(28 days)
Yes
The device description explicitly mentions the "AIR Recon DL software feature," and the performance studies describe its impact on image quality, strongly suggesting the use of deep learning (DL), a subset of AI/ML, for image reconstruction.
No.
The device is described as a "diagnostic imaging device" intended to "assist in diagnosis" by producing images. It does not directly treat or cure any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the SIGNA 7.0T system is "indicated for use as a diagnostic imaging device." It further explains that the images and/or spectra produced, "when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description clearly states it is a "whole-body magnetic resonance scanner" and includes hardware components like a "7.0T superconducting magnet" and "ultra-high performance gradient coil." While the submission mentions a software feature (AIR Recon DL), the device itself is a physical MRI system.
Based on the provided text, the SIGNA 7.0T system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it is a "diagnostic imaging device" to produce images and spectra of the structures and functions of the head and extremities. This is a description of an in vivo (within a living organism) diagnostic imaging system, not an in vitro (outside of a living organism) diagnostic device that analyzes biological samples.
- Device Description: The description details a magnetic resonance imaging system with a magnet, gradient coil, and patient bore. This is consistent with an MRI scanner used for imaging the human body.
- Input Imaging Modality: The input modality is Magnetic Resonance, which is an imaging technique applied directly to the patient.
- Anatomical Site: The specified anatomical sites (head and extremities) are parts of the human body being imaged.
- Mechanism of Action: The device produces images based on the magnetic resonance properties of nuclei within the body. This is the principle of MRI, not an IVD test.
IVD devices typically involve the analysis of biological samples (like blood, urine, tissue) outside of the body to provide diagnostic information. The SIGNA 7.0T system operates by imaging the patient directly.
No
The provided text does not mention that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The phrase "Control Plan Authorized (PCCP)" is marked "Not Found" in the input.
Intended Use / Indications for Use
The SIGNA 7.0T system is a whole-body magnetic resonance scanner designed to support high signal-tonoise 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 head and extremities.
The images produced by the SIGNA 7.0T system reflects 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 device is intended for patients > 20 kg / 44 lb.
Product codes
LNH, LNI, MOS
Device Description
SIGNA 7.0T is a high performance magnetic resonance imaging system designed to support high resolution imaging at 7.0T in particular anatomical regions determined by the available RF coils. The system includes a 7.0T superconducting magnet and an ultra-high performance gradient coil with a 60 cm patient bore, supporting scanning in axial, coronal, sagittal, oblique, and double oblique planes using a variety of pulse sequences, imaging techniques, acceleration methods, and reconstruction algorithms.
This 510(k) submission is for the SIGNA 7.0T MR System, and has been triggered by the addition of the AIR Recon DL software feature and inclusion of installed base magnet system upgrades.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head and extremities
Indicated Patient Age Range
The device is intended for patients > 20 kg / 44 lb.
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
Summary of Non-Clinical Tests:
The AIR Recon DL feature has undergone performance testing. These tests were designed to evaluate the AIR Recon DL feature and its impact on image quality, including SNR, sharpness, and low contrast detectability.
The nonclinical testing demonstrated that AIR Recon DL does improve SNR and image sharpness while maintaining low contrast detectability. 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.
Simulations and analyses were performed for the different installed base magnet types to ensure equivalence.
Summary of Clinical Tests:
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 study was performed on images with and without AIR Recon DL feature. Radiologists were asked to rate the images, and to comment on any notable aspects related to image quality. This study showed that AIR Recon DL feature provides images with better SNR and equivalent or better sharpness. The radiologists uniformly preferred the AIR Recon DL images for clinical evaluation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing evaluated the impact of AIR Recon DL on image quality, including SNR, sharpness, and low contrast detectability, demonstrating improvement in SNR and sharpness while maintaining low contrast detectability, and maintaining SNR for reduced scan time images. Clinical tests involved objective measures confirming SNR and sharpness improvements for in vivo images and a reader study where radiologists preferred AIR Recon DL images due to better SNR and equivalent or better sharpness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SNR, sharpness, low contrast detectability
Predicate Device(s)
Reference Device(s)
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.
0
May 13, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health and Human Services emblem. To the right of the symbol is a blue square containing the acronym "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GE Medical Systems, LLC % Mr. Brian R. Zielski Regulatory Affairs Leader 3200 Grandview Blvd. WAUKESHA WI 53188
Re: K211118
Trade/Device Name: SIGNA 7.0T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: April 14, 2021 Received: April 15, 2021
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/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
2
Indications for Use
510(k) Number (if known)
Device Name SIGNA 7.0T
Indications for Use (Describe)
The SIGNA 7.0T system is a whole-body magnetic resonance scanner designed to support high signal-tonoise 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 head and extremities.
