(21 days)
The MAGNETOM system 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 vield information that may assist in diagnosis.
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.
MAGNETOM Viato.Mobile with software syngo MR XA51A includes minor modified hardware compared to the predicate device. MAGNETOM Sola Fit with software syngo MR XA51A. A high level summary of the modified hardware is provided below:
Hardware
Modified Hardware
- Cover
Other Modifications and / or Minor Changes - Adaptations for installation in a mobile trailer
- MAGNETOM Viato.Mobile is a mobile MR system which enables the customers to relocate the MRI system to different locations and therefore provide imaging services where it is needed.
The provided text describes the 510(k) summary for the MAGNETOM Viato.Mobile device, focusing on its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria and a study specifically proving the device meets those criteria for software-driven performance aspects, nor does it include information about AI/ML models.
The document states: "No clinical study and no additional clinical tests were conducted to support substantial equivalence for the subject device." It primarily focuses on hardware modifications and compliance with general medical device standards.
Therefore, many of the requested details cannot be extracted from the provided text. Below is a summary of what can be inferred from the document and a clear indication of what information is missing.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the context of an AI/ML model for diagnostic accuracy. Instead, the "performance" discussed relates to the device's adherence to general safety and operational standards as a Magnetic Resonance Diagnostic Device (MRDD).
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document regarding the device's overall functionality and safety):
| Acceptance Criteria Category | Specific Criteria (Inferred from Standards) | Reported Device Performance (Inferred from substantially equivalent claim) |
|---|---|---|
| Magnetic Resonance Imaging Functionality | Production of transverse, sagittal, coronal, oblique images; spectroscopic images and/or spectra; display of internal structure/function of head, body, or extremities. Interpretation by trained physician assists in diagnosis. | Performs as intended, equivalent to predicate device. |
| Interventional Procedures | Compatibility with MR compatible devices (e.g., in-room displays, MR Safe biopsy needles) for imaging during interventional procedures. | Performs as intended, equivalent to predicate device. |
| Electrical Safety | Compliance with IEC 60601-1 (general requirements for basic safety and essential performance). | Compliant with IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (electromagnetic disturbances requirements and tests). | Compliant with IEC 60601-1-2. |
| MR-Specific Safety | Compliance with IEC 60601-2-33 (particular requirements for basic safety and essential performance of magnetic resonance equipment). | Compliant with IEC 60601-2-33. |
| Software Life Cycle Processes | Compliance with IEC 62304 (medical device software - software life cycle processes). | Compliant with IEC 62304. |
| Risk Management | Compliance with ISO 14971 (application of risk management to medical devices). | Compliant with ISO 14971. |
| Usability Engineering | Compliance with IEC 62366-1 (application of usability engineering to medical devices). | Compliant with IEC 62366-1. |
| DICOM Compatibility | Compliance with NEMA DICOM standards (Digital Imaging and Communications in Medicine). | Compliant with NEMA DICOM. |
| Image Quality Parameters | Compliance with NEMA standards for SNR, geometric distortion, image uniformity, slice thickness, acoustic noise, SAR. | Compliant with relevant NEMA standards for image quality. |
| Operational Environment | Equivalent to predicate device. | Equivalent to predicate device. |
| Programming Language | Equivalent to predicate device. | Equivalent to predicate device. |
| Operating System | Equivalent to predicate device. | Equivalent to predicate device. |
Regarding the study that proves the device meets acceptance criteria:
The document explicitly states: "No clinical study and no additional clinical tests were conducted to support substantial equivalence for the subject device."
The assessment for substantial equivalence was based on:
- Bench testing of modified hardware: Performed according to "Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices."
- Verification and validation (V&V) of modified hardware: Performed according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Electrical safety and electromagnetic compatibility (EMC) testing of the complete system: Performed per IEC 60601-1-2.
The conclusion is that these non-clinical data demonstrate the device performs as intended and is substantially equivalent to the predicate device, the MAGNETOM Sola Fit (K221733).
Missing Information (Not found in the provided text):
- Sample size used for the test set and the data provenance: Not applicable, as no performance study for diagnostic accuracy was conducted for an AI component. The tests were for hardware and system compliance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there was no test set requiring expert ground truth for diagnostic accuracy.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. The device is a Magnetic Resonance Diagnostic Device, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
This device is primarily an MR hardware system with software for operation and image generation, not a device incorporating AI/ML for diagnostic interpretation. The substantial equivalence relies on proving the modified hardware and mobile integration retain the fundamental safety and performance characteristics of the predicate device, as demonstrated through engineering tests and adherence to recognized standards.
