MAGiC

K161397 · Ge Medical Systems, LLC · LNH · Aug 31, 2016 · Radiology

Device Facts

• Record ID: K161397
• Device Name: MAGiC
• Applicant: Ge Medical Systems, LLC
• Product Code: LNH · Radiology
• Decision Date: Aug 31, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

MAGiC (MAGnetic resonance image Compilation) is a software option based on a combination and post processing software that is intended for use on GE imaging platforms. MAGiC generates multiple image contrasts from a single acquisition scan. MAGiC enables post-acquisition image contrast adjustment. MAGiC also allows for the generation of parametric maps for further analysis of MRI acquisition data. MAGiC is indicated for head imaging. When interpreted by a trained physician, MAGiC images can provide information useful in determining diagnosis.

Device Story

MAGiC is a software-based MRI post-processing tool for GE imaging platforms; utilizes multi-delay, multi-echo (MDME) acquisition data to generate multiple image contrasts (T1, T2, PD, IR-weighted) from a single scan; enables post-acquisition adjustment of TR, TE, and TI parameters to modify image contrast; generates parametric maps (T1, T2, R1, R2, PD) for analysis; eliminates inter-acquisition patient movement artifacts by deriving all contrasts from one scan; operated by clinicians/technicians on GE MRI systems; output viewed by physicians to assist in clinical diagnosis; benefits include improved slice registration and workflow efficiency via single-scan acquisition.

Clinical Evidence

A reader study was conducted to evaluate diagnostic image quality and radiologic finding classes. Results demonstrated acceptable image quality and equivalence to the predicate device.

Technological Characteristics

Software-only feature for GE MRI platforms. Complies with AAMI/ANSI 62304 (software lifecycle), AAMI/ANSI ES60601-1 (safety), IEC 60601-2-33 (MRI safety), and NEMA PS3.1-3.18 (DICOM). Utilizes multi-delay, multi-echo (MDME) acquisition processing to synthesize multiple contrast weightings and parametric maps from a single scan.

Indications for Use

Indicated for head imaging in patients requiring MRI diagnostic evaluation. Used by trained physicians to interpret images for diagnostic purposes.

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

• Discovery MR750 3.0T (K142085)
• Discovery MR450 1.5T (K142085)
• Discovery MR750w 3.0T (K142085)
• Optima MR450w 1.5T (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

August 31, 2016

GE Medical Systems, LLC Mary Mayka Regulatory Affairs Manager 3200 Grandview Blvd WAUKESHA WI 53188

Re: K161397 Trade/Device Name: MAGiC Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 29, 2016 Received: August 1, 2016

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 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.

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

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### Indications for Use

510(k) Number (if known) K161397

Device Name MAGiC

#### Indications for Use (Describe)

MAGiC (MAGnetic resonance image Compilation) is a software option based on a combination and post processing software that is intended for use on GE imaging platforms. MAGiC generates multiple image contrasts from a single acquisition scan. MAGiC enables post-acquisition image contrast adjustment. MAGiC also allows for the generation of parametric maps for further analysis of MRI acquisition data. MAGiC is indicated for head imaging.

When interpreted by a trained physician, MAGiC images can provide information useful in determining diagnosis.

Type of Use (Select one or both, as applicable)

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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: | July 28, 2016 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Glen Sabin<br>Regulatory Affairs Director<br>GE Healthcare<br>Phone: [phone]<br>Fax: [phone] |
| Device Trade Name: | MAGiC (MAGnetic resonance image Compilation) |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device |
| Classification Names: | Magnetic Resonance Diagnostic Device per 21 CFR<br>892.1000 |
| Product Code: | LNH |
| Predicate Device(s): | Discovery MR750 3.0T, Discovery MR450 1.5T,<br>Discovery MR750w 3.0T, Optima MR450w 1.5T<br>(K142085) |
| Device Description: | MAGiC (MAGnetic resonance image Compilation)<br>allows the user to generate multiple contrasts in a single<br>scan. MAGiC utilizes a multi-delay, multi-echo<br>acquisition (MDME). The data acquired is processed<br>using a technique to generate multiple image contrasts<br>simultaneously, such as T1, T2, PD and Inversion<br>Recovery (IR) weighted images (including: T1-FLAIR,<br>T2-FLAIR, STIR, Double IR and PSIR weighted images).<br>MAGiC generates all the different image contrasts from<br>the same acquisition, leading to enhanced image slice<br>registration, owing to the absence of inter-acquisition<br>patient movement. MAGiC provides the user the ability to<br>change the contrast of the images after acquisition. This is<br>performed by adjusting the TR, TE, and/or TI parameters<br>post-acquisition, to generate the specific contrast desired.<br>MAGiC also enables users to generate parametric maps,<br>such as T1, T2, R1, R2, PD, for further analysis of MRI<br>acquisition data. |
| Intended Use: | MAGiC (MAGnetic resonance image Compilation) is a<br>software option based on a combination of acquisition and<br>post processing software that is intended for use on GE<br>imaging platforms. MAGiC generates multiple image<br>contrasts from a single acquisition scan. MAGiC enables<br>post-acquisition image contrast adjustment. MAGiC also<br>allows for the generation of parametric maps for further<br>analysis of MRI acquisition data. MAGiC is indicated for<br>head imaging.<br>When interpreted by a trained physician, MAGiC images<br>can provide information useful in determining diagnosis. |
| Technology: | MAGiC employs the same fundamental scientific<br>technology as its predicate devices. |
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests: |
| | MAGiC is a software only feature and complies with the<br>following voluntary standards:<br>• AAMI/ANSI 62304<br>• AAMI/ANSI ES60601-1<br>• IEC 60601-2-33<br><br>In addition, MAGIC complies with NEMA PS3.1-3.18 for<br>DICOM conformance.<br><br>The following quality assurance measures were applied to<br>the development of the device:<br>• Risk Analysis<br>• Requirements Reviews<br>• Design Reviews<br>• Testing on unit level (Module verification)<br>• Integration testing (System verification)<br>• Performance testing (Verification)<br>• Safety testing (Verification)<br>• Simulated use testing (Validation)<br><br>The non-clinical tests have been summarized in the<br>verification and validation testing for MAGiC. The testing<br>was completed with passing results per the pass/fail<br>criteria defined in the test cases. This supports substantial<br>equivalence to its predicates because it was also<br>developed under quality assurance Design Controls. In<br>addition, the software complies with the same applicable<br>Standards.<br><br>Summary of Clinical Tests:<br>A reader study was conducted to demonstrate acceptable<br>diagnostic image quality and equivalent radiologic finding<br>classes compared to the predicate device. |
| Conclusion: | GE Healthcare considers MAGiC to be as safe, as<br>effective, and performance is substantially equivalent to<br>the predicate devices. |

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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle is surrounded by swirling, wave-like lines, also in blue, giving the logo a dynamic and recognizable appearance.

# GE Healthcare 510(k) Premarket Notification Submission

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# GE Healthcare 510(k) Premarket Notification Submission