GE 1.5T 8 CHANNEL TORSO COIL

K031209 · Ge Medical Systems, Inc. · MOS · May 23, 2003 · Radiology

Device Facts

• Record ID: K031209
• Device Name: GE 1.5T 8 CHANNEL TORSO COIL
• Applicant: Ge Medical Systems, Inc.
• Product Code: MOS · Radiology
• Decision Date: May 23, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The GE 1.5T 8 Channel Torso Coil is intended to be used in the abdomen, pelvis and chest regions for 2D and 3D Magnetic Resonance imaging and Parallel body imaging.

Device Story

GE 1.5T 8 Channel Torso Coil is a 12-element phased array MRI coil with integrated preamplifiers; designed for imaging abdomen, pelvis, and chest. Device utilizes optimized geometry to support parallel imaging (ASSET) techniques. Operated by MRI technicians/radiologists in clinical settings; output is raw signal data processed by the MRI system to generate diagnostic images. Benefits include improved imaging performance and parallel imaging capabilities for torso applications. Substantially equivalent to existing phased array coils; no new hazards introduced.

Clinical Evidence

Bench testing only. Testing was performed to demonstrate that the design of the 1.5T 8 Channel Torso Coil met predetermined acceptance criteria.

Technological Characteristics

12-element phased array MRI coil; integrated preamplifiers; optimized geometry for parallel imaging (ASSET). Designed for 1.5T MRI systems. Connectivity is via standard MRI coil interface.

Indications for Use

Indicated for patients requiring 2D and 3D Magnetic Resonance imaging and Parallel body imaging of the abdomen, pelvis, and chest regions.

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

• GE 3.0T Torso Phased Array Coil (K030495)
• GE 8 Channel Cardiac Phased Array Coil (K022669)

Submission Summary (Full Text)

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03/209

MAY 2 3 2003

GE Medical Systems

Page 1 of 2

General Electric Company P.O. Box 414, Milwaukee, WI 53201

# 510(k) Summary

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).

| Submitter: | GE Medical Systems<br>PO Box 414 (W-400)<br>Milwaukee, WI 53201 |
|-----------------|-----------------------------------------------------------------|
| Contact Person: | Larry A. Kroger Ph.D.<br>Manager, Regulatory Programs |
| Telephone: | 262- 544-3894 |
| Fax: | 262- 548-4768 |
| Date Prepared: | April 16, 2003 |

# Device Name:

GE 1.5T 8 Channel Torso Coil Magnetic Resonance Coil, 21 CFR 892.1000, 90-MOS

# Marketed Device:

The GE 1.5T 8 Channel Torso Coil is substantially equivalent to the currently marketed GE the 3.0T Torso Phased Array Coil (K030495) with the integration of the 8 channel technology in the currently marketed GE 8 Channel Cardiac Phased Array Coil (K022669).

# Device Description:

The GE 1.5T 8 Channel Torso Coil is a 12 element coil with integrated preamplifiers that provides optimized geometry for parallel imaging. The coil is designed to provide imaging of the abdomen, pelvis and chest regions. The device utilizes technology similar to the GE 8 Channel Cardiac Phased Array Coil (K022669), but is designed to image the torso, similar to the GE 3.0T Torso Phased Array Coil (K030495).

### Indications for Use:

The GE 1.5T 8 Channel Torso Coil is intended to be used in the abdomen, pelvis and chest regions for 2D and 3D Magnetic Resonance imaging and Parallel body imaging.

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Image /page/1/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 circular border. The background is black, and the letters and border are white, creating a high-contrast design.

General Electric Company P.O. Box 414, Milwaukee, WI 53201

# Comparison with Predicate Device:

The GE 1.5T 8 Channel Torso Coil is a modification of the GE 3.0T Torso Phased Array Coil (K030495), which presents an increase in the number of coil elements from four to twelve, and integrates the preamplifiers similar to the GE 8 Channel Cardiac Phased Array Coil (K022669). The GE 1.5T 8 Channel Torso Coil utilizes optimized geometry for parallel imaging (ASSET).

# Summary of Studies:

Testing was performed to demonstrate that the design of the 1.5T 8 Channel Torso Coil meet predetermined acceptance criteria.

# Conclusion:

It is the opinion of GE that the GE 1.5T 8 Channel Torso Coil is substantially equivalent to the GE 3.0T Torso Phased Array Coil (K030495), and the GE 8 Channel Cardiac Phased Array Coil (K022669). The usage of the GE 1.5T 8 Channel Torso Coil does not result in any new potential hazards.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wing. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2003

Larry Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems P.O. Box 414 MILWAUKEE WI 53201

Re: K031209 Trade/Device Name: GE 1.5T 8 Channel Torso Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: April 16, 2003 Received: April 17, 2003

Dear Dr. Kroger:

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 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); 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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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# KO31209

510(k) Number (if known):

Device Name: GE 1.5T 8 CHANNEL TORSO COIL Indications For Use:

The GE 1.5T 8 Channel Torso Coil is intended to be used in the abdomen, pelvis and chest regions for 2D and 3D Magnetic Resonance imaging and Parallel body imaging

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Over-The-Counter Use OR

Daniel R. Symm

(Division Sign-Off)
Division of Reproductiva, Abdominal,
and Radiological Devices
-10(k) Number K031209