SIGNA Premier

K171128 · Ge Medical Systems, LLC · LNH · Jul 14, 2017 · Radiology

Device Facts

• Record ID: K171128
• Device Name: SIGNA Premier
• Applicant: Ge Medical Systems, LLC
• Product Code: LNH · Radiology
• Decision Date: Jul 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

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 yield information that may assist in diagnosis.

Device Story

SIGNA Premier is a 3.0T whole-body MRI scanner; utilizes superconducting magnet and TDI RF architecture; produces axial, sagittal, coronal, oblique, and double oblique images, spectroscopic images, parametric maps, and spectra. Operated by trained clinicians in clinical settings. Inputs include magnetic resonance signals from patient tissues; processed via pulse sequences and reconstruction algorithms to generate diagnostic images. Output interpreted by physicians to assist in diagnosis. Features 70cm bore, 80 mT/m gradient amplitude, 200 T/m/s slew rate, and 146 receive channels. Designed for high signal-to-noise ratio and reduced scan times. Supports patient comfort and workflow efficiency.

Clinical Evidence

No clinical studies were required. Substantial equivalence supported by bench testing and sample clinical images demonstrating acceptable diagnostic performance per FDA guidance. Compliance with safety standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, ISO 10993-1) and NEMA standards (MS series, PS3/DICOM) confirmed.

Technological Characteristics

3.0T superconducting magnet; 70cm bore; 80 mT/m gradient amplitude; 200 T/m/s slew rate; 146-channel RF receive chain; TDI RF architecture; SIGNA Works software platform. Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, ISO 10993-1, NEMA MS standards, and NEMA PS3 (DICOM). Flame retardant materials used.

Indications for Use

Indicated for use as a diagnostic imaging device for the entire body (head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, musculoskeletal) in patients requiring MRI imaging. Contrast agents may be used.

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 Architect (K163331)

Submission Summary (Full Text)

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, often associated with healthcare.

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

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

k171128

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)

### 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/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.

k171128

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)<br>3200 N. Grandview Blvd.,<br>Waukesha, WI 53188<br>USA |
| Primary Contact Person: | Mary A. Mayka, Ph.D.<br>Regulatory Affairs Manager<br>GE Healthcare<br>Phone: [phone]<br>Fax: [phone] |
| Secondary Contact Person: | James McMahon<br>Senior Director, Regulatory Affairs<br>GE Healthcare<br>Phone: [phone]<br>Fax: [phone] |
| Device Trade Name: | SIGNA™ Premier |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device |
| Classification Names: | Magnetic Resonance Diagnostic Device per 21 CFR<br>892.1000 |
| Product Code: | LNH, LNI, MOS |
| Predicate Device(s): | SIGNATM Architect (K163331) |
| Device Description: | SIGNAT™ Premier is a whole body magnetic resonance<br>scanner designed to support high resolution, high signal-<br>to-noise ratio, and short scan times, and is designed for<br>improved patient comfort and workflow. The system<br>features a 3.0T superconducting magnet with a 70cm bore<br>size and can image in the sagittal, coronal, axial, oblique,<br>and double oblique planes, using various pulse sequences,<br>imaging techniques and reconstruction algorithms. The<br>system is designed to conform to NEMA DICOM<br>standards (Digital Imaging and Communications in<br>Medicine). |
| Indications for Use | The SIGNA™ Premier system is a whole body magnetic<br>resonance scanner designed to support high resolution,<br>high signal-to-noise ratio, and short scan times. It is<br>indicated for use as a diagnostic imaging device to<br>produce axial, sagittal, coronal, and oblique images,<br>spectroscopic images, parametric maps, and/or spectra,<br>dynamic images of the structures and/or functions of the<br> |
| Technology: | The SIGNA™ Premier employs the same fundamental<br>scientific technology as its predicate devices.<br><br>SIGNATM Premier builds on the 3.0T wide bore magnet,<br>TDI RF architecture and SIGNA™Works software<br>platform and application suite.<br><br>The following is a summary of the different technology<br>characteristics from the predicate devices:<br>Newly designed gradient system Expanded RF receive chain capabilities Redesigned body coil Updated patient table |
| Comparison of Indications<br>for Use | The changes in technology do not impact the indications<br>for use. The indications for use have not changed, other<br>than to reflect the SIGNATM Premier product name.<br><br>Therefore, the intended use is the same as the predicate<br>device in accordance with the FDA's guidance document<br>"The 510(k) Program: Evaluating Substantial Equivalence<br>in Premarket Notifications [510(k)]", dated 28 July 2014. |
| Comparison of<br>Technological<br>Characteristics | Overall, the SIGNATM Premier employs the same<br>fundamental scientific technology as the predicate device.<br><br><b>System Design:</b> There are two notable technological<br>differences between the SIGNATM Premier and the<br>predicate device: a newly designed gradient system and<br>an expanded channel count for the RF receive chain.<br><br>The differences are summarized below:<br><b>Gradient system:</b> The SIGNA Premier can deliver a<br>maximum gradient amplitude of 80 mT/m and<br>maximum gradient slew rate of 200 T/m/s compared<br>to the predicate's maximum gradient amplitude of 44<br>mT/m and maximum gradient slew rate of 200<br>T/m/s. <b>RF receive chain:</b> The SIGNATM Premier is<br>equipped with 146 receive channels as compared to<br>the predicate's 128 channels. <b>Operating Principles:</b> The SIGNATM Premier functions<br>using the same operating principles as the predicate<br>device.<br><br><b>Materials:</b> The SIGNATM Premier and the predicate<br>device both use flame retardant materials.<br><br><b>Safety and Performance Testing:</b> Both the SIGNATM<br>Premier and the predicate device comply with the same<br>safety and performance testing (see Determination of<br>Substantial Equivalence, below). |

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle is surrounded by a pattern of swirling lines, also in blue, which gives the impression of movement or energy.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls or flourishes around its perimeter, giving it a distinctive and recognizable appearance.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a shade of blue, and the background is white.

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) ●

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The logo is colored in a light blue hue, which gives it a clean and modern appearance.

| | Summary of Clinical Tests: |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The subject of this premarket submission, the SIGNATM<br>Premier, did not require clinical studies to support<br>substantial equivalence. Sample clinical images have been<br>included in this submission. |
| | The sample clinical images demonstrate acceptable<br>diagnostic image performance of the SIGNATM Premier in<br>accordance with the FDA Guidance "Submission of<br>Premarket Notifications for Magnetic Resonance<br>Diagnostic Devices" issued on November 18, 2016. |
| | The image quality of the SIGNATM Premier is<br>substantially equivalent to that of the predicate device. |
| | Substantial Equivalence Conclusion: |
| | The indications for use of the proposed device are<br>comparable to the claimed predicate device. The<br>SIGNA™ Premier employs equivalent technology to the<br>claimed predicate device. Additionally, the results from<br>the above non-clinical tests demonstrate that the device<br>performs as intended. Therefore, the SIGNA™ Premier is<br>substantially equivalent to the predicate device to which it<br>has been compared. |
| Conclusion: | In conclusion, GE Healthcare considers the SIGNATM<br>Premier to be as safe, as effective, with performance that<br>is substantially equivalent to the predicate device. |