Who is the manufacturer of CardIQ Suite?

GE Medical Systems SCS filed the 510(k) submission for CardIQ Suite (K233731).

What is the FDA product code for CardIQ Suite?

JAK. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for CardIQ Suite?

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

Does CardIQ Suite use AI or machine learning?

Yes. CardIQ Suite (K233731) 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 CardIQ Suite?

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 CardIQ Suite 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.

CardIQ Suite

K233731 · GE Medical Systems SCS · JAK · Aug 1, 2024 · Radiology

Device Facts

Record ID	K233731
Device Name	CardIQ Suite
Applicant	GE Medical Systems SCS
Product Code	JAK · Radiology
Decision Date	Aug 1, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K233731 · Aug 1, 2024	CardIQ Suite	GE Medical Systems SCS	Retrospective CT exam database	A database of retrospective CT exams, representative of clinical scenarios and acquisition protocols, was used to perform bench testing and validation of four new deep learning algorithms (automated heart segmentation, coronary segmentation, coronary centerline tracking, and coronary labeling).	Retrospective CT exams; Algorithm validation; Deep learning

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Algorithm validation bench testing; Retrospective performance evaluation	Clinical CT exams representative of intended use scenarios	Not applicable for this study	Algorithm performance against defined acceptance criteria

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Heart Segmentation	Deep learning algorithm	—	>90% acceptable	—	—	Reader study evaluation of clinical CT images	>1 (readers)
Coronary Tree Segmentation	Deep learning algorithm	—	>90% acceptable	—	—	Reader study evaluation of clinical CT images	>1 (readers)
Coronary Centerline Tracking	Deep learning algorithm	—	>90% acceptable	—	—	Reader study evaluation of clinical CT images	>1 (readers)
Coronary Artery Labeling	Deep learning algorithm	—	>90% acceptable	—	—	Reader study evaluation of clinical CT images	>1 (readers)

Indications for Use

CardIQ Suite is a collection of non-invasive software features intended to analyze CT cardiovascular anatomy and pathology and aid in determining treatment paths.

Device Story

CardIQ Suite is a non-invasive software application for analyzing cardiovascular CT DICOM data. It processes 2D/3D cardiac non-contrast and angiography images to provide automated/manual measurements, vessel visualization, and chamber mobility assessment. It features deep learning algorithms for automated heart segmentation, coronary tree segmentation, coronary centerline tracking, and coronary artery labeling. Calcium scoring is performed using Agatston/Janowitz 130 (AJ 130) and Volume/Adaptive Volume methods. Used in clinical settings by healthcare providers to aid diagnosis, treatment planning for coronary artery disease, and follow-up for stents/bypasses. Output includes quantitative scores, segmented images, and measurements, which are exported via DICOM SR or integrated into reports. The device improves workflow efficiency by automating tasks previously performed manually or via traditional signal processing/rule-based methods.

Clinical Evidence

Reader study evaluation using clinical CT images. Evaluated automated Heart Segmentation, Coronary Tree Segmentation, Coronary Centerline Tracking, and Coronary Artery Labeling using Likert and grading scales. Results showed automated outputs were acceptable for >90% of exams with good image quality. Study concluded that automation provides improved workflow efficiency compared to manual or traditional algorithmic methods used in predicate/reference devices.

Technological Characteristics

Software-only device; operates on AW Server platform. Complies with NEMA PS 3.1-3.20 (DICOM). Features deep learning-based algorithms for segmentation, tracking, and labeling. Supports Agatston/Janowitz 130 (AJ 130), Volume, and Adaptive Volume scoring. Connectivity via DICOM networking.

Indications for Use

Indicated for patients undergoing 2D or 3D CT cardiac non-contrast and angiography imaging. Used for visualization and measurement of vessels, chamber mobility, and cardiovascular disease diagnosis/treatment planning (coronary artery disease, functional parameters, stent/bypass follow-up, plaque imaging). Includes calcium scoring for evaluating calcified plaques in coronary arteries, heart valves, and great vessels (e.g., aorta) to monitor calcium progression and aid prognosis.

