(105 days)
Yes
The document explicitly states that a "Deep Learning Algorithm is incorporated in CardIQ Suite to automatically segment and label the calcific regions". Deep Learning is a subset of Machine Learning.
No
Explanation: The device is a software application designed for analysis, visualization, and measurement of cardiovascular anatomy and pathology to aid in diagnosis and treatment path determination, but it does not directly treat or provide therapy to a patient.
Yes
Explanation: The Intended Use/Indications for Use section explicitly states that "CardIQ Suite also aids in diagnosis and determination of treatment paths for cardiovascular diseases". The Device Description further highlights its capabilities in calcium scoring, which is a key diagnostic tool for evaluating calcified plaques and monitoring progression, thus aiding in the prognosis of cardiac disease.
Yes
The device is explicitly described as a "non-invasive software application" designed to work with existing DICOM CT data. The description focuses solely on the software's functionalities for analysis, visualization, and measurement, without mentioning any accompanying hardware components or hardware-specific validation.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description clearly states that CardIQ Suite is a software application that analyzes DICOM CT data from acquisitions of the heart. This data is generated by an imaging device (CT scanner) and represents images of the internal anatomy, not biological samples like blood, urine, or tissue.
- The intended use is for image analysis and interpretation. The software provides tools for visualization, measurement, and analysis of cardiovascular anatomy and pathology based on medical images. This is a function of medical image processing and analysis, not in vitro testing.
The device is a medical device software that aids in the diagnosis and treatment planning of cardiovascular diseases by processing and analyzing medical images. It falls under the category of medical imaging software, not in vitro diagnostics.
No
The input document does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
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, heart structures and follow-up for stent placement, bypasses and plaque imaging. CardIO 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. Calcium Scoring may be used to monitor the progression of calcium in coronary arteries overtime, which may aid in the prognosis of cardiac disease.
Product codes (comma separated list FDA assigned to the subject device)
JAK, LLZ
Device Description
CardlQ 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 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 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.
CardlQ Suite provides the Coronary 2D Review toolset which allows interactive 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 such as chambers, valves and arteries in motion. Distance measurement and ROI tools are available for quantitative evaluation of the anatomy.
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
CT
Anatomical Site
cardiovascular anatomy, heart, coronary arteries, heart valves, great vessels such as the aorta, cardiac structures, chambers, arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 validated CardIQ Suite Calcium Scoring algorithm's capability to automatically segment, label and score the calcific regions in the coronary arteries using a database of retrospective CT exams. This database of exams is representative of the clinical scenarios where CardlQ Suite is intended to be used, with consideration of acquisition protocols and clinical indicators.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Three board certified radiologists manually scored a representative set of clinical sample images using the predicate device and the results were compared with the automated score outputted by CardIQ Suite. Very high correlations were found between manual and automated methods for computing the total calcium score, demonstrating equivalent performance of the CardIQ Suite software to the predicate device SmartScore 4.0.
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.
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.
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.
0
March 11, 2022
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GE Medical Systems SCS % Yonghui Han Regulatory Affairs Leader 283, rue de la Miniere Buc, 78530 FRANCE
Re: K213725
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, LLZ Dated: February 17, 2022 Received: February 18, 2022
Dear Yonghui Han:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 medical devices and radiation-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,
Laurel Burk Assistant 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
Enclosure
2
Indications for Use
510(k) Number (if known)
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, heart structures and follow-up for stent placement, bypasses and plaque imaging. CardIO 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. Calcium Scoring may be used to monitor the progression of calcium in coronary arteries overtime, which may aid in 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 logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized, cursive font, enclosed within a circular shape. The circular shape is made up of swirling lines, giving it a dynamic and fluid appearance. The logo is presented in a blue color.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | November 23, 2021 |
|---|---|
| Submitter: | GE Medical Systems SCS |
| Establishment Registration Number - 9611343 | |
| 283 rue de la Miniere | |
| 78530 Buc, France | |
| Primary Contact Person: | Yonghui Han |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| (86)10 57083350/(+86) 13311387032 | |
| Yonghui.Han@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: | CardIQ Suite |
| Primary Regulation Number: | Computed Tomography X-Ray System (21 CFR 892.1750) |
| Primary Product Code: | JAK |
| Secondary Product Code: | LLZ |
| Classification: | Class II |
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Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by a series of swirling lines, resembling water droplets or waves, which are also blue. The overall design is simple and iconic, representing the company's brand identity.
