(122 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, MAGNETOM Free.Max with software syngo MR XA40A, is an 80 cm bore Magnetic Resonance Imaging system with an actively shielded 0.55T superconducting magnet. Which is the first 0.55T MRI system for clinical use in the U.S.
This FDA 510(k) summary for the MAGNETOM Free.Max MRI system focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria for a new AI/CADe algorithm. Therefore, much of the requested information regarding AI performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment is not present in this document.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria in terms of numerical thresholds for specific performance metrics (e.g., sensitivity, specificity for a diagnostic task). Instead, the performance testing aims to demonstrate equivalence in image quality and safety to the predicate device.
| Performance Test Type | Tested Hardware or Software | Rationale/Goal |
|---|---|---|
| Sample clinical images | Coils, new and modified software features, pulse sequence types | Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices (to show comparable image quality) |
| Image quality assessments by sample clinical images (including comparison with predicate device features) | New/modified pulse sequence types and algorithms | Diagnostic Devices (to demonstrate equivalent image quality/quantitative data) |
| Performance bench test | SNR and image uniformity measurements for coils; heating measurements for coils | (Implicitly, to ensure performance within expected limits and safety standards) |
| Software verification and validation | Mainly new and modified software features | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (to ensure software functions as intended and safely) |
| Peripheral Nerve Stimulation (PNS) effects study | Subject system | To understand and assess PNS effects. |
2. Sample size used for the test set and the data provenance
- Test Set (for PNS study): 12 individuals
- Data Provenance: Not explicitly stated, but the PNS study was a "clinical study" suggesting prospective data collection. The software verification and validation would likely use a mix of internally generated and potentially simulated data. Sample clinical images would be from human subjects but their precise origin isn't detailed beyond being "sample clinical images."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document does not describe the establishment of a "ground truth" by experts in the context of an algorithmic diagnostic performance study. The images are "interpreted by a trained physician" as per the Indications for Use, which is general clinical practice, not a specific ground truth establishment for algorithm evaluation.
4. Adjudication method for the test set
- Not applicable. No expert adjudication method is described for an algorithmic performance evaluation.
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
- No MRMC comparative effectiveness study involving human readers with and without AI assistance is mentioned. This submission is for the MRI system itself, not an AI-powered diagnostic aid that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The "software verification and validation" would assess the software's functional performance, but not in the context of a standalone diagnostic algorithm providing a clinical output that would typically be evaluated for sensitivity/specificity. The Deep Resolve Gain and Deep Resolve Sharp features hint at image processing algorithms, but their standalone diagnostic performance is not presented.
7. The type of ground truth used
- For the PNS study, the "ground truth" would be the physiological response of the individuals.
- For image quality assessments, the ground truth is subjective visual assessment and objective metrics (SNR, uniformity) compared against engineering specifications and predicate device performance.
- For software verification and validation, the ground truth is adherence to design specifications and expected functional behavior.
- No "expert consensus, pathology, or outcomes data" ground truth is described in the context of validating a diagnostic algorithm's performance against clinical findings.
8. The sample size for the training set
- Not specified. The document refers to "Deep Resolve Gain" and "Deep Resolve Sharp" which are likely AI-based image processing features. However, the details of their training data (sample size, origin, ground truth) are not provided. The listed clinical publications for these features (e.g., "Residual Dense Network for Image Super-Resolution") suggest they are based on deep learning techniques that would require training data.
9. How the ground truth for the training set was established
- Not specified. As noted above, details about training data for any potential AI components (like Deep Resolve) and their ground truth are not included in this summary.
Summary of what the document indicates about the device:
This 510(k) submission for the MAGNETOM Free.Max MRI system focuses on demonstrating substantial equivalence to an existing predicate device (MAGNETOM Sempra) by:
- Comparing technological characteristics (hardware and software).
- Performing non-clinical tests (sample clinical images, image quality assessments, bench tests for SNR/uniformity/heating, and general software V&V) to ensure the new device performs effectively and safely in a manner equivalent to the predicate.
- Conducting a small clinical study on Peripheral Nerve Stimulation (PNS) effects for safety.
- Referencing clinical publications for various new software features, implying that the underlying scientific principles and expected clinical utility of these features are generally accepted.
