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 inages 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.

Device Description

MAGNETOM Skyra Fit with software syngo MR XA50A includes new and modified hardware and software compared to the predicate device, MAGNETOM Vida with software syngo MR XA31A. A high level summary of the new and modified hardware and software is provided below:

Hardware
Modified Hardware

Cover: The cover has been modified to bring the system up to the Siemens Healthineers Design incl. all BioMatrix components and interfaces.
EPC (Electronic Cabinet and Measurement Control / Electronic Power Cabinet): upgrade of components to upgrade the EPC to the newest electronic cabinet series

Software
New Features and Applications

TSE MoCo: TSE MoCo is an image-based motion correction in the averagedimension for the TSE pulse sequence type.
Automatic fiducial detection: MR Breast Biopsy is improved with an automatic fiducial detection.

Modified Features and Applications

Fast GRE RefScan: A speed-optimized reference scan for GRAPPA and SMS kernel calibration for echo planar imaging pulse sequence types.
Other Modifications and / or Minor Changes
The MAGNETOM Skyra Fit is a new MRI System which is the result of an upgrade from a MAGNETOM Verio.

AI/ML Overview

The provided document is a 510(k) summary for the MAGNETOM Skyra Fit device, which is a Magnetic Resonance Diagnostic Device (MRDD). This document primarily focuses on establishing substantial equivalence to a predicate device (MAGNETOM Vida) and does not detail a clinical study with acceptance criteria, human reader performance, or training/test set specifics for an AI algorithm.

The document states:

"No additional clinical tests were conducted to support substantial equivalence for the subject device; however, as stated above, sample clinical images were provided. No clinical publications were referenced." (Page 6, Section 10. Clinical Tests / Publications)
The performance tests conducted were "Sample clinical images" and "Image quality assessments by sample clinical images." (Page 6, Section 9. Nonclinical Tests)

Therefore, based on the provided text, a detailed answer to your request, particularly concerning acceptance criteria for an AI device, human reader studies, and AI training/test set specifics, cannot be fully provided directly from this document. This document describes a new MR system, not an AI software.

However, I can extract the information that is present and explain where the requested information is not available:

A table of acceptance criteria and the reported device performance
- Not explicitly provided in terms of numerical acceptance criteria for a clinical study comparing performance against a predicate. The document states: "The results from each set of tests demonstrate that the subject device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared." (Page 6, Section 9. Nonclinical Tests). The performance assessment appears to be qualitative based on "sample clinical images" and "image quality assessments."
- Device Performance (as described): "The subject device performs as intended and is thus substantially equivalent to the predicate device." (Page 6)
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not provided. The document mentions "sample clinical images" but does not specify the sample size, data provenance, or whether they were retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not provided. The document refers to images interpreted by a "trained physician" for diagnosis (Page 5, Section 5. Intended Use), but this is a general statement about the use of an MRDD, not specific to establishing ground truth for a test set in the context of a new feature evaluation or AI study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not provided.
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 study was done. The document explicitly states, "No additional clinical tests were conducted to support substantial equivalence for the subject device..." (Page 6).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not done for an AI algorithm. This document is for an MR imaging system, not an AI diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated/not applicable in the context of an AI study. The "sample clinical images" were likely evaluated for image quality and equivalence to the predicate, rather than for diagnostic ground truth for an AI algorithm.
The sample size for the training set
- Not applicable/Not provided. This is not a submission for an AI algorithm that would require a distinct training set.
How the ground truth for the training set was established
- Not applicable/Not provided.

Summary based on the provided document:

This 510(k) submission for the MAGNETOM Skyra Fit MRI system focuses on demonstrating substantial equivalence to a previously cleared predicate device (MAGNETOM Vida) by showing that new and modified hardware and software features maintain equivalent safety and performance. This is typically achieved through non-clinical performance testing, including image quality assessments, software verification and validation, and electrical/mechanical safety tests, rather than multi-reader clinical studies or AI algorithm performance evaluations.

The "sample clinical images" mentioned are likely used to qualitatively demonstrate that the new system's output images are comparable in quality to those of the predicate device, thereby supporting the claim of substantial equivalence for diagnosis when interpreted by a trained physician. The document explicitly states that no additional clinical tests were conducted, meaning there were no new studies involving human readers or comparative effectiveness with or without AI assistance.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Medical Solutions USA, Inc. % Martin Rajchel Senior Regulatory Affairs Manager 40 Liberty Boulevard, Mail Code 65-1A MALVERN PA 19355

Re: K220589

Trade/Device Name: MAGNETOM Skyra Fit Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: February 25, 2022 Received: March 1, 2022

Dear Martin Rajchel:

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Thalia T. Mills, Ph.D. Director DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K220589

Device Name MAGNETOM Skyra 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 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 inages 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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/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 words is a graphic of orange dots arranged in a circular pattern.

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
	Malvern, PA 19355, USA
Registration Number:	2240869

Date Prepared: May 3, 2022
Manufacturer: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany Registration Number: 3002808157

2. Contact Information

Martin Rajchel Sr. Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Phone: +1 484-473-4209 Fax: (610) 448-1787 E-mail: martin.rajchel@siemens-healthineers.com

Device Name and Classification 3.

Device/ Trade name:	MAGNETOM Skyra Fit
Classification Name:	Magnetic Resonance Diagnostic Device (MRDD)
Classification Panel:	Radiology
CFR Code:	21 CFR § 892.1000
Classification:	II
Product Code:	Primary: LNHSecondary: LNI. MOS

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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.

