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

Compressed Sensing GRASP-VIBE is intended to be used in dynamic and/or non-contrast liver examinations to support patients who cannot reliably hold their breath for a conventional breath-hold measurement.

Device Description

The subject device, MAGNETOM Vida, is an MR system. The software syngo MR XA10A is the latest software for the Siemens MAGNETOM Vida and includes software sequences, applications, coils and other hardware for the MAGNETOM scanner. The software sequences, applications, coils and other hardware were previously cleared with K170396.

MAGNETOM Vida will be offered ex-factory (new production) with software syngo MR XA10A and Compressed Sensing GRASP-VIBE. Installed MAGNETOM Vida systems can be updated by activating the blocked license.

This filing describes the new imaging feature intended to be used with the MAGNETOM Vida. Compressed Sensing GRASP-VIBE is intended to be used in dynamic and/or non-contrast liver examinations to support patients who cannot reliably hold their breath for a conventional breath-hold measurement.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Siemens MAGNETOM Vida with Compressed Sensing GRASP-VIBE. The document asserts substantial equivalence to a predicate device and does not detail specific acceptance criteria or a comprehensive study proving the device meets them in the way clinical trials typically do. Instead, it relies on demonstrating that the new feature does not introduce new safety or effectiveness concerns.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not explicitly addressed or applicable in the context of this 510(k) submission, which focuses on device modifications and substantial equivalence to an already cleared predicate.

However, based on the limited information available, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of quantitative acceptance criteria for image quality or clinical performance that would typically be found in a clinical study report. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device through non-clinical testing and qualitative assessment of sample clinical images.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Functional Equivalence to Predicate	Functionality compared to reference device feature by detailed simulations with a numerical phantom showed equivalence.
Safety Profile Equivalent to Predicate	Risk management via ISO 14971:2007; adheres to recognized industry practices and standards (IEC 60601-1 series, IEC, ISO, NEMA standards) to minimize risks. No new issues of safety or effectiveness identified.
Performance Profile Equivalent to Predicate	Conclusions from verification and validation data suggest an equivalent performance profile to the predicate device. Device performs as intended.
Intended Use Adherence	Compressed Sensing GRASP-VIBE supports patients who cannot reliably hold their breath for conventional breath-hold measurements, as intended.
Compliance with Standards	Conforms to IEC 62304:2006, IEC, ISO and NEMA standards.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not explicitly stated for a dedicated clinical "test set." The document mentions "sample clinical images" were included in the determination of substantial equivalence, but not the number of images or patients.
Data Provenance: Not specified. Given it's a Siemens product, it's likely international data, but no country of origin is mentioned. The type of data (retrospective or prospective) is also not specified for these "sample clinical images."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided. The document states that the images and physical parameters, "when interpreted by a trained physician yield information that may assist in diagnosis." For the "sample clinical images" used, it does not specify how many experts reviewed them nor their qualifications or the process of establishing ground truth.

4. Adjudication Method for the Test Set

Not specified. This level of detail is typically not included in a 510(k) summary focused on substantial equivalence through non-clinical data and general claims.

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 MRMC comparative effectiveness study is mentioned. This submission focuses on the performance of the device itself (specifically the new imaging feature) in relation to a predicate device, not on comparing human reader performance with or without the device's assistance.

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

The document implies a standalone assessment of the new imaging feature's technical performance. It states: "A comparison of the functionality was performed between the new feature and the reference device feature by detailed simulations with a numerical phantom." This indicates an algorithm-only evaluation for technical characteristics, though not a clinical standalone performance study in the sense of diagnostic accuracy.

7. The Type of Ground Truth Used

For the "detailed simulations with a numerical phantom," the ground truth would be the known properties of the numerical phantom.
For the "sample clinical images," the type of ground truth is not explicitly stated. However, medical image interpretation typically relies on expert consensus, clinical follow-up, or pathology reports for ground truth in diagnostic accuracy studies. This document only mentions "interpretation by a trained physician" assisting in diagnosis, without specifying how ground truth was established for comparison.

8. The Sample Size for the Training Set

Not applicable/mentioned. This is a 510(k) submission for an MRI system and its software feature, not a machine learning algorithm that underwent a separate training phase with a distinct training set. The "Compressed Sensing GRASP-VIBE" is a technical imaging feature, not an AI diagnostic algorithm in the typical sense that would require a ground-truthed training set for learning.

9. How the Ground Truth for the Training Set was Established

Not applicable/mentioned, as there is no indication of a "training set" in the context of an AI algorithm learning from data.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA acronym and the agency's name are in blue.

Siemens Medical Solutions USA, Inc. Cordell Fields Regulatory Specialist 65 Valley Stream Parkway Mailcode 65-1A Malvern, Pennsylvania 19533

March 30, 2018

Re: K173617

Trade/Device Name: MAGNETOM Vida with Compressed Sensing GRASP-VIBE Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: March 6, 2018 Received: March 7, 2018

Dear Cordell 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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. O'Hara For

Robert A. 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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Indications for Use

510(k) Number (if known) K173617

Device Name

MAGNETOM Vida with Compressed Sensing GRASP-VIBE

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)	□

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Section 5 510(k) Summary

This 510(k) summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.