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September 6, 2023
Siemens Medical Solutions USA, Inc. % Alina Goodman Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355
Re: K232482
Trade/Device Name: MAGNETOM Viato.Mobile Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: August 15, 2023 Received: August 16, 2023
Dear Alina Goodman:
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
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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 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 (OS) 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,
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
MAGNETOM Viato.Mobile
Indications for Use (Describe)
The MAGNETOM system 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 vield information that may assist in diagnosis.
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
e-Counter Use (21 CFR 801 Subpart C)
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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 BoulevardMalvern, PA 19355, USARegistration Number: 2240869 |
|---|---|
| Date Prepared: | August 15, 2023 |
| Manufacturer: | Siemens Healthcare GmbHHenkestrasse 12791052 ErlangenGermanyRegistration Number: 3002808157 |
2. Contact Information
Alina Goodman Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Phone: +1 (224) 526-1404 E-mail: alina.goodman@siemens-healthineers.com
Device Name and Classification 3.
| Device/ Trade name: | MAGNETOM Viato.Mobile |
|---|---|
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNH |
| Secondary: LNI, MOS |
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4. Legally Marketed Predicate Device
| Trade name: | MAGNETOM Sola Fit |
|---|---|
| 510(k) Number: | K221733 |
| Clearance Date: | December 13, 2022 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNHSecondary: LNI, MOS |
Intended Use / Indications for Use 5.
The indications for use for the subject device is the same as the predicate device:
The MAGNETOM system 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 vield information that may assist in diagnosis.
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.
6. Device Description
MAGNETOM Viato.Mobile with software syngo MR XA51A includes minor modified hardware compared to the predicate device. MAGNETOM Sola Fit with software syngo MR XA51A. A high level summary of the modified hardware is provided below:
Hardware
Modified Hardware
- Cover
Other Modifications and / or Minor Changes
- Adaptations for installation in a mobile trailer
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- । MAGNETOM Viato.Mobile is a mobile MR system which enables the customers to relocate the MRI system to different locations and therefore provide imaging services where it is needed.
7. Substantial Equivalence
MAGNETOM Viato.Mobile with software syngo MR XA51A is substantially equivalent to the following predicate device:
| Predicate Device | FDA Clearance Numberand Date | ProductCode | Manufacturer |
|---|---|---|---|
| MAGNETOM Sola Fit withsyngo MR XA51A | K221733,cleared December 13, 2022 | LNHLNI, MOS | Siemens HealthcareGmbH |
MAGNETOM Viato.Mobile with software syngo MR XA51A includes hardware already cleared on the following reference devices:
| Reference Devices | FDA Clearance Numberand Date | ProductCode | Manufacturer |
|---|---|---|---|
| MAGNETOM Aera withsoftware syngo MR XA30APlease note: the Mobile Solution,as part of MAGNETOM Aera withsoftware syngo MR XA30A, is thereference device related tomodifications performed to fit thesubject device to the mobileenvironment. | K202014,cleared September 8, 2020 | LNHLNI, MOS | Siemens HealthcareGmbH |
| MAGNETOM Avanto Fitwith software syngo MRXA50APlease note: reference devicerelated to the cover | K220151,cleared April 1, 2022 | LNHLNI, MOS | Siemens HealthcareGmbH |
Comparison of technological Characteristics with the Predicate Device 8.
The subject device, MAGNETOM Viato.Mobile with software syngo MR XA51A, is substantially equivalent to the predicate device with regard to the operational environment, programming lanquage, 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 no differences in technological characteristics between the subject device and predicate device, but minor modified hardware and an installation in a mobile trailer, these differences have been tested and the conclusion from the non-clinical data suggests that the system bears an equivalent safety and performance profile to that of the predicate device.
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Nonclinical Tests 9.
The following performance testing was conducted on the subject device.
| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|---|---|---|
| Performance bench test | modified hardware | Guidance for Submission ofPremarket Notifications forMagnetic ResonanceDiagnostic Devices |
| Verification and validation | modified hardware | Guidance for the Content ofPremarket Submissions forSoftware Contained in MedicalDevices |
| Electrical safety andelectromagnetic compatibility(EMC) | complete system | IEC 60601-1-2 |
The results from each set of tests demonstrate that the subject device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.
