MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit

K192924 · Siemens Medical Solutions USA, Inc. · LNH · Mar 11, 2020 · Radiology

Device Facts

• Record ID: K192924
• Device Name: MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Mar 11, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Your MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal, and oblique cross sectional mages, spectroscopic images and or spectra, and that displays the internal structure and/or function of the head, body, or extremittes. 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 inages and or spectra and the plysical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.

Device Story

MAGNETOM Vida, Lumina, and Vida Fit are 3T MRI systems using syngo MR XA20A software. Systems acquire MR signals to produce cross-sectional images, spectroscopic data, and derived physical parameters for diagnostic interpretation by physicians. Used in clinical settings by trained professionals; supports interventional procedures with MR-safe equipment. New features include: Simultaneous Multi-Slice (SMS) for TSE Dixon, RESOLVE, and QDWI; Compressed Sensing (CS) for TOF MRA and SPACE sequences; GOLiver and GOKnee2D for workflow optimization; respiratory self-gating; metal artifact correction (SEMAC); and inline motion correction using camera-based tracking. Data is processed to improve image quality, reduce scan times, and minimize motion artifacts. Output assists clinicians in anatomical and functional assessment, potentially improving diagnostic accuracy and patient throughput.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing, software verification/validation, and sample clinical images comparing new/modified features to the predicate. Clinical publications were cited to support the efficacy of specific features like ZOOMit DWI and EP2D_SE_MRE.

Technological Characteristics

3T MRI system; includes new BM Body 18 receive coil (18-element). Software features include SMS, Compressed Sensing, and various pulse sequences (TSE, GRE, EPI, SPACE). Connectivity via DICOM. Conforms to IEC 60601-1, IEC 60601-2-33, IEC 62304 (software), and NEMA MS standards. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients requiring diagnostic MR imaging of the head, body, or extremities; produces cross-sectional images, spectroscopic images/spectra, and derived physical parameters to assist in diagnosis; supports interventional procedures using MR-compatible devices.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• MAGNETOM Vida with syngo MR XA11B (K183254)

Reference Devices

• MAGNETOM Skyra with software syngo MR E11C-AP04 (K173592)
• MAGNETOM Aera with syngo MR E11C-AP01 (K182299)
• MAGNETOM Lumina with software syngo MR XA11B (K183244)
• MAGNETOM Skyra with syngo MR D13C (K123510)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Medical Solutions USA, Inc. % Mr. Andrew Turner Regulatory Affairs Professional 40 Liberty Boulevard, MailCode 65-1A MALVERN PA 19355

Re: K192924

Trade/Device Name: MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: February 7, 2020 Received: February 10, 2020

Dear Mr. 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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

March 11, 2020

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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 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 ([e-mail]) or phone [phone] 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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#### Section 4: Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K192924

Device Name

MAGNETOM Vida, MAGNETOM Lumina, and MAGNETOM Vida Fit

#### Indications for Use (Describe)

Your MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal, and oblique cross sectional mages, spectroscopic images and or spectra, and that displays the internal structure and/or function of the head, body, or extremittes. 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 inages and or spectra and the plysical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.

Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display 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 [e-mail]

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FORM FDA 3881 (7/17)

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0013-443-6740 EF

#### Traditional Premarket Notification 510(k)

October 9, 2019

Siemens MR Systems: MAGNETOM Vida, MAGNETOM Lumina and MAGNETOM Vida Fit (3T) with new Software syngo MR XA20A

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Image /page/3/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 word "Healthineers" is a graphic of orange dots.

# 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 |

Date Prepared: October 9, 2019

- Siemens Healthcare GmbH Manufacturer: Henkestrasse 127 91052 Erlangen Germany Registration Number: 3002808157
# 2. Contact Information

Andrew Turner Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355, USA Phone: [phone] Fax: [phone] E-mail: [e-mail]

#### Device Name and Classification 3.

| Device name: | MAGNETOM Vida, MAGNETOM Lumina and<br>MAGNETOM Vida Fit |
|-----------------------|---------------------------------------------------------|
| Trade name: | MAGNETOM Vida, MAGNETOM Lumina and<br>MAGNETOM Vida Fit |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |

#### Traditional Premarket Notification 510(k)

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October 9, 2019

Image /page/4/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.

| Classification: | II |
|-----------------|---------------------|
| Product Code: | Primary: LNH |
| | Secondary: LNI, MOS |

## 4. Legally Marketed Predicate Device

| Trade name: | MAGNETOM Vida |
|-----------------------|---------------------------------------------|
| 510(k) Number: | K183254 |
| Clearance Date: | January 18, 2019 |
| 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. Intended Use

The indications for use for the subject devices is the same as the predicate device:

Your 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.

