(34 days)
The MAGNETOM MR system [Aera / Skyra] is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays 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 MR system [Aera / Skyra] may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR-Safe biopsy needles.
The MAGNETOM MR system is a magnetic resonance device (MRDD) producing transverse, sagittal, coronal, and oblique sectional images, spectroscopic images and/or spectra, and displaying 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.
The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR-safe biopsy needles.
The software syngo MR D13A is the latest software for the Siemens MAGNETOM scanners including software sequences, applications, coils and other hardware for the MAGNETOM scanners. This software was previously cleared under K121434.
New scanners are manufactured with syngo MR D13A: existing scanners can be upgraded to this software version.
This filing describes additional local coils intended to be used with the MAGNETOM Aera and MAGNETOM Skyra.
For MAGNETOM Skyra the Head/Neck 64, the Breast 18 and the Body 18 long are new coils. For MAGNETOM Aera the Breast 18 and the Body 18 long are new coils.
The provided text is a 510(k) summary for the Siemens MAGNETOM Aera/Skyra MR system with additional local coils. This document describes a submission for a modification to an existing medical device, specifically the addition of new coils to an already cleared MR system.
Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| SNR (Signal-to-Noise Ratio) | Tested; results demonstrate the device performs as intended. |
| Image Uniformity | Tested; results demonstrate the device performs as intended. |
| Heating (Safety) | Tested; results demonstrate the device performs as intended. |
| Compliance with NEMA standards | Tested per applicable NEMA standards. |
| Compliance with IEC standards | Tested per applicable IEC standards. |
| Substantial Equivalence to Predicate Device | Established through non-clinical testing and comparison. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No clinical tests were conducted. The non-clinical tests were performed on the new coils themselves.
- Data Provenance: Not applicable. No human subject data (clinical data) was used. The tests were non-clinical, likely engineering and performance tests on the hardware.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No clinical ground truth was established by experts for this specific submission as no clinical tests were performed.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No clinical ground truth was established.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This submission is for modifications to a magnetic resonance diagnostic device (MRDD) through the addition of new coils. It does not involve AI or algorithms requiring MRMC studies for comparative effectiveness with human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Study: No. This submission focused on the physical performance and safety of new hardware (MR coils), not on the performance of a standalone algorithm.
7. The type of ground truth used
- Type of Ground Truth: Not applicable for clinical ground truth. The "ground truth" for the non-clinical tests was likely established by reference to engineering specifications, NEMA/IEC standards, and direct measurements with calibrated equipment.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This submission concerns hardware additions (coils) and their physical performance, not machine learning algorithms that require training sets.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable.
Summary of the Study and Why the Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria was non-clinical performance testing conducted on the newly added local coils (Head/Neck 64, Breast 18, and Body 18 long) for the MAGNETOM Aera and Skyra MR systems.
The acceptance criteria focused on the fundamental performance characteristics of MR coils:
- Signal-to-Noise Ratio (SNR): A measure of image quality.
- Image Uniformity: Ensuring consistent image quality across the scanned area.
- Heating: A critical safety parameter, ensuring the coils do not generate excessive heat during operation.
These tests were performed "per applicable NEMA and IEC standards." These standards provide established, rigorous methodologies for evaluating the performance and safety of MR devices and components.
The report explicitly states: "The test results demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared." This indicates that the coils' performance met the predefined thresholds or expectations set by these standards and compared favorably to the performance of previously cleared coils or the system as a whole.
No clinical studies were conducted because this was a Special 510(k) submission for a minor change (new coils) to an already cleared predicate device (syngo MR D13A software for various MAGNETOM systems, K121434). The FDA determined that the non-clinical tests were sufficient to establish substantial equivalence for the new coils, given that there were "no system change and no software change" to the core MR system. The safety and effectiveness were further supported by compliance with risk management standard ISO 14971:2007 and general medical electrical equipment standards like IEC 60601-1.
§ 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.