(246 days)
Not Found
No
The description focuses on pharmacokinetic modeling using a General Kinetic Model (GKM), which is a traditional mathematical approach, and does not mention AI or ML terms.
No
The device provides information for assessing tissue vascular properties, but it does not directly treat or diagnose a disease. It functions as a post-processing software for diagnostic imaging.
Yes
The device processes medical imaging data to calculate functional parameters related to tissue flow and contrast agent leakage, which are used by a trained physician to assess tissue vascular properties. This information aids in the diagnosis or assessment of medical conditions.
Yes
The device description explicitly states that GenIQ is a "software application" used for analysis of existing MRI data. There is no mention of any accompanying hardware components or hardware-specific functions.
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: GenIQ processes imaging data (MRI), not biological samples. It analyzes the dynamic changes in signal intensity within the body after the administration of a contrast agent.
- Intended Use: The intended use is to generate parametric images and calculate functional parameters related to tissue flow and contrast agent leakage, which are interpreted by a physician to assess tissue vascular properties. This is a form of medical image analysis, not an in vitro test.
Therefore, GenIQ falls under the category of medical image processing software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
GenIQ is an automated post-processing software option that is indicated for use on dynamic magnetic resonance imaging data sets to generate parametric image intensity variations over time. This dynamic change in signal intensity is used to calculate functional parameters related to tissue flow and leakage of the contrast agent from the intravascular to the extracellular space.
GenIQ provides information that when interpreted by a trained physician, can be useful for assessing tissue vascular properties.
Product codes
LLZ
Device Description
GenIQ is a software application used for the pharmacokinetic analysis of Dynamic Contrast Enhanced (DCE) MRI data sets. The application is used to perform a General Kinetic Model (GKM)-based pharmacokinetic modeling of DCE-MRI data. The goal of GenIQ is to extract functional parameters describing tissue vascular properties such as forward and backward transfer constants, plasma volume, and volume of extra-cellular space.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Dynamic Magnetic Resonance Imaging (MRI)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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
Simulated use testing was performed on digital phantom data referenced by Quantitative Imaging Biomarkers Alliance (QIBA). In addition, anonymized MR contrast-enhanced images were used as clinical datasets to validate the GenIQ application.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Simulated use testing was performed on digital phantom data referenced by Quantitative Imaging Biomarkers Alliance (QIBA). This validation demonstrated good implementation of the General Kinetic Model. In addition, anonymized MR contrast-enhanced images were used as clinical datasets to validate the GenIQ application.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2015
GE Medical Systems, LLC % Ms. Jenny Wong Regulatory Affairs Leader, Magnetic Resonance 3200 N. Grandview Blvd. WAUKESHA WI 53188
Re: K143368
Trade/Device Name: GenIO Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 7, 2015 Received: July 8, 2015
Dear Ms. Wong:
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.
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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143368
Device Name GenIQ
Indications for Use (Describe)
GenIQ is an automated post-processing software option that is indicated for use on dynamic magnetic resonance imaging data sets to generate parametric image intensity variations over time. This dynamic change in signal intensity is used to calculate functional parameters related to tissue flow and leakage of the contrast agent from the intravascular to the extracellular space.
GenIQ provides information that when interpreted by a trained physician, can be useful for assessing tissue vascular properties.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script inside. There are three white teardrop shapes evenly spaced around the inside of the circle, creating a swirling effect. The logo is simple and recognizable, representing the company's long history and global presence.
Section 5: 510(k) Summary
GenIQ
4
Image /page/4/Picture/0 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. There are decorative swirls around the letters. The logo is simple and recognizable, and it is often used to represent the company's brand.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: November 24, 2014
| Submitter: | GE Medical Systems SCS
283 Rue de la Miniere
Buc, France 78530
FDA Registration Number: 9611343 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Jenny Wong
Regulatory Affairs Leader, MR
GE Medical Systems, LLC
Phone (262) 521-6102
Fax (262) 546-0902 |
| Secondary Contact Person: | Glen Sabin
Regulatory Affairs Director, MR
GE Medical Systems, LLC
Phone (262) 521-6848
Fax (262) 364-2785 |
| Device: | GenIQ |
| Trade Name: | GenIQ |
| Common/Usual Name: | System, image processing, radiological- Picture archiving
and communications system. |
| Classification Names: | 21CFR 892.2050 |
| Product Code: | LLZ |
5
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular frame. The color of the logo is a light blue.
| Predicate Device(s): Predicate Device Name: MR Permeability Software | |
|---|---|
| Predicate 510k Number: K130278 | |
| Predicate Manufacturer: Philips Medical Systems | |
| Nederland B.V. | |
| Device Description: | GenIQ is a software application used for the |
| pharmacokinetic analysis of Dynamic Contrast Enhanced | |
| (DCE) MRI data sets. The application is used to perform a | |
| General Kinetic Model (GKM)-based pharmacokinetic | |
| modeling of DCE-MRI data. The goal of GenIQ is to | |
| extract functional parameters describing tissue vascular | |
| properties such as forward and backward transfer | |
| constants, plasma volume, and volume of extra-cellular | |
| space. | |
| Indications for Use: | GenIQ is an automated post-processing software option |
| that is indicated for use on dynamic magnetic resonance | |
| imaging data sets to generate parametric images from the |
image intensity variations over time. This dynamic change in signal intensity is used to calculate functional parameters related to tissue flow and leakage of the contrast agent from the intravascular to the extracellular space.
GenIQ provides information that when interpreted by a trained physician, can be useful for assessing tissue vascular properties.
Comparison of The proposed medical device, GenIQ, employs the same Technological fundamental scientific technology as its predicate device, Characteristics with MR Permeability. The proposed device (GenIQ) is Predicate Device: substantially equivalent to the predicate device because it is a post-processing software option for use on dynamic contrast enhanced (DCE) MR image datasets.
6
Summary of Non-Clinical and Clinical Tests: Determination of
Substantial Equivalence:
The GenIO and its applications comply with voluntary standards:
- . ISO 13485
- ISO 14971
- IEC 62304 ●
- IEC 62366
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)
Simulated use testing was performed on digital phantom data referenced by Quantitative Imaging Biomarkers Alliance (QIBA). This validation demonstrated good implementation of the General Kinetic Model. In addition, anonymized MR contrast-enhanced images were used as clinical datasets to validate the GenIQ application.
- GE Healthcare considers the GenIQ application to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device.
Image /page/6/Picture/19 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle has four stylized flourishes extending from it, one at each cardinal direction.