The document does not detail the validation of a specific AI/CADe diagnostic algorithm with acceptance criteria related to clinical diagnostic performance metrics. If "Deep Resolve Gain" and "Deep Resolve Sharp" involve AI, their validation is presented as part of overall system performance and image quality rather than as a standalone diagnostic aid.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Siemens Medical Solutions USA, Inc. Andrew Turner Regulatory Affairs Specialist 40 Liberty Boulevard, Mailcode 65-1A Malvern, Pennsylvania 19355
Re: K210611
Trade/Device Name: MAGNETOM Free.Max Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, MOS Dated: May 27, 2021 Received: June 1, 2021
Dear Andrew Turner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
July 1, 2021
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210611
Device Name MAGNETOM Free.Max
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5: 510(k) Summary
Section 5 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act 1990 and 21 CFR § 807.92.
1. General Information
| Establishment: | Siemens Medical Solutions USA, Inc. |
|---|---|
| 40 Liberty Boulevard | |
| Mail Code 65-1A | |
| Malvern, PA 19355, USA | |
| Registration Number: 2240869 |
June 30, 2021 Date Prepared:
Siemens Shenzhen Magnetic Resonance Ltd. Manufacturer: Siemens MRI Center, Gaoxin C. Ave., 2nd Hi-Tech Industrial Park 518057 Shenzhen PEOPLE'S REPUBLIC OF CHINA Registration Number: 3004754211
Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany Registration Number: 3002808157
2. Contact Information
Andrew Turner, Requlatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355, USA Phone: (610) 850-5627 Fax: (610) 448-1787 E-mail: andrew.turner@siemens-healthineers.com
Siemens MR System: MAGNETOM Free.Max(0.55T) with Software Version syngo MR XA40A
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Device Name and Classification 3.
| Device name: | MAGNETOM Free.Max |
|---|---|
| Trade name: | MAGNETOM Free.Max |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNHSecondary: MOS |
4. Legally Marketed Predicate Device
| Trade name: | MAGNETOM Sempra |
|---|---|
| 510(k) Number: | K183221 |
| Clearance Date: | February 14, 2019 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNHSecondary: LNI, MOS |
5. Intended Use
The indications for use for the subject devices are within that of the predicate device:
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.
6. Device Description
The subject device, MAGNETOM Free.Max with software syngo MR XA40A, is an 80 cm bore Magnetic Resonance Imaging system with an actively shielded 0.55T superconducting magnet. Which is the first 0.55T MRI system for clinical use in the U.S.
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Image /page/5/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a triangular shape.
MAGNETOM Free.Max is a MRI system that has equivalencies to the predicate device MAGNETOM Sempra with syngo MR XA12 (K183221, cleared on February 14, 2019). Whilst the subject device comes with significant new and modified hardware, the resultant customer clinical value is based on the predicate device MAGNETOM Sempra with syngo MR XA12 (K183221).
A high level summary of the new hardware comparing to the predicate device is provided below:
| Hardware New Hardware | - | Magnet with no Quench Pipe includingAutoramp up and Ramp down capability |
|---|---|---|
| - | Gradient Coil and Gradient Power Amplifier | |
| - | System Cover | |
| - | Patient Table (fixed with/without vertical drive) | |
| - | RF system | |
| - | Select&GO Display (TPAN_2G) and ControlPanel (CPAN_2G) | |
| - | Patient Communication Unit (Intercom withSystem Power On/Off Function integrated) | |
| - | Computer system | |
| - | myExam 3D Camera | |
| New Coils | - | Body Coil |
| - | Head/Neck Coil | |
| - | Spine Coil | |
| - | BioMatrix Contour L Coil | |
| - | Contour S Coil |
lole software syngo MR XA40A brings new/modified software features:
| Software | New Applications/Software Features |
|---|---|
| - Sequence Booster | |
| - SMS Averaging | |
| - SWI with 3D segmented EPI | |
| - Ramp sampling mode | |
| - Skewed SPAIR | |
| - Accelerated Shim (STEAM-based field map | |
| - Deep Resolve Gain | |
| - Deep Resolve Sharp |
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Image /page/6/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
The following new features for the subject device are migrated from the reference software version syngo MR XA30A (K202014, September 8, 2020):
-
ı Motion correction for Haste with multiple averages
-
myExam Companion, which consists of: New Software Platform/ Workflow
-
myExam 3D camera ー
-
myExam Cockpit (new name for Dot — Cockpit)
-
myExam Assist (new name for Dot | Engines)
-
myExam Autopilot.
