CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM

K962627 · Siemens Medical Solutions USA, Inc. · LNI · Apr 3, 1997 · Radiology

Device Facts

• Record ID: K962627
• Device Name: CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNI · Radiology
• Decision Date: Apr 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Siemens developed the Clinical Phosphorus Spectroscopy Option for the Magnetom Vision system to allow the non-invasive in vivo analysis of energy metabolites in muscle, liver and heart tissue. The package allows observation of phosphocreatine (PCr), inorganic phosphate (Pi), Adenosine triphosphate (ATP), phosphomonoester (PME), phosphodiester (PDE) levels. Information provided by phosphorus spectroscopy data allows evaluation of the energetic state of examined tissues and intracellular pH, measured from the chemical shift of Pi.

Device Story

Clinical Phosphorus Spectroscopy Option for MAGNETOM VISION; hardware/software extensions, RF surface coil, and QA phantom. Inputs: MR signals from muscle, liver, heart tissue. Transformation: spatial encoding via time-varying magnetic field gradients and RF energy; spectroscopy analysis of metabolites (PCr, Pi, ATP, PME, PDE). Output: metabolite levels and intracellular pH measurements. Used in clinical MR imaging environments; operated by trained MR technologists/radiologists. Output used by clinicians to assess tissue energetic state. Benefit: non-invasive metabolic assessment.

Clinical Evidence

Bench testing only; no clinical data provided. Safety and effectiveness supported by system integration and performance verification within the existing MAGNETOM VISION framework.

Technological Characteristics

MR imaging and spectroscopy system; uses time-varying magnetic field gradients and RF energy for spatial encoding. Includes hardware/software extensions, RF surface coil, and QA phantom. No change to base system technological characteristics.

Indications for Use

Indicated for non-invasive in vivo analysis of energy metabolites in muscle, liver, and heart tissue to evaluate tissue energetic state and intracellular pH.

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

• Proton Spectroscopy Option for the MAGNETOM VISION
• Spectroscopy Option for the MAGNETOM 63SP

Submission Summary (Full Text)

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SIEMENS
510 (k) SUMMARY
APR - 3 1997

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:** Kathleen M. Rutherford
Manager, Regulatory Submissions
[phone]
- **Date of Summary Preparation:** July 3, 1996

**Device Name:**
- **Trade Name:** Clinical Phosphorus Spectroscopy Option / Siemens MAGNETOM VISION
- **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 the Substantial Equivalence Determination.

**Device Description:**
The new Clinical Phosphorus Spectroscopy Option for the MAGNETOM VISION consists of hardware/software extensions, a new rf surface coil, and a new quality assurance phantom.

Siemens Medical Systems, Inc. 07/03/96
510(k) Summary: Page 1
186 Wood Ave. South
Iselin, NJ 08830
Tel: [phone]
Fax: [phone]

{1}

07/03/96
510(k) Summary: Page 2

# SIEMENS

## Intended Use

Siemens developed the Clinical Phosphorus Spectroscopy Option for the Magnetom Vision system to allow the non-invasive in vivo analysis of energy metabolites in muscle, liver and heart tissue. The package allows observation of phosphocreatine (PCr), inorganic phosphate (Pi), Adenosine triphosphate (ATP), phosphomonoester (PME), phosphodiester (PDE) levels. Information provided by phosphorus spectroscopy data allows evaluation of the energetic state of examined tissues and intracellular pH, measured from the chemical shift of Pi.

## Technological Characteristics

The MAGNETOM VISION is a magnetic resonance (MR) imaging and spectroscopy system which uses time-varying magnetic field gradients and rf energy to spatially encode the anatomy of a patient. Introduction of the new clinical phosphorus spectroscopy package will not affect the technological characteristics of this system.

## General Safety and Effectiveness Concerns:

The Clinical Phosphorus Spectroscopy Option will not affect the safety and imaging performance parameters specified for the MAGNETOM VISION system.

## Substantial Equivalence:

The Siemens Clinical Phosphorus Spectroscopy Option is substantially equivalent to the commercially available Proton Spectroscopy Option for the MAGNETOM VISION, and the Spectroscopy Option for the MAGNETOM 63SP.