(54 days)
The MAGNETOM systems, Avanto, Espree, Symphony A Tim System, Trio A Tim The Mr ONE Verio with software syngo MR B19, are indicated for use as magnetic oyoten, and volto many man one (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities.
Other physical parameters derived from the images and/or spectra may also be produced, Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.
The MAGNETOM systems, Avanto, Espree, Symphony A Tim System, Trio A Tim System, and Verio with software syngo MR B19, may also be used for imaging during interventional procedures when performed with MR compatible devices such as inroom display and MR-safe biopsy needles.
Software syngo MR B19 is a new software version for five Siemens MR systems: MAGNETOM Avanto (1.5T), Espree (1.5T), Symphony A Tim System (1.5T), Trio A Tim System (3T), and Verio (3T). Systems that are already in clinical use and at customer sites (referred to as "field upgrades" throughout the rest of the submission) can be uparaded to this software version; some of the five MAGNETOM systems will be manufactured (referred to as "ex-factory systems" throughout the rest of this submission) with this software version (please see table below).
This new software version includes new software sequences, coils and other hardware for the five MAGNETOM systems. While some new features (hardware and software) are only available for certain systems (of the five listed), the basic syngo MR B19 software can run on each of the five MAGNETOM systems. Therefore, while five MAGNETOM systems are mentioned throughout this submission, the software version is the subject of this 510(k).
The Siemens Medical Solutions USA, Inc. 510(k) submission for "Software syngo MR B19 for MAGNETOM Avanto, Espree, Symphony A Tim System, Trio A Tim System, and Verio" provides information about device performance validation, but does not include acceptance criteria as a table, nor does it detail a study proving the device meets specific acceptance criteria in the manner typically associated with clinical performance studies for AI/CAD devices.
This submission is for a software upgrade (syngo MR B19) to existing Magnetic Resonance Diagnostic Devices (MRDDs). The focus of the submission is on demonstrating substantial equivalence to previously cleared predicate devices (syngo MR B17 and syngo MR D13A), rather than proving net new clinical performance characteristics through comparative studies against quantitative acceptance thresholds.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:
1. A table of acceptance criteria and the reported device performance
- Not present in the form requested. The submission focuses on demonstrating substantial equivalence by comparing the new software's features and performance to existing predicate devices. It states:
- "The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate devices to which it has been compared."
- "Performance testing such as SNR, image uniformity, and heating were conducted on the subject device. Additionally, all software features were verified and validated."
- The new features "do not introduce any new issues of safety or effectiveness."
- The document implies that the "acceptance criteria" are the standards of performance (SNR, uniformity, heating) met by the predicate devices, and the new software meets or exceeds these. However, no specific numerical thresholds or a table like:
| Metric | Acceptance Criteria | syngo MR B19 Performance |
|---|---|---|
| SNR | > X% of predicate | Met/Exceeded |
| Image Uniformity |
§ 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.