MAGNETOM Avanto fit; MAGNETOM Skyra fit

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 14, 2023 Siemens Medical Solutions USA, Inc. Milind Dhamankar Clinical Affairs Professional 40 Liberty Boulevard Malvern, PA 19355 Re: K232494 Trade/Device Name: MAGNETOM Avanto": MAGNETOM Skyrafff Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: August 13, 2023 Received: August 17, 2023 Dear Milind Dhamankar: 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 (the 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 available 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. {1}------------------------------------------------ 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. {2}------------------------------------------------ For comprehensive regulatory information about medical devices and radiation-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, D. R. K. Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K232494 Device Name MAGNETOM Avanto fit; MAGNETOM Skyra fit 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) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 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.<br>40 Liberty Boulevard<br>Malvern, PA 19355, USA<br>Registration Number: 2240869 | |----------------|-----------------------------------------------------------------------------------------------------------------------| |----------------|-----------------------------------------------------------------------------------------------------------------------| - Date Prepared: August 08, 2023 - Manufacturer: Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany Registration Number: 3002808157 #### 2. Contact Information Milind Dhamankar Clinical Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Phone: +1(610) 517-9484 Fax: (610) 448-6547 E-mail: milind.dhamankar@siemens-healthineers.com #### 3. Device Name and Classification | Device/ Trade name: | MAGNETOM Avantofit<br>MAGNETOM Skyrafit | |-----------------------|---------------------------------------------| | Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) | | Classification Panel: | Radiology | | CFR Code: | 21 CFR § 892.1000 | | Classification: | II | | Product Code: | Primary: LNH<br>Secondary: LNI, MOS | {5}------------------------------------------------ ## 4. Legally Marketed Predicate and Reference Device #### Predicate Device for MAGNETOM Skyrafit 4.1. | Trade name: | MAGNETOM Vida | |-----------------------|---------------------------------------------| | 510(k) Number: | K213693 | | Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) | | Classification Panel: | Radiology | | CFR Code: | 21 CFR § 892.1000 | | Classification: | II | | Product Code: | Primary: LNH<br>Secondary: LNI, MOS | #### Predicate Device for MAGNETOM Avantofit 4.2. | Trade name: | MAGNETOM Sola | |-----------------------|---------------------------------------------| | 510(k) Number: | K221733 | | 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 | #### Reference Device for MAGNETOM Skyrafit 4.3. | <b>Trade name:</b> MAGNETOM Skyrafit | |-------------------------------------------------------------------------| | <b>510(k) Number:</b> K162102 | | <b>Classification Name:</b> Magnetic Resonance Diagnostic Device (MRDD) | | <b>Classification Panel:</b> Radiology | | <b>CFR Code:</b> 21 CFR § 892.1000 | | <b>Classification:</b> II | | <b>Product Code:</b> Primary: LNH<br>Secondary: LNI, MOS | #### 4.4. Reference Device for MAGNETOM Avanto™ | Trade name: | MAGNETOM Avantofit | |-----------------------|---------------------------------------------| | 510(k) Number: | K162102 | | Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) | | Classification Panel: | Radiology | | CFR Code: | 21 CFR § 892.1000 | | Classification: | II | | Product Code: | Primary: LNH<br>Secondary: LNI, MOS | {6}------------------------------------------------ ## 4. Intended Use / Indications for Use The indications for use for the subject devices are 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 yield 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. #### 5. Device Description The subject devices, MAGNETOM Avanto® and MAGNETOM Skyra™ with software syngo MR XA61A, consist of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Sola with syngo MR XA51A (K221733) and MAGNETOM Vida with syngo MR XA50A (K213693). A high-level summary of the new and modified hardware and software is provided below: MAGNETOM Avanto™ with syngo MR XA61A: #### Hardware New Hardware: - Flex Loop Large । - -UltraFlex Large 18 - । UltraFlex Small 18 - -Contour 24 Modified Hardware: - -Host computers ((syngo MR Acquisition Workplace (MRAWP) and syngo MR Workplace (MRWP)) #### Software New Features and Applications: - י GRE_PC - Physiologging . - । Open Recon Framework Modified Features and Applications: - -BEAT_nav (re-naming only) {7}------------------------------------------------ #### MAGNETOM Skyraft with syngo MR XA61A: #### Hardware New Hardware: - -UltraFlex Large 18 - UltraFlex Small 18 . - -Contour 24 #### Modified Hardware: - -Host computers ((syngo MR Acquisition Workplace (MRAWP) and syngo MR Workplace (MRWP)) - MaRS (Measurement and Reconstruction System) computer - ## New Features and Applications: - । GRE_PC - . Physiologging - । Open Recon Framework Modified Features and Applications: - -BEAT nav (re-naming only) - myExam Angio Advanced Assist (Test Bolus) #### 6. Substantial Equivalence MAGNETOM Avanto™ and MAGNETOM Skyra™ with software syngo MR XA61A is substantially equivalent to the following predicate device: | Predicate Device | FDA Clearance Number and<br>Date | Product<br>Code | Manufacturer | |--------------------------------------------------|----------------------------------|------------------|-------------------------| | MAGNETOM Sola with <i>syngo</i><br>MR XA51A | K221733 on September 13,<br>2022 | LNH,<br>LNI, MOS | Siemens Healthcare GmbH | | MAGNETOM Vida with <i>syngo</i><br>MR XA50A | K213693 on February 25, 2022 | LNH,<br>LNI, MOS | Siemens Healthcare GmbH | | Reference Device | FDA Clearance Number and<br>Date | Product<br>Code | Manufacturer | | MAGNETOM Avantofit with<br><i>syngo</i> MR VE11E | K162102 on November 22,<br>2016 | LNH,<br>LNI, MOS | Siemens Healthcare GmbH | | MAGNETOM Skyrafit with | K162102 on November 22, | LNH, | Siemens Healthcare GmbH | # 7. Technological Characteristics The subject devices, MAGNETOM Avanto® and MAGNETOM Skyra™ with software syngo MR XA61A, are substantially equivalent to the predicate devices with regard to the operational environment, programming language, operating system and performance. The subject devices conform to the standard for medical device software (IEC 62304) and other relevant IEC and NEMA standards. {8}------------------------------------------------ There are some differences in technological characteristics between the subject device and predicate device, including new and modified hardware/software. Here is summary of differences: | | Subject Devices | Predicate Device | Reference Devices | |-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------| | Hardware | MAGNETOM Avantofit<br>MAGNETOM Skyrafit<br>with software syngo MR<br>XA61A | MAGNETOM Vida with<br>syngo MR XA50A<br>(K213693)<br>MAGNETOM Sola with<br>syngo MR XA51A<br>(K221733) | MAGNETOM Avantofit<br>MAGNETOM Skyrafit with<br>syngo MR VE11E1<br>(K162102) | | Magnet System | Yes | Yes | Yes | | RF System | Yes | Yes | Yes | | Transmission<br>technique | Yes | Yes | Yes | | Gradient System | Yes | Yes | Yes | | Patient Table | Yes | Yes | Yes | | Multi-Nuclear<br>Option - Supported<br>Nuclei | Yes<br>Only for MAGNETOM Skyrafit | Yes<br>Only for MAGNETOM Vida | Yes<br>Only for MAGNETOM<br>Skyrafit | | Computer | Yes<br>Modified compared to<br>predicate device:<br>- New MRAWP and MRWP<br>- New MaRS hardware for<br>MAGNETOM Skyrafit | Yes | Yes | | Coils | Yes, new coils<br>- Flex Loop Large (only for<br>MAGNETOM Avantofit)<br>- UltraFlex Large 18<br>- UltraFlex Small 18<br>- Contour 24/482 | Yes | Yes | | Other HW<br>components | Yes | Yes | Yes | Summary hardware comparison table for the subject and predicate/reference device Summary software comparison table for the subject and predicate devices | | Subject Devices | Predicate Device | |----------|----------------------------------------|--------------------| | Software | MAGNETOM Avantofit | MAGNETOM Vida with | | | MAGNETOM Skyrafit | syngo MR XA50A | | | with software syngo MR XA61A (K213693) | | ¹ Change released by internal documentation based on MAGNETOM Skyraf" with syngo MR E11C (K162102) 2 Contour 24 (K183111, cleared on December 7, 2018 and K173446, was cleared November 17, 2017) {9}------------------------------------------------ | | | MAGNETOM Sola with | |----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------| | | | syngo MR XA51A (K221733) | | Sequences | | | | SE-based pulse sequence types | Yes | Yes | | GRE-based/Steady-State pulse<br>sequence types | New or modified pulse sequences:<br>- GRE_PC new pulse sequence<br>- BEAT_NAV pulse sequence re-<br>naming | Yes | | EPI-based pulse sequence types | New features:<br>- Physiologging for EPI2D_BOLD<br>and EPI2D_PACE | Yes | | Spectroscopy pulse sequence types | Yes | Yes | | Feature and Applications | | | | Other features and<br>applications such as:<br>-Application Suites<br>-myExam Assists<br>-Other Imaging Applications | Modified application feature:<br>- myExam Angio Assist (Test Bolus<br>and Care bolus) for MAGNETOM<br>Skyrafit | Yes | | User interface and user interaction | Yes | Yes | | Viewing and post-processing | Yes | Yes | | Workflow and software utilization | Yes | Yes | | Patient Management | Yes | Yes | | Scan Modes and Pulse Sequences | Yes | Yes | | Scanning | Yes | Yes | | Reconstruction | New feature:<br>- OpenRecon Framework | Yes | | Image Display | Yes | Yes | | File/Data Management | Yes | Yes | The differences have been tested and the conclusion from the non-clinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate device. #### 8. Nonclinical Tests The following performance testing was conducted on the subject devices: | Performance Test | Tested Hardware or<br>Software | Source/Rationale for test | |----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | Software verification<br>and validation | New or modified software<br>features | Guidance for the Content of Premarket<br>Submissions for Software Contained in<br>Medical Devices | | Sample clinical images | New or modified software<br>features and coils | Guidance for submission of Premarket<br>Notifications for Magnetic Resonance<br>Diagnostic Devices | | Image quality<br>assessment by sample<br>clinical images | - new / modified pulse<br>sequence types.