(84 days)
Not Found.
No
The summary describes image processing and analysis tools but does not mention AI, ML, or related concepts like deep learning or neural networks. The "automatic tracking" feature is described as pre-processing, not necessarily indicative of AI/ML.
No
The device is an image analysis software package intended to aid in diagnosing cardiovascular disease from CT angiographic images, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "aids in diagnosing of cardiovascular disease."
Yes
The device is explicitly described as a "post processing software option" and an "image analysis software package" that runs on existing hardware platforms (AW Platform, CT scanner, PACS, Centricity systems). The description focuses solely on the software's functionalities for analyzing CT images.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: CardIQ Xpress 2.0 is a software package that analyzes medical images (CT angiographic images) of the cardiovascular system. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states that it analyzes images to aid in determining treatment paths and diagnosing cardiovascular disease based on the visual information from the CT scans.
Therefore, CardIQ Xpress 2.0 falls under the category of medical image analysis software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
CardIO Xpress 2.0 is an optimized non-invasive application to analyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. CardIQ Xpress 2.0 is a CT, noninvasive, image analysis software package, which aids in diagnosing of cardiovascular disease to include, coronary artery disease, functional parameters of the heart, heart structures and follow-up for stent placement, bypasses and plaque imaging.
CardIQ Xpress 2.0 offers unique tools such as automatic tracking, which will pre-process the CT data into multiple viewing ports to allow for an expedited read time improving workflow. With CardIQ Xpress 2.0, the user can color code the myocardial tissue to show hypo/hyperdense areas in the myocardial tissue of the heart. With the IVUS-like view the user can color code the HU units of the plaque to better visualize the difference between calcified and non-calcified plaque in the wall of the vessel and the lumen to determine the amount of atherosclerosis. The user can see the different valve planes along with a variety of new layouts to align the heart. The IVUS like view is created by applying GE's Volume Rendering on a cross-section perpendicular to the detected centerline. This view merely displays a cross section as in IVUS imaging and color codes like IVUS images. No new or additional diagnostic information is added.
CardIQ Xpress 2.0 is for use on the Advantage Workstation (AW) platform, CT scanner, PAC or Centricity stations, which can be used in the analysis of 2D or 3D CT angiography images/data derived from DICOM 3.0 CT scans.
Product codes
JAK
Device Description
The GE Medical Systems CardIQ Xpress 2.0 software is a post processing software option for the Advantage Workstation (AW) Platform, CT scanner, PACS or Centricity systems. This product can be used in the analysis of CT angiographic images to view the coronary vessels to determine if the patient has normal coronary arteries, arteriolosclerosis or severe stenosis, which needs to go on for treatment. This software also can look at the heart structures to include valve imaging, heart motion and ejection fraction. CardIO Xpress 2.0 contains both graphic and text report capabilities with predefined templates for ease of use.
CardIO Xpress 2.0 with SnapShot* Freeze is additionally designed to reduce the coronary artery motion blurring in a CT image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Computed Tomography (CT) Angiographic images, DICOM 3.0 CT scans.
Anatomical Site
cardiovascular anatomy, coronary vessels, heart, coronary artery, myocardial tissue.
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
As referenced in Section 20, the CT acquired clinical images used for the completion of verification and validation testing for CardIQ Xpress 2.0 with Snapshot Freeze Option were obtained from a non-significant risk reader study of care patient images.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s)
Reference Device(s)
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circular border. The letters and the border are black, creating a strong contrast. The logo is a well-known symbol associated with the General Electric company.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | March 21, 2012 |
|---|---|
| Submitter: | GE Medical Systems, SCS (d.b.a. GE Healthcare) |
| 283, rue de la Miniere BP34 | |
| 78530 Buc Cedex - France | |
| FDA Registration Number: 9611343 | |
| Primary Contact | |
| Person: | Stephen Slavens, RAC |
| Regulatory Affairs Director, MICT | |
| GE Healthcare | |
| Phone: (262) 548-4992 | |
| FAX: 262-548-3844 | |
| Stephen.Slavens@ge.com | |
| Secondary Contact | |
| Person: | Helen Peng, RAC |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| Phone: (262) 548-5091 | |
| FAX: 262-548-3844 | |
| Hong.Peng@ge.com | |
| Device: | |
| Trade Name: | CardIQ Xpress 2.0 with SnapShot* Freeze Option |
| Common/Usual | |
| Name: | Accessory to: System, x-ray, tomography, computed |
| Classification Names: | 21CFR 892.1750 |
| Product Code: | JAK |
| Predicate Device(s): | Predicate Device Name: CardIQ Xpress Version 2.0 |
| Predicate 510k Number: K073138 | |
| Predicate Manufacturer: GE Medical Systems | |
| Device Description: | The GE Medical Systems CardIQ Xpress 2.0 software is a |
| post processing software option for the Advantage | |
| Workstation (AW) Platform, CT scanner, PACS or Centricity | |
| systems. This product can be used in the analysis of CT | |
| angiographic images to view the coronary vessels to | |
| determine if the patient has normal coronary arteries, | |
| arteriolosclerosis or severe stenosis, which needs to go on |
1
Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are solid black, creating a strong contrast against the white background.
