SIGNA 7.0T

K211118 · Ge Medical Systems, LLC · LNH · May 13, 2021 · Radiology

Device Facts

• Record ID: K211118
• Device Name: SIGNA 7.0T
• Applicant: Ge Medical Systems, LLC
• Product Code: LNH · Radiology
• Decision Date: May 13, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

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.

Device Story

SIGNA 7.0T is a high-performance whole-body MRI system; utilizes 7.0T superconducting magnet and ultra-high performance gradient coil; 60 cm patient bore. Inputs: magnetic resonance signals from patient anatomy. Processing: includes AIR Recon DL software feature for image reconstruction and noise reduction. Outputs: high-resolution axial, sagittal, coronal, oblique images, spectroscopic images, parametric maps, and spectra. Used in clinical settings by trained physicians/technicians. AIR Recon DL improves signal-to-noise ratio (SNR) and sharpness; assists physicians in diagnostic interpretation. Benefits: higher quality images, potentially reduced scan times, improved diagnostic confidence.

Clinical Evidence

Reader study performed comparing images with and without AIR Recon DL. Radiologists rated images for quality; results showed AIR Recon DL provided better SNR and equivalent or better sharpness. Radiologists uniformly preferred AIR Recon DL images for clinical evaluation. Objective measures of in vivo images confirmed improvements in SNR and sharpness.

Technological Characteristics

7.0T superconducting magnet; ultra-high performance gradient coil; 60 cm patient bore. Software includes AIR Recon DL feature for image reconstruction/noise reduction. Supports axial, coronal, sagittal, oblique, and double oblique planes. Connectivity: standard MR imaging system interfaces.

Indications for Use

Indicated for patients > 20 kg (44 lb) requiring diagnostic MR imaging of head and extremities; produces axial, sagittal, coronal, oblique images, spectroscopic images, parametric maps, and dynamic images.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• SIGNA 7.0T (K201615)

Reference Devices

• SIGNA Premier (K193282)

Submission Summary (Full Text)

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May 13, 2021

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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

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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 ([e-mail]) or phone [phone] 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)

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)

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### 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)<br>3200 N. Grandview Blvd.,<br>Waukesha, WI 53188<br>USA |
| Primary Contact Person: | Brian R. Zielski<br>Regulatory Affairs Leader<br>Phone: [phone]<br>Email: [e-mail] |
| Secondary Contact<br>Person: | Glen Sabin<br>Senior Director, Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |
| Device Trade Name: | SIGNA 7.0T |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device |
| Classification Names:<br>Regulation<br>Number: | Magnetic Resonance Diagnostic Device<br>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<br>imaging system designed to support high resolution imaging<br>at 7.0T in particular anatomical regions determined by the<br>available RF coils. The system includes a 7.0T<br>superconducting magnet and an ultra-high performance<br>gradient coil with a 60 cm patient bore, supporting scanning<br>in axial, coronal, sagittal, oblique, and double oblique planes<br>using a variety of pulse sequences, imaging techniques,<br>acceleration methods, and reconstruction algorithms.<br><br>This 510(k) submission is for the SIGNA 7.0T MR System, and<br>has been triggered by the addition of the AIR Recon DL<br>software feature and inclusion of installed base magnet<br>system upgrades. |
| Indications for Use | The addition of the AIR Recon DL feature and installed base<br>magnet system upgrades does not impact the intended use<br>of the SIGNA 7.0T system. The Indications for Use remain<br>identical: |
| | The SIGNA 7.0T system is a whole-body magnetic resonance<br>scanner designed to support high resolution, high signal-to-<br>noise ratio, and short scan times. It is indicated for use as a<br>diagnostic imaging device to produce axial, sagittal, coronal,<br>and oblique images, spectroscopic images, parametric maps,<br>and/or spectra, dynamic images of the structures and/or<br>functions of the head and extremities. |
| | The images produced by the SIGNA 7.0T system reflects the<br>spatial distribution or molecular environment of nuclei<br>exhibiting magnetic resonance. These images and/or spectra<br>when interpreted by a trained physician yield information<br>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<br>technology as its predicate device. |
| | The software used on the proposed SIGNA 7.0T system has<br>been modified to include the AIR Recon DL feature. The user<br>interface provides operators of the system with new options |
| | for selecting AIR Recon DL and adjusting the associated level<br>of image noise reduction. The resulting images can have<br>higher SNR and improved sharpness compared to images<br>reconstructed without AIR Recon DL.<br>AIR Recon DL has been previously cleared for use with GE<br>Healthcare's 3T SIGNA Premier system through K193282.<br>Due to the technical similarities, SIGNA Premier (K193282) is<br>used as a reference device for this submission.<br>Upgrades to SIGNA 7.0T are also being expanded to be<br>compatible with additional 7.0T magnets in the installed |
| | base. |
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests: |
| | The AIR Recon DL feature has undergone performance<br>testing. These tests were designed to evaluate the AIR Recon<br>DL feature and its impact on image quality, including SNR,<br>sharpness, and low contrast detectability. |
| | The nonclinical testing demonstrated that AIR Recon DL does<br>improve SNR and image sharpness while maintaining low<br>contrast detectability. AIR Recon DL was also able to<br>maintain image SNR and did not sacrifice sharpness for<br>images acquired with a reduced scan time. The nonclinical<br>testing passed the defined acceptance criteria, and did not<br>identify any adverse impacts to image quality or other<br>concerns related to safety and performance. |
| | Simulations and analyses were performed for the different<br>installed base magnet types to ensure equivalence. |
| | Summary of Clinical Tests: |
| | Objective measures of in vivo images were analyzed to<br>confirm that AIR Recon DL improves SNR and image<br>sharpness for typical clinical use cases. |
| | A reader study was performed on images with and without<br>AIR Recon DL feature. Radiologists were asked to rate the<br>images, and to comment on any notable aspects related to<br>image quality. This study showed that AIR Recon DL feature<br>provides images with better SNR and equivalent or better<br>sharpness. The radiologists uniformly preferred the AIR<br>Recon DL images for clinical evaluation. |
| Conclusion: | The Indications for Use of the SIGNA 7.0T are identical to the<br>predicate device. The modifications to the SIGNA 7.0T<br>system do not change the fundamental scientific technology<br>of the device. The results of design controls activities<br>demonstrate that the SIGNA 7.0T is substantially equivalent<br>to the predicate with regards to safety and efficacy. |
| | GE Healthcare considers the SIGNA 7.0T to be as safe, as<br>effective, and performance is substantially equivalent to the<br>predicate device. |
| | In conclusion, GE Healthcare believes that SIGNA 7.0T with<br>AIR Recon DL and installed base magnet system upgrades is<br>substantially equivalent to the predicate device, and is safe<br>and effective for its intended use. |

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