K Number
K233731
Device Name
CardIQ Suite
Date Cleared
2024-08-01

(254 days)

Product Code
Regulation Number
892.1750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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 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.
More Information

Yes
The device description explicitly states that the calcium segmentation/labeling uses a "new deep learning algorithm." Deep learning is a subset of machine learning.

No.

The device is a software application designed for the analysis, visualization, and measurement of cardiovascular anatomy and pathology based on medical images. It aids in diagnosis and determination of treatment paths by providing information such as calcium scoring and measurements, but it does not directly treat or prevent diseases.

Yes
The "Intended Use / Indications for Use" section explicitly states that the "CardIQ Suite also aids in diagnosis and determination of treatment paths for cardiovascular diseases".

Yes

The device description explicitly states it is a "non-invasive software application" and details its functions related to processing and analyzing DICOM CT data. There is no mention of accompanying hardware components that are part of the device itself.

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
  • This device analyzes medical images: CardIQ Suite processes and analyzes medical images (CT scans) of the heart and cardiovascular system. It does not interact with or analyze biological samples.

The device is a software application for image analysis and visualization, which falls under the category of medical imaging software, not In Vitro Diagnostics.

No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The relevant text section is "Not Found".

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

JAK, QIH

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 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Yes

Input Imaging Modality

CT

Anatomical Site

Cardiovascular anatomy, heart, coronary arteries, heart valves, great vessels such as the aorta.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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.

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing:
Bench testing was performed for the newly introduced deep learning algorithms (automated heart segmentation, coronary segmentation, coronary centerline tracking, and coronary labeling) using a database of retrospective CT exams. The algorithm validation successfully passed defined acceptance criteria.

Clinical Testing:
A reader study was conducted using a sample of clinical CT images processed with CardIQ Suite. The study evaluated the output of automated Heart Segmentation, Coronary Tree Segmentation, Coronary Centerline Tracking, and Coronary Artery Labeling using Likert Scales and Additional Grading Scales. The results indicated that the automated outputs for Heart Segmentation, Coronary Tree Segmentation, Coronary Centerline tracking, and Coronary Labeling were scored as acceptable by readers for greater than 90% of exams with good image quality. The study concluded that the automation of these functions provides an improvement in workflow efficiency compared to predicate and reference devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K213725

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K073138

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.

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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

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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)
Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

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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

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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 NameSystem, 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

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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:

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| 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 |

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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.

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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.

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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. |

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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.

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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.

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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.