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

CardIQ Suite (K213725)

Reference Devices

CardIQ Xpress 2.0 (K073138)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION". GE Medical Systems SCS °/o Peter Uhlir Regulatory Affairs Program Manager 283 Rue De La Miniere Buc, 78530 FRANCE Re: K233731 Trade/Device Name: CardIQ Suite Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK, OIH Dated: November 21, 2023 Received: July 3, 2024 Dear Peter Uhlir: 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. 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). {1}------------------------------------------------ for Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. 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 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, Gabriela M. Digitally signed by Rodal -S Gabriela M. Rodal -S Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233731 Device Name CardIQ Suite #### Indications for Use (Describe) CardIQ Suite is a non-invasive software application designed to provide an optimized application to analyze cardiovascular anatomy and pathology based on 2D or 3D CT cardiac non contrast and angiography DICOM data from acquisitions of the heart. It provides capabilities for the visualization and measurement of vessels and visualization of chamber mobility. CardIQ Suite also aids in diagnosis and determination of treatment paths for cardiovascular diseases to include, coronary artery disease, functional parameters of the heart structures and follow-up for stent placement, bypasses and plaque imaging. CardIQ Suite provides calcium scoring, a non-invasive software application, that can be used with non-contrasted cardiac images to evaluate calcified plaques in the coronary arteries, heart valves and great vessels such as the clinician can use the information provided by calcium scoring to monitor the progression of calcium in coronary arteries over time, and this information may aid the clinician in their determination of the prognosis of cardiac disease. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the text "510(k) Summary – K233731" in bold black font. The text is centered on a white background. The text indicates that the document is a summary related to a 510(k) submission, which is a type of premarket submission to the FDA for medical devices, and the number K233731 is the submission number. are In accordance with 21 CFR 807.92 the following summary of information is provided: | Date: | July 31, 2024 | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Medical Systems SCS Establishment Registration Number - 9611343 283 rue de la Miniere 78530 Buc, France | | Primary Contact Person: | Peter Uhlir Regulatory Affairs Program Manager GE HealthCare Tel: (+36) 70-436-9317 Email: peter.uhlir@ge.com | | Secondary Contact Person: | Elizabeth Mathew Senior Regulatory Affairs Manager GE HealthCare Tel: 262-424-7774 Email: Elizabeth.Mathew@ge.com | | Device Trade Name: | CardIQ Suite | | Common/Usual Name: | System, X-Ray, Tomography, Computed | | Primary Classification name: | Computed tomography x-ray system | | Primary Regulation Number: | 21 CFR 892.1750 | | Primary Product Code: | JAK | | Secondary Product Code: | QIH | | Classification: | Class II | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains the GE Healthcare logo. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized, circular design with intertwined elements, and the text is in a sans-serif font, both rendered in a shade of purple. | Primary Predicate Device | | |--------------------------|-------------------------------------| | Device name: | CardIQ Suite | | Common/Usual Name: | System, X-Ray, Tomography, Computed | | Manufacturer: | GE Medical Systems SCS | | 510(k) number: | K213725 | | Classification Name: | Computed tomography x-ray system | | Regulation Number: | 21 CFR 892.1750 | | Product Code: | JAK | | Classification: | Class II | | Reference Device: | | | Device name: | CardIQ Xpress 2.0 | | Common/Usual Name | System, X-Ray, Tomography, Computed | | Manufacturer: | GE Medical Systems SCS | | 510(k) number: | K073138 | | Classification Name: | Computed tomography x-ray system | | Regulation Number: | 21 CFR 892.1750 | | Product Code: | JAK | | Classification: | Class II | ## Device Description: CardIQ Suite is a non-invasive software application designed to work with DICOM CT data acquisitions of the heart. It is a collection of tools that provide capabilities for generating measurement's both automatically and manually, displaying images and associated measurements in an easy-to-read format and tools for exporting images and measurements in a variety of formats. CardIQ Suite provides an integrated workflow to seamlessly review calcium scoring and coronary CT angiography (CCTA) data. Calcium Scoring has the capability to automatically