(116 days)
The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD), which produces transverse, sagittal, coronal, and oblique cross sectional images that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images may also be produced. Depending on the region of interest, contrast agents may be used.
These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist in diagnosis.
The subject device software version, syngo MR XA50A, can support the following two MRI systems:
- MAGNETOM Free.Max, which has been cleared with its initial software version syngo MR XA40A, through K210611 on July 1, 2021;
- MAGNETOM Free.Star, a new product.
With the introduction of MAGNETOM Free.Star, we extend the Free. platform, which consists of two products with a field strength of 0.55 Tesla on our high-value MRI platform. The main difference between these two products is the bore size, MAGNETOM Free.Star is equipped with a 60 cm patient bore while the MAGNETOM Free.Max is equipped with an 80 cm patient bore. The Gradient system, body coil and the system cover for MAGNETOM Free.Star are modified based those of the predicate device MAGNETOM Free.Max with syngo MR XA40A (K210611) to accommodate the smaller bore diameter. The other main components for the new device MAGNETOM Free.Star are the same as those of MAGNETOM Free.Max as cleared with K210611.
Apart from the hardware adaption applied for MAGNETOM Free.Star for the smaller bore diameter, the new / modified hardware and software features for the subject devices comparing to the predicate device MAGNETOM Free.Max with software version syngo MR XA40A (K210611, cleared on July 1, 2021) are listed below:
MAGNETOM Free.Max software version syngo MR XA50A
New/Modified Hardware
Common for both subject devices:
- Scanner User Interface (SUI): introduce option to have two SUI set on both sides of the scanner, while there is only one set available on the left hand side as the standard configuration for the predicate device MAGNETOM Free.Max with software version syngo MR XA40A (K210611); Swap the orientation of patient pictogram on Select&GO is supported syngo MR XA50A.
- myExam 3D Camera: auto registration with detection of patient height. weight and orientation are supported in the subject device software version syngo MR XA50A. The hardware remains unchanged as cleared with K210611 on July 1, 2021.
- New Patient Video: A new patient video with 1920×1080 pixels is introduced.
Applicable to the following subject device(s)
MAGNETOM Free.Max
MAGNETOM Free.Star
New Local Coils
Contour M Coil
Contour M Coil
New Patient table – High-load patient table: a new fixed patient table with vertical movement for heavy load patient is introduced.
N/A
Software Features
Common for both subject devices:
New Software Platform/Workflow
myExam Autopilot is extended the supporting body region to shoulder:
- myExam Shoulder Autopilot: it helps users to automate a shoulder examination.
Migrated Software feature - EP2D FID: Single-shot FID EPI pulse sequence type optimized for perfusion-imaging in the brain.
- Inline Perfusion: Automatic real-time calculation of parameter maps with Inline technology based on image data acquired with the ep2d fid pulse sequence type.
- Access-i: Provides an interface to enable the connection of a 3rd party workstation to the MR syngo Acquisition Workplace via a network router and secure local network connection.
Modified Software Platform/Workflow
Modify in Scan assistance: Modified guidance of off-center imaging is provided to users who encounter the scan suspension by too off-centered shim volume.
The provided text is a 510(k) summary for the MAGNETOM Free.Max and MAGNETOM Free.Star with syngo MR XA50A. This document asserts substantial equivalence to a predicate device (MAGNETOM Free.Max with syngo MR XA40A) and does not describe specific acceptance criteria or a study designed to prove the device meets those criteria in detail as requested.
Instead, it states that:
- "The results from each set of tests demonstrate that the devices perform as intended and are thus substantially equivalent to the predicate device to which it has been compared."
- "No clinical tests were conducted to support substantial equivalence for the subject device; however, as stated above, sample clinical images were provided."
- "The device labeling contains instructions for use and any necessary cautions and warnings to ensure safe and effective use of the device."
Therefore, it is not possible to provide the specific details requested in your prompt based solely on the provided text, as this document focuses on demonstrating substantial equivalence to a previously cleared device through non-clinical testing, rather than reporting on a study with detailed acceptance criteria for standalone performance or comparative effectiveness.
The document mentions non-clinical tests conducted, which include:
- Sample clinical images: To evaluate coils, new and modified software features, and pulse sequence types.
- Performance bench test: For SNR and image uniformity measurements for coils, and heating measurements for coils.
- Software verification and validation: Mainly for new and modified software features.
These tests were conducted in accordance with guidance documents like "Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
In summary, the provided document does not contain the specific information requested in your prompt regarding detailed acceptance criteria and a study proving the device meets them, sample sizes, expert qualifications, adjudication methods, or MRMC study results for human reader improvement. The document focuses on demonstrating substantial equivalence through non-clinical testing against established standards and predicate devices.
§ 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.