(246 days)
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.
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.
Acceptance Criteria and Study for GenIQ
The provided document describes the GenIQ, an automated post-processing software option for dynamic Magnetic Resonance Imaging (MRI) data sets. It calculates functional parameters related to tissue flow and contrast agent leakage.
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or AUC. Instead, it states that "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."
This implies the acceptance criterion for the phantom study was the accurate implementation of the General Kinetic Model (GKM) as validated against QIBA reference data. The reported performance is that the "validation demonstrated good implementation" of this model.
For clinical data, the document states, "anonymized MR contrast-enhanced images were used as clinical datasets to validate the GenIQ application." Again, specific performance metrics against an acceptance criterion are not detailed, but the overall conclusion is that "GE Healthcare considers the GenIQ application to be as safe, as effective, and performance is substantially equivalent to the predicate device." This suggests the clinical validation aimed to demonstrate performance comparable to its predicate (Philips MR Permeability Software - K130278), which would inherently imply meeting certain effectiveness and safety standards.
Table of Acceptance Criteria and Reported Device Performance (Inferred):
| Acceptance Criteria Category | Specific Metric/Target | Reported Device Performance |
|---|---|---|
| Phantom Data Validation | Accurate implementation of the General Kinetic Model (GKM) as referenced by QIBA. | "Demonstrated good implementation of the General Kinetic Model." |
| Clinical Data Validation | Performance comparable to the predicate device (Philips MR Permeability Software - K130278) in terms of efficacy and safety for assessing tissue vascular properties. | "Considered to be as safe, as effective, and performance is substantially equivalent to the predicate device." |
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set:
- Digital Phantom Data: Not specified.
- Clinical Datasets: Not specified, only described as "anonymized MR contrast-enhanced images."
- Data Provenance: The document does not explicitly state the country of origin.
- Digital Phantom Data: Referenced by the Quantitative Imaging Biomarkers Alliance (QIBA).
- Clinical Data: Described as "anonymized MR contrast-enhanced images." The study is likely retrospective as it used existing "anonymized" images.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
This information is not provided in the document. For the digital phantom data, the ground truth is inherently defined by the QIBA reference data and the mathematical model itself. For the clinical datasets, the method of establishing ground truth (e.g., expert consensus, pathology) and the number/qualifications of experts are not described.
4. Adjudication Method (Test Set)
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study is not explicitly mentioned. The validation focused on the software's ability to implement the GKM and its equivalence to a predicate device. The document states, "GenIQ provides information that when interpreted by a trained physician," implying human-in-the-loop, but there's no study comparing human readers with and without AI assistance to quantify an effect size.
6. Standalone Performance
The evaluation primarily describes the "GenIQ application" as an automated post-processing software option, suggesting a focus on its standalone (algorithm-only) performance in calculating pharmacokinetic parameters from DCE-MRI data. While the output is "interpreted by a trained physician," the validation described (GKM implementation on phantom data, and validation on clinical datasets) focuses on the algorithm's accuracy in producing these parameters.
7. Type of Ground Truth Used
- Digital Phantom Data: The ground truth was based on the Quantitative Imaging Biomarkers Alliance (QIBA) reference data and the theoretical correctness of the General Kinetic Model (GKM). These are essentially simulated/known data sets designed to test the mathematical implementation.
- Clinical Datasets: The document does not specify the type of ground truth used for the clinical validation. It only states that images were used "to validate the GenIQ application." This could imply comparison to a reference standard established by expert consensus, other imaging modalities, or clinical outcomes, but it is not detailed.
8. Sample Size for the Training Set
This information is not provided in the document. The document describes testing and validation, but not the development or training of the software.
9. How Ground Truth for the Training Set was Established
This information is not provided in the document as the training set details are absent.
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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.
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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
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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)
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Section 5: 510(k) Summary
GenIQ
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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 SCS283 Rue de la MiniereBuc, France 78530FDA Registration Number: 9611343 |
|---|---|
| Primary Contact Person: | Jenny WongRegulatory Affairs Leader, MRGE Medical Systems, LLCPhone (262) 521-6102Fax (262) 546-0902 |
| Secondary Contact Person: | Glen SabinRegulatory Affairs Director, MRGE Medical Systems, LLCPhone (262) 521-6848Fax (262) 364-2785 |
| Device: | GenIQ |
| Trade Name: | GenIQ |
| Common/Usual Name: | System, image processing, radiological- Picture archivingand communications system. |
| Classification Names: | 21CFR 892.2050 |
| Product Code: | LLZ |
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| Predicate Device(s): Predicate Device Name: MR Permeability Software | |
|---|---|
| Predicate 510k Number: K130278 | |
| Predicate Manufacturer: Philips Medical SystemsNederland B.V. | |
| Device Description: | GenIQ is a software application used for thepharmacokinetic analysis of Dynamic Contrast Enhanced(DCE) MRI data sets. The application is used to perform aGeneral Kinetic Model (GKM)-based pharmacokineticmodeling of DCE-MRI data. The goal of GenIQ is toextract functional parameters describing tissue vascularproperties such as forward and backward transferconstants, plasma volume, and volume of extra-cellularspace. |
| Indications for Use: | GenIQ is an automated post-processing software optionthat is indicated for use on dynamic magnetic resonanceimaging 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.
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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.
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§ 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).