(59 days)
Yes
The summary explicitly states that the AIRx software feature, which is a modification to the device, was developed using deep learning algorithms.
No
The device 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." It is not described as treating or alleviating a medical condition.
Yes
The Indications for Use explicitly state it is "indicated for use as a diagnostic imaging device."
No
The device description clearly states that SIGNA Premier is a "whole body magnetic resonance scanner," which is a hardware device. While the submission mentions "AIRx software features" and "AIRx software only feature" in the context of modifications and testing, the core device being cleared is the entire MRI system, not just the software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SIGNA Premier system is a "diagnostic imaging device" that produces images and spectra. These images and spectra are then "interpreted by a trained physician" to "assist in diagnosis." This describes an imaging system used for in-vivo (within the living body) diagnosis, not an in-vitro (outside the living body) diagnostic test.
- Device Description: The description details a "whole body magnetic resonance scanner," which is a type of medical imaging equipment used on patients.
- Input Imaging Modality: The input is "Magnetic Resonance," which is an imaging technique applied to the body.
- Anatomical Site: The device is used to image various parts of the "entire body."
IVD devices are typically used to examine specimens (like blood, urine, tissue) outside of the body to detect diseases, conditions, or infections. The SIGNA Premier system operates by scanning the patient directly.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The SIGNA Premier system is a whole body magnetic resonance scanner designed to support high resolution, 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 region of interest being imaged, contrast agents may be used.
The images produced by the SIGNA 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 yield information that may assist in diagnosis.
Product codes
LNH, LNI, MOS
Device Description
SIGNA 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 modifications to this system include the AIRx software features, which allows users the flexibility to automate and standardize a number of connected steps required for an MRI examination of the brain.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
AIRx was developed using deep learning algorithms.
Input Imaging Modality
Magnetic Resonance
Anatomical Site
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.
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
Summary of Non-Clinical Tests:
The modifications to SIGNA Premier include the AIRx software only feature and complies with the following voluntary standards:
• IEC 62304
• ANSI/AAMI 60601-1
• IEC 60601-2-33
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
• Integration testing (System verification)
• Performance testing (Verification)
• Simulated use testing (Validation)
The non-clinical tests have been summarized in the verification and validation testing for AIRx. The testing was completed with passing results per pass/fail criteria defined in the test cases. This supports substantial equivalence to its predicate because it was also developed under quality assurance Design Controls. In addition, the software complies with the same applicable Standards.
Summary of Clinical Tests:
Internal scans were conducted as part of validation for AIRx workflow to confirm the productivity and consistency benefits of the proposed feature. The AIRx feature is a pre-scan algorithm, and the MR System maintains the same imaging performance results as its predicate device (K171128).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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GE Medical Systems, LLC % Mr. Brian R. Zielski Regulatory Affairs Leader 3200 N. Grandview Blvd WAUKESHA WI 53188
January 18, 2019
Re: K183231
Trade/Device Name: SIGNA Premier Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI and MOS Dated: November 19, 2018 Received: November 20, 2018
Dear Mr. Zielski:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'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
2
Indications for Use
510(k) Number (if known)
Device Name SIGNA Premier
Indications for Use (Describe)
The SIGNA Premier system is a whole body magnetic resonance scanner designed to support high resolution, 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 region of interest being imaged, contrast agents may be used.
The images produced by the SIGNA 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 yield information that may assist in diagnosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 81 CFR 201 Subpart D) | ☐ Over-The-Counter Use (81 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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GE Healthcare 510(k) Premarket Notification Submission K183231
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | November 19, 2018 |
|---|---|
| Submitter: | GE Medical Systems, LLC (GE Healthcare) |
| 3200 N. Grandview Blvd., | |
| Waukesha, WI 53188 | |
| USA | |
| Primary Contact Person: | Brian R. Zielski |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| Phone: 262-521-6609 | |
| Secondary Contact Person: | James McMahon |
| Senior Director, Regulatory Affairs | |
| GE Healthcare | |
| Phone: 508-382-2858 | |
| Device Trade Name: | SIGNA Premier |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device |
| Classification Names: | Magnetic Resonance Diagnostic Device per 21 CFR |
| 892.1000 | |
| Product Code: | LNH, LNI, MOS |
| Predicate Device(s): | SIGNA Premier (K171128) |
| Device Description: | SIGNA 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 modifications to this system include the AIRx | |
| software features, which allows users the flexibility to | |
| automate and standardize a number of connected steps | |
| required for an MRI examination of the brain. | |
| Indications for Use | The SIGNA Premier system is a whole body magnetic |
| resonance scanner designed to support high resolution, | |
| 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 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 | |
| yield information that may assist in diagnosis. | |
| Comparison of Indications | |
| for Use | The indications for use statement and intended use are |
| identical to the predicate device, in accordance with the | |
| FDA's guidance document "The 510(k) Program: | |
| Evaluating Substantial Equivalence in Premarket | |
| Notifications [510(k)]", dated 28 July 2014. | |
| Technology: | The SIGNA Premier with the proposed software feature |
| employ the same fundamental technology as the predicate | |
| device. | |
| The SIGNA Premier has been modified to include the | |
| AIRx feature, which automates and standardizes a number | |
| of connected steps required for an MRI examination of the | |
| brain. AIRx was developed using deep learning | |
| algorithms. | |
| These technological differences do not raise any different | |
| questions regarding safety and effectiveness. Both devices | |
| must allow for an effective method to setup an appropriate | |
| scan prescription. The performance data described in this | |
| submission include results of both bench testing and | |
| clinical testing that show the performance of the SIGNA | |
| Premier compared to the predicate device. | |
| Determination of | |
| Substantial Equivalence: | Summary of Non-Clinical Tests: |
| The modifications to SIGNA Premier include the AIRx | |
| software only feature and complies with the following | |
| voluntary standards: | |
| • IEC 62304 | |
| • ANSI/AAMI 60601-1 | |
| • IEC 60601-2-33 |
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
• Integration testing (System verification)
• Performance testing (Verification)
• Simulated use testing (Validation)
The non-clinical tests have been summarized in the
verification and validation testing for AIRx. The testing
was completed with passing results per pass/fail criteria
defined in the test cases. This supports substantial
equivalence to its predicate because it was also developed
under quality assurance Design Controls. In addition, the
software complies with the same applicable Standards. |
| | Summary of Clinical Tests:
Internal scans were conducted as part of validation for
AIRx workflow to confirm the productivity and
consistency benefits of the proposed feature. The AIRx
feature is a pre-scan algorithm, and the MR System |
| | maintains the same imaging performance results as its
predicate device (K171128). |
| Conclusion: | The SIGNA Premier with the modified software feature
has the same intended use as the predicate. This 510(k)
submission includes information on the technological
characteristics of the proposed software feature, as well as
performance data demonstrating that the feature is as safe
and effective as the predicate, and does not raise different
questions of safety and effectiveness.
In conclusion, GE Healthcare considers the SIGNA
Premier to be as safe, as effective, and performance is
substantially equivalent to the predicate devices. |
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GE Healthcare 510(k) Premarket Notification Submission
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GE Healthcare 510(k) Premarket Notification Submission
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GE Healthcare 510(k) Premarket Notification Submission