segment and label the calcifications within the coronary arteries, and then automatically compute a total and per territory calcium score. The calcium segmentation/labeling is using a new deep learning algorithm. The calcium scoring is based on the standard Agatston/Janowitz 130 (AJ 130) and Volume scoring methods for the segmented calcific regions. The software also provides the users a manual calcium scoring capability that allows them to edit (add/delete or update) auto scored {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the GE Healthcare logo. The logo consists of a purple circular emblem with intertwined letters, followed by the text "GE HealthCare" in purple. The text is written in a clean, sans-serif font. lesions. It also allows the user to manually score calcific lesions within coronary arteries, aorta, aortic valve and mitral valve as well as other general cardiac structures. Calcium scoring offers quantitative results in the AJ 130 score, Volume and Adaptive Volume scoring methods. Calcium Scoring results can be exported as DICOM SR to assist with integration into structured reporting templates. Images can be saved and exported for sharing with referring physicians, incorporating into reports and archiving as part of the CT examination. The Multi-Planar Reformat (MPR) Cardiac Review and Coronary Review steps provide an interactive toolset for review of cardiac exams. Coronary CTA datasets can be reviewed utilizing the double oblique angles to visually track the path of the coronary arteries as well as to view the common cardiac chamber orientations. Cine capability for multi-phase data may be useful for visualization of cardiac structures in motion such as chambers, valves and arteries, automatic tracking and labeling will allow a comprehensive analysis of the coronaries. Distance measurement and ROI tools are available for quantitative evaluation of the anatomy. #### Intended Use: CardIQ Suite is a collection of non-invasive software features intended to analyze CT cardiovascular anatomy and pathology and aid in determining treatment paths. #### Indication for Use: CardIQ Suite is a non-invasive software application designed to provide an optimized application to analyze cardiovascular anatomy and pathology based on 2D or 3D CT cardiac non contrast and angiography DICOM data from acquisitions of the heart. It provides capabilities for the visualization and measurement of vessels and visualization of chamber mobility. CardIQ Suite also aids in diagnosis and determination of treatment paths for cardiovascular diseases to include, coronary artery disease, functional parameters of the heart structures and follow-up for stent placement, bypasses and plaque imaging. CardIQ Suite provides calcium scoring, a non-invasive software application, that can be used with non-contrasted cardiac images to evaluate calcified plaques in the coronary arteries, heart valves and great vessels such as the aorta. The clinician can use the information provided by calcium scoring to monitor the progression of calcium in coronary arteries over time, and this information may aid the clinician in their determination of the prognosis of cardiac disease. #### Technology: The proposed device CardIQ Suite employs the same fundamental scientific technology as its predicate and reference devices. #### Comparison: The table below summarizes the key feature/technological differences and similarities between the predicate devices: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the GE HealthCare logo. The logo consists of a circular emblem with intertwined letters on the left, followed by the text "GE HealthCare" on the right. The emblem and text are both in a purple color. | Specification | Primary Predicate Device: CardIQ Suite (K213725) | Subject Device: CardIQ Suite | Comparison | |--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Input Data for Calcium Scoring | Image Requirements: * 120kVp * Gated cardiac acquisition * DFOV - 24 cm - 26 cm * Slice thickness ≤ 3mm * Non-contrast | Image Requirements: * 120kVp * Gated cardiac acquisition * DFOV - 24 cm - 35 cm * Slice thickness ≤ 3mm * Non-contrast | Substantially equivalent. The only modification in the subject device comes from the DFOV limitation that has been adjusted to be less restrictive. | | Segmentation and labeling calcific regions in the coronaries | Yes, Automated using deep learning algorithm | Yes, Automated using deep learning algorithm | Identical | | Manual Segmentation and labeling of calcific regions | Yes | Yes | Identical | | Labeling of calcifications | The software provides the following labels for the coronary arteries according to regional territories. • LAD territory: Left Main Artery (LMA), Ramus Intermedius Branch (RIB), Left Anterior Descending (LAD) and all Diagonal branches. • LCX territory: Left Circumflex