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 MR system may also be used for imaging during interventional procedures with MR compatible devices such as in-room displays and MR Safe biopsy needles.

Device Description

The subject device, MAGNETOM Avanto® with software syngo MR E11E. is a modification of the previously cleared predicate device, MAGNETOM Avanto" with software syngo MR E11C-AP04 (K173592). The software version syngo E11E for MAGNETOM Avanto™ has been modified to include the software application "Compressed Sensing (CS) Cardiac Cine." This software application was migrated unchanged from the previously cleared MAGNETOM Skyra and Aera systems with syngo MR E11C-AP02 (K163312).

AI/ML Overview

The provided document is a 510(k) summary for the Siemens MAGNETOM Avanto® with software syngo MR E11E. It details the device's substantial equivalence to a predicate device, focusing on a new software feature. However, this document does not contain the specific information required to answer your detailed questions about acceptance criteria and a study proving the device meets those criteria.

The 510(k) summary states:

No clinical tests were conducted to support the claim of substantial equivalence between the subject and predicate device (page 7).
Nonclinical performance testing was conducted, including software verification and validation, and performance testing in accordance with FDA guidance documents (page 6). However, it does not provide details of acceptance criteria for these tests or specific results in numerical form that can be presented in a table against a predefined "acceptance criteria."
The document implies that the "new" feature (Compressed Sensing (CS) Cardiac Cine) was migrated unchanged from a previously cleared device (MAGNETOM Skyra and Aera systems with syngo MR E11C-AP02 (K163312)). This suggests that the performance and safety of this feature were established in the clearance of the reference device, not necessarily re-tested as a new standalone study for this specific 510(k).

Therefore, based solely on the provided text, I cannot extract the following information:

A table of acceptance criteria and the reported device performance: This document reports that testing was done and standards were conformed to, but not the specific metrics, thresholds, or measured values.
Sample size used for the test set and the data provenance: Clinical test data with sample sizes are not present, and for nonclinical tests, specific "test sets" in the sense of patient data are not detailed.
Number of experts used to establish the ground truth and their qualifications: As no clinical study is reported, this information is not applicable to the data provided.
Adjudication method for the test set: Not applicable without a clinical study.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: The document explicitly states "No clinical tests were conducted."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: While "performance testing" was mentioned for nonclinical data, the specifics of an algorithm-only standalone study with human-level metrics are not provided.
The type of ground truth used: Not specified, as clinical data and ground truth establishment methods are not detailed.
The sample size for the training set: This is a 510(k) for a hardware/software system, not an AI/ML device that typically has a "training set" in the context of deep learning. The new feature is a "Compressed Sensing (CS) Cardiac Cine" software application, which is a signal processing technique, not necessarily a machine learning algorithm that requires a "training set" in the conventional AI sense.
How the ground truth for the training set was established: Not applicable for the reasons mentioned above.

Conclusion based on the provided document:

The 510(k) summary focuses on demonstrating substantial equivalence through:

Confirmation that the device's indications for use are the same as the predicate device.
Confirmation that the new software feature ("Compressed Sensing (CS) Cardiac Cine") was migrated unchanged from an already cleared reference device (K163312).
Compliance with recognized standards (IEC, ISO, NEMA) for safety and software development.
Software verification and validation testing, and general device performance testing, all non-clinical.

The document does not contain the details of a study with specific acceptance criteria, reported performance metrics, or clinical ground truth establishment as requested in your prompt. This type of detailed performance data is typically found in accompanying test protocols and reports, which are part of the larger 510(k) submission but not always fully summarized in the publicly available 510(k) summary.

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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".

Siemens Medical Solution USA, Inc. % Cordell L Fields, Esq. Regulatory Affairs Specialist 40 Liberty Boulevard, Mail Code 65-1A MALVERN PA 19355

Re: K190757

Trade/Device Name: MAGNETOM Avantofft Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: March 22, 2019 Received: March 25, 2019

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

May 31, 2019

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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 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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality 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.

DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: 06/30/2020
Indications for Use	See PRA Statement below.

510(k) Number (if known)

K190757 Device Name MAGNETOM Avantofit

Indications for Use (Describe)

Your MAGNETOM MR system may also be used for imaging during interventional procedures 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

PSC Publishing Services (301) 443-6740

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510(k) Summary MAGNETOM Avantofit with software syngo MR E11E

Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Establishment Registration Number: 2240869

March 22, 2019 Date Prepared

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

1. General Information

Importer/Distributor:

Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Establishment Registration Number: 2240869

Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany Establishment 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) 448-6545 Fax: (610) 448-6469 E-mail: cordell.fields@siemens-healthineers.com

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3. Device Name and Classification

Trade Name	MAGNETOM Avantofit
Classification Name:	Magnetic Resonance Diagnostic Device (MRDD)
Classification Panel:	Radiology
CFR Code:	21 CFR § 892.1000
Classification:	Class II
Product Code:	Primary: LNHSecondary: LNI, MOS

4. Legally Marketed Predicate Device

Trade Name	MAGNETOM Avantofit
------------	--------------------

510(k) Number	K173592, Cleared February 13, 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. Device Description

6. Indication for Use

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

Your MAGNETOM MR 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 MR 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.

