(109 days)
The SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems are whole body magnetic resonance scanners designed to support high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal. coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMI, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used.
The images produced by the SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Architect and SIGNA Artist systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. The systems each feature a superconducting magnet. The data acquisition system accommodates up to 128 independent receive channels in various increments and multiple independent coil elements per channel during a single acquisition series. Each system uses a combination of time varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. Each system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms. The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Architect. SIGNA Artist systems are designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
The original description hasn't changed from predicate devices (K160618), other than reflecting the additional receive channels available.
The modifications to these systems include the MAGIC DWI and CardioMaps software features, delivered via the DV26 program. The proposed software features will be ported over to other GE Healthcare MR systems based on appropriate design controls and evaluation of the change in accordance with FDA's Guidance—Deciding When to Submit a 510(k) for a Change to an Existing Device.
This document describes the premarket notification (510(k)) for GE Medical Systems' SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Magnetic Resonance (MR) diagnostic devices. The submission focuses on the addition of MAGIC DWI (Diffusion-Weighted Imaging) and CardioMaps software features.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific quantitative acceptance criteria or performance metrics for the MAGIC DWI and CardioMaps software features in a table format. Instead, it indicates that testing was completed with "passing results per the pass/fail criteria defined in the test cases."
Implicit Acceptance Criteria (inferred from the document):
- Safety and Effectiveness: The primary acceptance criterion is that the modified software features (MAGIC DWI and CardioMaps) are "as safe and effective as the predicate" devices and do "not raise different questions of safety and effectiveness."
- Compliance with Standards: The software features must comply with voluntary standards: AAMI/ANSI 62304, AAMI/ANSI ES60601-1, and IEC 60601-2-33.
- Acceptable Performance: Phantom testing for both software features must demonstrate "acceptable performance."
Reported Device Performance:
| Feature/Criterion | Reported Performance |
|---|---|
| Safety and Effectiveness | The submission concludes that the MR systems with modified software features are "as safe and effective as the predicate, and does not raise different questions of safety and effectiveness." Implicitly, this means the software features perform within acceptable limits for diagnostic imaging. |
| Compliance with Standards | The features "comply with the following voluntary standards: AAMI/ANSI 62304, AAMI/ANSI ES60601-1, IEC 60601-2-33." |
| Phantom Testing | "Phantom testing for both Synthetic DWI and CardioMaps was completed to demonstrate acceptable performance. Testing was completed with passing results per the pass/fail criteria defined in the test cases." No specific quantitative metrics (e.g., SNR, image quality scores, measurement accuracy) or exact "passing results" values are provided in this summary. |
| Clinical Images | "Sample clinical images are included in this submission in accordance with the MR guidance on premarket notification submissions." (This suggests visual review and subjective assessment of image quality in a clinical context.) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for either the phantom testing or the clinical images. It generically refers to "phantom testing" and "sample clinical images."
- Data Provenance: Not explicitly stated. For phantom testing, it's typically controlled laboratory conditions. For clinical images, it's not mentioned whether they are retrospective or prospective, nor their country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide this information.
The summary states that images and/or spectra are interpreted by a "trained physician," but it doesn't detail the number or qualifications of experts involved in establishing ground truth for the specific performance evaluation of the new software features.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method.
It states that "passing results per the pass/fail criteria defined in the test cases" were achieved for phantom testing. For clinical images, it mentions they are "interpreted by a trained physician," implying clinical judgment, but no formal adjudication process (like 2+1 or 3+1) is described for the evaluation presented in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not indicate that an MRMC comparative effectiveness study was performed.
The evaluation relies on compliance with standards, phantom testing, and presentation of sample clinical images to demonstrate "substantial equivalence" rather than a comparative effectiveness study measuring human reader improvement with AI assistance. The software features are enhancements to image acquisition and processing, not explicitly AI-assisted diagnostic tools in the context of comparative reading studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the software features (MAGIC DWI and CardioMaps) represent algorithm-only additions, the document emphasizes that the "images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis."
The "phantom testing" and quality assurance measures (e.g., unit-level, integration, performance, safety testing) can be considered standalone evaluations of the algorithms' output quality and adherence to specifications. However, the ultimate "performance" in the diagnostic context is tied to physician interpretation. The regulatory focus here is on the system producing diagnostically useful images, not on an algorithm making a standalone diagnosis.
7. The Type of Ground Truth Used
- For Phantom Testing: The ground truth would typically be established by known physical properties or measurements of the phantom itself. The "pass/fail criteria" would be based on expected quantitative accuracy, image quality, or signal properties against these known values.
- For Clinical Images: The document mentions "images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis." This implies that the effectiveness in a clinical setting is ultimately judged by expert clinical interpretation, but it does not specify a formal "ground truth" (e.g., pathology, surgical findings, long-term outcomes) used to validate the clinical utility of the specific new software features. It's more about demonstrating that the images produced can be interpreted by a physician to assist diagnosis.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This is likely because the referenced software features are defined as modifications to existing MR systems, and while they involve algorithms, the summary doesn't describe them as machine learning models that require distinct "training sets" in the typical sense. The development process described (risk analysis, requirements reviews, design reviews, various levels of testing) is a standard software engineering approach.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned for machine learning, information on how its ground truth was established is not applicable or provided in this document.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 17, 2017
GE Medical Systems, LLC % Mary A Mayka, Ph.D. Regulatory Affairs Manager 3200 Grandview Blvd. WAUKESHA WI 53188
Re: K163331
Trade/Device Name: SIGNA Architect. SIGNA Artist. Discovery MR750 3.0T. Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: February 17, 2017 Received: February 21, 2017
Dear Dr. Mayka:
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. 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) K163331
.