Your 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

MAGMETOM Vida, MAGNETOM Lumina, and MAGNETOM Vida Fit with software synqo MR XA20A include new and modified hardware and software compared to the predicate device, MAGNETOM Vida with syngo MR XA11B. A high level summary of the hardware and software is provided below:

#### Traditional Premarket Notification 510(k)

Siemens MR Systems: MAGNETOM Vida, MAGNETOM Lumina and MAGNETOM Vida Fit (3T) with new Software syngo MR XA20A

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# Hardware

Hardware

- Computer

Coils

- BM Body 18: The new BM Body 18 coil is a receive coil with 18 elements and is based on the Body 18 coil, (cleared with K101347). It is a general purpose coil.
The BM Body 18 coil can be used with two different cables of different length; this capability was introduced with the BM Body 12 coil.

# Software

Features and Applications

- SMS for TSE DIXON: Simultaneous excitation and acquisition of multiple ı slices with the Simultaneous multi-slice (SMS) technique for TSE Dixon imaging.
- । GOLiver is a set of optimized pulse sequence for fast and efficient imaging of the abdomen / liver. It is designed to provide consistent exam slots and to reduce the workload for the user in abdominal / liver MRI.
- -Angio TOF with Compressed Sensing (CS): The Compressed Sensing (CS) functionality is now available for TOF MRA within the BEAT pulse sequence type for the 1.5 T MR systems. Scan time can be reduced by an incoherent undersampling of k-space data. The usage of CS as well as the acceleration factor and further options can be freely selected by the user.
- RT Respiratory self-gating for FL3D VIBE: Non-contrast abdominal and thoracic examination in free breathing with reduced blur induced by respiratory motion.
- -SMS for RESOLVE and QDWI: Simultaneous excitation and acquisition of multiple slices with the Simultaneous multi-slice (SMS) technique for readoutsegmented echo planar imaging (RESOLVE) and quiet diffusion weighted imaging (QDWI).
- -SPACE with Compressed Sensing (CS): The Compressed Sensing (CS) functionality is now available for the SPACE pulse sequence type. Scan time can be reduced by the incoherent under-sampling of the k-space data. The usage of CS as well as the acceleration factor and other options can be freely selected by the user.
- i SEMAC: SEMAC is a method for metal artifact correction in ortho imaging of patients with whole joint replacement. Using Compressed Sensing the acquisition can be accelerated.
- TSE_MDME: A special variant of the TSE pulse sequence type which acquires several contrasts (with different TI and TE, i.e. Multi Delay Multi Echo) within a single sequence.

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Image /page/6/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.

