3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM

K990550 · Ge Medical Systems, Inc. · LNH · May 11, 1999 · Radiology

Device Facts

• Record ID: K990550
• Device Name: 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
• Applicant: Ge Medical Systems, Inc.
• Product Code: LNH · Radiology
• Decision Date: May 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Signa VH/i system is a head-only scanner designed to support higher resolution imaging and shorter scan times. The Signa VH/i 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.. The images produced by the Signa VH/i 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

3.0T Signa VH/i Magnetic Resonance System is a high-resolution, head-only MRI scanner. Device utilizes a superconducting magnet to acquire 2D single-slice, multi-slice, and 3D volume images of internal head structures. Inputs consist of magnetic resonance signals from hydrogen nuclei; system transforms these via pulse sequences and 2D/3D Fourier transformation techniques into anatomical images. Operated by trained professionals in clinical settings. Output images reflect proton density, T1, T2, and flow properties; interpreted by physicians to assist in clinical diagnosis. Benefits include higher resolution imaging and shorter scan times compared to lower-field systems.

Clinical Evidence

Bench testing only. Device evaluated against NEMA performance standards and IEC 601-1 and IEC 601-2-33 safety standards for magnetic resonance equipment.

Technological Characteristics

Superconducting magnet operating at 3.0 Tesla; head-only configuration. Imaging planes: sagittal, coronal, axial, oblique, double oblique. Reconstruction: 2D and 3D Fourier transformation. Compliant with NEMA performance standards and IEC 601-1/601-2-33 safety standards.

Indications for Use

Indicated for diagnostic imaging of internal head structures in patients requiring high-resolution anatomical assessment. Contraindications not specified.

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 CV/i Magnetic Resonance System

Submission Summary (Full Text)

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K 990550

### GE Medical Systems

P.O. Box 414, W-709 Milwaukee, WI 53201 USA

MAY 1 1 1999

# SUMMARY OF SAFETY AND EFFECTIVENESS

- o This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
- o Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, February 19, 1999
- o Identification of the Product 3.0T Signa VH/i Magnetic Resonance System

Manufactured by:

GE Medical Systems 3200 N. Grandview Blvd. Waukesha, WI 53188

### o Marketed Devices

The 3.0T Signa VH/i Magnetic Resonance System is substantially equivalent to the currently marketed Signa CV// Magnetic Resonance System with the only difference being a different magnetic field strength. The Signa CV/i Magnetic Resonance System has a magnetic field strength of 1.5Tesla and is a whole body scanner while the 3.0T Signa VH// Magnetic Resonance System has a magnetic field strength of 3.0T and is a head only scanner.

### o Device Description

The 3.0T Signa VH/i Magnetic Resonance System is a modification to the Signa CV// Magnetic Resonance System which utilizes a superconducting magnet to acquire 2D singleslice and multi-slice, and 3D volume images. The GE 3T Signa VH/i MR System is a high resolution, head imaging system operating at 3 Tesla. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences. Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques. The system is intended for high resolution anatomical applications and shorter scan times.

- o Indications for Use
The Signa VH/i System is a head-only scanner designed to support higher resolution imaging and shorter scan times. The Signa VH/i 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.. The images produced by the Signa VH// 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.

Image /page/0/Picture/16 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and there are four small, teardrop-shaped elements evenly spaced around the outside of the circle.

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GE Medical Systems

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P.O. Box 414, W-709 Milwaukee. WI 53201 USA

## SUMMARY OF SAFETY AND EFFECTIVENESS

### o Comparison with Predicate

The 3.0T Signa VH/i Magnetic Resonance System is comparable to the Signa CV/i Magnetic Resonance System with the main differences being the higher magnetic field strength and no body coil since the 3.0T Signa VH// System is a head only scanner.

### o Summary of Studies

The 3.0T Signa VH/i Magnetic Resonance System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard and IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis. The 3.0T Signa VH/i Magnetic Resonance System is comparable to the Signa CV/i Magnetic Resonance System.

#### o Conclusions

It is the opinion of GE that the 3.0T Signa VH/i Magnetic Resonance System is substantially equivalent to the Signa CV/i Magnetic Resonance System. The 3.0T Signa VH/i Magnetic Resonance System does not include any new indications for use, nor does use of this device result in any new potential hazards.

Image /page/1/Picture/10 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circle. The circle has small, leaf-like shapes around its perimeter, adding a decorative element to the design. The logo is black and white.

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Image /page/2/Picture/16 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1 1999

Larry A. Kroger. Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414. W-709 Milwaukee, Wisconsin 53201

Re:

K990550 3.0T Signa VH/I magnetic Resonance System Dated: February 19, 1999 Received: February 22, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Dr. Kroger:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: 3.0T Signa VH/i MR System

Indications For Use:

The Signa VH/i system is a head-only scanner designed to support higher resolution imaging and shorter scan times. The Signa VH/i 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.. The images produced by the Signa VH/i 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thind A. Seymour

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Deyic 510(k) Number

OR

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use