(135 days)
Not Found
Yes
The device description explicitly states that the submission is prompted by the introduction of "AIR Recon DL," which is described as a "deep-learning based reconstruction technique." Deep learning is a subset of machine learning.
No.
The device is clearly indicated as a "diagnostic imaging device" with the images and spectra "interpreted by a trained physician yield information that may assist in diagnosis." It does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "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..." and "...These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis."
No
The device described is a whole-body magnetic resonance scanner (SIGNA Premier system), which is a hardware device. The submission is for a new software feature (AIR Recon DL) added to this existing hardware system. While the submission focuses on the software modification, the overall device is not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is a magnetic resonance scanner used to produce images and spectra of the human body. These images are interpreted by a trained physician to assist in diagnosis. This is a form of in vivo diagnostic imaging, not in vitro testing.
- Device Description: The description details hardware components like a magnet, coils, and a patient support system, all characteristic of an imaging device used on a living patient.
- Input Imaging Modality: The input is Magnetic Resonance, which is an imaging technique applied to the body, not a sample outside the body.
- Anatomical Site: The device is used on the "entire body," further confirming its in vivo nature.
In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, outside of the body. This device does not perform such tests.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The provided text for "Control Plan Authorized (PCCP) and relevant text" is "Not Found".
Intended Use / Indications for Use
The SIGNA 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LNH, LNI, MOS
Device Description
SIGNA Premier is a whole-body magnetic resonance scanner featuring a 3.0T superconducting magnet with a 70cm bore size. Major elements of the system include the magnet, gradient coils, body RF transmit coil, RF receive subsystem, patient support system (table), host computer, and system software. The system is compatible with a suite of RF receive coils, and is capable of using various pulse sequences, imaging techniques and reconstruction algorithms.
This submission is prompted by the introduction of a new software feature called AIR Recon DL onto the SIGNA Premier system. AIR Recon DL is a deep-learning based reconstruction technique designed to improve signal-to-noise ratio (SNR) and image sharpness. The feature also enables shorter scan times while preserving SNR and image sharpness.
The addition of the AIR Recon DL feature involved modifications to the SIGNA Premier system software. There were no changes related to AIR Recon DL to the system's hardware components.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Magnetic Resonance
Anatomical Site
whole 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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing: The AIR Recon DL feature was tested with a digital reference object and phantom imaging. These tests evaluated image quality, including SNR, sharpness, low contrast detectability, and noise spectral content. Analysis confirmed that the feature does not introduce significant bias that might impact quantitative measurements based on signal intensity. The influence of motion during image acquisition on the performance of AIR Recon DL was also evaluated. The results showed that AIR Recon DL improves SNR and image sharpness while maintaining low contrast detectability and having minimal impacts on noise spectral content, average signal intensity, or the appearance of motion artifacts. It also maintained image SNR and did not sacrifice sharpness for images acquired with reduced scan time. The nonclinical testing passed defined acceptance criteria and did not identify adverse impacts or concerns.
Clinical Testing:
- Objective Measures of In Vivo Images: Objective measures of in vivo images were analyzed to confirm that AIR Recon DL improves SNR and image sharpness for typical clinical use cases.
- Reader Evaluation Study: A reader evaluation study was performed on AIR Recon DL images acquired across a variety of pulse sequences and anatomies. Radiologists conducted blinded reads of both AIR Recon DL images and images without AIR Recon DL. Comparisons were also made between AIR Recon DL images from shorter scan time acquisitions and images without AIR Recon DL taken with longer scan times. The results confirmed that the AIR Recon DL feature provides images with equivalent or better image quality in terms of the legibility of clinically relevant structures. The radiologists also indicated a preference for the AIR Recon DL images.
- Sample Image Evaluation: Sample images from clinically indicated scans, both with and without the AIR Recon DL feature, were evaluated. These samples included images using exogenous contrast and images involving pathology across various anatomies and pulse sequences. Radiologists rated the images and commented on notable aspects related to image quality. This study showed that lesion conspicuity is maintained with AIR Recon DL, and radiologists preferred the AIR Recon DL images for clinical use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GE Healthcare (GE Medical Systems, LLC) % Mr. Glen Sabin Regulatory Affairs Director, MR 3200 N Grandview Blvd. WAUKESHA WI 53188
April 10, 2020
Re: K193282
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, MOS Dated: March 11, 2020 Received: March 12, 2020
Dear Mr. Sabin:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K193282
Device Name
SIGNA Premier
Indications for Use (Describe)
The SIGNA 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 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) | |
|---|---|
| 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 SIGNA Premier
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 26 November 2019 |
|---|---|
| Submitter: | GE Medical Systems, LLC |
| 3200 N. Grandview Blvd. | |
| Waukesha, WI 53188 | |
| Primary Contact: | Glen Sabin |
| Regulatory Affairs Director | |
| Phone: 262 521-6848 | |
| Email: Glen.Sabin@GE.com | |
| Secondary Contact: | Jim McMahon |
| Senior Director - Regulatory Affairs | |
| Phone: 508 382-2858 | |
| Email: James.D.McMahon@GE.com | |
| Device Trade Name: | SIGNA Premier |
| Common / Usual Name: | MR System |
| Classification Name: | |
| Regulation Number: | |
| Primary Product Code: | |
| Secondary Product Codes: | Magnetic Resonance Diagnostic Device |
| 21 CFR 892.1000 | |
| LNH | |
| LNI, MOS | |
| Predicate Device: | |
| 510(k) Number: | |
| Device Name: | |
| Manufacturer: | K183231 |
| SIGNA Premier | |
| GE Medical Systems, LLC |
Device Description:
SIGNA Premier is a whole-body magnetic resonance scanner featuring a 3.0T superconducting magnet with a 70cm bore size. Major elements of the system include the magnet, gradient coils, body RF transmit coil, RF receive subsystem, patient support system (table), host computer, and system software. The system is compatible with a suite of RF receive coils, and is capable of using various pulse sequences, imaging techniques and reconstruction algorithms.
