Cleerly LABS is a web-based software application that is intended to be used by trained medical professionals as an interactive tool for viewing and analyzing cardiac computed tomography (CT) data for determining the presence and extent of coronary plaques (i.e. atherosclerosis) and stenosis in patients who underwent Coronary Computed Tomography (CCTA) for evaluation of CAD or suspected CAD. This software post processes CT images obtained using any Computed Tomography (CT) scanner. The software provides tools for the measurement and visualization of coronary arteries.

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.

Device Description

Cleerly LABS is a post-processing web-based software application that enables trained medical professionals to analyze 2D/3D coronary images acquired from Coronary Computed Tomography Angiography (CCTA) scans. The software is a post-processing tool that aids in determining treatment paths for patients suspected of having coronary artery disease (CAD).

Cleerly LABS utilizes machine learning and simple rule-based mathematical calculation components which are performed on the backend of the software. The software applies deep learning methodology to identify high quality images, segment and label coronary arteries, and segment lumen and vessel walls. 2D and 3D images are presented to the user for review and manual editing. This segmentation is designed to improve efficiency for the user, and help shorten tedious, timeconsuming manual tasks.

The user is then able to edit the suggested segmentation as well as adjust plaque thresholds, demarcate stenosis, stents, and chronic total occlusions (CTOs) as well as select dominance and indicate coronary anomalies. Plaque, stenosis, and vessel measurements are output based on the combination of user-editable segmentation and user-placed stenosis, stent, and CTO markers. These outputs are mathematical calculations and are not machine-learning based.

Cleerly LABS provides a visualization of the Cleerly LABS analysis in the CORONARY Report. The CORONARY Report uses data previously acquired from the Cleerly LABS image analysis to generate a visually interactive and comprehensive report that details the atherosclerosis and stenosis findings of the patient. This report is not intended to be the final report (i.e., physician report) used in patient diagnosis and treatment. Cleerly Labs provides the ability to send the text report page of the CORONARY Report to the user's PACS system.

Cleerly LABS software does not perform any functions that could not be accomplished by a trained user with manual tracing methods or other commercially available software. Rather, it represents a more robust semiautomatic software intended to enhance the performance of time-intensive, potentially error-prone, manual tasks, thereby improving efficiency for medical professionals in the assessment of coronary artery disease (CAD).

AI/ML Overview

The provided FDA 510(k) summary for Cleerly LABS (v2.0) indicates that no new clinical testing was conducted to demonstrate safety or effectiveness for this submission (K242338), as the non-clinical testing was deemed sufficient. The submission primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, Cleerly LABS v2.0 (K202280), primarily due to modifications in product labeling, workflow, and minor technological enhancements, without changes to the underlying algorithms or mathematical calculations.

Therefore, the document does not contain details about specific acceptance criteria, device performance, sample sizes for test sets, data provenance, expert adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a new clinical study. Instead, it refers to the sufficiency of previous non-clinical testing and substantial equivalence to the predicate device.

Given this, I will extract information related to the overall performance claims and testing mentioned, emphasizing that these refer to the previous evaluation or software testing for this specific submission, rather than a new clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria and corresponding reported device performance metrics for a new clinical study. It states that "Results of testing re-confirmed that the software requirements fulfilled the pre-defined acceptance criteria." However, these specific criteria and results are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable for a new clinical study in this submission. The document states, "No clinical testing was conducted to demonstrate safety or effectiveness as the device's non-clinical testing was sufficient to support the intended use of the device." For software evaluation, it states "multiple pre-production environments using simulated data and in production for release verification." No specific sample sizes for these internal software tests or data provenance are provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for a new clinical study in this submission. Ground truth establishment for previous studies or internal validation is not detailed.

4. Adjudication Method for the Test Set

Not applicable for a new clinical study in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC comparative effectiveness study was mentioned or performed for this submission. The device is described as "more robust semiautomatic software intended to enhance the performance of time-intensive, potentially error-prone, manual tasks, thereby improving efficiency for medical professionals." However, no specific effect size or improvement metrics are provided for human readers with or without AI assistance in this document.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is described as a "web-based software application that is intended to be used by trained medical professionals as an interactive tool" and "not intended to replace the skill and judgment of a qualified medical practitioner." It also mentions that "The software applies deep learning methodology to identify high quality images, segment and label coronary arteries, and segment lumen and vessel walls." While the core functions are supported by AI, the tool is semi-automatic with user review and editing capabilities. The document doesn't explicitly state if a standalone performance study (without human interaction) was performed for regulatory submission, but rather focuses on its role as an interactive tool for professionals.

7. The Type of Ground Truth Used

Not explicitly stated for the "software evaluation activities" mentioned. For the underlying algorithms (which were unchanged from the predicate), the document implies that expert review and manual editing are part of the process, suggesting expert consensus or reference standards may have been used in the original development.

8. The Sample Size for the Training Set

No information on the sample size for the training set is provided in this document.

9. How the Ground Truth for the Training Set Was Established

No information on how the ground truth for the training set was established is provided in this document.

Summary

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March 7, 2025

Image /page/0/Picture/1 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 seal on the left, and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration".

Cleerly, Inc. % Felicia Hosey Interim Senior Director, Regulatory Affairs 1099 18th St Suite 2860 DENVER CO 80202

Re: K242338

Trade/Device Name: Cleerly LABS (v2.0) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: August 7, 2024 Received: February 10, 2025

Dear Felicia Hosey:

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 (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS 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 Re"). 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-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 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

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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,

Z.h.Ke

, for

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K242338

Device Name

Cleerly LABS (v2.0)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

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K242338 510(k) Summary

This 510(k) Summary is provided per the requirements of section 21 CFR 807.92 on March 5th, 2025.

