Cleerly Labs

{0}------------------------------------------------ November 5, 2019 Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Cleerly Inc. % John J. Smith, M.D., J.D. Regulatory Counsel Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW WASHINGTON DC 20004 Re: K190868 Trade/Device Name: Cleerly Labs Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 9, 2019 Received: October 9, 2019 Dear Dr. 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 (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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190868 Device Name Cleerly Labs ### Indications for Use (Describe) 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 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 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. | Type of Use (Select one or both, as applicable) | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | <table border="0"><tr><td><div><span style="font-size:12pt"><img src="checkbox_checked.png"/></span>Prescription Use (Part 21 CFR 801 Subpart D)</div></td></tr><tr><td><div><span style="font-size:12pt"><img src="checkbox_unchecked.png"/></span>Over-The-Counter Use (21 CFR 801 Subpart C)</div></td></tr></table> | <div><span style="font-size:12pt"><img src="checkbox_checked.png"/></span>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span style="font-size:12pt"><img src="checkbox_unchecked.png"/></span>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | | <div><span style="font-size:12pt"><img src="checkbox_checked.png"/></span>Prescription Use (Part 21 CFR 801 Subpart D)</div> | | | | <div><span style="font-size:12pt"><img src="checkbox_unchecked.png"/></span>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | | | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the word "clearly" in a stylized font. The word starts with a stylized "c" that is made up of small squares that are green and blue. The rest of the word is in a sans-serif font and is blue. The word is written in lowercase letters. # 510(k) Summary Cleerly Labs (K190868) #### 1. General Information ## Table 1: Cleerly, Inc. Information | 510(k) Sponsor | Cleerly, Inc. | |----------------|---------------------------------------------------| | Address | 101 Greenwich St, Suite 11C<br>New York, NY 10006 | | Phone/Fax # | 646-362-4255 | | Contact Person | Kimberly Elmore | | Date Prepared | October 9, 2019 | #### 2. Device Information Table 2: Cleerly Labs Information | Trade Name | Cleerly Labs (K190868) | |-------------------|----------------------------------------------------------------| | Common Name | System, Image Processing, Radiological | | Regulation Number | 21 CFR 892.2050 Picture Archiving And Communications<br>System | | Classification | Class II | | Product Code | LLZ | | Predicate Device | Autoplaque (K122429) | | Reference Device | SurePlaque (K043111) | #### Device Description 3. Cleerly Labs is a post-processing web-based software application that enables trained medical professionals to analyze 2D/3D coronary images acquired from Computed Tomography (CT) angiographic scans. The software is a post-processing tool that aids in determining treatment paths for patients suspected to have coronary artery disease (CAD). To aid in image analysis, tools are provided to users to navigate and manipulate images. Manual and semi-automatic segmentation of the coronary artery images are possible using editing tools, thus providing the user the flexibility to perform the coronary analysis. The output of the software includes visual images of coronary arteries, distance and volume measurements of the lumen wall, vessel wall, and plaque, remodeling index as well as stenosis diameter and area. These measurements are based on user segmentation. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "clearly" in a stylized font. The word is written in a gradient of colors, starting with green on the left and fading into blue on the right. To the left of the word, there is a cluster of small squares that appear to be disintegrating or pixelating, adding a digital or technological feel to the logo. The overall design is clean and modern. #### Indications for Use 4. 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 and stenosis in patients who underwent Coronary Computed Tomography Angiography (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. #### ട. Software Functionality Users of Cleerly Labs can edit the lumen and vessel walls of the suggested segmentation, and demarcate stenosis and stents, to more efficiently perform coronary analysis. Users are provided with image viewing tools to aid in their analysis. Plaque and stenosis measurements are output based on the combination of fully user-editable segmentation and user-placed demarcations of coronary artery characteristics. #### Cybersecurity 6. Cleerly Labs has implemented security features for device and data protection. Cybersecurity requirements, risk analysis, and mitigation was addressed in accordance with FDA guidance, "Content of Premarket Submission for Management of Cybersecurity in Medical Devices". {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "clearly" in a stylized font. The word is written in a gradient of colors, starting with a light green on the left and transitioning to a dark blue on the right. The left side of the word has a pixelated effect, as if the letters are dissolving into small squares. #### 7. Comparison of Technological Characteristics to the Predicate Devices | Feature | Subject Device:<br>Cleerly Labs (K190868) | Predicate Device:<br>Autoplaque (K122429) | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | Operating Requirements | | | | Platform | Client-Server Google<br>Chrome Application | Windows OS | | Image Input | DICOM 3.0 Compliant (or<br>higher) | DICOM 3.0 Compliant (or<br>higher) | | Image Acquisition | CT Images | CT Images | | Navigation Tools | Window Width/Level Zoom Pan Rotation Tracker | Window Width/Level Zoom Pan Rotation Tracker | | Visualization / Edit<br>Tools | Lumen Wall Vessel Wall Segment Stenosis Centerline Plaque Chronic Total Occlusion (CTO) Stent Exclude Distance | Lumen Wall Vessel Wall Segment Stenosis Centerline Plaque Exclude Distance | | 2D Imaging | Yes | Yes | | 3D Imaging | Yes | Yes | | Multiplanar<br>Reformat (MPR) | Yes | Yes | | Segmentation of<br>region of interest | Manual and Semi-Automatic | Manual and Semi-Automatic | | Feature | Subject Device:<br>Cleerly Labs (K190868) | Predicate Device:<br>Autoplaque (K122429) | | Plaque<br>Composition<br>Overlay | User-Modifiable<br>Thresholds:<br>• Non-Calcified Plaque (NCP)<br>• Calcified Plaque (CP)<br>• Low-Density Non-Calcified Plaque (LD-NCP) | User-Modifiable<br>Thresholds:<br>• Non-Calcified Plaque (NCP)<br>• Calcified Plaque (CP)<br>• Low-Density Non-Calcified<br>Plaque (LD-NCP) | | Quantification | | | | Hounsfield Unit<br>(HU) | Yes | Yes | | Distance<br>Measurements | • Vessel<br>• Lesion<br>• Length | • Vessel<br>• Lesion<br>• Length | | Volumetric<br>Measurements | • Total Vessel<br>• Total Lumen<br>• Non-Calcified Plaque<br>(NCP)<br>• Low-Density Non-<br>Calcified Plaque (LD-<br>NCP)<br>• Calcified Plaque (CP)<br>• Total Plaque | • Total Vessel<br>• Non-Calcified Plaque (NCP)<br>• Low-Density Non-Calcified<br>Plaque (LD-NCP)<br>• Calcified Plaque (CP)<br>• Total Plaque | | Remodeling Index | Yes | Yes | | Stenosis | • % Area Stenosis<br>• % Diameter Stenosis | • % Area Stenosis<br>• % Diameter Stenosis | ## Table 3: Device Features Comparison Table Cleerly Labs Traditional 510(k) Submission {6}------------------------------------------------ # clesrly #### Performance Data 8. Software verification and validation activities were performed in accordance with the standards identified in Table 4 below, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices." Cleerly Labs Traditional 510(k) Submission {7}------------------------------------------------ The software was considered as a "moderate" level of concern, since "a malfunction of, or a latent design flaw in, the Software Device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury." During product development, potential hazards were controlled by a risk management plan including activities of risk analysis, risk mitigation and risk-benefit analysis. Verification, validation and usability testing data demonstrated that the device meets all of its specification, including compliance with the following standards in Table 4. | Standards<br>No | Standard<br>Organization | Title | Version | Date | |-----------------|--------------------------|----------------------------------------------------------------------------------------------|-------------------------------|------------| | PS 3.1-<br>3.20 | NEMA | Digital Imaging<br>And<br>Communications In<br>Medicine (DICOM)<br>Set | 2016 | 06-27-2016 | | 62304 | ANSI/AAMI/<br>IEC | Medical device<br>software - Software<br>life cycle processes | 2006+AMD1:2015<br>Edition 1.1 | 06-26-2016 | | 14971 | ISO | Medical Devices -<br>Application Of Risk<br>Management To<br>Medical Devices | 2007<br>Edition 2.0 | 03-01-2007 | | 62366-1 | ANSI AAMI<br>IEC | Medical Devices -<br>Part 1: Application<br>Of Usability<br>Engineering To<br>Medical Device | 2015<br>Edition 1.1 | 02-24-2015 | Table 4: Standards applied to device development Additionally, the performance of the software was compared to ground truth results produced by expert readers. Pearson Correlation Coefficients and Bland-Altman Agreements between Cleerly Labs and expert reader results is reported Table 5. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "clearly" in a stylized font. The word starts with a green color that transitions to blue as it moves to the right. The left side of the word has a pixelated effect, with small squares of green and blue fading away from the main text. | Output | Pearson Correlation | Bland-Altman Agreement | |-------------------------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Coefficient | | | Lumen Volume | 0.91 | 96% | | Vessel Volume | 0.93 | 97% | | Total Plaque Volume | 0.85 | તે તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો | | Calcified Plaque Volume | 0.94 | તે તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો | | Non-Calcified Plaque | 0.74 | તેરજ | | Volume | | | | Low-Density-Non- | 0.53 | 97% | | Calcified Plaque Volume | | | ## Table 5: Cleerly Labs Performance ## Non-Clinical Testing: Safety, performance, cybersecurity and usability of Cleerly Labs have been evaluated and verified in accordance with software pre-defined specifications and applicable performance standards through software verification and validation testing. - Verification and validation testing confirmed that the software requirements ● fulfilled the pre-defined acceptance criteria. - A Usability test was conducted with U.S. board certified radiologists and ● technicians to ensure the clinical acceptability of the device. - The machine learning algorithms were evaluated by comparing the output of the ● software to that of the ground truth using multiple ground truthers. - A side-by-side comparison testing was conducted to evaluate the simple rule-based ● calculations as they compared to an already cleared device with a similar intended use. - . A cybersecurity penetration testing was conducted to ensure that there were no unidentified vulnerabilities and that the appropriate risk control measures were implemented to protect from known vulnerabilities when the device is subject to a source of threat. The non-clinical verification and validation test results established that the device meets its design requirements and intended use. During the development, potential hazards were evaluated and controlled through risk management activities. The performance testing demonstrates that the device meets all its specifications. ## Clinical Testing No clinical testing was conducted to demonstrate safety or effectiveness as the device's non-clinical (bench) testing was sufficient to support the intended use of the device. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the word "clearly" in a stylized font. The word is written in a gradient of colors, starting with green on the left and transitioning to blue on the right. The first letter of the word is stylized with a pixelated effect. ## 9. Conclusion Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing comparison to the predicate, the Cleerly Labs device raises no new questions of safety or effectiveness and is substantially equivalent to the predicate in terms of safety, efficacy, and performance.