SIGNA Creator, SIGNA Explorer

K143251 · Ge Healthcare (Ge Medical Systems, LLC) · LNH · Feb 4, 2015 · Radiology

Device Facts

• Record ID: K143251
• Device Name: SIGNA Creator, SIGNA Explorer
• Applicant: Ge Healthcare (Ge Medical Systems, LLC)
• Product Code: LNH · Radiology
• Decision Date: Feb 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

1.5T SIGNA Creator and 1.5T SIGNA Explorer 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 1.5T SIGNA Creator and 1.5T SIGNA Explorer 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.

Device Story

1.5T SIGNA Creator and 1.5T SIGNA Explorer are whole-body MRI scanners using a 1.5 Tesla superconducting magnet. The system utilizes time-varying magnetic field gradients and RF transmissions to excite nuclei, capturing spatial distribution and molecular environment data. The data acquisition system supports 16 independent receive channels and multiple coil elements per acquisition series. Operated by trained professionals in clinical settings, the device produces axial, sagittal, coronal, oblique, and spectroscopic images, parametric maps, and dynamic images. These outputs are interpreted by physicians to assist in clinical diagnosis. The system is designed for high resolution, high signal-to-noise ratio, and short scan times.

Clinical Evidence

No clinical studies were required. Substantial equivalence is supported by bench testing, including internal validation of workflow and image quality, and the inclusion of sample clinical images.

Technological Characteristics

1.5T superconducting magnet; 16-channel data acquisition system; supports DICOM (NEMA PS3.1-3.20). Complies with IEC 60601-1, IEC 60601-2-33, IEC 60601-1-1, IEC 60601-1-2, and NEMA MS1-MS5, MS8 standards.

Indications for Use

Indicated for whole-body diagnostic MRI imaging in patients requiring axial, sagittal, coronal, oblique, spectroscopic, or dynamic imaging of head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions. 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

• 1.5T Brivo MR355 and 1.5T Optima MR360 (K123417)
• 1.5T Optima MR450w (K142085)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 4, 2015

GE Healthcare (GE Medical Systems, LLC) % Mr. Glen Sabin Regulatory Affairs Director 3200 N. Grandview Blvd. WAUKESHA WI 53188

Re: K143251

Trade/Device Name: 1.5T SIGNA Creator and 1.5T SIGNA Explorer Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 7, 2014 Received: November 12, 2014

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. 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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/Resourcesfor You/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 yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K143251

Device Name

1.5T SIGNA Creator and 1.5T SIGNA Explorer

#### Indications for Use (Describe)

1.5T SIGNA Creator and 1.5T SIGNA Explorer 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 1.5T SIGNA Creator and 1.5T SIGNA Explorer 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.

| 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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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: | November 7, 2014 |
| Submitter: | GE Healthcare (GE Medical Systems, LLC)<br>3200 N. Grandview Blvd.,<br>Waukesha, WI 53188<br>USA |
| Primary Contact Person: | Glen Sabin<br>Regulatory Affairs Director<br>GE Healthcare<br>Phone: [phone]<br>Fax: [phone] |
| Secondary Contact Person: | Ruoqian Liu<br>Regulatory Affairs Director<br>GE Healthcare<br>Phone: [phone]<br>Fax: [phone] |
| Device: | Trade Name: 1.5T SIGNA Creator, 1.5T SIGNA Explorer |
| Common/Usual Name: | Magnetic Resonance Imaging System |
| Classification Names: | Magnetic resonance diagnostic device |
| Product Code: | LNH |
| Predicate Device(s): | 1.5T Brivo MR355 and 1.5T Optima MR360 (K123417)<br>1.5T Optima MR450w (K142085) |
| Device Description: | 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body<br>magnetic resonance scanner designed to support high resolution,<br>high signal-to-noise ratio, and short scan times. The 1.5T SIGNA<br>Creator and 1.5T SIGNA Explorer features a superconducting<br>magnet operating at 1.5 Tesla. The system uses a combination of<br>time-varying magnetic fields (gradients) and RF transmissions to<br>obtain information regarding the density and position of nuclei<br>exhibiting magnetic resonance. The data acquisition system<br>accommodates 16 independent receive channels and multiple<br>independent coil elements per channel during a single acquisition<br>series. |

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# GE Healthcare 510(k) Premarket Notification Submission

- 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body Intended Use: 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 1.5T SIGNA Creator and 1.5T SIGNA Explorer 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.

- Proposed 1.5T SIGNA Creator and 1.5T SIGNA Explorer Technology: employs the same fundamental scientific technology as its predicate device 1.5T Brivo MR355 and 1.5T Optima MR360 (K123417).
Determination of Summary of Non-Clinical Tests:

Substantial Equivalence: 1.5T SIGNA Creator and 1.5T SIGNA Explorer and its applications underwent testing to comply with voluntary standards, including IEC60601-1. IEC60601-2-33, IEC60601-1-1, IEC60601-1-2. In addition, the following FDA-recognized performance standards were used to test the 1.5T SIGNA Creator and 1.5T SIGNA Explorer: NEMA MS1, MS2, MS3, MS4, MS5 and MS8. Additionally, the communication interface for the 1.5T SIGNA Creator and 1.5T SIGNA Explorer is designed to support DICOM format as defined in the NEMA PS PS3.1-3.20 set of standards. The predicate devices also complied with these standards.

> As with the predicate devices, 1.5T SIGNA Creator and 1.5T SIGNA Explorer applied the following quality assurance measures:

- Risk Analysis ●
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)

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- Performance testing (Verification)
- . Safety testing (Verification)
- Simulated use testing (Validation)

### Summary of Clinical Tests:

The subject of this premarket submission, 1.5T SIGNA Creator and 1.5T SIGNA Explorer did not require clinical studies to support substantial equivalence. Internal scans were conducted as part of validation for workflow and image quality, and sample clinical images are included in the submission.

### Substantial Equivalence Conclusion:

The indications for use of the proposed systems and the predicates are nearly identical. The name of the device has changed and minor updates were made to the feature set. 1.5T SIGNA Creator and 1.5T SIGNA Explorer employs equivalent technology to the reference devices. Additionally, the result of the above described testing demonstrates that the device performs as intended.

- GE Healthcare considers the 1.5T SIGNA Creator and 1.5T Conclusion: SIGNA Explorer to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).