MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)

• K Number: K971684
• Device Name: MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)
• Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Date Cleared: 1997-08-05 ( 90 days)
• Product Code: LNH
• Regulation Number: 892.1000
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

The SIEMENS MAGNETOM Project 047 is a 1.5 Tesla whole body magnetic resor:ance imaging (MRI) system intended for general diagnostic use. This MRI system will present images which reflect the spatial distribution and/or magnetic resonance spectra which are a function of the 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.

Device Description

The SIEMENS MAGNETOM Project 047 is a 1.5T whole body magnetic resonance imaging (MRI) system. The MAGNETOM Project 047 is the second member of a family of magnetic resonance imaging (MRI) systems. The MAGNETOM Project 047 system is a high field strength system. The new MAGNETOM system has a new compact design and a redesigned patient table and rf coil system.

AI/ML Overview

This submission is for a 1.5T whole body magnetic resonance imaging (MRI) system, the SIEMENS MAGNETOM Project 047. The primary claim for safety and effectiveness is based on substantial equivalence to previously cleared devices (SIEMENS MAGNETOM Vision and MAGNETOM Impact systems), rather than a study demonstrating specific performance against acceptance criteria for a new clinical indication.

Therefore, the following information is not applicable or not provided in the submitted document:

• Acceptance Criteria and Reported Device Performance Table: No such table is presented as the device is not undergoing a new performance validation against specific criteria.
• Sample Size and Data Provenance for Test Set: No specific test set or clinical study data is provided to demonstrate the device's performance against acceptance criteria. The claim is based on the equivalency of technological characteristics.
• Number of Experts and Qualifications for Ground Truth: Not applicable, as there's no clinical performance study requiring expert ground truth.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable, as no human reader studies are mentioned.
• Standalone (Algorithm Only) Performance Study: Not applicable, as this is a hardware and software system, not an AI algorithm being evaluated in isolation.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable, as no specific AI model or training set is mentioned in the context of performance validation.
• How Ground Truth for Training Set was Established: Not applicable.

Summary of the provided information regarding acceptance criteria and study:

The submission focuses on establishing substantial equivalence to existing, legally marketed MRI systems (MAGNETOM Vision and MAGNETOM Impact).

The "study" in this context is a comparison of technological characteristics and safety features.

Acceptance Criteria (Implied by Substantial Equivalence):

• The device must be a 1.5T whole-body MRI system.
• Its technological characteristics (e.g., compact design, redesigned patient table, rf coil system) must be similar to or provide equivalent safety and effectiveness as the predicate devices.
• It must have the same intended use: whole-body magnetic resonance imaging for general diagnostic use.
• It must produce images reflecting spatial distribution and/or magnetic resonance spectra, and other physical parameters derived from these, including hydrogen-1 (proton) imaging.
• It must not raise additional safety concerns compared to the predicate devices.

Reported Device Performance (Implied by Substantial Equivalence):

• The device is a 1.5T whole body MRI system.
• It is considered to have safety and performance characteristics within the scope of parameters cleared for market for the MAGNETOM Vision and MAGNETOM Impact systems.
• No additional safety concerns have been raised.
• The device labeling will contain appropriate instructions, indications, precautions, cautions, contraindications, and warnings.

The Study Proving Equivalence:

The "study" is outlined under "II. Safety and Effectiveness Information Supporting Substantial Equivalence."

1. Device Description: The SIEMENS MAGNETOM Project 047 is described as a 1.5T whole-body MRI system, and the second member of a family of MRI systems.
2. Intended Use: "Whole body magnetic resonance imaging."
3. Technological Characteristics: The MAGNETOM Project 047 is described as a "high field strength system" with a "new compact design and a redesigned patient table and rf coil system."
4. General Safety and Effectiveness Concerns: The key statement is that "The safety and performance characteristics for this system are within the scope of parameters cleared for market for the MAGNETOM Vision and MAGNETOM Impact systems. No additional safety concerns have been raised."
5. Substantial Equivalence: The conclusion is explicitly stated: "The MAGNETOM Project 047 system is substantially equivalent to the SIEMENS MAGNETOM Vision and MAGNETOM Impact magnetic resonance imaging systems."

The FDA's letter (K971684) confirms this determination, stating that the device is "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This FDA letter is the official "proof" of the device meeting the substantial equivalence criteria.

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.