- TSE and GRE with Inline Motion Correction: TSE and GRE with Inline Motion Correction: Tracking of motion of the head during head scans with a nose marker and a camera system. The MR system uses the tracking information to compensate for the detected motion.
- EP SEG PHS: pulse sequence type EP SEG PHS, based on BEAT EPI and modified with a silent period that can be used by external devices/applications for synchronization with the MR imaging
- । GRE PHS: pulse sequence type GRE PHS, is a GRE pulse sequence type, modified to provide a silent period that can be used by external devices/applications for synchronization with the MR imaging.
- । GRE_Proj: The GRE projection pulse sequence type "" allows the acquisition of 1-D projection data for different orientations.
- -GOKnee2D: GOKnee2D is a set of multi-band pulse sequence types with Simultaneous Multislice TSE for fast and efficient imaging of the knee. It is designed to provide consistent exam slots and to reduce the workload for the user in Knee MRI.
- BEAT_interactive: The BEAT_Interactive pulse sequence type is a modification of the BEAT IRTTT pulse sequence type in order to interactively increase the slice thickness and switch on and off a magnetization pulse that the user can select prior to the measurement start.
- i EP2D_SE_MRE: As an alternative of greMRE, EP2D_SE_MRE pulse sequence type is based on single-shot EP2D SE MRE sequence. It offers acquisition of multiple slices in a single, short breath-hold, and it is more robust against signal dephasing effects
- ZOOMit DWI: syngo ZOOMit based on EPI diffusion allows diffusion weighted imaging (DWI) while avoiding signal and artifacts from surrounding tissue. The feature is now available for 1-ch-systems and enables improved robustness to infolding artifacts from tissue from outside the excited region.
- SPACE Flair Improvements: SPACE pulse sequence type offers a magnetization preparation mode for brain imaging with FLAIR contrast (FLuid Attenuated Inversion Recovery); improving the image quality of FLAIR images.
- External Phase Correction Scan for EPI Diffusion: Separate N/2 Nyquist ghost । correction acquisition method for diffusion imaging in the presence of fat.
- -MR Breast Biopsy Workflow improvements: The changes made to MR Breast Biopsy application target two areas: the improved readability of planning results and the ability to handle the planning of multiple biopsy targets.
- GOBrain / GOBrain+: GOBrain (brain examination in short acquisition time) । GOBrain+ (adaptation of GOBrain pulse sequences)

# Software / Platform

- Dot Cockpit: MR Protocol Manager as part of a scanner fleet with connection via a share.
#### Traditional Premarket Notification 510(k)

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Image /page/7/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a pattern.

- i Access-i: The interface Access-i allows 3rd party devices to establish a bidirectional communication with the MR scanner via a secure local network connection, supporting data transfer to and triggering of data acquisition from the 3rd party device. It enables the 3rd party client to control and edit a measurement program on the MR.
- -Table positioning mode: A new table positioning mode "FIX" is introduced which complements the existing table positioning modes ISO and LOC to support workflows in which the user needs to be in control of a defined Zposition at which measurements get executed.

# Other Modifications and / or Minor Changes

- MAGNETOM Vida Fit: The MAGNETOM Vida Fit is a new MRI System which is the result of an upgrade from a MAGNETOM Aera.
- i BM Body 12: For MR examinations of head and neck in situations where a rigid rf head coil cannot be used, e.g. with patients positioned in thermoplastic masks used for radiotherapy planning, aiming at higher signal-to-noise and spatial resolution as what can be achieved with 4-channel Flex rf coils
- । Body 18: For MR examinations of head and neck in situations, where a rigid ff head coil cannot be used, e.g. with patients positioned in thermoplastic masks used for radiotherapy planning, aiming at higher signal-to-noise and spatial resolution than what can be achieved with 4-channel Flex rf coils
- -UltraFlex Large 18, UltraFlex Small 18: For MR examinations of head and neck in situations, where a rigid rf head coil cannot be used, e.q. with patients positioned in thermoplastic masks used for radiotherapy planning, aiming at higher signal-to-noise and spatial resolution than what can be achieved with 4channel Flex rf coils
- Broad band / narrow band online supervision: The broadband/narrowband i supervision checks the correctness of the measurement values used for the SAR calculation. With syngo MR XA20A, the supervision cycle is reduced significantly.
- । LiverLab Dot Engine - debundling: LiverLab is now offered separately as standalone workflow and is also still available as part of the Abdomen Dot Engine.

