(199 days)
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No
The summary does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is designed to support diagnostic and interventional procedures, but it does not directly treat a disease or condition. It is a tool for guiding procedures, not a therapeutic agent itself.
Yes
The "Intended Use / Indications for Use" states that the device is "designed to support diagnostic...needle biopsies and drainages."
No
The device description explicitly states that the package contains new hardware components, including a scan room console, imaging coil, in-bore light, and chair, 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 is to "support diagnostic, interventional needle biopsies and drainages." This describes a procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is a hardware and software package for an MR system, including components like a console, coil, light, and chair. These are tools used during a medical procedure, not for analyzing biological samples.
- Input Imaging Modality: The input is Magnetic Resonance, which is an imaging technique applied to the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing tests on samples, or providing diagnostic information based on the analysis of samples.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate procedures performed in vivo (within the body) using MR imaging.
N/A
Intended Use / Indications for Use
The MR-guided procedure package is designed to support diagnostic, interventional needle biopsies and drainages.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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
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 pertainging to safety and effectiveness.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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The 10 1896
Appendix 9:
510(k) Summary
11/22/95 510(k) Premarket Notification MAGNETOM OPEN MR GUIDED PROCEDURES PACKAGE
Appendix 9 Page 1
1
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 | |
| (908) 321-4887 | |
| (908) 321-4841 | |
| • 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.
● 9
2
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,
- i 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 reevaluated. 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 pertainging to safety and effectiveness.
Kathleen Rutherford
Kathleen M. Rutherford
Kathleen M. Rutherford Manager, Regulatory Submissions
11/20/95
Date