artery (LCX) and all Obtuse marginal branches. • RCA territory: Right Coronary Artery (RCA), Posterior Descending Artery (PDA) and | The software provides the following labels for the coronary arteries according to regional territories. • LAD territory: Left Main Artery (LMA), Ramus Intermedius Branch (RIB), Left Anterior Descending (LAD) and all Diagonal branches. • LCX territory: Left Circumflex artery (LCX) and all Obtuse marginal branches. • RCA territory: Right Coronary Artery (RCA), Posterior Descending Artery (PDA) and | Identical | | Specification | Primary Predicate Device: CardIQ Suite (K213725) | Subject Device: CardIQ Suite | Comparison | | | Posterior Lateral Branch (PLB). | Posterior Lateral Branch (PLB). | | | Computation of Agatston score | Yes | Yes | Identical | | Calcium Score – Volume Scoring Method | Yes, Volume and Adaptive Volume | Yes, Volume and Adaptive Volume | Identical | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the GE HealthCare logo. The logo consists of a circular emblem with the letters 'GE' intertwined inside, followed by the text 'GE HealthCare' in a simple, sans-serif font. The emblem and text are both in a matching shade of purple. {8}------------------------------------------------ Image /page/8/Picture/1 description: This image shows a table comparing the primary predicate device, subject device, and comparison for cardiac review using CardIQ Suite (K213725) and CardIQ Suite. The primary predicate device and subject device both involve coronary 2D review to assist readers in coronary artery imaging. The comparison states that the devices are substantially equivalent, with the only difference being the introduction of a new deep learning algorithm to automatically segment the heart and provide a segmented 3D Volume Rendering model of the heart. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the GE HealthCare logo. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is purple and features a stylized design. The text is also purple and in a sans-serif font. | Specification | Primary Predicate Device: CardIQ Suite (K213725) | Subject Device: CardIQ Suite | Comparison | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Data Export | CardIQ Suite provides a variety of methods for sharing the results with clinical partners. * Calcium Score results and scored images can be saved as DICOM SR series and networked to DICOM destinations for structured reporting purposes. * Copy individual images or the results table to paste into personalized communications. * Screen capture individual images and results to save data pertinent to the patient file for selective archiving needs. * Generate file for importing into customized report templates or research file management needs * Export selected Images | CardIQ Suite provides a variety of methods for sharing the results with clinical partners. * Calcium Score results and scored images can be saved as DICOM SR series and networked to DICOM destinations for structured reporting purposes. * Copy individual images or the results table to paste into personalized communications. * Screen capture individual images and results to save data pertinent to the patient file for selective archiving needs. * Generate file for importing into customized report templates or research file management needs * Export selected Images | Identical | | Coronary Review step | No | Yes | Substantial Equivalent Deep-Learning Algorithms are incorporated in the subject device to automatically segment coronary, automatically track and label coronary centerline in order to improve workflow efficiency. The same functionalities already exist in the reference device CardIQ Xpress 2.0 (K073138), the difference is in how the functionality is | | Specification | Primary Predicate Device: | Subject Device: | Comparison | | | CardIQ Suite (K213725) | CardIQ Suite | implemented in the devices. For the Coronary tree segmentation, the reference device, CardIQ Xpress 2.0 (K073138) utilizes signal processing methods to achieve coronary segmentation, whereas in the subject device a deep-learning based algorithm is implemented to perform the same function. | | | | CardIQ Suite | For the Coronary centerline tracking, the reference device CardIQ Xpress 2.0 utilizes mathematical morphology, leveraging on hessian filters and ray tracing to provide the coronary centerline tracking, whereas in the subject device a deep-learning based algorithm is implemented to perform the same function. The prerequisite for this algorithm is that the Coronary tree segmentation must be performed. | | | | CardIQ Suite | For the Coronary labeling, the reference device CardIQ Xpress 2.0 utilizes a rules- based algorithm, based on the knowledge of the anatomy of the coronaries, whereas in the subject device a deep-learning based algorithm is implemented to perform the