## 7. Substantial Equivalence

MAGNETOM Vida. MAGNETOM Lumina and MAGNETOM Vida Fit with software syngo MR XA20A are substantially equivalent to the following predicate device:

| Predicate Device | FDA Clearance Number<br>and Date | Product<br>Code | Manufacturer |
|--------------------------------------|--------------------------------------|-----------------|----------------------------|
| MAGNETOM Vida with<br>syngo MR XA11B | K183254,<br>cleared January 18, 2019 | LNH<br>LNI, MOS | Siemens Healthcare<br>GmbH |

#### Traditional Premarket Notification 510(k)

Siemens MR Systems: MAGNETOM Vida, MAGNETOM Lumina and MAGNETOM Vida Fit (3T) with new Software synqo MR XA20A

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October 9, 2019

MAGNETOM Vida, MAGNETOM Lumina and MAGNETOM Vida Fit with software syngo MR XA20A includes hardware and software already cleared on the following reference devices:

| Reference Devices | FDA Clearance Number<br>and Date | Product<br>Code | Manufacturer |
|--------------------------------------------------------|---------------------------------------|-----------------|----------------------------|
| MAGNETOM Skyra with<br>software syngo MR E11C-<br>AP04 | K173592,<br>cleared February 13, 2018 | LNH<br>LNI, MOS | Siemens Healthcare<br>GmbH |
| MAGNETOM Aera with<br>syngo MR E11C-AP01 | K182299,<br>cleared October 26, 2018 | LNH<br>LNI, MOS | Siemens Healthcare<br>GmbH |
| MAGNETOM Lumina with<br>software syngo MR XA11B | K183244,<br>cleared January 24, 2019 | LNH<br>LNI, MOS | Siemens Healthcare<br>GmbH |
| MAGNETOM Skyra with<br>syngo MR D13C | K123510,<br>cleared May 17, 2013 | LNH | Siemens AG |

# 8. Technological Characteristics

The subject devices, MAGNETOM Vida, MAGNETOM Lumina and MAGNETOM Vida Fit with software syngo MR XA20A, are substantially equivalent to the predicate device 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.

While there are some differences in technological characteristics between the subject devices and predicate device, including new and modified hardware and software, these differences have been tested and the conclusions from the nonclinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate device.

# 9. Nonclinical Tests

The following performance testing was conducted on the subject devices.

| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Sample clinical images | coils, new and modified<br>software features | Guidance for Submission of<br>Premarket Notifications for |
| Image quality assessments by<br>sample clinical images. In<br>some cases a comparison of<br>the image quality / quantitative<br>data was made. | - new / modified pulse<br>sequence types.<br>- comparison images between<br>the new / modified features<br>and the predicate device<br>features | Magnetic Resonance<br>Diagnostic Devices |
| Performance bench test | mainly new and modified<br>hardware | |

#### Traditional Premarket Notification 510(k)

Siemens MR Systems: MAGNETOM Vida, MAGNETOM Lumina and MAGNETOM Vida Fit (3T) with new Software syngo MR XA20A

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Image /page/9/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.

| Software verification and<br>validation | mainly new and modified<br>software features | Guidance for the Content of<br>Premarket Submissions for<br>Software Contained in Medical<br>Devices |
|--------------------------------------------------------------------------|----------------------------------------------|------------------------------------------------------------------------------------------------------|
| Biocompatibility | surface of applied parts | ISO 10993-1 |
| Electrical, mechanical,<br>structural, and related system<br>safety test | complete system | - AAMI / ANSI ES60601-1<br>- IEC 60601-2-33 |
| Electrical safety and<br>electromagnetic compatibility<br>(EMC) | complete system | IEC 60601-1-2 |

The results from each set of tests demonstrate that the devices perform as intended and are therefore substantially equivalent to the predicate device to which it has been compared.

# 10. Clinical Tests/Publications

No additional clinical tests were conducted to support substantial equivalence for the subject devices; 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 |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ZOOMit DWI | Finsterbusch J. et al., "Improving the performance of diffusion-weighted<br>inner field-of-view echo-planar imaging based on 2D-selective<br>radiofrequency excitations by tilting the excitation plane". J Magn Reson<br>Imaging, 35:984-992 (2012) |
| | Schneider R. et al., "Asymmetric Two-Dimensional Spatially Selective<br>Excitation in Echo-Planar Imaging". Proc Intl Soc Mag Reson Med 22<br>(2014), p. 4436 |
| | Alley M. T. et al., "Angiographic Imaging with 2D RF Pulses". Magn<br>Reson Med 37:260-267 (1997) |
| EP2D_SE_MRE | Wagner M. et al., "Magnetic Resonance Elastography of the Liver:<br>Qualitative and Quantitative Comparison of Gradient Echo and Spin Echo<br>Echoplanar Imaging Sequences”. Invest Radiol. 2016 Sep;51(9):575-81.<br>Kim Y. S. et al., "Comparison of spin-echo echoplanar imaging and<br>gradient recalled echo-based MR elastography at 3 Tesla with and<br>without gadoxetic acid administration". Eur Radiol. 2017 Oct;27(10):4120-<br>4128.<br>Serai S. D. et al., "Spin-echo Echo-planar Imaging MR<br>Elastography versus Gradient-echo MR Elastography for<br>Assessment of Liver Stiffness in Children and Young Adults Suspected of<br>Having Liver Disease". Radiology. 2017 Mar;282(3):761-770. |

