3.0T GEM RT Open Array

K143389 · Ge Healthcare Coils (Usa Instruments, Inc.) · MOS · Mar 6, 2015 · Radiology

Device Facts

• Record ID: K143389
• Device Name: 3.0T GEM RT Open Array
• Applicant: Ge Healthcare Coils (Usa Instruments, Inc.)
• Product Code: MOS · Radiology
• Decision Date: Mar 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The 3.0T GEM RT Open Array Coil, part of the Oncology Suite, is a receive-only RF coil designed for use with 3.0T MRI systems manufactured by GE. The indications for use include the head, neck, and brachial plexus anatomies and vasculature imaging. The nucleus excited is hydrogen.

Device Story

3.0T GEM RT Open Array is a receive-only, 8-channel phased array RF coil; designed for posterior head, neck, and brachial plexus imaging. Device integrates with GE 3.0T MRI systems and Oncology Suite; connects to patient table via P-connector at head or foot end. Operates as multi-element phased array with integrated preamplifiers; captures hydrogen signals for MR image reconstruction. Used in clinical radiology settings by trained MRI technologists/radiologists. Output is raw RF signal data processed by the MRI scanner into diagnostic images; assists clinicians in visualizing anatomy and vasculature for diagnostic decision-making. Benefits include improved signal-to-noise ratio, penetration, and uniformity for specific anatomical regions.

Clinical Evidence

No clinical studies were required. Substantial equivalence supported by non-clinical bench testing and sample clinical images.

Technological Characteristics

Multi-element phased array receive-only RF coil; 8-channel configuration; integrated preamplifiers. Compliant with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, and NEMA MS 6-2008. Designed for 3.0T MRI systems. Connectivity via P-connector to patient table.

Indications for Use

Indicated for head, neck, and brachial plexus and vasculature imaging in patients undergoing MRI procedures using GE 3.0T systems. Nucleus excited is hydrogen.

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 GEM RT Open Array (K123327)

Reference Devices

• GEM patient table (K103327)

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

March 6, 2015

GE Healthcare Coils (USA Instruments, Inc.) % Ms. Candice Mandera Regulatory Affairs Leader, Magnetic Resonance 1515 Danner Drive AURORA OH 44202

Re: K143389

Trade/Device Name: 3.0T GEM RT Open Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: MOS Dated: February 5, 2015 Received: February 6, 2015

Dear Ms. Mandera:

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K143389

Device Name 3.0T GEM RT Open Array

Indications for Use (Describe)

The 3.0T GEM RT Open Array Coil, part of the Oncology Suite, is a receive-only RF coil designed for use with 3.0T MRI systems manufactured by GE. The indications for use include the head, neck, and brachial plexus and vasculature imaging. The nucleus excited is hydrogen.

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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Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script in the center. There are water droplet-like shapes around the outside of the circle. The logo is simple and recognizable.

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:<br>Submitter: | November 24, 2014<br>GE Healthcare Coils, (USA Instruments, Inc.)<br>Establishment Registration Number: 1529041<br>1515 Danner Dr.<br>Aurora, OH 44202-9273<br>USA |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Candice Mandera<br>Regulatory Affairs Leader<br>GE Healthcare (USA Instruments, Inc.)<br>1515 Danner Drive<br>Aurora, OH - 44202<br>USA<br>Phone: [phone]<br>Fax: [phone] |
| Secondary Contact Person: | Andrew Menden<br>Regulatory Affairs Manager<br>GE Healthcare (GE Medical Systems LLC.)<br>3200 N Grandview Blvd., Mail Code - W-827<br>Waukesha, WI-53188<br>USA<br>Phone: [phone]<br>Fax: [phone] |

| Device: | Trade Name: | 3.0T GEM RT Open Array |
|-----------------------|-------------------------------------------------------|------------------------|
| Common/Usual Name: | Coil, Magnetic Resonance, Specialty | |
| Classification Names: | 21CFR 892.1000 – Magnetic resonance diagnostic device | |

| Product Code: | MOS |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device(s): | K123327, 1.5T GEM RT Open Array |
| Device Description: | The 3.0T GEM RT Open Array is a receive-only coil designed to provide optimal penetration, uniformity, and signal to noise ratio for the posterior head-neck and brachial plexus. The 3.0T GEM RT Open Array coil is an 8-Channel Phased Array, which is sold as an |

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Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The letters are also blue. There are several white teardrop shapes around the perimeter of the circle.

option to the Oncology Suite that is compatible with the 3.0T GE GEM compatible MR Scanner. The GEM RT Open Array is a posterior coil that comes with a Pconnector that can be plugged into the head end (P2) or foot end (P4) of the 3.0T GEM patient table (K103327). When used with the Oncology suite the GEM RT Open Array coil can be inserted into the GEM cradle at the head end.

Intended Use: The 3.0T GEM RT Open Array Coil, part of the Oncology Suite, is a receive-only RF coil designed for use with 3.0T MRI systems manufactured by GE. The indications for use include the head, neck, and brachial plexus anatomies and vasculature imaging. The nucleus excited is hydrogen.

Technology: The GE 3.0T GEM RT Open Array is a multi-element phased array receive-only RF coil with integrated preamplifiers. The 3.0T GEM RT Open Array coil operates on the same principles and is an addition to the GEM suite of coils (K103327). The GEM RT Open Array is designed to fit into the GEM table at the head or foot end adjacent to where the existing integrated posterior array in the GEM table resides. The 3.0T GEM RT Open Array employs the same fundamental scientific technology as its predicate device.

Determination of Summary of Non-Clinical Tests: Substantial Equivalence:

> The GE 3.0T GEM RT Open Array has used the same non-clinical voluntary standards to to demonstrate substantial equivalence of safety and performance:

> AAMI/ANSI ES60601-1 (IEC 60601-1): Electrical Safety - compliant with all applicable sections

> 60601-1-2: Compatibility IEC Electromagnetic compliant with all applicable sections (i.e., electrostatic discharge)

> IEC 60601-2-33: Electrical Safety - compliant with all

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Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized, cursive font in the center. There are decorative swirls around the edge of the circle. The logo is simple and recognizable, and it has been used by GE for many years.

## applicable sections

NEMA MS 6-2008: SNR and Uniformity of Phased Array Coils - compliant with all applicable sections.

The following quality assurance measures were applied to the development of the device:

- Risk Analysis
- Requirements Reviews ●
- Design Reviews
- Testing on unit level (Module verification) ●
- Integration testing (System verification) ●
- Performance testing (Verification)
- Safety testing (Verification) ●
- . Simulated use testing (Validation)

### Summary of Clinical Tests:

The subject of this premarket submission, 3.0T GEM RT Open Array, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission.

## Substantial Equivalence Conclusion:

The indications for use of the proposed device are identical to the claimed predicate device. The 3.0T GEM RT Open Array employs equivalent technology to the claimed predicate device. Additionally, the results from the above non-clinical tests demonstrate that the device performs as intended. Thus, the 3.0T GEM RT Open Array is substantially equivalent to the predicate device to which it has been compared.

- Conclusion: GE Healthcare considers the 3.0T GEM RT Open Array to be as safe, as effective, and performance is substantially equivalent to the predicate device.