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7. Substantial Equivalence

The MAGNETOM Avanto® with software syngo MR E11E is substantially equivalent to the following device:

Predicate Device	FDAClearanceNumber	FDAClearanceDate	ProductCode
MAGNETOM Avantofitwith Software syngo MRE11C-AP04	K173592	February 13,2018	LNH, LNI,MOS

As described above, the MAGNETOM Avanto" with software syngo MR E11E includes one new feature that is already cleared with the following reference device:

Reference Device	FDAClearanceNumber	FDAClearanceDate	ProductCode
MAGNETOM Aera withSoftware syngo MRE11C-AP02	K163312	January 27, 2017	LNH, LNI,MOS

8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device

The subject device MAGNETOM Avanto®" with software syngo MR E11E is substantially equivalent to the predicate device, MAGNETOM Avanto™ with software syngo MR E11C-AP04, with regard to the operational environment, programming language, operating system, and performance.

The subject device, MAGNETOM Avanto" with software syngo MR E11E, conforms to the IEC 62304, Edition 1.1, 2015-06, standard for software medical devices and other relevant IEC and NEMA standards.

While there is a difference in technological characteristics between the subject device and predicate device (the difference being the software application migrated from the previously cleared MAGNETOM Aera system with syngo MR E11C-AP02 (K163312)), this difference has been tested and the conclusions from the nonclinical data suqgests that the feature bear an equivalent safety and performance profile as that of the predicate device.

9. Nonclinical Performance Testing

The following performance testing was conducted on the subject device:

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.

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SIEMENS

Performance testing was completed in accordance with the FDA guidance । document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices", dated November 18, 2016
The results from each set of tests demonstrate that the device performs as intended and is therefore substantially equivalent to the predicate device to which it has been compared.

MAGNETOM Avanto™ with software syngo MR E11E conforms to the following FDA recognized and international IEC and ISO standards:

RecognitonNumber	ProductArea	Title of Standard	ReferenceNumber anddate	StandardsDevelopmentOrganization
19-4	General II(ES/EMC)	C1:2009/(R)2012 and A2:2010/(R)2012(Consolidated Text) Medical electricalequipment - Part 1: Generalrequirements for basic safety andessential performance (IEC 60601-1:2005, MOD)	ES60601-1:2005/(R)2012and A1:2012,	AAMI ANSI
19-8	General	Medical electrical equipment - Part 1-2:General requirements for basic safetyand essential performance - CollateralStandard: Electromagneticdisturbances - Requirements and tests	60601-1-2 Edition4.0 2014-02	IEC
12-295	Radiology	Medical electrical equipment - Part 2-33: Particular requirements for thebasic safety and essential performanceof magnetic resonance equipment formedical diagnostic	60601-2-33 Ed.3.2 B:2015	IEC
5-40	General I(QS/RM)	Medical devices - Application of riskmanagement to medical devices	14971 SecondEdition 2007-03-01	ISO
5-114	General	Medical devices - Application ofusability engineering to medical devices	62366-1:2015	AAMI ANSIIEC
13-32	Software/Informatics	Medical device software - Software lifecycle processes	IEC 62304 Edition1.1 2015-06	AAMI ANSIIEC
12-300	Radiology	Digital Imaging and Communications inMedicine (DICOM) Set 03/16/2012Radiology	PS 3.1 - 3.20(2016)	NEMA

No clinical tests were conducted to support the claim of substantial equivalence between the subject and predicate device.

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10. General Safety and Effectiveness Concerns

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 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 device is intended for healthcare professionals familiar with and responsible for the acquisition and-post processing of magnetic resonance images.

11.Conclusion as to Substantial Equivalence

There are no changes to the indications for use for the subject device as compared to that of the legally marketed predicate device, MAGNETOM Avanto™ with software syngo MR E11C-AP04 (K173592).

While the new software feature provides an additional capability compared to the predicate device, the additional capability is currently cleared features of the reference device MAGNETOM Aera with software syngo MR E11C-AP02 (K163312) and do not raise new questions of safety and effectiveness. All features have been verified and validated to support the claim of substantial equivalence to the predicate device.

For the aforementioned mentions Siemens believes that the subject device, MAGNETOM Avanto™ with software syngo MR E11E, is substantially equivalent to the predicate device, MAGNETOM Avanto10 with software syngo MR E11C-AP04.

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.