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Image /page/10/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 in a circular pattern.

## 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 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 Vida, MAGNETOM Lumina and MAGNETOM Vida Fit with software syngo MR XA20A conform to the following FDA recognized and international IEC, ISO and NEMA standards:

| Recognition<br>Number | Product<br>Area | Title of Standard | Reference<br>Number and date | Standards<br>Development<br>Organization |
|-----------------------|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------|
| 19-4 | General | Medical electrical equipment -<br>Part 1: general requirements for<br>basic safety and essential<br>performance | ES60601-<br>1:2005/(R) 2012<br>and A1:2012 | AAMI / ANSI |
| 19-8 | General | Medical electrical equipment -<br>Part 1-2: General requirements<br>for basic safety and essential<br>performance - Collateral<br>Standard: Electromagnetic<br>disturbances - Requirements<br>and tests | 60601-1-2, Ed.<br>4.0:2014-02 | IEC |
| 12-295 | Radiology | Medical electrical equipment -<br>Part 2-33: Particular<br>requirements for the basic<br>safety and essential<br>performance of magnetic<br>resonance equipment for<br>medical diagnosis | 60601-2-33, Ed.<br>3.2:2015 | IEC |
| 5-40 | General | Medical devices - Application of<br>risk management to medical<br>devices | 14971, Ed. 2:2007-<br>10 | ISO |
| 5-114 | General | Medical devices - Application of<br>usability engineering to medical<br>devices | 62366, Ed.<br>1.0:2015 | AAMI<br>ANSI<br>IEC |
| 13-79 | Software | Medical device software -<br>Software life cycle processes | 62304:2015-06 | AAMI<br>ANSI<br>IEC |

#### Traditional Premarket Notification 510(k)

Siemens MR Systems: MAGNETOM Vida, MAGNETOM Lumina and MAGNETOM Vida Fit (3T) with new Software synqo MR XA20A

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October 9, 2019

| 12-232 | Radiology | Acoustic Noise Measurement<br>Procedure for Diagnosing<br>Magnetic Resonance Imaging<br>Devices | MS 4:2010 | NEMA |
|--------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------|---------------------|
| 12-288 | Radiology | Characterization of Phased<br>Array Coils for Diagnostic<br>Magnetic Resonance Images<br>(MRI) | MS 9:2008 | NEMA |
| 12-300 | Radiology | Digital Imaging and<br>Communications in Medicine<br>(DICOM) Set 03/16/2012<br>Radiology | PS 3.1 - 3.20:2016 | NEMA |
| 2-220 | Biocompatibility | Biological evaluation of medical<br>devices - Part 1: evaluation and<br>testing within a risk<br>management process<br>(Biocompatibility) | 10993-1:2009 | AAMI<br>ANSI<br>ISO |

# 12. Conclusion as to Substantial Equivalence

MAGNETOM Vida, MAGNETOM Lumina and MAGNETOM Vida Fit with software syngo MR XA20A have the same intended use and same basic technological characteristics than the predicate device system, MAGNETOM Vida with syngo MR XA11B. While there are some differences in technological characteristics/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 Vida, MAGNETOM Lumina and MAGNETOM Vida Fit with software syngo MR XA20A are substantially equivalent to the currently marketed predicate device MAGNETOM Vida with software syngo MR XA11B (K183254, cleared on January 18, 2019).

#### Traditional Premarket Notification 510(k)

MR XA20A