(88 days)
The SIGNA(TM) Premier system is a whole body magnetic resonance scanner 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, TMJ, 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(TM) Premier system 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.
SIGNAT™ Premier is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times, and is designed for improved patient comfort and workflow. The system features a 3.0T superconducting magnet with a 70cm bore size and can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
The provided text is related to the FDA's 510(k) premarket notification for the GE Medical Systems, LLC (GE Healthcare) SIGNA™ Premier device, a Magnetic Resonance Diagnostic Device.
The submission focuses on establishing substantial equivalence to a predicate device (SIGNA™ Architect, K163331) rather than conducting a de novo study with strict acceptance criteria and a detailed study proving the device meets them. Therefore, many of the requested elements (like specific numerical acceptance criteria, comprehensive device performance against these, ground truth establishment for training/test sets, MRMC studies, effect sizes, etc.) are not explicitly stated or detailed in this 510(k) summary.
The primary method to demonstrate equivalence here is through non-clinical testing (bench testing, compliance with standards) and sample clinical images to show acceptable diagnostic image performance.
Here's an attempt to answer the questions based on the provided text, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of numerical acceptance criteria for image quality parameters. Instead, it states the overall conclusion regarding performance:
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Provide adequate level of image quality appropriate for diagnostic use. | "The sample clinical images demonstrate acceptable diagnostic image performance of the SIGNA™ Premier in accordance with the FDA Guidance 'Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices' issued on November 18, 2016." |
| Image quality substantially equivalent to the predicate device. | "The image quality of the SIGNA™ Premier is substantially equivalent to that of the predicate device." |
| Device performs as intended. | "Additionally, the results from the above non-clinical tests demonstrate that the device performs as intended." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Sample clinical images have been included in this submission" but does not specify the sample size for this clinical image test set. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective status).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not describe the establishment of a formal "ground truth" for the sample clinical images. It states, "These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis." However, it does not specify the number of experts or their qualifications who evaluated the "sample clinical images" to determine their diagnostic acceptability or equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method for the clinical image evaluation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was mentioned or performed. This device is a diagnostic imaging system (MRI scanner), not an AI-assisted diagnostic tool for interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not directly applicable to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The SIGNA™ Premier is an MRI scanner, a hardware device that produces images. It is not an algorithm for image interpretation that would have standalone performance. Its performance relates to the quality of the images it generates, which are then interpreted by a human physician.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document does not describe the use of formal ground truth (e.g., expert consensus, pathology, or outcomes data) for evaluating the sample clinical images. The evaluation appears to be based on the general diagnostic acceptability of the images by "trained physician[s]" as per FDA guidance for MR diagnostic devices.
8. The sample size for the training set
The document does not mention or describe a training set. As a hardware device (MRI scanner) rather than an AI/ML algorithm, a "training set" in the traditional sense is not applicable for its performance evaluation for regulatory submission.
9. How the ground truth for the training set was established
Not applicable, as no training set is described.
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Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2017
GE Medical Systems, LLC (GE Healthcare) % Mary A. Mayka, Ph.D. Regulatory Affairs Manager 3200 N. Grandview Blvd. WAUKESHA WI 53188
Re: K171128
Trade/Device Name: SIGNA" Premier Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, MOS Dated: April 14, 2017 Received: April 17, 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
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forth in the quality systems (OS) 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 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/ResourcesforYou/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,
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)
Device Name SIGNA(TM) Premier
Indications for Use (Describe)
The SIGNA(TM) Premier system is a whole body magnetic resonance scanner 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, TMJ, 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(TM) Premier system 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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Image /page/3/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has a white outline and is surrounded by three curved lines on each side, resembling stylized water droplets or waves.
