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.

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.
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.

AI/ML Overview

The provided FDA 510(k) summary for the MAGNETOM Vida (K183254) does not contain the specific details for acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-based medical devices or devices with new diagnostic functionalities.

This 510(k) is for an updated version of an existing MRI system (MAGNETOM Vida with software syngo MR XA11B) compared to its predicate (MAGNETOM Vida with syngo MR XA11A). The changes primarily involve new hardware (1 mention) and several new or modified software features for image acquisition and processing (e.g., motion correction, optimized pulse sequences, metal artifact correction, accelerated imaging techniques).

The document states: "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 guidance document 'Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices', dated November 18, 2016."

This indicates that the primary focus of the submission was on demonstrating that the new features maintain the safety and performance profile of the predicate device through non-clinical testing (image quality assessments, software verification/validation) and by providing sample clinical images (not a formal clinical study with acceptance criteria).

Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text because such a detailed study with acceptance criteria, ground truth, expert readers, and effect sizes was not performed or described in this 510(k) submission for this specific device clearance.

Below, I will indicate which information is not present in the document and briefly explain why, based on the nature of this 510(k) (which is for an updated MRI system, not an AI/ML diagnostic algorithm).

Acceptance Criteria and Study for MAGNETOM Vida (K183254)

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
NOT PRESENT. This 510(k) does not define specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for its new features. The submission focuses on demonstrating through non-clinical testing that the new features maintain an equivalent safety and performance profile to the predicate device.	NOT PRESENT. No specific performance metrics against clinical acceptance criteria are reported. The document states "The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device." This refers to non-clinical tests (image quality assessments, software verification/validation).

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: NOT PRESENT. The document mentions "sample clinical images were provided," but it does not specify the number of images or patients used for these samples, nor does it describe a formal "test set" in the context of a diagnostic performance study.
Data Provenance (country of origin, retrospective/prospective): NOT PRESENT. The origin of the "sample clinical images" is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

NOT APPLICABLE/NOT PRESENT. Since no formal clinical study with a defined "test set" and "acceptance criteria" was described for diagnostic performance, there's no mention of experts establishing ground truth for such a study. The product is an MRI system, and interpretations are made by "trained physicians."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

NOT APPLICABLE/NOT PRESENT. No formal adjudication method is described, as no specific clinical diagnostic performance test set requiring such expert consensus was presented in this 510(k).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

NO. An MRMC study was not conducted or described for this submission. This device is an MRI scanner with new and modified acquisition and processing features, not an AI-assisted diagnostic tool that directly aids human readers to improve diagnostic accuracy.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

NO. This is an MRI system. Its "performance" is inherently tied to image acquisition and quality, which are then interpreted by a human. It does not perform a standalone diagnostic function like an AI algorithm for disease detection.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

NOT APPLICABLE/NOT PRESENT. No formal ground truth definition is provided for a clinical performance study since one was not conducted for the purpose of demonstrating substantial equivalence. The device's performance was evaluated through non-clinical tests (e.g., image quality assessments).

8. The sample size for the training set:

NOT APPLICABLE/NOT PRESENT. The document describes software modifications including some advanced imaging techniques (e.g., Compressed Sensing). While these might involve optimization based on data, the submission does not describe a traditional "training set" in the context of an AI/ML algorithm development or a diagnostic study. The software development and testing follow IEC 62304 and other relevant standards.

9. How the ground truth for the training set was established:

NOT APPLICABLE/NOT PRESENT. As no "training set" in the context of diagnostic AI/ML was described, no information on its ground truth establishment is provided.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a bright teal. The letters are evenly spaced and the word is horizontally oriented. The image appears to be a logo or branding element for the company Siemens.

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 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."

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: (610) 448-6469 Fax: (610) 640-4481 E-mail: cordell.fields@siemens-healthineers.com

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

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:

RecognitionNumber	ProductArea	Title of Standard	Reference Numberand date	StandardsDevelopmentOrganization
19-4	General	Medical electrical equipment -part 1: general requirements forbasic safety and essentialperformance	ES60601-1:2005/(R) 2012and A1:2012	AAMI / ANSI
19-8	General	Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances - Requirementsand tests	60601-1-2 Edition4.0:2014-02	IEC
12-295	Radiology	Medical electrical equipment -Part 2-33: Particularrequirements for the basic safetyand essential performance ofmagnetic resonance equipmentfor medical diagnosis	60601-2-33 Ed.3.2:2015	IEC
5-40	General	Medical devices - Application ofrisk management to medicaldevices	14971 Secondedition 2007-10	ISO
5-96	General	Medical devices - Application ofusability engineering to medicaldevices	62366 Edition 1.02015	AAMIANSIIEC
13-32	Software	Medical device software -Software life cycle processes	62304:2006	AAMIANSIIEC
12-232	Radiology	Acoustic Noise MeasurementProcedure for DiagnosingMagnetic Resonance ImagingDevices	MS 4-2010	NEMA
12-288	Radiology	Characterization of PhasedArray Coils for DiagnosticMagnetic Resonance Images(MRI)	MS 9-2008	NEMA
12-300	Radiology	Digital Imaging andCommunications in Medicine(DICOM) Set 03/16/2012Radiology	PS 3.1 - 3.20(2016)	NEMA
RecognitionNumber	ProductArea	Title of Standard	Reference Numberand date	StandardsDevelopmentOrganization
2-156	Biocompatibility	biological evaluation of medicaldevices - part 1: evaluation andtesting within a risk managementprocess. (Biocompatibility)	10993-1:2009/(R)2013	AAMIANSIISO

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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 ClearanceNumber and Date	Product code	Manufacturer
MAGNETOM Vida with syngo MRXA11A	K181433,cleared October19, 2018	LNHLNI,MOS	Siemens HealthcareGmbH

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

Reference Devices	FDA ClearanceNumber and Date	Productcode	Manufacturer
Biograph mMR with syngo MRE11P	K163234,cleared February28, 2017	OUOLNH, LNI,KPS	Siemens HealthcareGmbH
syngo.via VB30A2based on syngo.via VB10A	syngo.via VB10A:K150843,cleared April 24,2015	LLZ	Siemens HealthcareGmbH

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).

Regulation Number and Section

§ 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.