5.1 General Information

Establishment	Siemens Medical Solutions USA, Inc.40 Liberty BoulevardMail Code 65-1AMalvern, PA 19355, USARegistration Number: 2240869
Date Prepared	November 21, 2017
Manufacturer	Siemens Healthcare GmbHHenkestrasse 127Erlangen, Bayern, Germany 91052Registration Number: 3002808157
Contact Person	Cordell L. Fields, EsqRegulatory Affairs Technical SpecialistSiemens Medical Solutions USA, Inc.
Device Name	MAGNETOM Vida with Compressed Sensing GRASP-VIBE
Trade Name	MAGNETOM Vida with Compressed Sensing GRASP-VIBE
Classification Name:Classification Panel:CFR Code:Classification:Product Code:	Magnetic Resonance Diagnostic Device (MRDD)Radiology21 CFR § 892.1000Class IIPrimary: LNH, Secondary: LNI, MOS

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Information Supporting Substantial 5.2 Equivalence

DEVICE DESCRIPTION

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 vield 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.

Compressed Sensing GRASP-VIBE is intended to be used in dynamic and/or noncontrast liver examinations to support patients who cannot reliably hold their breath for a conventional breath-hold measurement.

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SIEMEN

Technological Characteristics

The MR system MAGNETOM Vida with Compressed Sensing GRASP-VIBE has one different technological characteristic (Compressed Sensing GRASP-VIBE) compared to the predicate device MAGNETOM Vida (K170396; cleared June 14, 2017). While there is a feature that varies with respect to the predicate device MR System, the conclusions from all verification and validation data suggest that the feature bears an equivalent safety and performance profile as that of the predicate device and the reference devices.

The subject device is substantially equivalent to the predicate device with regard to the software, hardware, operational environment, programming language, operating system and performance.

MAGNETOM Vida conforms to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.

NONCLINICAL TESTS

The following performance testing was conducted on the subject device:

-A comparison of the functionality was performed between the new feature and the reference device feature by detailed simulations with a numerical phantom.
-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"
-Performance tests were completed in accordance with the FDA guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" dated November 18, 2016
No testing in accordance with the applicable Performance Standards (NEMA) is needed due to the nature of the new imaging feature (software change only).

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.

CLINICAL TESTS

Sample clinical images, rather than a clinical study, were included in the determination of substantial equivalence.

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SUBSTANTIAL EQUIVALENCE

The MAGNETOM Vida with software syngo MR XA10A including the new imaging feature Compressed Sensing GRASP-VIBE is substantially equivalent to the following predicate device, described in Table 1.

Predicate and reference devices for MAGNETOM Vida with software Table 1: syngo MR XA10A including Compressed Sensing GRASP-VIBE

Predicate Device	FDAClearanceNumber	FDAClearanceDate	MainProductCode
Software syngo MR XA10A for theMR System MAGNETOM Vida	K170396	June 14, 2017	LNH, LNI,MOS
Reference Devices	FDAClearanceNumber	FDAClearanceDate	MainProductCode
syngo MR E11A forMAGNETOM Skyra	K141977	November19, 2014	LNHLNI, MOS
syngo MR D13C forMAGNETOM Skyra	K123510	May 17, 2013	LNH

The subject device, MAGNETOM Vida, has been modified to include the new imaging feature, Compressed Sensing GRASP-VIBE. No other software modifications have been made, and there are no hardware changes.

SAFETY AND EFFECTIVENESS

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.

Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 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 risk. Furthermore, the operators are healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.

MAGNETOM Vida with software syngo MR XA10A conforms to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document as stated in the following table.

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SIEM

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
19-1	General	Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility - Requirements andtests	60601-1-2 Edition3:2007-03	IEC
12-271	Radiology	Medical electrical equipment -Part 2-33: Particularrequirements for the basic safetyand essential performance ofmagnetic resonance equipmentfor medical diagnosis	60601-2-33 Ed.3.1:2013	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
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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SUBSTANTIAL EQUIVALENCE CONCLUSION

The MR system MAGNETOM Vida with software syngo MR XA10A with the new imaging feature Compressed Sensing GRASP-VIBE has the same intended use and one different technological characteristic compared to the predicate device system, MAGNETOM Vida with syngo MR XA10A, with respect to the magnetic resonance features and functionalities. While there is a feature that varies with respect to the predicate device MR System, the conclusions from all verification and validation data suggest that the feature bears an equivalent safety and performance profile as that of the predicate device and the reference devices. The new imaging feature offers the user additional possibilities to perform examinations. The modification aims to improve the user's workflow and reduces the complexity of the imaging procedure.

In summary, MAGNETOM Vida has the same functionalities as the predicate device and, based on the aforementioned information, does not introduce any new issues of safety or effectiveness. Therefore, Siemens is of the opinion that MAGNETOM Vida with software syngo MR XA10A with Compressed Sensing GRASP-VIBE does not raise new questions of safety or effectiveness and is substantially equivalent to the currently marketed device MAGNETOM Vida with software syngo MR XA10A (K170396 cleared on June 14, 2017).

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.