The images produced by the SIGNA 7.0T system reflects 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 device is intended for patients > 20 kg / 44 lb.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 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. There are three white teardrop shapes around the circle. The logo is simple and recognizable.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | April 13, 2021 |
|---|---|
| Submitter: | GE Medical Systems, LLC (GE Healthcare) |
| 3200 N. Grandview Blvd., | |
| Waukesha, WI 53188 | |
| USA | |
| Primary Contact Person: | Brian R. Zielski |
| Regulatory Affairs Leader | |
| Phone: 262-227-3596 | |
| Email: Brian.Zielski@GE.com | |
| Secondary Contact | |
| Person: | Glen Sabin |
| Senior Director, Regulatory Affairs | |
| Phone: 262-894-4968 | |
| Email: Glen.Sabin@GE.com | |
| Device Trade Name: | SIGNA 7.0T |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device |
| Classification Names: | |
| Regulation | |
| Number: | Magnetic Resonance Diagnostic Device |
| 21 CFR 892.1000 | |
| Product Code: | |
| Primary: | |
| Secondary: | |
| Predicate Device(s): | SIGNA 7.0T (K201615) |
| Device Description: | SIGNA 7.0T is a high performance magnetic resonance |
| imaging system designed to support high resolution imaging | |
| at 7.0T in particular anatomical regions determined by the | |
| available RF coils. The system includes a 7.0T | |
| superconducting magnet and an ultra-high performance | |
| gradient coil with a 60 cm patient bore, supporting scanning | |
| in axial, coronal, sagittal, oblique, and double oblique planes | |
| using a variety of pulse sequences, imaging techniques, | |
| acceleration methods, and reconstruction algorithms. |
This 510(k) submission is for the SIGNA 7.0T MR System, and
has been triggered by the addition of the AIR Recon DL
software feature and inclusion of installed base magnet
system upgrades. |
| Indications for Use | The addition of the AIR Recon DL feature and installed base
magnet system upgrades does not impact the intended use
of the SIGNA 7.0T system. The Indications for Use remain
identical: |
| | The SIGNA 7.0T 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 head and extremities. |
| | The images produced by the SIGNA 7.0T system reflects 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 device is intended for patients > 20 kg / 44 lb. |
| Technology: | The SIGNA 7.0T employs the same fundamental scientific
technology as its predicate device. |
| | The software used on the proposed SIGNA 7.0T system has
been modified to include the AIR 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.
AIR Recon DL has been previously cleared for use with GE
Healthcare's 3T SIGNA Premier system through K193282.
Due to the technical similarities, SIGNA Premier (K193282) is
used as a reference device for this submission.
Upgrades to SIGNA 7.0T are also being expanded to be
compatible with additional 7.0T magnets in the installed |
| | base. |
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Tests: |
| | The AIR Recon DL feature has undergone performance
testing. These tests were designed to evaluate the AIR Recon
DL feature and its impact on image quality, including SNR,
sharpness, and low contrast detectability. |
| | The nonclinical testing demonstrated that AIR Recon DL does
improve SNR and image sharpness while maintaining low
contrast detectability. 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. |
| | Simulations and analyses were performed for the different
installed base magnet types to ensure equivalence. |
| | Summary of Clinical Tests: |
| | 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 study was performed on images with and without
AIR Recon DL feature. Radiologists were asked to rate the
images, and to comment on any notable aspects related to
image quality. This study showed that AIR Recon DL feature
provides images with better SNR and equivalent or better
sharpness. The radiologists uniformly preferred the AIR
Recon DL images for clinical evaluation. |
| Conclusion: | The Indications for Use of the SIGNA 7.0T are identical to the
predicate device. The modifications to the SIGNA 7.0T
system do not change the fundamental scientific technology
of the device. The results of design controls activities
demonstrate that the SIGNA 7.0T is substantially equivalent
to the predicate with regards to safety and efficacy. |
| | GE Healthcare considers the SIGNA 7.0T to be as safe, as
effective, and performance is substantially equivalent to the
predicate device. |
| | In conclusion, GE Healthcare believes that SIGNA 7.0T with
AIR Recon DL and installed base magnet system upgrades is
substantially equivalent to the predicate device, and is safe
and effective for its intended use. |
4
Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white, stylized script in the center. There are three water droplet-like shapes surrounding the circle.
5
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. The frame has four stylized water droplets or flourishes, one at each cardinal direction (top, bottom, left, and right). The logo is a solid blue color.
6
Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. There are three white water droplet shapes surrounding the circle. The logo is simple and recognizable, representing the company's brand identity.