Device Name
SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T
Indications for Use (Describe)
The SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems are whole body magnetic resonance scanners designed to support high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal. coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMI, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used.
The images produced by the SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 05: 510(k) Summary Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T, SIGNA Architect, SIGNA Artist
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| In accordance with 21 CFR 807.92 the following summary of information is provided: | ||
|---|---|---|
| Date: | November 22, 2016 | |
| Primary Contact Person: | Mary A. Mayka, Ph.D.Regulatory Affairs ManagerGE HealthcarePhone: 262-527-3148Fax: 262-364-2785 | |
| Secondary Contact Person: | Glen SabinRegulatory Affairs Director, MRGE Healthcare, (GE Medical Systems, LLC)Phone: 262-521-6848Fax: 414-908-9585 | |
| Device Trade Name: | Discovery MR750w 3.0T, Discovery MR750 3.0T, OptimaMR450w 1.5T, Discovery MR450 1.5T, SIGNA Architect,SIGNA Artist | |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device | |
| Classification Names: | Magnetic Resonance Diagnostic Device(21 CFR 892.1000) | |
| Product Code: | LNH | |
| Predicate Devices: | K160618: Discovery MR750 3.0T, Discovery MR450 1.5T,Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNAArchitect, SIGNA Artist | |
| Device Description: | The Discovery MR750 3.0T, Discovery MR450 1.5T,Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNAArchitect and SIGNA Artist systems are whole bodymagnetic resonance scanners designed to support highresolution, high signal-to-noise ratio, and short scan times.The systems each feature a superconducting magnet. Thedata acquisition system accommodates up to 128independent receive channels in various increments andmultiple independent coil elements per channel during asingle acquisition series. Each system uses a combination oftime varying magnetic fields (gradients) and RFtransmissions to obtain information regarding the densityand position of elements exhibiting magnetic resonance.Each system can image in the sagittal, coronal, axial,oblique, and double oblique planes, using various pulsesequences and reconstruction algorithms.The Discovery MR750 3.0T, Discovery MR450 1.5T,Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNAArchitect. SIGNA Artist systems are designed to conform to |
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Image /page/5/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The space between the letters and the border is filled with a light blue color. The logo is simple and recognizable, representing the company's brand identity.
| NEMA DICOM standards (Digital Imaging andCommunications in Medicine). | |
|---|---|
| The original description hasn't changed from predicatedevices (K160618), other than reflecting the additionalreceive channels available.The modifications to these systems include the MAGIC DWIand CardioMaps software features, delivered via the DV26program. The proposed software features will be portedover to other GE Healthcare MR systems based onappropriate design controls and evaluation of the change inaccordance with FDA's Guidance—Deciding When toSubmit a 510(k) for a Change to an Existing Device. | |
| Indications for Use: | The SIGNA Architect, SIGNA Artist, Discovery MR7503.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T andthe Optima MR450w 1.5T systems are whole body magneticresonance scanners designed to support high resolution, highsignal-to-noise ratio, and short scan times. It is indicated foruse as a diagnostic imaging device to produce axial, sagittal,coronal, and oblique images, spectroscopic images,parametric maps, and/or spectra, dynamic images of thestructures and/or functions of the entire body, including, butnot limited to, head, neck, TMJ, spine, breast, heart,abdomen, pelvis, joints, prostate, blood vessels, andmusculoskeletal regions of the body. Depending on theregion of interest being imaged, contrast agents may be used.The images produced by the SIGNA Architect, SIGNAArtist, Discovery MR750 3.0T, Discovery MR450 1.5T,Discovery MR750w 3.0T and the Optima MR450w 1.5Tsystems reflect the spatial distribution or molecularenvironment of nuclei exhibiting magnetic resonance. Theseimages and/or spectra when interpreted by a trainedphysician yield information that may assist in diagnosis. |
| Comparison of IntendedUse | The addition of the proposed software features does notimpact the indications for use. The indications for use havenot changed, other than the addition of the SIGNA Architectand SIGNA Artist systems (K160618/001 andK160618/002).Therefore, the intended use is the same as the predicatedevice in accordance with the FDA's guidance document"The 510(k) Program: Evaluating Substantial Equivalence in |
| Comparison ofTechnologicalCharacteristics: | The MR systems with the proposed software featuresemploy the same fundamental technology as the predicatedevices. |
| Performance Data: | Summary of Non-Clinical Tests:The changes are software only features and comply with thefollowing voluntary standards:• AAMI/ANSI 62304• AAMI/ANSI ES60601-1• IEC 60601-2-33 |
| The following quality assurance measures were applied tothe development of the device:• 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) | |
| The non-clinical tests have been summarized in this 510(k).Phantom testing for both Synthetic DWI and CardioMapswas completed to demonstrate acceptable performance.Testing was completed with passing results per the pass/failcriteria defined in the test cases. This supports substantialequivalence to its predicates because it was also developedunder quality assurance Design Controls.Summary of Clinical Tests: | |
| Sample clinical images are included in this submission inaccordance with the MR guidance on premarket notificationsubmissions. | |
| Conclusion: | The GE MR systems with the modified software featureshave the same intended use as the predicate. This 510(k)submission includes information on the technologicalcharacteristics of the proposed software features, as well asperformance data demonstrating that the features are as safeand effective as the predicate, and does not raise differentquestions of safety and effectiveness. |
| In conclusion, GE Healthcare believes that the MR systemswith the modified software features are substantiallyequivalent to the predicate 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 is surrounded by a series of curved lines that resemble water droplets or splashes. The logo is simple and recognizable, and it is often used to represent the company's brand.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.