This submission is prompted by the introduction of a new software feature called AIR Recon DL onto the SIGNA Premier system. AIR Recon DL is a deep-learning based reconstruction technique designed to improve signal-to-noise ratio (SNR) and image sharpness. The feature also enables shorter scan times while preserving SNR and image sharpness.
The addition of the AIR Recon DL feature involved modifications to the SIGNA Premier system software. There were no changes related to AIR Recon DL to the system's hardware components.
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Indications for Use:
The Indications for Use statement for the proposed device is identical to that of the predicate device:
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.
The addition of the AIR Recon DL feature does not impact the intended use of the SIGNA Premier system.
Comparison of Technological Characteristics:
Many of the technological characteristics of the proposed SIGNA Premier system are unchanged from the predicate device. There are no changes to the magnet, gradient, and RF subsystems compared to the predicate K183231. Key performance specifications (such as magnet homogeneity and stability, maximum gradient strength and slew rate, etc.) for the system are also unchanged.
The software used on the proposed SIGNA Premier system has been modified to include the AR Recon DL feature. The user interface provides operators of the system with new options for selecting AIR Recon DL and adjusting the associated level of image noise reduction. The resulting images can have higher SNR and improved sharpness compared to images reconstructed without AIR Recon DL.
Summary of Nonclinical Testing:
The AIR Recon DL feature has undergone testing with a digital reference object and phantom imaging. These tests were designed to evaluate the AIR Recon DL feature and its impact on image quality, including SNR, sharpness, low contrast detectability, and noise spectral content. Analysis was performed to confirm that the feature does not introduce significant bias that might impact quantitative measurements based on signal intensity. The influence of motion during image acquisition on the performance of AIR Recon DL was also evaluated.
The nonclinical testing demonstrated that AIR Recon DL does improve SNR and image sharpness while maintaining low contrast detectability and having minimal impacts to noise spectral content, average signal intensity, or the appearance of motion artifacts. AIR Recon DL was also able to maintain image SNR and did not sacrifice sharpness for images acquired with a reduced scan time. The nonclinical testing passed the defined acceptance criteria, and did not identify any adverse impacts to image quality or other concerns related to safety and performance.
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Summary of Clinical Testing:
Objective measures of in vivo images were analyzed to confirm that AIR Recon DL improves SNR and image sharpness for typical clinical use cases.
A reader evaluation study was performed on AIR Recon DL images acquired across a variety of pulse sequences and anatomies. Radiologists were asked to perform blinded reads of both AIR Recon DL images and images without AL Recon DL. Comparisons were also made between AlR Recon DL images from shorter scan time acquisitions and images without AIR Recon DL taken with longer scan times. The results confirmed that the AIR Recon DL feature provides images with equivalent or better image quality in terms of the legibility of clinically relevant structures. The radiologists reading the images also indicated a preference for the AIR Recon DL images.
Additionally, sample images from clinically indicated scans were evaluated both with and without the AIR Recon DL feature. These samples included images using exogenous contrast and images involving pathology spanning a variety of anatomies and pulse sequences. Radiologists were asked to rate the images, and to comment on any notable aspects related to image quality. This study showed that lesion conspicuity is maintained with AIR Recon DL, and that the radiologists preferred the AIR Recon DL images for clinical use.
Conclusions Drawn from Performance Testing:
The nonclinical and clinical testing demonstrated that AIR Recon DL satisfies the product claims of improved SNR and image sharpness, and can enable shorter scan times while maintaining SNR and image sharpness.
The proposed SIGNA Premier system with AIR Recon DL has been developed under GE Healthcare's quality system and is at least as safe and effective as the legally marketed predicate. The performance testing did not identify any new hazards, adverse effects, or safety or performance concerns that are significantly different from those associated with MR imaging in general.
Therefore, GE Healthcare believes that SIGNA Premier with AIR Recon DL is substantially equivalent to the predicate device, and is safe and effective for its intended use.