GEM OPTION FOR 1.5 MRI SYSTEMS

K103335 · GE Healthcare · MOS · Mar 7, 2011 · Radiology

Device Facts

• Record ID: K103335
• Device Name: GEM OPTION FOR 1.5 MRI SYSTEMS
• Applicant: GE Healthcare
• Product Code: MOS · Radiology
• Decision Date: Mar 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

The GEM Option for 1.5T MRI systems is a set of receive-only RF surface coils designed for use with 1.5T MRI systems manufactured by GE Healthcare. The GEM Option for 1.5T MRI systems is indicated for use for: head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone imaging. The nucleus detected is hydrogen.

Device Story

GEM Option for 1.5T MRI systems comprises integrated receive-only RF surface coils; includes head/neurovascular array, anterior imaging array, peripheral-vascular lower leg array, and posterior imaging array integrated into MR table. Designed for GE Healthcare 1.5T MRI systems. Coils used individually or combined for head-to-foot anatomical coverage; facilitates high-resolution, high-SNR whole-body imaging. Operated by MRI technicians/radiologists in clinical imaging environments. Replaces existing MR table with GEM table to improve workflow by reducing need for coil changes. Output is MR image data used by clinicians for diagnostic assessment of specified anatomical regions.

Clinical Evidence

Bench testing only. Compliance with electrical safety (IEC 60601-1, IEC 60601-2-33), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-1) standards. Clinical images provided to demonstrate performance equivalence.

Technological Characteristics

Receive-only RF surface coil arrays; integrated into MR table. Materials compliant with ISO 10993-1. Operates at 1.5T magnetic field strength; detects hydrogen nucleus. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-33 (MRI safety).

Indications for Use

Indicated for head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone imaging using hydrogen nucleus detection in patients undergoing 1.5T MRI.

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

• Optima MR450w (K091536)

Submission Summary (Full Text)

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103335 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: 16 February 2011

> GE Healthcare (GE Medical Systems, LLC) Submitter: Establishment Registration Number: 2183553 3200 N Grandview Blvd., Mail Code - W-827 Waukesha, WI 53188, USA

Primary Contact Person: Mr. Michael S. Preto Regulatory Affairs Leader, MR GE Healthcare Coils (USA Instruments, Inc.) Phone: [phone] Fax: [phone] Email: [e-mail]

Secondary Contact Person: Mr. Glen Sabin Regulatory Affairs Director, MR GE Healthcare (GE Medical Systems, LLC) 3200 N Grandview Blvd., Mail Code - W-827 Waukesha, WI 53188, USA Phone: [phone] Fax: [phone] Email: [e-mail]

Device: Trade Name: GEM Option for 1.5T MRI systems

Common/Usual Name: Magnetic resonance diagnostic device

Classification Names: 21 CFR 892.1000 Product Code: 90LNH, 90MOS

Predicate Device(s): K091536, Optima MR450w

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## GE Healthcare 510(k) Premarket Notification Submission

Device Description: The GEM Option for 1.5T MRI systems consists of a set integrated receive-only RF coils designed for use with 1.5T MRI systems manufactured by GE Healthcare. This coil set includes a head and neurovascular array, an anterior imaging array, a peripheral-vascular lower leg array, and a posterior imaging array integrated into the MR table for complete head-to-foot coverage. The coils can be used individually or combined to provide the anatomical coverage desired. The combined use of the entire GEM suite will facilitate high-resolution, high-SNR whole-body imaging from the top of the head down to the feet.

The GEM Option for 1.5T MRI systems is a set of Intended Use: receive-only RF surface coils designed for use with 1.5T MRI systems manufactured by GE Healthcare. The GEM Option for 1.5T MRI systems is indicated for use for: head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone imaging. The nucleus detected is hydrogen.

Technology: Comparison with Optima MR450w (K091536): The GEM Option for 1.5T MRI systems replaces the existing MR table with the GEM table. The system operates on the same principles with workflow improvement by reducing the need to change coils.

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## GE Healthcare 510(k) Premarket Notification Submission

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The GEM Option for 1.5T MRI systems has integrated surface coils to accommodate the improved workflow. The same non-clinical voluntary standards are used to demonstrate substantial equivalence of safety and performance:

IEC 60601-1: Electrical Safety - compliant with all applicable sections

IEC 60601-1-2: Electromagnetic Compatibility -

compliant with all applicable sections (i.e. electrostatic discharge)

IEC 60601-2-33: Electrical Safety – compliant with all applicable sections

ISO 10993-1: Biocompatibility -- determination of post market acceptability of materials

Clinical images are used to demonstrate substantial equivalence of performance.

Conclusion: GE Healthcare considers the GEM Option for 1.5T MRI systems to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

GE Healthcare (GE Medical Systems, LLC) Mr. Michael S. Preto Regulatory Affairs Leader, MR GE Healthcare Coils (USA Instruments, Inc.) 1515 Danner Drive AURORA OH 44202

MAR - 7 2011

Re: K103335

Trade/Device Name: GEM Option for 1.5T MRI Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: February 16, 2011 Received: February 18, 2011

Dear Mr. Preto:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary S Postel

Mary Pastel. ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: GEM Option for 1.5T MRI systems

Indications for Use:

The GEM Option for 1.5T MRI systems is a set of receive-only RF surface coils designed for use with 1.5T MRI systems manufactured by GE Healthcare. The GEM Option for I .5T MRI systems is indicated for use for: head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone imaging. The nucleus detected is hydrogen.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary Statt

Division Sign-Off Office of In Vitto Diagnostic Device Evaluation and Safety

510(k) K123335

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