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: | April 14, 2017 |
|---|---|
| Submitter: | GE Medical Systems, LLC (GE Healthcare)3200 N. Grandview Blvd.,Waukesha, WI 53188USA |
| Primary Contact Person: | Mary A. Mayka, Ph.D.Regulatory Affairs ManagerGE HealthcarePhone: 262-527-3148Fax: 262-364-2785 |
| Secondary Contact Person: | James McMahonSenior Director, Regulatory AffairsGE HealthcarePhone: 508-382-2858Fax: 262-364-2785 |
| Device Trade Name: | SIGNA™ Premier |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device |
| Classification Names: | Magnetic Resonance Diagnostic Device per 21 CFR892.1000 |
| Product Code: | LNH, LNI, MOS |
| Predicate Device(s): | SIGNATM Architect (K163331) |
| Device Description: | SIGNAT™ Premier is a whole body magnetic resonancescanner designed to support high resolution, high signal-to-noise ratio, and short scan times, and is designed forimproved patient comfort and workflow. The systemfeatures a 3.0T superconducting magnet with a 70cm boresize and can image in the sagittal, coronal, axial, oblique,and double oblique planes, using various pulse sequences,imaging techniques and reconstruction algorithms. Thesystem is designed to conform to NEMA DICOMstandards (Digital Imaging and Communications inMedicine). |
| Indications for Use | The SIGNA™ Premier system is a whole body magneticresonance scanner designed to support high resolution,high signal-to-noise ratio, and short scan times. It isindicated for use as a diagnostic imaging device toproduce axial, sagittal, coronal, and oblique images,spectroscopic images, parametric maps, and/or spectra,dynamic images of the structures and/or functions of the |
| Technology: | The SIGNA™ Premier employs the same fundamentalscientific technology as its predicate devices.SIGNATM Premier builds on the 3.0T wide bore magnet,TDI RF architecture and SIGNA™Works softwareplatform and application suite.The following is a summary of the different technologycharacteristics from the predicate devices:Newly designed gradient system Expanded RF receive chain capabilities Redesigned body coil Updated patient table |
| Comparison of Indicationsfor Use | The changes in technology do not impact the indicationsfor use. The indications for use have not changed, otherthan to reflect the SIGNATM Premier product name.Therefore, the intended use is the same as the predicatedevice in accordance with the FDA's guidance document"The 510(k) Program: Evaluating Substantial Equivalencein Premarket Notifications [510(k)]", dated 28 July 2014. |
| Comparison ofTechnologicalCharacteristics | Overall, the SIGNATM Premier employs the samefundamental scientific technology as the predicate device.System Design: There are two notable technologicaldifferences between the SIGNATM Premier and thepredicate device: a newly designed gradient system andan expanded channel count for the RF receive chain.The differences are summarized below:Gradient system: The SIGNA Premier can deliver amaximum gradient amplitude of 80 mT/m andmaximum gradient slew rate of 200 T/m/s comparedto the predicate's maximum gradient amplitude of 44mT/m and maximum gradient slew rate of 200T/m/s. RF receive chain: The SIGNATM Premier isequipped with 146 receive channels as compared tothe predicate's 128 channels. Operating Principles: The SIGNATM Premier functionsusing the same operating principles as the predicatedevice.Materials: The SIGNATM Premier and the predicatedevice both use flame retardant materials.Safety and Performance Testing: Both the SIGNATMPremier and the predicate device comply with the samesafety and performance testing (see Determination ofSubstantial Equivalence, below). |
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These technological differences do not raise any different questions regarding safety and effectiveness. Both devices must address questions of whether they provide an adequate level of image quality appropriate for diagnostic use. The performance data described in this submission include results of both bench testing and clinical testing that show the image quality performance of SIGNA™ Premier compared to the predicate device. Determination of Summary of Non-Clinical Tests: Substantial Equivalence: The SIGNA™ Premier and the predicate device were subject to similar risk management testing to demonstrate substantial equivalence of safety and performance. Testing to the following voluntary standards included: AAMI/ANSI ES60601-1 ● IEC 60601-1-2 ● ● IEC 60601-2-33 AAMI/ANSI 62304 ● ● ISO 10993-1 In addition, the SIGNA™ Premier complies with applicable NEMA MS standards for MRI and NEMA PS3 standard for DICOM, as does the predicate device. Both the SIGNATM Premier and the predicate device have a successful biocompatibility track record, as demonstrated by ISO 10993 testing and by their history of use in previously cleared devices. The following quality assurance measures were applied to the development of the subject device, as they were for the predicate device: Risk Analysis ● Requirements Reviews ● ● Design Reviews . Testing on unit level (Module verification) ● Integration testing (System verification) ● Performance testing (Verification) Simulated use testing (Validation) ●
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| Summary of Clinical Tests: | |
|---|---|
| The subject of this premarket submission, the SIGNATMPremier, did not require clinical studies to supportsubstantial equivalence. Sample clinical images have beenincluded in this submission. | |
| The sample clinical images demonstrate acceptablediagnostic image performance of the SIGNATM Premier inaccordance with the FDA Guidance "Submission ofPremarket Notifications for Magnetic ResonanceDiagnostic Devices" issued on November 18, 2016. | |
| The image quality of the SIGNATM Premier issubstantially equivalent to that of the predicate device. | |
| Substantial Equivalence Conclusion: | |
| The indications for use of the proposed device arecomparable to the claimed predicate device. TheSIGNA™ Premier employs equivalent technology to theclaimed predicate device. Additionally, the results fromthe above non-clinical tests demonstrate that the deviceperforms as intended. Therefore, the SIGNA™ Premier issubstantially equivalent to the predicate device to which ithas been compared. | |
| Conclusion: | In conclusion, GE Healthcare considers the SIGNATMPremier to be as safe, as effective, with performance thatis substantially equivalent to the predicate device. |
§ 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.