| Predicate Device | |
|---|---|
| Device name: | SmartScore 4.0 |
| Manufacturer: | GE Medical Systems SCS |
| 510(k) number: | K020929 |
| Regulation Number: | 21 CFR 892.1750 Computed tomography X-Ray System |
| Product Code: | JAK |
| Classification: | Class II |
| Reference Devices | |
| Device name: | CardIQ Xpress 2.0 |
| Manufacturer: | GE Medical Systems SCS |
| 510(k) number: | K073138 |
| Regulation Number: | 21 CFR 892.1750 Computed tomography X-Ray System |
| Product Code: | JAK |
| Classification: | Class II |
| Device name: | Syngo.CT CaScoring |
| Manufacturer: | Siemens Medical Solutions USA, Inc. |
| 510(k) number: | K201034 |
| Regulation Number: | 21 CFR 892.1750 Computed tomography X-Ray System |
| Product Code: | JAK |
| Classification: | Class II |
Device Description:
CardlQ 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.
5
Image /page/5/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The letters are stylized and connected, and there are white swirls around the outside of the circle. The logo is simple and recognizable, and it is often used to represent the company.
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 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 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.
CardlQ Suite provides the Coronary 2D Review toolset which allows interactive 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 such as chambers, valves and arteries in motion. 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, 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 noncontrasted cardiac images to evaluate calcified plaques in the coronary arteries, heart valves and great vessels such as the aorta. Calcium Scoring may be used to monitor the progression of calcium in coronary arteries overtime, which may aid in the prognosis of cardiac disease.
Technology:
The proposed device CardIQ Suite employs the same fundamental scientific technology as its predicate device and reference devices.
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Image /page/6/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle has a swirling design around the letters. The logo is simple and recognizable.
Comparison:
The table below summarizes the key feature/technological differences and similarities between the predicate device and the proposed device:
| Specification | Predicate
Device:
SmartScore 4.0
(K020929) | Proposed
Device:
CardIQ Suite | Comparison |
|--------------------------------------------------------------------------|-----------------------------------------------------|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Segmentation
and labeling
calcific regions
in the
coronaries | Manual | Automated | Substantial Equivalent
Deep Learning Algorithm is incorporated in CardIQ Suite to
automatically segment and label the calcific regions in the
coronary arteries in order to improve workflow efficiency
over the manual approach that exists in the predicate
device.
Automated calcium scoring evaluation already exists in the
reference device Syngo.CT CaScoring (K201034). |
| Manual
Segmentation
and labeling of
calcific regions | Yes | Yes | Identical |
| Computation
of Agatston
score | Yes | Yes | Identical |
| Coronary 2D
Review | Not Available | Yes | Substantial Equivalent
Coronary 2D Reviews Toolset is available in CardIQ Suite to
assist users for a seamless integrated review of coronary
artery imaging along with automated calcium scoring
feature.
This tool set contains identical features to what already
exists in the reference device CardIQ Xpress 2.0 (K073138) |
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
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Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular shape. The color of the logo is a bright blue. The logo is simple and recognizable, representing the General Electric brand.
device complies with NEMA PS 3.1 - 3.20 (2016) 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 device. Software documentation is for a MODERATE level of concern.
In addition, Engineering has validated CardIQ Suite Calcium Scoring algorithm's capability to automatically segment, label and score the calcific regions in the coronary arteries using a database of retrospective CT exams. This database of exams is representative of the clinical scenarios where CardlQ 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
Three board certified radiologists manually scored a representative set of clinical sample images using the predicate device and the results were compared with the automated score outputted by CardIQ Suite. Very high correlations were found between manual and automated methods for computing the total calcium score, demonstrating equivalent performance of the CardIQ Suite software to the predicate device SmartScore 4.0.
Conclusion:
CardIQ Suite has substantial equivalent technological characteristics as its predicate device.
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 predicate.
Based on development under GE Healthcare's quality system, successful design verification, software documentation for a "Moderate" level of concern, along with the engineering bench testing and sample 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.