Magnetom Vida

K183254 · Siemens Medical Solutions USA, Inc. · LNH · Jan 18, 2019 · Radiology

Device Facts

• Record ID: K183254
• Device Name: Magnetom Vida
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jan 18, 2019
• 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 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.

Device Story

MAGNETOM Vida is an MRI system utilizing magnetic resonance to generate cross-sectional images and spectra of human anatomy. The system processes RF signals and magnetic field gradients to reconstruct images. New features include: nose marker-based inline motion correction for 3D head scans; GOLiver optimized pulse sequences for abdominal/liver imaging; TSE_MDME for multi-contrast acquisition; SEMAC for metal artifact reduction in orthopedic imaging; Compressed Sensing (CS) for accelerated TOF MRA and SPACE sequences; Simultaneous Multi-Slice (SMS) for RESOLVE and QDWI; and respiratory self-gating for abdominal/thoracic imaging. Operated by healthcare professionals in clinical settings. Output consists of diagnostic images/spectra interpreted by physicians to assist in clinical diagnosis and interventional guidance. Benefits include reduced scan times, improved image quality via motion/artifact correction, and consistent exam throughput.

Clinical Evidence

No clinical tests conducted. Evidence consists of bench testing, software verification/validation, and sample clinical images to demonstrate performance of new/modified features. Compliance with IEC 62304, IEC 60601-2-33, and NEMA standards confirmed.

Technological Characteristics

Magnetic resonance diagnostic device. Hardware includes nose marker for motion tracking. Software features: Compressed Sensing, Simultaneous Multi-Slice (SMS), and various pulse sequences (TSE_MDME, SEMAC, VIBE). Connectivity via DICOM. Conforms to IEC 60601-1, IEC 60601-2-33, ISO 14971, and IEC 62304 standards.

Indications for Use

Indicated for patients requiring diagnostic MR imaging of the head, body, or extremities to visualize internal structure and function. Used for diagnostic imaging and interventional procedures. No specific age or gender restrictions; contraindications include presence of non-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 XA11A (K181433)

Reference Devices

• Biograph mMR with syngo MR E11P (K163234)
• syngo.via VB30A2 (based on syngo.via VB10A, K150843)

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. % Cordell L. Fields, Esq. Regulatory Affairs Specialist 40 Liberty Boulevard, Mailcode 65-1A MALVERN PA 19355

January 18, 2019

#### Re: K183254

Trade/Device Name: MAGNETOM Vida Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI and MOS Dated: November 19, 2018 Received: November 21, 2018

Dear Mr. Fields:

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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form |
|-----------------------------------------|------------|
| Food and Drug Administration | Expiration |
| Indications for Use | See P |

Approved: OMB No. 0910-0120 tion Date: 06/30/2020 RA Statement below.

510(k) Number (if known)

#### K183254

Device Name

MAGNETOM Vida

Indications for Use (Describe)

Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectroscopic 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 yicld 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.

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.

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FORM FDA 3881 (7/17)

Page 1 of 1

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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 Boulevard |
| | Mail Code 65-1A |
| | Malvern, PA 19355, USA |
| | Registration Number: 2240869 |

- Date Prepared November 19, 2018
- Manufacturer Siemens Healthcare GmbH Henkestrasse 127 Erlangen, Bayern, Germany 91052 Registration Number: 3002808157

# 2. Contact Information

Cordell L. Fields, Esq. Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, USA Phone: [phone] Fax: [phone] E-mail: [e-mail]

# 3. Device Name and Classification

| Device Name: | MAGNETOM Vida |
|-----------------------|---------------------------------------------|
| Trade Name: | MAGNETOM Vida |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | Class II |
| Product Code: | Primary: LNH, Secondary: LNI, MOS |

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### 4. Legally Marketed Predicate Device

| Trade Name: | MAGNETOM Vida |
|-----------------------|--------------------------------------------|
| 510(k) Number: | K181433, cleared October 19, 2018 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | Class II |
| Product Code: | Primary: LNH, Secondary: LNI, MOS |

## 5. Intended Use

The indications for use for the subject device 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

MAGNETOM Vida with software syngo MR XA11B includes new and modified component, features and software compared to the predicate device, MAGNETOM Vida with syngo MR XA11A. A high level summary of the new and modified features is provided below:

### Hardware

New Hardware

- Nose Marker for Inline Motion Correction
### Software

New Features and Applications

- TFL with Inline Motion Correction: Tracking of motion of the head during 3D MPRAGE head scans with a nose marker and a camera system. The MR system uses the tracking information to compensate for the detected motion.

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# SIEMENS

- i GOLiver: 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.
- 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.
- SEMAC: SEMAC is a method for metal artifact correction in ortho imaging of patients i with whole joint replacement. Using Compressed Sensing the acquisition can be accelerated.
- Angio TOF with Compressed Sensing: The Compressed Sensing (CS) functionality is now available for TOF MRA within the BEAT pulse sequence type. 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.
- SMS for RESOLVE and QDWI: Simultaneous excitation and acquisition of multiple i slices with the Simultaneous multi-slice (SMS) technique for readout-segmented echo planar imaging (RESOLVE) and quiet diffusion weighted imaging (QDWI).
- i SPACE with Compressed Sensing: 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.
- RT Respiratory self-gating for FL3D_VIBE: Non-contrast abdominal and thoracic i examination in free breathing with reduced blur induced by respiratory motion.