-
New Scanner User Interface: ।
- Manual positioning —
- Select&GO extension
- Guidance of general patient setup, and coil preparation
-
। System functional safety test
Modified Software Software Platform/ Workflow
ı Improved System on/off/standby behavior
7. Substantial Equivalence
MAGNETOM Free.Max with software syngo MR XA40A is substantially equivalent to the predicate device:
| Predicate Device | FDA Clearance Numberand Date | ProductCode | Manufacturer |
|---|---|---|---|
| MAGNETOM Semprawith syngo MR XA12 | K183221,cleared February 14, 2019 | LNHLNI, MOS | Siemens HealthcareGmbH |
The subject software syngo MR XA40A is modified based on the reference software XA30A; MAGNETOM C!, which is a low field device(0.35T) with permanent magnet is listed as a reference device as well:
| Reference Devices | FDA Clearance Numberand Date | ProductCode | Manufacturer |
|---|---|---|---|
| MAGNETOM Aera withsyngo MR XA30A | K202014,cleared September 8, 2020 | LNH,LNI, MOS | Siemens AG / SiemensHealthcare GmbH |
| MAGNETOM C! | K082331,cleared October 1, 2008 | LNH,MOS | Siemens ShenzhenMagnetic ResonanceLtd. |
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Technological Characteristics 8.
The subject device. MAGNETOM Free.Max with software syngo MR XA40A. is substantially equivalent to the predicate device with regard to the operational environment, programming language, operating system and performance.
The subject device conforms to the standard for medical device software (IEC 62304) and other relevant IEC and NEMA standards.
There are some differences in technological characteristics between the subject device and predicate device, including different hardware and modified software. These differences have been tested and the conclusions from the non-clinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate device.
9. Nonclinical Tests
| Performance Test | Tested Hardware orSoftware | Source/Rationale for test |
|---|---|---|
| Sample clinical images | Coils, new and modifiedsoftware features, pulsesequence types | Guidance for Submission ofPremarket Notifications forMagnetic ResonanceDiagnostic Devices |
| Image quality assessmentsby sample clinical images.In some cases, acomparison of the imagequality / quantitative datawas made. | - new / modified pulsesequence types andalgorithms.- comparison imagesbetween the new / modifiedfeatures and the predicatedevice features | Diagnostic Devices |
| Performance bench test | - SNR and image uniformitymeasurements for coils- heating measurements forcoils | |
| Software verification andvalidation | mainly new and modifiedsoftware features | Guidance for the Content ofPremarket Submissions forSoftware Contained inMedical Devices |
The following performance testing was conducted on the subject devices.
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.
10. Clinical Tests / Publications
In order to practically learn Peripheral Nerve Stimulation (PNS) effects of the subject system, a clinical study of 12 individuals were conducted (see Results of stimulation study in Appendix 3).
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No additional clinical tests were conducted to support substantial equivalence for the subject device; however, as stated above, sample clinical images were provided. Clinical publications were referenced to provide information on the use of the following features and functions.
| Feature / Function | Clinical Publication |
|---|---|
| SMS Averaging for TSE | [1] C. H. OH et al., 1984. Line-Integral ProjectionReconstruction (LPR) with Slice Encoding Techniques:Multislice Regional Imaging in NMR Tomography, IEEETrans Med Imaging. 1984; 3(4):170-178 |
| Ramp sampling modefor Beat | [2] Matt A.Bernstein, Kevin F.king, Xiaohong Joe Zhou,Handbook Of MRI Pulse Sequences, 2004: P706-P712. |
| SWI with 3D segmentedEPI | [3] Zwanenburg JJ, et al. Fast high resolution whole brainT2* weighted imaging using echo planar imaging at 7T.Neuroimage. 2011; 56:1902-1907. |
| Accelerated Shim(STEAM-based fieldmap) | [4] Liu W, et al. 3D Flow Compensated Interleaved EPI for aFast High-Resolution Susceptibility-Weighted Imaging at1.5T. Proc. Intl. Soc. Mag. Reason. Med 2019; 27: 3326. |
| [5] Nehrke, K., and Börnert, P. "DREAM—a novel approachfor robust, ultrafast, multislice B1 mapping." Magneticresonance in medicine 68.5 (2012): 1517-1526. | |
| Skewed SPAIR | [6] Hwang, T. L., van Zijl, P. C., and Garwood, M. 1999.Asymmetric adiabatic pulses for NH selection. J. Magn.Reson. 138: 173-177. |
