GE SIGNA ASSET IMAGING OPTION

K012970 · GE Medical Systems · LNH · Sep 24, 2001 · Radiology

Device Facts

• Record ID: K012970
• Device Name: GE SIGNA ASSET IMAGING OPTION
• Applicant: GE Medical Systems
• Product Code: LNH · Radiology
• Decision Date: Sep 24, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Signa Magnetic Resonance System is a whole body scanner. The Signa Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa Magnetic Resonance System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Device Story

ASSET (Array Spatial Sensitivity Encoding Technique) is an image reconstruction software option for GE Signa MRI systems; utilizes phased array coils to reduce phase encode steps; increases distance between steps or reduces field of view; eliminates aliasing/wrapping artifacts using known B1 coil field data; operated by MRI technicians/physicians in clinical settings; output is reconstructed diagnostic MR images; assists physicians in clinical diagnosis by providing spatial distribution of protons; benefits patients through potentially faster scan times.

Clinical Evidence

Bench testing only. Software hazard analysis and verification test procedures were performed in accordance with 21 C.F.R. 820.30 to verify performance of the reconstruction option.

Technological Characteristics

Software-based image reconstruction technique (ASSET) for MRI systems; utilizes phased array coils; operates by reducing phase encode steps and applying B1 field knowledge to correct aliasing; integrated into existing GE Signa MR system architecture.

Indications for Use

Indicated for use as a diagnostic imaging device for whole body scanning to produce transverse, sagittal, coronal, and oblique images of internal head or body structures in patients requiring MRI diagnostic evaluation.

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

• Signa 1.5T TwinSpeed Magnetic Resonance System (K012200)
• Signa VH/i MR System (K990550)
• Signa VH/i MR System (K003575)
• Signa HFO/i MR System (K992746)

Submission Summary (Full Text)

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Ko12970

# SEP 2 4 2001


Page 1 of 2

GE Medical Systems

eral Flectric Company 0. 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<br>Milwaukee, WI 53201 |
|-----------------|---------------------------------------------------------|
| Contact Person: | Larry A. Kroger Ph.D.<br>Manager, Regulatory Program |
| Telephone: | 262- 544-3894 |
| Fax: | 262- 544-3863 |
| Date Prepared: | August 30, 2001 |

## Device Name:

GE Signa ASSET Imaging Option Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH

## Marketed Device:

The Signa ASSET Imaging Option is substantially equivalent to the Array Processor subsystem and reconstruction techniques of the currently marketed Signa 1.5T TwinSpeed Magnetic Resonance System rconstruction recemiques of the outsions of the Supers on K006313) and Signa HFO/i MR System (K992746).

### Device Description:

ASSET (Array Spatial Sensitivity Encoding Technique) is an image reconstruction technique used in A conjunction with phased array coils in which the number of phase encode steps is reduced by increasing the distance between steps, or equivalently, by reducing the field of view. Aliasing or wrapping caused by the object extending outside the reduced field of view is eliminated using knowledge of the B1 fields of the coils.

#### Indications for Use:

The Signa Magnetic Resonance System is a whole body scanner. The Signa Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa Magnetic Resonance System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

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

# Comparison with Predicate Device:

It is the opinion of GE Medical Systems that the ASSET Imaging Option is substantially equivalent to the Array Processor subsystem and Reconstruction Techniques used in the currently cleared Signa 1.5T TwinSpeed Magnetic Resonance System (K012200), Signa VH/i MR System (K990550; K003575; and I winspect hilghout Resorted (K992746). It has the same intended use, and operating modes as the predicate devices.

# Summary of Studies:

The ASSET Imaging Option was developed in conformance with design control requirements as specified in 21 C.F.R. 820.30. Software hazard analysis and verification test procedures were completed. Evaluation testing was done to verify the performance of the option.

# Conclusion:

It is the opinion of GE that the ASSET Imaging option does not result in any new potential hazards.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2001

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

Re: K012970 Trade/Device Name: GE Signa Asset Imaging Option for MRI Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: 90 LNH Dated: August 30, 2001 Received: September 4, 2001

Dear Dr. Kroger:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewary our becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the Merceded)76, the enactment date of the Medical Device Amendments, or to conniner of the 11th 11th 2011-05-12, 11:22 accordance with the provisions of the Federal Food, Drug, de nees mar nat o boon resulted require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may , itereror mains 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 or any I 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 (21 OFF Part 801), accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rordly and ation 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 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 this 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" (21 CFR Part 807.97). 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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KO12970 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Signa ASSET Imaging Option

## Indications For Use:

The Signa Magnetic Resonance System is a whole body scanner. The Signa Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa Magnetic Resonance System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

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> om Concurrence of DRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________