4. Legally Marketed Predicate Device

Trade name:	MAGNETOM Vida
510(k) Number:	K203443
Clearance Date:	March 31, 2021
Classification Name:	Magnetic Resonance Diagnostic Device (MRDD)
Classification Panel:	Radiology
CFR Code:	21 CFR § 892.1000
Classification:	II
Product Code:	Primary: LNHSecondary: 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 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.

6. Device Description

Hardware

Modified Hardware

Cover: The cover has been modified to bring the system up to the Siemens Healthineers Design incl. all BioMatrix components and interfaces.
EPC (Electronic Cabinet and Measurement Control / Electronic Power Cabinet): upgrade of components to upgrade the EPC to the newest electronic cabinet series

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Software

New Features and Applications

TSE MoCo: TSE MoCo is an image-based motion correction in the averagedimension for the TSE pulse sequence type.
Automatic fiducial detection: MR Breast Biopsy is improved with an automatic fiducial detection.

Modified Features and Applications

Fast GRE RefScan: A speed-optimized reference scan for GRAPPA and SMS kernel calibration for echo planar imaging pulse sequence types.
Other Modifications and / or Minor Changes
The MAGNETOM Skyra Fit is a new MRI System which is the result of an upgrade from a MAGNETOM Verio.

7. Substantial Equivalence

MAGNETOM Skyra Fit with software synqo MR XA50A is substantially equivalent to the following predicate device:

Predicate Device	FDA Clearance Numberand Date	ProductCode	Manufacturer
MAGNETOM Vida withsyngo MR XA31A	K203443,cleared March 31, 2021	LNHLNI, MOS	Siemens Healthcare GmbH

MAGNETOM Skyra Fit with software syngo MR XA50A includes hardware and software already cleared on the following reference devices:

Reference Devices	FDA Clearance Numberand Date	ProductCode	Manufacturer
MAGNETOM Verio withsoftware syngo MR E11D	K181613,cleared November 6, 2018	LNHLNI, MOS	Siemens HealthcareGmbH
MAGNETOM Skyrafit withsoftware syngo MR E11C-AP04	K173592,cleared February 13, 2018	LNHLNI, MOS	Siemens HealthcareGmbH

8. Comparison of technological Characteristics with the Predicate Device

The subject device, MAGNETOM Skyra Fit with software syngo MR XA50A, is substantially equivalent to the predicate device with reqard to the operational environment, programming language, operating system and performance.

The subject device conforms 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 device and predicate device, including new and modified hardware and software, these differences have been tested and the conclusions from the non

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clinical 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 device.

Performance Test	Tested Hardware or Software	Source/Rationale for test
Sample clinical images	coils, new and modifiedsoftware features	Guidance for Submission ofPremarket Notifications forMagnetic ResonanceDiagnostic Devices
Image quality assessments bysample clinical images. Insome cases a comparison ofthe image quality / quantitativedata was made.	- new / modified pulsesequence types.- comparison images betweenthe new / modified featuresand the predicate devicefeatures
Performance bench testSoftware verification andvalidation	new and modified hardwarenew and modified softwarefeatures	Guidance for the Content ofPremarket Submissions forSoftware Contained in MedicalDevices
Electrical, mechanical,structural, and related systemsafety test	complete system	- AAMI / ANSI ES60601-1- IEC 60601-2-33

The results from each set of tests demonstrate that the subject device performs as intended and is thus 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 device; however, as stated above, sample clinical images were provided. No clinical publications were referenced.

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

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

MAGNETOM Skyra Fit with software syngo MR XA50A conforms to the following FDA recognized and international IEC, ISO and NEMA standards:

RecognitionNumber	ProductArea	Title of Standard	ReferenceNumber and date	StandardsDevelopmentOrganization
19-4	General II(ES/EMC)	Medical electrical equipment -Part 1: General requirements forbasic safety and essentialperformance (IEC 60601-1:2005, MOD)	ES60601-1:2005/(R)2012and A1:2012,C1:2009/(R)2012andA2:2010/(R)2012(Consolidated Text)	ANSI AAMI
12-295	Radiology	Medical electrical equipment -Part 2-33: Particularrequirements for the basicsafety and essentialperformance of magneticresonance equipment formedical diagnosis	60601-2-33 Ed. 3.2b:2015	IEC
5-40	General I(QS/RM)	Medical devices - Application ofrisk management to medicaldevices	14971 Secondedition 2007-03-01	ISO
5-114	General I(QS/RM)	Medical devices - Part 1:Application of usabilityengineering to medical devices[Including CORRIGENDUM 1(2016)]	62366-1 Edition 1.02015-02	IEC
13-79	Software/Informatics	Medical device software -Software life cycle processes	62304 Edition 1.12015-06CONSOLIDATEDVERSION	IEC
12-232	Radiology	Acoustic Noise MeasurementProcedure for DiagnosingMagnetic Resonance ImagingDevices	MS 4:2010	NEMA
12-300	Radiology	Digital Imaging andCommunications in Medicine(DICOM) Set	PS 3.1 - 3.20:2016	NEMA

12. Conclusion as to Substantial Equivalence

MAGNETOM Skyra Fit with software syngo MR XA50A has the same intended use and same basic technological characteristics than the predicate device system, MAGNETOM Vida with syngo MR XA31A, with respect to the magnetic resonance features and functionalities. While there are some differences in

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Image /page/8/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 words is a graphic of orange dots arranged in a circular pattern.

technical 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 Skyra Fit with software syngo MR XA50A is substantially equivalent to the currently marketed device MAGNETOM Vida with software syngo MR XA31A (K203443, cleared on March 31, 2021).

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.