MAGNETIC RESONANCE DIAGNOSTIC SYSTEM

K980114 · GE Medical Systems · LNH · Mar 30, 1998 · Radiology

Device Facts

• Record ID: K980114
• Device Name: MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
• Applicant: GE Medical Systems
• Product Code: LNH · Radiology
• Decision Date: Mar 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

The Signa CVMR system is a whole body scanner designed for shorter scan times. The Signa CVMR 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 CVMR 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

Signa CVMR is a modified whole-body magnetic resonance imaging (MRI) system. It utilizes a superconducting magnet to acquire 2D (single/multi-slice) and 3D volume images based on proton density, T1, T2, and flow. The system incorporates an upgraded Body/Gradient coil to provide expanded gradient capabilities, enabling shorter scan times compared to the predicate. Imaging options include cardiac/peripheral gating, flow compensation, and fat/water suppression to mitigate motion artifacts. Operated by trained professionals in clinical settings, the system produces images for interpretation by physicians to assist in clinical diagnosis. The device functions as a diagnostic imaging tool; it does not introduce new hazards or indications.

Clinical Evidence

Bench testing only. The device was evaluated against NEMA performance standards and IEC 601-1 and IEC 601-2-33 safety standards for magnetic resonance equipment. No clinical data provided.

Technological Characteristics

Superconducting magnet MRI system; utilizes Body/Gradient coil for expanded gradient capabilities. Supports pulse sequences including inversion recovery, spin echo, gradient echo, gradient recalled, and steady state free precession. Imaging features: cardiac/peripheral gating, flow compensation, fat/water suppression. Complies with NEMA performance standards and IEC 601-1/601-2-33 safety standards.

Indications for Use

Indicated for use as a diagnostic whole-body MR imaging device for patients requiring transverse, sagittal, coronal, and oblique internal structure imaging. No specific age or gender contraindications stated.

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 Horizon System

Submission Summary (Full Text)

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K98 0 11

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GE Medical Systems

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

MAR 3 0 1998

## SUMMARY OF SAFETY AND EFFECTIVENESS

- This 510(k) summary of safety and effectiveness information is submitted in accordance o with the requirements of 21 CFR Part 807.87(h).
- 0 Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, January 8, 1998
- o Identification of the Product Signa CVMR Magnetic Resonance System

Manufactured by:

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

#### o Marketed Devices

The Signa CVMR System is substantially equivalent to the currently marketed Signa Horizon System with the only difference being a different Body/Gradient coil.

#### o Device Description

The Signa CVMR System is a modification to the Signa Horizon MR Systems which utilize a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. In addition to the wide variety of pulse sequences provided to the Signa Horizon operator, such as inversion recovery, spin echo, gradient echo, gradient recalled, and steady state, and free precession acquisitions, the Signa CVMR operator has the ability for shorter scan times due to expanded gradient capabilities. Imaging options such as cardiac gating, peripheral gating, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality.

#### o Indications for Use

The Signa CVMR system is a whole body scanner designed for shorter scan times. The Signa CVMR 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 CVMR 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), spinspin 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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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 Signa CVMR System is comparable to the Signa Horizon Systems with the main difference being with the Body/Gradient coil which allows for expanded gradient capabilities, enabling shorter scan times.

#### o Summary of Studies

The Signa CVMR 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 Signa CVMR System is comparable to the Signa Horizon MR Systems.

### Conclusions

0

It is the opinion of GE that the Signa CVMR System is substantially equivalent to the Signa Horizon MR Systems. The Signa CVMR Magnetic Resonance System does not include any new indications for use, nor does use of this device result in any new potential hazards.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 3 0 1998

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

Re:

K980114 Signa CVMR Magnetic Resonance System Dated: January 12, 1998 Received: January 13, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. 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 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 II (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 (OS) for Medical Devices: General regulation (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 coucerning 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 vito 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/cdrb/dsmaldsmam.html".

Sincerely yours,

Kiliai Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_ K98 0114

Device Name: Signa CVMR System

Indications For Use:

The Signa CVMR system is a whole body scanner designed for shorter scan times. The Signa CVMR 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 CVMR 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)

David G. Seysom

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

OR

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use