MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM

K955389 · Siemens Medical Solutions USA, Inc. · LNH · Jun 10, 1996 · Radiology

Device Facts

• Record ID: K955389
• Device Name: MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jun 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MR-guided procedure package is designed to support diagnostic, interventional needle biopsies and drainages.

Device Story

MR-guided procedure package for MAGNETOM OPEN system; enables interventional procedures (biopsies, drainages) within MR environment. Components: scan room console/footswitch, imaging coil, in-bore light, chair, software, optimized sequences. Physician/technologist operates system while remaining in imaging room for extended periods. Device provides MR images to guide needle placement; assists clinicians in performing minimally invasive procedures. Safety features include updated warnings/contraindications for in-room personnel and emergency magnet shutdown procedures.

Clinical Evidence

Laboratory and clinical testing performed to validate substantial equivalence. Measurements included SNR and image uniformity for the new imaging coil. Safety analysis conducted regarding increased in-room time for clinicians.

Technological Characteristics

Hardware/software package for MAGNETOM OPEN. Includes scan room console, footswitch, imaging coil, in-bore light, and chair. Optimized imaging sequences. Operates within existing MR diagnostic system parameters (static field, RF exposure).

Indications for Use

Indicated for patients requiring diagnostic, interventional needle biopsies, and drainages performed under MR guidance.

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 (standard system)

Submission Summary (Full Text)

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Appendix 9: 510(k) Summary

K955389

JUN 10 1996

Appendix 9:
510(k) Summary

MAGNETOM OPEN 510(k) Premarket Notification 11/22/95 Appendix 9 Page 1
MR GUIDED PROCEDURES PACKAGE

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Appendix 9: 510(k) Summary

# 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:** Cathy Anne Pinto
Sr. Technical Specialist, Regulatory Affairs
[phone]
[phone]

- **Date of Summary Preparation:** November 22, 1995

**Device Name:**

- **Trade Name:** MR Guide Procedures Package/MAGNETOM OPEN

- **Classification Name:** Magnetic Resonance Diagnostic Device, CFR § 892.1000

- **Classification:** Class II

- **Performance Standards:** None established under Section 514 of the Food, Drug, and Cosmetic Act.

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

- **Device Description:**
The MR-guided procedure package is an optional hardware and software package for the Magnetom Open. The package contains a new scan room console (/footswitch), new imaging coil, in-bore light, chair, new software and optimized sequences.

- **Intended Use**
The MR-guided procedure package is designed to support diagnostic, interventional needle biopsies and drainages.

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Appendix 9: Page 1

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Appendix 9: 510(k) Summary

## Technological Characteristics

The magnet, RF system, and gradient system, of the MAGNETOM OPEN configured with the MR Guided Procedures Package is substantially equivalent to the standard MAGNETOM OPEN system.

## General Safety and Effectiveness Concerns:

Operation of the MAGNETOM OPEN system with the new MR Guided Procedures Package is substantially equivalent to standard operation of the MAGNETOM OPEN system. The following safety parameter action levels:

- static field strength,
- RF exposure,

and performance levels:

- signal-to-noise,
- high contrast spatial resolution,
- slice thickness,
- image uniformity and,
- geometric distortion.

specified by the FDA guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification. Additional SNR and image uniformity measurements were performed for a new imaging coil.

Even though the imaging room has always been accessible to the physician and/or technologist during the MR procedure (assuming the identified warnings and contraindications for the system were adhered to) the new configuration for the OPEN requires the user to remain within the imaging room for a higher percentage of time. Therefore, the warnings, contraindications, precautions, and safety instructions (e.g. emergency shutdown of the magnet) for the system have been re-evaluated. As a result of this analysis existing warnings have been revised and additional warnings have been included.

## 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

11/20/95
Date

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