FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR

K984221 · Siemens Corp. · LNH · Feb 12, 1999 · Radiology

Device Facts

• Record ID: K984221
• Device Name: FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR
• Applicant: Siemens Corp.
• Product Code: LNH · Radiology
• Decision Date: Feb 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

The BOLD MRI Package for MAGNETOM VISION and SYMPHONY MR systems. provides dedicated acquisition and reconstruction techniques which offer the possibility of visualization of small susceptibility changes, due to increased levels of oxygen, by parametric images. The parametric images provide parameter information, instead of anatomical information. These parametric images can be overlaid on the anatomical images to optimize the presentation of information to support the diagnostic process. These BOLD images when interpreted by a trained physician, yield information that may assist in diagnosis.

Device Story

BOLD MRI Package is a post-processing software option for Siemens MAGNETOM VISION and SYMPHONY MR systems. It utilizes dedicated acquisition and reconstruction techniques to detect small susceptibility changes caused by increased oxygen levels. The device transforms raw MR signal data into parametric images representing physiological information rather than purely anatomical structures. These parametric maps are overlaid onto standard anatomical MR images. The system is operated by trained physicians in a clinical radiology setting. The output provides visual data to assist the physician in the diagnostic process, potentially aiding in the assessment of brain function or pathology by highlighting oxygen-dependent susceptibility variations.

Clinical Evidence

Laboratory and clinical testing were performed to support the claim of substantial equivalence. No specific quantitative metrics (e.g., sensitivity, specificity, p-values) are provided in the summary document.

Technological Characteristics

Software post-processing package for existing MR systems. Operates on MAGNETOM VISION and SYMPHONY platforms. Uses standard MR hardware (magnet, RF, gradient systems). Parametric imaging based on susceptibility changes related to oxygen levels. No changes to core MR safety parameters (static field, RF power, acoustic noise).

Indications for Use

Indicated for use by trained physicians to visualize small susceptibility changes related to oxygen levels in patients undergoing MRI, providing parametric images that may be overlaid on anatomical images to assist in the diagnostic process.

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.

Submission Summary (Full Text)

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0/12/99.

SIEMENS

198422

## 510 (k) Summary

This summary of 510(k), safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### I. General Information.

#### Establishment:

- . Address: Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, N.J. 08830
Registration Number: 2240869

| Contact Person: | Ms. Kathleen Rutherford<br>Manager, Regulatory Submissions |
|-----------------|------------------------------------------------------------|
| Telephone: | [phone] |
| FAX: | [phone] |

Date of Summary Preparation: 4/18/97

#### Device Name:

BOLD MRI Package for MAGNETOM VISION and MAGNETOM Trade Name: SYMPHONY MR Systems

| | • Systems Classification Name: Magnetic Resonance Diagnostic<br>Device, CFR $\alpha$ 892.1000 |
|-----------------------|-----------------------------------------------------------------------------------------------|
| Classification | : Class II |
| Performance Standards | : None established under Section 514 the Food, Drug,<br>and Cosmetic Act. |

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# ਟੀEMENS

## II. Safety and Effectiveness Information Supporting Substantial Equivalence.

#### · Device Description:

The BOLD MRI Package is an postprocessing option for the MAGNETOM VISION and MAGNETOM SYMPHONY Systems

#### • Intended Use

The BOLD MRI Package for MAGNETOM VISION and SYMPHONY MR systems. provides dedicated acquisition and reconstruction techniques which offer the possibility of visualization of small susceptibility changes, due to increased levels of oxygen, by parametric images. The parametric images provide parameter information, instead of anatomical information. These parametric images can be overlaid on the anatomical images to optimize the presentation of information to support the diagnostic process. These BOLD images when interpreted by a trained physician, yield information that may assist in diagnosis.

#### • Technological Characteristics

The magnet, RF system, and gradient system, of the MAGNETOM VISION and MAGNETOM SYMPHONY configured with the BOLD MRI Package is substantially equivalent to the standard MAGNETOM V4SION and MAGNETOM SYMPHONY systems.

#### · General Safety and Effectiveness Concerns:

Operation of the MAGNETOM VISION and MAGNETOM SYMPHONY with the BOLD MRI Package is substantially equivalent to standard operation of the MAGNETOM VISION and MAGNETOM SYMPHONY systems. The following MR safety and performance parameters are unaffected by the modification:

## [Safety]

- . Maximum Static Field
- . Rate of Change of Magnetic Field
- . RF Power Deposition
- . Acoustic Noise Levels
- . Specification Volume

## [Performance]

- . Signal to Noise
- . Image Uniformity
- . Geometric Distortion
- . Slice Profile, Thickness and Gap
- . High Contrast Spatial Resolution

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## • Substantial Equivalence:

Laboratory and clinical testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.

Kathleen M. Rutherford

Manager, Regulatory Submissions

1/19/99
Date

..

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 1999

Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

Re:

BOLD MRI Package for MAGNETOM VISION AND MAGNETOM SYMPHONY MR SYSTEMS Dated: November 24, 1998 Received: November 25, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Ms. Rutherford:

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). 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.

K984221

If vour device is classified (see above) into either class II (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 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 requlatory 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,

Cant. Daniel C. Schultz, M.D.

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) K984221

Device Name: BOLD MRI Package for MAGNETOM VISION and SYMPHONY MR

Indications for Use:

The BOLD MRI Package for MAGNETOM VISION and SYMPHONY MR systems, provides dedicated acquisition and reconstruction techniques which offer the possibility of visualization of small susceptibility changes, due to increased levels of oxygen, by parametric images. The parametric images provide parameter information, instead of anatomical information. These parametric images can be overlaid on the anatomical images to optimize the presentation of information to support the diagnostic process. These BOLD images when interpreted by a trained physician, yield information that may assist in diagnosis.

(please do not write below this line- continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation Prescription Use V OR Over-The-Counter Use

David A. Legan
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Dev 510(k) Number