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 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.

AI/ML Overview

I am sorry, but your request could not be fulfilled. The document does not contain the necessary information to answer your questions because it is a very old 510(k) summary (from 1996) and describes a "Clinical Phosphorus Spectroscopy Option" for an MRI system, not an AI/ML device. Therefore, a study that proves the device meets the acceptance criteria is not included in the provided text. Additionally, the information requested in your prompt (such as "sample size", "ground truth", "reader study", etc.) is typically associated with the evaluation of AI/ML-driven devices and is not applicable to the traditional medical device described in this document.

Summary

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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.

General Information. I.
Establishment: · Address:

Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, N.J. 08830

· Registration Number:
· Contact Person:

2240869

July 3, 1996

Kathleen M. Rutherford Manager, Regulatory Submissions (908) 321-4779

Date of Summary Preparation:
Device Name:

· Trade Name: / MR System

· Classification Name:

· Classification:

· Performance Standards:

Clinical Phosphorus Spectroscopy Option / Siemens MAGNETOM VISION

Magnetic Resonance Diagnostic Device, CFR § 892.1000

Class II

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.

07/03/96 Siemens Medical Systems. Inc.

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SIEMENS

Intended Use

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.

Ketler Rutherford
Signature

7/3/96
Date

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
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).(b)
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.