(110 days)
Not Found
No
The summary describes image processing software for calculating cardiac parameters but does not mention AI, ML, or related terms. The focus is on automated calculation based on user selection of heart chambers and phases.
No.
The device is described as an image analysis software package that aids in determining treatment paths and assessing cardiac function and cardiovascular disease diagnosis and management. It calculates and displays functional parameters. It does not directly provide therapy.
Yes
Explanation: The intended use states that the device aids in determining treatment paths and in the assessment of cardiac function and determination of cardiovascular disease diagnosis and management.
Yes
The device is described as a "post processing software option" and a "software package" that analyzes existing CT images. It is intended to run on existing hardware platforms (Advantage Workstation, CT Scanner, PACS, Centricity stations) and does not include any dedicated hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 Function Xpress analyzes medical images (CT angiographic images) to assess cardiovascular anatomy and function. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states it analyzes images to aid in determining treatment paths and assessing cardiac function and disease. This is image analysis, not in vitro testing.
Therefore, CardIQ Function Xpress falls under the category of medical image analysis software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CardIQ Function Xpress 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 Function Xpress in conjunction with CT cardiac images to automatically calculate and display various left ventricular and right ventricular functional parameters as ejection fraction, end systolic and end diastolic volumes, stroke volumes, wall motion, wall thickening, cardiac output, myocardial mass, systemic and pulmonary vascular resistance. Volume measurement of each chamber of the heart is also available. With CardIQ Function Xpress atrium volumes may be used to determine volume assessment of atrial disease to include but not limited to atrial fibrillation. CardIQ Function Xpress is a CT, non-invasive image analysis software package, which aids in the assessment of cardiac function and in determination of cardiovascular disease diagnosis and management.
CardIQ Function Xpress 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 (comma separated list FDA assigned to the subject device)
JAK, LLZ
Device Description
The GE Medical Systems CardIQ Function Xpress 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 calculate and display ventricular analysis of several functional cardiac parameters. The software has the ability to select the chambers of the heart and diastolic and/or systolic phases to determine the hearts function. CardIO Function Xpress contains both graphic and text report capabilities with predefined templates for ease of use.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT) Angiographic images, 2D or 3D CT angiography images/data derived from DICOM 3.0 CT scans.
Anatomical Site
cardiovascular, heart, left ventricular, right ventricular
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software and medical device design validation have been completed. Medical device design included testing and evaluation of previously acquired diagnostic images.
The results concluded the device was acceptable for use.
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.
Not Found
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
510(K) Summary As Required by 21 CFR 807.92
510(k) Number: ___________________
1. Submitter Information
FEB 26 20CB
- GE Medical Systems SCS Submitter Name: 283, rue de la Minière 78533 Buc Cedex, FRANCE
9611343 Establishment Reg:
Contact Person: Stephen Slavens Global RA Premarket Director 3000 N Grandview Blvd. Waukesha, WI 53188 Tel: 262-548-4992 Fax: 262-548-4710 stephen.slavens@ge.com
August 22nd, 2007 Date Prepared:
2. Device information
| Trade Name: | CardIQ Function Xpress |
|---|---|
| Common Name: | Picture Archiving and Communication Device |
| Classification Name: | System, Image Processing, Radiological |
| Procode: | JAK |
| Class: | Class II per 21 CFR 892.1750 |
3. Predicate Devices
CardIQ Function Xpress is substantially equivalent to the predicate devices listed below:
| Device Name | FDA Clearance |
|---|---|
| GE CardIQ Analysis III | K041267 |
| GE CardIQ Function | K013422 |
1
4. Device Description
The GE Medical Systems CardIQ Function Xpress 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 calculate and display ventricular analysis of several functional cardiac parameters. The software has the ability to select the chambers of the heart and diastolic and/or systolic phases to determine the hearts function. CardIO Function Xpress contains both graphic and text report capabilities with predefined templates for ease of use.
5. Indication for Use
CardIQ Function Xpress 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 Function Xpress in conjunction with CT cardiac images to automatically calculate and display various left ventricular and right ventricular functional parameters as ejection fraction, end systolic and end diastolic volumes, stroke volumes, wall motion, wall thickening, cardiac output, myocardial mass, systemic and pulmonary vascular resistance. Volume measurement of each chamber of the heart is also available. With CardIQ Function Xpress atrium volumes may be used to determine volume assessment of atrial disease to include but not limited to atrial fibrillation. CardIQ Function Xpress is a CT, non-invasive image analysis software package, which aids in the assessment of cardiac function and in determination of cardiovascular disease diagnosis and management.
CardIQ Function Xpress 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.
2
6. Summary of non-clinical and/or clinical tests and results
The software was designed to meet the following standards:
| Standard | Standards
Organization | Standard Title |
|---------------|---------------------------|------------------------------------------------------------|
| PS 3.1 - 3.18 | NEMA | Digital Imaging and Communications
in Medicine (DICOM) |
| SW68 | AAMI/ANSI | Medical Device Software - Software
life cycle processes |
Software and medical device design validation have been completed. Medical device design included testing and evaluation of previously acquired diagnostic images.
The results concluded the device was acceptable for use.
7. Statement of Equivalence
The General Electric CardIQ Function Xpress workstation software is equivalent to a combination of the predicate General Electric CardIQ Analysis III and CardIQ Function devices and is safe and effective for use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines forming the body and wings. The logo is black and white.
FEB 26 2008
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
GE Medical Systems SCS % Mr. Jay Y. Kogoma Senior Staff Engineer - Medical Devices Intertek Testing Services 2307 E. Aurora Road, Unit B7 TWINSBURG OH 44087
Re: K073153
Trade/Device Name: CardIQ Function Xpress Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK, LLZ Dated: February 8, 2008 Received: February 11, 2008
Dear Mr. Kogoma:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle. The word "Centennial" is at the bottom of the circle. There are stars below the word "Centennial".
Protecting and Promoting Public Health.
4
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 Actor 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): 073153
Device Name: CordIO Function Xpress
Indications For Use: CardIQ Function Xpress 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.
Cardia Function Xpress in conjunction with CT cardiac images to automatically calculate and display various left ventricular and right ventricular functional parameters as ejection fraction, end systolic and end diastolic volumes, stroke volumes, wall motion, wall thickening, cardiac output, myocardlal mass, systemic and pulmonary vascular resistance. Volume measurement of each chamber of the heart is also available. With CardiQ Function Xpress atrium volumes may be used to determine volume assessment of atrial disease to include but not limited to atrial fibrillation. CardIQ Function Xpress is a CT, non-Invasive image analysis software package, which alds in the assessment of cardiac function and in determination of cardlovascular disease diagnosis and management.
CardIQ Function Xpress 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 anglography images/data derived from DICOM 3.0 CT scans.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Homi Khan
(Division Sign-Off)
Division of Reproductive, Abdomina and Radiological Device 510(k) Number
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