# Other Modifications and / or Minor Changes

- i Turbo Suite is a marketing bundle of components for accelerated MR imaging offered for the MAGNETOM Vida MR systems.
- i Noise masking: a mechanism to remove the noise floor in outer regions is now available for RESOLVE and QDWI.

# 7. Technological Characteristics

The subject device, MAGNETOM Vida with software syngo MR XA11B, is substantially equivalent to the predicate device with regard to the operational environment, programming language, operating system, and performance.

MAGNETOM Vida with software syngo MR XA11B conforms to the standard for medical device software (IEC 62304:2006) and other relevant IEC and NEMA standards.

While there are some differences in technological characteristics between the subject device and predicate device, including new and modified software applications and

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hardware additions, 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.

# 8. Nonclinical Tests

The following performance testing was conducted on the subject device:

- Sample clinical images were taken for the new and modified software features.
- Image quality assessments of all new/modified pulse sequence types and algorithms were completed. In some cases a comparison of the image quality was made between the new/modified features and the predicate device features.
- Software verification and validation testing was completed in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", dated May 11, 2005.
- । Performance tests were completed in accordance with the FDA quidance document. "Submission of Premarket Notifications for Maqnetic Resonance Diagnostic Devices" dated November 18, 2016.

The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.

# 9. Clinical Tests

No clinical tests were conducted to support substantial equivalence for the subject device; however, sample clinical images were provided to support the new/modified component and software features per the FDA quidance document "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices", dated November 18, 2016. Clinical publications were referenced to provide information on the use of some features and functions.

# 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 ISO 14971:2007 compliance to identify and provide mitigation of potential hazards in a risk analysis early in the design phase and continuously throughout the development of the product. These risks are controlled via measures realized in hardware and software development, testing, and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards, such as the IEC 60601-1 series, to minimize electrical and mechanical risks. Furthermore, the device is intended for healthcare professionals

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# SIEMENS

familiar with and responsible for the acquisition and post processing of magnetic resonance images.

MAGNETOM Vida with software syngo MR XA11B conforms to the following FDA recognized and international IEC, ISO and NEMA standards:

| Recognition<br>Number | Product<br>Area | Title of Standard | Reference Number<br>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 Edition<br>4.0:2014-02 | IEC |
| 12-295 | Radiology | Medical electrical equipment -<br>Part 2-33: Particular<br>requirements for the basic safety<br>and essential performance of<br>magnetic resonance equipment<br>for 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 Second<br>edition 2007-10 | ISO |
| 5-96 | General | Medical devices - Application of<br>usability engineering to medical<br>devices | 62366 Edition 1.0<br>2015 | AAMI<br>ANSI<br>IEC |
| 13-32 | Software | Medical device software -<br>Software life cycle processes | 62304:2006 | AAMI<br>ANSI<br>IEC |
| 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<br>(2016) | NEMA |
| Recognition<br>Number | Product<br>Area | Title of Standard | Reference Number<br>and date | Standards<br>Development<br>Organization |
| 2-156 | Biocompati<br>bility | biological evaluation of medical<br>devices - part 1: evaluation and<br>testing within a risk management<br>process. (Biocompatibility) | 10993-1:2009/(R)<br>2013 | AAMI<br>ANSI<br>ISO |

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### 11. Substantial Equivalence

MAGNETOM Vida with software syngo MR XA11B is substantially equivalent to the following predicate device:

| Predicate Device | FDA Clearance<br>Number and Date | Product code | Manufacturer |
|--------------------------------------|-----------------------------------------|----------------|----------------------------|
| MAGNETOM Vida with syngo MR<br>XA11A | K181433,<br>cleared October<br>19, 2018 | LNH<br>LNI,MOS | Siemens Healthcare<br>GmbH |

MAGNETOM Vida with syngo MR XA11B includes features already cleared on the following reference devices:

| Reference Devices | FDA Clearance<br>Number and Date | Product<br>code | Manufacturer |
|----------------------------------------------|-----------------------------------------------------------|-------------------------|----------------------------|
| Biograph mMR with syngo MR<br>E11P | K163234,<br>cleared February<br>28, 2017 | OUO<br>LNH, LNI,<br>KPS | Siemens Healthcare<br>GmbH |
| syngo.via VB30A2<br>based on syngo.via VB10A | syngo.via VB10A:<br>K150843,<br>cleared April 24,<br>2015 | LLZ | Siemens Healthcare<br>GmbH |

# 12. Conclusion as to Substantial Equivalence

MAGNETOM Vida with software syngo MR XA11B has the same intended use and same basic technological characteristics than the predicate device system, MAGNETOM Vida with syngo MR XA11A, with respect to the magnetic resonance features and functionalities. While there are some differences in technical features

വ Change released by internal documentation based on syngo.via VB10 (K150843).

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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 with software syngo MR XA11B is substantially equivalent to the currently marketed device MAGNETOM Vida with software syngo MR XA11A (K181433, cleared on October 19, 2018).