10. Clinical Tests / Publications
No clinical study and no additional clinical tests were conducted to support substantial equivalence for the subject device.
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 cvcle and continuously throughout the development of the product. Siemens Healthcare GmbH 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 Viato.Mobile with software syngo MR XA51A conforms to the following FDA recognized and international IEC, ISO and NEMA standards:
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| RecognitionNumber | ProductArea | Title of Standard | ReferenceNumber and date | StandardsDevelopmentOrganization |
|---|---|---|---|---|
| 19-4 | General II(ES/ EMC) | Medical electrical equipment -Part 1: General requirements forbasic safety and essentialperformance (IEC 60601-1:2005, MOD) | ES60601-1:2005/(R)2012and A1:2012,C1:2009/(R)2012andA2:2010/(R)2012(Consolidated Text) | ANSI AAMI |
| 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.3.2:2015 | IEC |
| 5-125 | General I(QS/ RM) | Medical devices - Application ofrisk management to medicaldevices | 14971 Third Edition2019-12 | ISO |
| 5-114 | General I(QS/ RM) | Medical devices - Part 1:Application of usabilityengineering to medical devices[Including CORRIGENDUM 1(2016)] | 62366-1 Edition 1.02015-02 | IEC |
| 13-79 | Software/Informatics | Medical device software -Software life cycle processes | 62304 Edition 1.12015-06CONSOLIDATEDVERSION | IEC |
| 2-258 | Biocompatibility | Biological evaluation of medicaldevices - part 1: evaluation andtesting within a riskmanagement process | 10993-1 Fifthedition 2018-08 | ISO |
| 12-342 | Radiology | Digital Imaging andCommunications in Medicine(DICOM) Set | PS 3.1 - 3.202021e | NEMA |
| 12-188 | Radiology | Determination of Signal-to-Noise Ratio (SNR) in DiagnosticMagnetic Resonance Images | MS 1:2008 (R2020) | NEMA |
| 12-196 | Radiology | Determination of Two-dimensional GeometricDistortion in DiagnosticMagnetic Resonance Images | MS 2:2008 (R2020) | NEMA |
| 12-187 | Radiology | Determination of ImageUniformity in DiagnosticMagnetic Resonance Images | MS 3:2008 (R2020) | NEMA |
| 12-232 | Radiology | Acoustic Noise MeasurementProcedure for DiagnosingMagnetic Resonance ImagingDevices | MS 4:2010 | NEMA |
| 12-322 | Radiology | Determination of SliceThickness in DiagnosticMagnetic Resonance Imaging | MS 5:2018 | NEMA |
| 12-195 | Radiology | Determination of Signal-to-Noise Ratio and ImageUniformity for Single-Channel,Non-Volume Coils in DiagnosticMagnetic Resonance Imaging(MRI) | MS 6:2008 (R2014) | NEMA |
| 12-315 | Radiology | Characterization of the SpecificAbsorption Rate for MagneticResonance Imaging Systems | MS 8:2016 | NEMA |
| 12-288 | Radiology | Standards PublicationCharacterization of PhasedArray Coils for DiagnosticMagnetic Resonance Images | MS 9-2008 (R2020) | NEMA |
| 12-298 | Radiology | Determination of Local SpecificAbsorption Rate (SAR) inDiagnostic Magnetic ResonanceImaging Systems | MS 10 - 2010 | NEMA |
| 12-306 | Radiology | Quantification and Mapping ofGeometric Distortion for SpecialApplications | MS 12 - 2016 | NEMA |
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12. Conclusion as to Substantial Equivalence
MAGNETOM Viato.Mobile with software syngo MR XA51A has the same intended use and same basic technological characteristics than the predicate device system, MAGNETOM Sola Fit with syngo MR XA51A, with respect to the magnetic resonance features and functionalities. There are no differences in technical features compared to the predicate device, but minor modified hardware and an installation in a mobile trailer. The resulting differences have been tested and the conclusions from all verification and validation data suggest that the system bears an equivalent safety and performance profile to that of the predicate device and reference devices.
Siemens believes that MAGNETOM Viato.Mobile with software syngo MR XA51A is substantially equivalent to the currently marketed device MAGNETOM Sola Fit with software syngo MR XA51A (K221733, cleared on December 13, 2022).
§ 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.