(272 days)
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No
The summary describes a spectroscopy option for an MRI system focused on analyzing specific phosphorus metabolites. There is no mention of AI, ML, or related terms, nor any description of training or test data sets which are typical for AI/ML-based devices. The technology described is standard spectroscopy analysis.
No
The device is used for non-invasive in vivo analysis and observation of metabolic levels for diagnostic evaluation, not for treating any condition.
Yes
The device allows for the "non-invasive in vivo analysis of energy metabolites" and provides "information ... [that] allows evaluation of the energetic state of examined tissues and intracellular pH," which are all diagnostic functions.
No
The device description explicitly states that the new option consists of "hardware/software extensions, a new rf surface coil, and a new quality assurance phantom," indicating it includes hardware components in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "non-invasive in vivo analysis". IVD devices are designed to perform tests on samples taken from the body (in vitro), such as blood, urine, or tissue biopsies. This device analyzes the tissue within the living body.
- Device Description: The description mentions hardware/software extensions, an RF surface coil, and a quality assurance phantom, all consistent with an in vivo imaging or spectroscopy system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components associated with IVD testing.
Therefore, the Siemens Clinical Phosphorus Spectroscopy Option for the Magnetom Vision system is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
magnetic resonance (MR)
Anatomical Site
muscle, liver and heart tissue
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
SIEME
Keded7
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.
1
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.
Ketler Rutherford
Signature
7/3/96
Date