| [7] Pfeuffer J. et al. "Zoomed Functional Imaging in theHuman Brain at 7 Tesla with Simultaneous High Spatial andHigh Temporal Resolution” Neurolmage 17(1), 2002, p. 272-286. | |
| Deep Resolve Gain | [8] Kellman P. et al. Image Reconstruction in SNR Units: AGeneral Method for SNR Measurement. MRM 2005;54:1439. Erratum in MRM 2007; 58:311. |
| [9] Blu T. et al. The SURE-LET approach to image denoisingIEEE Transactions on Image Processing 16(11):2778-86 | |
| Deep Resolve Sharp | [10] Yulun Zhang, et al. Residual Dense Network for ImageSuper-Resolution, IEEE conference on computer vision andpattern recognition. 2018 |
| [11] Eirikur Agustsson, Radu Timofte. NTIRE 2017Challenge on Single Image Super-Resolution: Dataset andStudy. CVPRW, 2017. 5 | |
| [12] Justin Johnson, et al. Perceptual Losses for Real-TimeStyle Transfer and Super-Resolution. European conferenceon computer vision. Springer, Cham, 2016 |
Siemens MR System: MAGNETOM Free.Max(0.55T) with Software Version syngo MR XA40A
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11. Safety and Effectiveness
The device labeling contains instructions for use and any necessary cautions and warnings to ensure safe and effective use of the device.
Risk Management is ensured via a risk analysis in compliance with ISO 14971, to identify and provide mitigation of potential hazards early in the design cycle and continuously throughout the development of the product. Siemens adheres to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards. Furthermore, the device is intended for healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
MAGNETOM Free.Max with software syngo MR XA40A conform to the following FDA recognized and international IEC, ISO and NEMA standards:
| RecognitionNumber | ProductArea | Title of Standard | ReferenceNumber and date | StandardsDevelopmentOrganization |
|---|---|---|---|---|
| 19-4 | General | Medical electrical equipment -part 1: general requirements forbasic safety and essentialperformance | ES60601-1:2005/(R) 2012and A1:2012 | AAMI / ANSI |
| 19-8 | General | Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances - Requirementsand tests | 60601-1-2, Ed.4.0:2014 | IEC |
| 12-295 | Radiology | Medical electrical equipment -Part 2-33: Particularrequirements for the basicsafety and essentialperformance of magneticresonance equipment formedical diagnosis | 60601-2-33, Ed.3.2 b:2015 | IEC |
| 5-40 | General | Medical devices - Application ofrisk management to medicaldevices | 14971, Ed. 2:2007 | ISO |
| 5-114 | General | Medical devices - Application ofusability engineering to medicaldevices | 62366, Edition1.0:2015 | AAMIANSIIEC |
| 13-79 | Software | Medical device software -Software life cycle processes | 62304:2006 +A1:2015 | AAMIANSIIEC |
| 12-232 | Radiology | Acoustic Noise MeasurementProcedure for DiagnosingMagnetic Resonance ImagingDevices | MS 4:2010 | NEMA |
Traditional Premarket Notification 510(k)
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Section 5: 510(k) Summary
| 12-288 | Radiology | Characterization of PhasedArray Coils for DiagnosticMagnetic Resonance Images(MRI) | MS 9:2008 | NEMA |
|---|---|---|---|---|
| 12-300 | Radiology | Digital Imaging andCommunications in Medicine(DICOM) Set 03/16/2012Radiology | PS 3.1 - 3.20:2016 | NEMA |
| 2-258 | Biocompatibility | biological evaluation of medicaldevices - part 1: evaluation andtesting within a riskmanagement process(Biocompatibility) | 10993-1:2018 | AAMIANSIISO |
12. Conclusion as to Substantial Equivalence
MAGNETOM Free.Max with software syngo MR XA40A has the same basic technological characteristics as the predicate device, MAGNETOM Sempra with syngo MR XA12, with respect to the magnetic resonance features and functionalities. And the indications for use of the subject device falls within the intended use of the predicate device.
While there are some differences in technical features compared to the predicate device, the differences have been tested and the conclusions from all verification and validation data suggest that the features bear an equivalent safety and performance profile to that of the predicate device and reference devices.
Siemens believes that MAGNETOM Free.Max with software syngo MR XA40A is substantially equivalent to the currently marketed device MAGNETOM Sempra with software syngo MR XA12 (K183221, cleared on February 14, 2019).
§ 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.