.0 measurements for total plaque volume, calcified plaque volume, non-calcified plaque volume, and diameter stenosis using the acceptance criteria of an intraclass correlation coefficient and correlation coefficient. An excellent agreement was shown between the subject device and expert reader measurements for total plaque volume, noncalcified plaque volume, calcified plaque volume, and diameter stenosis. In addition, the average per-patient plaque analysis time was 5.7 seconds for the subject device versus 25-30 minutes taken by experts. ### 3. Comparative Study with the Predicate Device To establish that the subject device provides clinical performance for total plaque volume, calcified plaque volume, non-calcified plaque volume, and diameter stenosis that is substantially equivalent to the predicate device, a total of 30 lesions (from 27 patients) throughout the coronary artery tree were analyzed using both the subject and predicate devices. The patient population were 60% men and 40% women with a mean of age 64.5 ± 10.1 years. The CT scanner used to collect the images was a commercial Siemens CT scanner. There was an excellent correlation between the subject and predicate devices for total plaque volume, noncalcified volume, calcified plaque volume, and diameter stenosis. These measurements also demonstrated excellent intraclass correlation agreement. It took less than 2 seconds per lesion for the subject device Autoplaque 3.0 to analyze, which was much faster than the predicate device (30 seconds per lesion). #### IX. Conclusion The information provided above supports that Autoplaque 3.0 is as safe and effective as the predicate device. Although there are minor differences between the subject and predicate devices, the differences are addressed through software verification and validation studies, and performance testing. Therefore, it is concluded that Autoplaque 3.0 is substantially equivalent to the predicate device.