MAGNETIC RESONANCE DIAGNOSTIC SYSTEM

K972990 · GE Medical Systems · LNH · Feb 5, 1998 · Radiology

Device Facts

• Record ID: K972990
• Device Name: MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
• Applicant: GE Medical Systems
• Product Code: LNH · Radiology
• Decision Date: Feb 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Diffusion Weighted EPI imaging produces magnetic resonance (MR) images whose contrast is dependent on the local diffusion coefficient of water. Diffusion Weighted EPI can be useful in visualizing the apparent loss of diffusion (mobility) by water molecules in brain tissues affected by acute stroke. Diffusion Weighted EPI is more accurate than conventional MRI pulse sequence (ie Fast FLAIR and Fast Spin Echo) in identifying the occurrence of acute stroke.

Device Story

Diffusion Weighted EPI Imaging Option is an add-on software feature for existing MRI systems; utilizes single-shot Echo Planar Imaging (EPI) pulse sequence. Input: MR signals; Output: MR images with contrast dependent on local water diffusion coefficients. Used in clinical radiology settings by trained MRI technologists/radiologists. Provides visualization of restricted water diffusion in brain tissue; assists clinicians in identifying acute stroke more accurately than conventional Fast FLAIR or Fast Spin Echo sequences. Benefits patient by enabling earlier or more precise stroke detection.

Clinical Evidence

Bench testing only. Evaluation performed against IEC 601-2-33 international medical equipment safety standard for Magnetic Resonance Systems. Accuracy of imaging performance verified against user manual specifications.

Technological Characteristics

Software-based imaging option for MRI systems. Utilizes single-shot Echo Planar Imaging (EPI) pulse sequence. Operates on existing MR hardware. Complies with IEC 601-2-33 safety standards.

Indications for Use

Indicated for patients requiring visualization of water molecule diffusion in brain tissue to identify acute stroke.

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

• Siemens Medical System Diffusion Weighted MR Imaging Option (K971055)

Submission Summary (Full Text)

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K972990

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## GE Medical Systems

PO Box 414. W-709 Milwaukee, WI 53201 USA

## SUMMARY OF SAFETY AND EFFECTIVENESS

FEB - 5 1998

- 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, August 13, 1997
- o Identification of the Product Diffusion Weighted EPI Imaging Option

Manufactured by:

GE Medical Systems 3200 N. Grandview Blvd. Waukesha. Wi 53188

- o Device Description
The Diffusion Weighted EPI Imaging Option provides an additional imaging option to the Echo Planar Imaging pulse sequence. The DW-EPI option is a single shot EPI pulse designed to create images that differentiates tissues with restricted diffusion from tissues with normal diffusion.

o Indications for Use

> Diffusion Weighted EPI imaging produces magnetic resonance (MR) images whose contrast is dependent on the local diffusion coefficient of water. Diffusion Weighted EPI can be useful in visualizing the apparent loss of diffusion (mobility) by water molecules in brain tissues affected by acute stroke.

Diffusion Weighted EPI is more accurate than conventional MRI pulse sequence (ie Fast FLAIR and Fast Spin Echo) in identifying the occurrence of acute stroke.

- 0 Comparison with Predicate
The Diffusion Weighted EPI Imaging Option is substantially equivalent to the currently marketed Siemens Medical System Diffusion Weighted MR Imaging Option (510k #K971055).

- o Summary of Studies
The Diffusion Weighted EPI Imaging Option was evaluated to the IEC 601-2-33 International medical equipment safety standard for Magnetic Resonance Systems. Evaluation testing confirmed accuracy statements in the User Manual.

- o Conclusions
It is the opinion of GE that the Diffusion Weighted EPI Imaging Option does not result in any new potential hazards.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Larry Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical System PO Box 414, W-709 Milwaukee, WI 53201

Re:

K972990 Diffusion Weighted EPI Imaging Option Dated: November 20, 1997 Received: November 21, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

FEB - 5 1998

Dear Dr. Kroger:

We have reviewed your Section 510(k) notification of intent to market the device 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 requirement, 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 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 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 (30) 594-4639. 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/dsmamain.html":. -------------------------------------------------------------------------------------------

Sincerely vours,

h. liau Yi

Lillian Yin, Ph.D. 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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Device Name: Diffusion Weighted EPI Imaging Option

Indications For Use:

- ﺬ-

Diffusion Weighted EPI imaging produces magnetic resonance (MR) images whose contrast is dependent on the local diffusion coefficient of water. Diffusion Weighted EPI can be useful in visualizing the apparent loss of diffusion (mobility) by water molecules in brain tissues affected by acute stroke.

Diffusion Weighted EPI is more accurate than conventional MRI pulse sequence (ie Fast FLAIR and Fast Spin Echo) in identifying the occurrence of acute stroke.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Wint le Seymon

on of Reproductive, Abdominal, E d Radiological De

510(k) Number K972990

OR

**Prescription Use**
(Per 21 CFR 801.109) *✓*

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________