1. Submitter

Submitter	Cleerly, Inc.
Contact Person	Amit Relia, Vice President, Regulatory and Quality Affairs
Address	1099 18th St Suite 2860, Denver CO 80202
Phone	(949) 701-6918
Email	Amit.Relia@cleerlyhealth.com

Device Information 2.

Trade Name	Cleerly LABS (v2.0)
Common Name	Automated radiological image processing software
Classification Name	Medical image management and processing system.
Product Classification	Class II, § 892.2050
Primary Product Code	QIH
Subsequent Product Code	LLZ

3. Predicate Device

Trade Name	Cleerly LABS (v2.0)
Common Name	System, Image Processing, Radiological
Classification Name	Medical image management and processing system.
Product Classification	Class II, § 892.2050
Product Code	LLZ
Submission Number	K202280

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4. Device Description

5. Intended Use / Indications for Use

Cleerly Labs is a web-based software application that is intended to be used by trained medical professionals as an interactive tool for viewing and analyzing cardiac computed tomography (CT) data for determining the presence and extent of coronary plaques (i.e. atherosclerosis) and stenosis in patients who underwent Coronary Computed Tomography (CCTA) for evaluation of CAD or suspected CAD. This software post processes CT images obtained using any Computed Tomography (CT) scanner. The software provides tools for the measurement and visualization of coronary arteries.

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6. Substantial Equivalence

The subject version of Cleerly LABS has an identical intended use and similar operating principles and technological characteristics as the previously cleared predicate Cleerly LABS v2.0 (K202280) device. The subject device introduces modifications to the product labeling as well as changes to the device's operating principle (i.e., workflow) and minor incremental technological enhancements/changes. The modifications do not introduce any changes to the previously cleared existing algorithms or simple mathematical calculations (Cleerly LABS v2.0 (K202280)) and, consequently, could not significantly affect safety or effectiveness. Software testing demonstrates that the subject device Cleerly LABS continues to be safe and effective for its intended use and substantially equivalent to the predicate device Cleerly LABS v2.0.

In addition, the core functions of Cleerly LABS are supported by artificial intelligence, nonadaptive machine learning algorithms for CCTA processing and analysis. As a result, an administrative change to the product code has been introduced for the subject device.

Feature	Subject DeviceCleerly LABS	Predicate DeviceCleerly LABS v2.0, K202280
Primary Product Code	QIH	LLZ
Subsequent Product Code	LLZ	n/a
Operating Platform	Client-Server Google ChromeApplication	Client-Server Google ChromeApplication
Image Input	DICOM 3.0 Compliant (or higher)	DICOM 3.0 Compliant (or higher)
Image Acquisition	CT Images	CT Images
Secured Network Server Integration	Yes	Yes
Study Analysis Tools -Navigation	Yes	Yes
Study Analysis Tools - Editing/Visualization	Yes	Yes
2D Imaging	Yes	Yes
3D Imaging	Yes	Yes
Multiplanar Reformat (MPR)	Yes	Yes
Segmentation of Region of Interest	Yes	Yes

The following table compares the key features of the subject and predicate device.

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Feature	Subject DeviceCleerly LABS	Predicate DeviceCleerly LABS v2.0, K202280
Plaque Composition Overlay	Yes	Yes
Hounsfield Unit (HU)	Yes	Yes
Distance Measurements	Yes	Yes
Volumetric Measurements	Yes	Yes
Remodeling Index	Yes	Yes
Stenosis	Yes	Yes
Coronary Anatomical Findings	Yes	Yes
Cleerly Core Lab Image Analysis	Yes	Not defined

7. Performance Data

Cleerly LABS has been designed, verified and validated in compliance with 21 CFR, Part 820.30 (Design Controls) requirements. The device has been designed to meet the requirements associated with ISO 14971, 2019-12, Medical Devices – Application of Risk Management to Medical Devices and AAMI TIR 57:2016, Principles for medical device security – Risk management. In addition, Cleerly complies with DICOM (Digital Imaging and Communications in Medicine) - Developed by the American College of Radiology and the National Electrical Manufacturers Association.

Software evaluation activities were performed in accordance with ANSI AAMI IEC 62304:2005/A1:2016, Medical Device Software - Software Life Cycle Processes |Including Amendment 1 (2016)] in multiple pre-production environments using simulated data and in production for release verification. Results of testing re-confirmed that the software requirements fulfilled the pre-defined acceptance criteria. Additionally, regression testing was completed, confirming that changes in technological characteristics did not affect the overall performance or functionality of the device.

Outputs of design control activities and software evaluation demonstrate that the modified device continues to be safe and effective for its intended use and is substantially equivalent and intended for the same clinical application, as the originally cleared device under K202280.

8. Clinical Data

No clinical testing was conducted to demonstrate safety or effectiveness as the device's non-clinical testing was sufficient to support the intended use of the device.

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9. Conclusions

The subject version of Cleerly LABS has the same intended use, indications for use, software algorithm and fundamental technology design as the predicate Cleerly LABS v2.0 (K202280). The modifications to the product labeling as well as changes to the device's operating principle (i.e., workflow) and minor incremental technological enhancements/changes do not raise different questions of safety or efficacy. No changes have been made to machine learning algorithms or simple mathematical equations. Software testing demonstrates that the subject device Cleerly LABS continues to perform as intended; therefore, the subject version of Cleerly LABS is as safe and effective as the predicate Cleerly LABS v2.0 (K202280). Thus, Cleerly Labs v2.0 is substantially equivalent.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).