same function. The prerequisite for this algorithm is that the Coronary tree segmentation and Coronary centerline tracking must be performed. | | | | CardIQ Suite | From the user perspective the output of the coronary segmentation, tracking and labeling, the editing capability for coronary segmentation, tracking and labeling and the workflow remains the same between the subject device and reference device. The main reason to incorporate the deep learning algorithms is to improve the workflow efficiency. | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the text "GE HealthCare" is written in a sans-serif font, also in purple. The logo is simple and clean, with a focus on the company's name and brand identity. {11}------------------------------------------------ Image /page/11/Picture/1 description: The image contains the GE Healthcare logo. The logo consists of a circular emblem with intertwined letters, followed by the text "GE HealthCare" in a sans-serif font. The color of the logo and text is a shade of purple. #### Determination of Substantial Equivalence: #### Summary of Non-Clinical, Design Control Testing CardIQ Suite has successfully completed the design control testing per GE's quality system. It was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. No additional hazards were identified, and no unexpected test results were observed. The proposed device complies with NEMA PS 3.1 - 3.20 (2022) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard. The following quality assurance measures were applied to the development of the device: - Requirements Definition - Risk Analysis - Technical Design Reviews - Formal Design Reviews ● - Software Development Lifecycle - Performance testing (Verification, Validation) - Safety Testing (Verification) The proposed CardIQ Suite has been successfully verified on the AW Server platform. All the testing and results did not raise new or different questions of safety and effectiveness other than those already associated with predicate devices. The documentation level was determined to be Basic Documentation Level. In addition, Engineering has performed bench testing for the four newly introduced deep learning algorithms in the subject device for automated heart segmentation, coronary segmentation, coronary centerline tracking and coronary labeling, using a database of retrospective CT exams. This database of exams is representative of the clinical scenarios where CardIQ Suite is intended to be used, with consideration of acquisition protocols and clinical indicators. The result of the algorithm validation showed that the algorithm successfully passed the defined acceptance criteria. #### Summary of Clinical Testing A reader study evaluation was performed with a sample of clinical CT images which were processed with the CardIQ Suite software. The purpose of this study was to evaluate the output of the automated Heart Segmentation, Coronary Tree Segmentation, Coronary Centerline Tracking and Coronary Artery Labeling using the Likert Scales and Additional Grading Scales. The reader evaluation concluded that the automated outputs provided by the Heart Segmentation, Coronary Tree Segmentation, Coronary Centerline tracking and Coronary Labeling algorithms incorporated in the subject device CardIQ Suite were scored to be acceptable by the readers for greater than 90% of the exams which had good image quality. Based on the reader study evaluation, we conclude that the automation of Heart Segmentation, Coronary Tree Segmentation, Coronary Centerline Tracking and Coronary Artery Labeling provides an improvement in workflow efficiency when compared to the predicate and reference devices wherein these functionalities were performed manually by the user or using traditional algorithms. {12}------------------------------------------------ Image /page/12/Picture/1 description: The image contains the GE Healthcare logo. The logo consists of a purple circle with a stylized "GE" inside, followed by the text "GE HealthCare" in purple. The text is written in a clean, sans-serif font. ## Conclusion: CardIQ Suite has substantial equivalent technological characteristics as its predicate devices. GE's quality system's design, verification, and risk management processes did not identify any new questions of safety or effectiveness, hazards, unexpected results, or adverse effects stemming from the changes to the predicates. Based on development under GE HealthCare's quality system, successful design verification, software documentation for a "Basic Documentation Level", along with the engineering bench testing and reader study, GE HealthCare believes that the proposed CardIQ Suite is substantially equivalent to, and hence as safe and as effective for its Intended Use as the legally marketed predicate device.

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