GE Healthcare 510(k) Premarket Notification Submission
for treatment. This software also can look at the heart structures to include valve imaging, heart motion and ejection fraction. CardIO Xpress 2.0 contains both graphic and text report capabilities with predefined templates for ease of use.
CardIO Xpress 2.0 with SnapShot* Freeze is additionally designed to reduce the coronary artery motion blurring in a CT image.
Indications for Use:
CardIO Xpress 2.0 is intended to provide an optimized noninvasive application to analyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. CardIQ Xpress 2.0 is a CT, noninvasive, image analysis software package, which aids in diagnosina of cardiovascular disease to include, coronary artery disease, functional parameters of the heart, heart structures and follow-up for stent placement, bypasses and plaque imaging.
CardIQ Xpress 2.0 offers unique tools such as automatic tracking, which will pre-process the CT data into multiple viewing ports to allow for an expedited read time improving workflow. With CardIQ Xpress 2.0, the user can color code the myocardial tissue to show hypo/hyperdense areas in the myocardial tissue of the heart. With the IVUS-like view the user can color code the HU units of the plaque to better visualize the difference between calcified and non-calcified plaque in the wall of the vessel and the lumen to determine the amount of atherosclerosis. The user can see the different valve planes along with a variety of new lavouts to alian the heart. The IVUS like view is created by applying GE's Volume Rendering on a crosssection perpendicular to the detected centerline. This view merely displays a cross section as in IVUS imaging and color codes like IVUS images. No new or additional diagnostic information is added.
CardIQ Xpress 2.0 is for use on the Advantage Workstation (AW) platform, CT scanner, PAC or Centricity stations, which can be used in the analysis of 2D or 3D CT angiography
2
Image /page/2/Picture/0 description: The image shows the text "k120910_S001". The text is in a sans-serif font and is black. The background is white. The text appears to be a file name or identifier.
Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized with curved lines, and the circle has decorative elements around its perimeter.
GE Healthcare 510(k) Premarket Notification Submission
images/data derived from DICOM 3.0 CT scans.
Technology: The proposed medical device, CardIQ Xpress 2.0 with Snapshot Freeze Option, employs the same fundamental scientific technology as its predicate device CardIQ Xpress 2.0.
Determination of Substantial
Equivalence:
Summary of Non-Clinical Tests:
CardIQ Xpress 2.0 with SnapShot Freeze Option complies with voluntary standards as discussed in Section 9, and 11 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- . Risk Analysis
- . Requirements Reviews
- Design Reviews .
- . Testing on unit level (Module verification)
- Integration testing (System verification) .
- Performance testing (Verification) .
- . Safety testing (Verification)
- . Simulated use testing (Validation)
Summary of Clinical Tests:
As referenced in Section 20, the CT acquired clinical images used for the completion of verification and validation testing for CardIQ Xpress 2.0 with Snapshot Freeze Option were obtained from a non-significant risk reader study of care patient images.
- GE Healthcare considers the CardIQ Xpress 2.0 with Conclusion: Snapshot Freeze Option application to be as safe, as effective, and performance is substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping bodies, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 8 2012
GE Healthcare c/o Mr. Stephen Slavens Regulatory Affairs Director, MICT 3000 N Grandview Blvd W 1140 Waukesha, WI 53188
Re: K120910
Trade Name: CardIO Xpress 2.0 with Snapshot Freeze Option Regulation Number: 21.CFR892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II (two) Product Codes: JAK Dated: June 17, 2012 Received: June 22, 2012
Dear Mr. Slavens:
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. 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.
4
Page 2 –Mr. Slavens
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part -807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram DA Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are in black, set against a white background. The design is simple and recognizable, representing the brand identity of General Electric.
K120910 S001
GE Healthcare 510(k) Premarket Notification Submission
510(k) Number (if known):
Device Name: CardIO Xpress 2.0 with SnapShot* Freeze Option
Indications for Use:
CardlQ Xpress 2.0 is intended to provide an optimized non-invasive application to andyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. CardlQ Xpress 2.0 is a CT, noninvasive, image analysis software package, which aids in diagnosing of cardiovascular disease to include, coronary artery disease, functional parameters of the heart, heart structures and follow-up for stent placement, bypasses and plaque imaging.
CardIQ Xpress 2.0 offers unique tools such as automatic tracking, which will pre-process the CT data into multiple viewing ports to allow for an expedited read time improving workflow. With CardIQ Xpress 2.0, the user can color code the myocardial tissue to show hyperdense areas in the myocardial tissue of the heart. With the IVUS-like view the user can color code the HU units of the plaque to better visualize the difference between calcified and noncalcified plaque in the wall of the vessel and the lumen to determine the amount of atherosclerosis. The user can see the different valve planes along with a variety of new layouts to alian the heart. The IVUS like view is created by applying GE's Volume Rendering on a cross-section perpendicular to the detected centerline. This view merely displays a cross section as in IVUS imaging and color codes like IVUS images. No new or additional diagnostic informotion is added.
CardIQ Xpress 2.0 is for use on the Advantage Workstation (AW) platform, CT scanner, PAC or Centricity stations, which can be used in the analysis of 2D or 3D CT angiography images/data derived from DICOM 3.0 CT scans.
*ShapShot is a trademark of General Electric Company
Prescription Use x . AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subport C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510k)
Page 1 of 1
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Signature
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