INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM

K990826 · Siemens Medical Solutions USA, Inc. · LNH · Nov 1, 1999 · Radiology

Device Facts

• Record ID: K990826
• Device Name: INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Nov 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Siemens Interactive MR Localizer is indicated for use as a navigation system. The Interactive THE Localizer performs interactive slice positioning with a pointing instrument for planning and control of interventional and interoperative procedures. The system comprises of a stereoscopic camera, a sterilizable pointing device, a calibration phantom, and an Interactive MR (IMR) software.

Device Story

Interactive MR Localizer functions as navigation system for MAGNETOM Open and Open viva MRI systems; utilizes stereoscopic camera and sterilizable pointing instrument to track position; enables interactive slice positioning for planning/control of interventional and interoperative procedures. System includes calibration phantom and IMR software. Operated by clinicians in clinical/OR settings; provides visual guidance for slice placement; assists in procedural planning and real-time control. Benefits include improved accuracy and efficiency in interventional MRI workflows.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Navigation system comprising stereoscopic camera, sterilizable pointing instrument, calibration phantom, and IMR software. Integrates with MAGNETOM Open/Open viva MRI systems. Maintains standard MRI hardware (magnet, RF, gradient systems).

Indications for Use

Indicated for use as a navigation system for interactive slice positioning during interventional and interoperative procedures. Patient population 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.

Reference Devices

• MAGNETOM Open System
• Open viva System

Submission Summary (Full Text)

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#### 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:

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

- Contact Person: Mr. Jamie Yieh Technical Specialist, Regulatory Submissions [phone] [phone]
- 03/11/99 Date of Summary Preparation:

#### Device Name:

- Interactive MR Localizer / MAGNETOM Open and • Trade Name: Open viva System
- · Classification Name: Magnetic Resonance Diagnostic Device, CFR & 892.1000
- Classification: Class II
- Performance Standards:

None established under Section 514 the Food, Drug, and Cosmetic Act.

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# II. Safety and Effectiveness Information Supporting Substantial Equivalence.

## • Device Description:

The Interactive MR Localizer is a navigation system for the MAGNETOM Open and Open viva System.

# • Intended Use

Interactive slice positioning with a pointing instrument and stereoscopic camera system for planing and control of interventional and interoperative procedures.

# · Technological Characteristics

The magnet, RF system, and gradient system, of the MAGNETOM Open and Open viva System configured with the Interactive MR Localizer is substantially equivalent to the standard the MAGNETOM Open and Open viva System.

# · General Safetv and Effectiveness Concerns:

Operation of the MAGNETOM Open and Open viva System configured with the Interactive MR Localizer is substantially equivalent to standard operation of the MAGNETOM Open and Open viva System. The following safety parameter action levels:

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

#### and performance levels

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

specified by the FDA guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification.

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# • Substantial Equivalence:

Laboratory 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 Rutherford

Kathleen M. Rutherford Manager, Regulatory Submissions

3/11/99
Date

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - I 1993

Jamie Yieh Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

Re:

K990826 MR Localizer for Magnetom Open and Open Viva Systems Dated: August 9, 1999 Received: August 10, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Yieh:

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.

If your 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 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 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,

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: Interactive MR Localizer

#### Indications for Use:

The Siemens Interactive MR Localizer is indicated for use as a navigation system. The Interactive THE Localizer performs interactive slice positioning with a pointing instrument for planning and control of interventional and interoperative procedures. The system comprises of a stereoscopic camera, a sterilizable pointing device, a calibration phantom, and an Interactive MR (IMR) software.

(please do not write below this line- continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation

| Prescription Use | ✓ |
|------------------|----------------------------|
| OR | Over-The-Counter Use _____ |

(Division Sign-Off
Division of Reproductive, Abdominal, ENT,
and Radiological Devices)

| 510(k) Number | K990826 |
|---------------|---------|
|---------------|---------|

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