<br>- comparison images<br>between the new / modified<br>features and the predicate<br>device features | | {10}------------------------------------------------ | Physiologging<br>Verification Report | Physiologging | New Feature Introduction | |--------------------------------------|---------------|--------------------------| |--------------------------------------|---------------|--------------------------| The following performance testing for local coils was conducted on the predicate and the reference devices and can be reused for the subject devices: | Performance Test | Tested Hardware or Software | Source/Rationale for test | |------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | Performance bench test | - SNR and image uniformity<br>measurements for coils<br>- Heating measurements for coils | Guidance for Submission of<br>Premarket Notifications for<br>Magnetic Resonance Diagnostic<br>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. ## 9. Clinical Tests / Publications No clinical tests were conducted to support substantial equivalence for the subject devices; however, as stated above, sample clinical images were provided. Furthermore, additional clinical publications were referenced to provide information on the use of the following features and functions: | Feature | Publications | |---------|--------------------------------------------------------------------------------------------------------------| | GRE_PC | [1] Guenthner C. et al. Ristretto MRE: A generalized multi-shot GRE-MRE sequence. NMR Biomed 2019; 32:e4049. | # 10. 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 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 Avanto® and MAGNETOM Skyra™ with software syngo MR XA61A conforms to the following FDA recognized and international IEC, ISO and NEMA standards: {11}------------------------------------------------ | Recognitio<br>n Number | Product<br>Area | Title of Standard | Reference Number<br>and date | Standards<br>Development<br>Organization | |------------------------|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------| | 19-4 | General | Medical electrical equipment - part 1:<br>general requirements for basic safety<br>and essential performance | ES60601-<br>1:2005/(R)2012 and<br>A1:2012<br>C1:2009/(R)2012 | AAMI / ANSI | | 19-8 | General | Medical electrical equipment - Part 1-2:<br>General requirements for basic safety<br>and essential performance - Collateral<br>Standard: Electromagnetic disturbances<br>- Requirements and tests | 60601-1-2 Edition<br>4.0:2014-02 | IEC | | 12-295 | Radiology | Medical electrical equipment - Part 2-<br>33: Particular requirements for the<br>basic safety and essential performance<br>of magnetic resonance equipment for<br>medical diagnosis | 60601-2-33 Ed. 3.2<br>b:2015 | IEC | | 5-125 | General | Medical devices - Application of risk<br>management to medical devices | 14971 Third Edition<br>2019-12 | ISO | | 5-114 | General I<br>(QS/<br>RM) | Medical devices - Part 1: Application of<br>usability engineering to medical devices | 62366-1:2015 | ANSI AAMI IEC | | 13-79 | Software/<br>Informatics | Medical device software - Software life<br>cycle processes | 62304 Edition 1.1<br>2015-06<br>CONSOLIDATED<br>VERSION | IEC | | 12-195 | Radiology | NEMA MS 6-2008 (R2014)<br>Determination of Signal-to-Noise Ratio<br>and Image Uniformity for Single-<br>Channel Non-Volume Coils in<br>Diagnostic MR Imaging | MS 6-2008 (R2014) | NEMA | | 12-342 | Radiology | Digital Imaging and Communications in<br>Medicine (DICOM) Set | PS 3.1 - 3.20<br>(2021e) | NEMA | | 2-258 | Biocompati<br>bility | Biological evaluation of medical devices<br>- part 1: evaluation and testing within a<br>risk management process.<br>(Biocompatibility) | 10993-1 Fifth<br>edition 2018-08 | AAMI<br>ANSI<br>ISO | # 11. Conclusion as to Substantial Equivalence MAGNETOM Avanto® and MAGNETOM Skyra® with software syngo MR XA61A have the same intended use and same basic technological characteristics than the predicate device system, MAGNETOM Vida with syngo MR XA50A and MAGNETOM Sola with syngo MR XA51A, with respect to the magnetic resonance features and functionalities. While there are some differences in technical features compared to the predicate device, the differences have been tested and the {12}------------------------------------------------ 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 Avanto® and MAGNETOM Skyra™ with software syngo MR XA61A are substantially equivalent to the currently marketed devices MAGNETOM Vida with software syngo MR XA50A (K213693, cleared on February 25, 2022) and MAGNETOM Sola with syngo MR XA51A (K221733 on September 13, 2022).