Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional 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 display and MR-Safe biopsy needles.

Device Description

The application package AP01, "Implant Suite" for MAGNETOM Aera, enables diagnostic imaging for patients with MR Conditional active and passive implants. Three different Fixed Parameter Options (FPO), Scan Limits 1, 2, and 3, provide conditional implant scan limitations as shown below:

Fixed ParameterOptions	B1+ peak	B1+ rms	WB SAR	dB/dtpeak	dB/dt rms	Slew rate
Scan Limits 1	-	-	≤ 2 W/kg	-	-	≤ 200T/m/s
Scan Limits 2	-	≤ 2.0 μT	≤ 0.8 W/kg	-	-	≤ 200T/m/s
Scan Limits 3	≤ 30 μT	≤ 2.0 μT	≤ 0.8 W/kg	≤ 50 T/s	≤ 56 T/s	≤ 125T/m/s

Without a scan limitation selected, the subject device operates identically to the predicate device. The AP01 application package, "Implant Suite", is an optional feature.

With application package AP01, "Implant Suite" for MAGNETOM Aera, the following changes are introduced:

Hardware	ModifiedHardware	- Additional segregated control path to safelyswitch-off the gradient power in case the limits arereached during a scan- Additional supply-voltage supervisions in thegradient amplifier- Additional measures to ensure permanent activeRF sensor data communication- Additional segregated TX- switch-off path (TSObox)- New computer hardware for MRAWP and MRWPdue to obsolescence
Software	New Featuresand Applications	- Implant Suite (syngo MR E11C-AP01)Including:- New Online Patient Safety supervision (OPS)interface- New safe reaction (switch-off) path for whenimplant related limits are exceeded- Extended look-ahead functionality (prediction)to avoid starting sequences that couldpotentially exceed implant-related limits- New internal supervision to detect latentfailures in the control path- New Implant Suite UI (IUI)- New means to control coil usage- Adapted pulse sequences with restrictedoperation mode

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the MAGNETOM Aera with syngo MR E11C-AP01 software, which is a Magnetic Resonance Diagnostic Device (MRDD). The submission aims to demonstrate substantial equivalence to a predicate device (MAGNETOM Aera with syngo MR E11C-AP04 software, K173592).

The core of the submission revolves around the new "Implant Suite" feature, which enables diagnostic imaging for patients with MR Conditional active and passive implants by implementing specific scan limitations.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical performance target format (e.g., sensitivity, specificity, or image quality scores against a baseline). Instead, the acceptance criteria are implicitly defined by the successful verification of the new features and limitations implemented for safe scanning of patients with MR Conditional implants, and the demonstration of equivalent safety and performance to the predicate device.

The reported device performance is therefore described in terms of its ability to implement and adhere to these new limitations and to maintain image quality.

Acceptance Criteria (Implicit)	Reported Device Performance/Study Findings
New Fixed Parameter Options (FPO) and Respective Limitations: The device must correctly implement and enforce the specified B1+ peak, B1+ rms, WB SAR, dB/dt peak, dB/dt rms, and Slew rate limits for different Scan Limits (1, 2, and 3) to ensure safe scanning of MR Conditional implants.	Verification testing of the new Fixed Parameter Options (FPO) and respective limitations: "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." (This implies successful adherence to the defined limits.)
Image Quality: The modified measurement protocols, incorporating the new limitations, must maintain diagnostic image quality.	Image quality assessments of the modified measurement protocols: "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." (This implies that image quality was found acceptable for diagnostic purposes even with the new limitations.) Additionally, "clinical images were provided to support the imaging performance of the device when using the limitations of the new 'Implant Suite' feature."
Software Functionality and Safety: The new software features (Online Patient Safety supervision, safe reaction path, extended look-ahead functionality, internal supervision, Implant Suite UI, coil usage control, adapted pulse sequences) should function correctly and safely.	Software verification and validation testing: "completed in accordance with the FDA guidance document, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (May 11, 2005)." The results demonstrated that "the device performs as intended."
Hardware Functionality and Safety: The modified hardware (segregated control path, supply-voltage supervisions, RF sensor data communication, segregated TX- switch-off path, new computer hardware) must function correctly and safely.	Non-clinical data suggests equivalent safety and performance: "While there are some differences in technological characteristics between the subject device and predicate device... 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."
Compliance with Standards: The device must conform to relevant medical device standards (e.g., IEC 62304, IEC 60601 series, ISO 14971, NEMA DICOM).	The document explicitly states compliance with: IEC 62304:2015, ES60601-1:2005/(R)2012 and A1:2012, 60601-1-2 Edition 4.0 2014-02, 60601-2-33 Ed. 3.2 B:2015, 14971 Second edition 2007-03-01, 60601-1-6 Edition 3.1 2013-10, 62366-1:2015, and NEMA PS 3.1 - 3.20 (2016).

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

Sample Size for Test Set: The document does not specify a numerical sample size for any of the performance tests (image quality assessments, FPO verification, or software V&V).
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. It only mentions that "clinical images were provided," suggesting real-world data, but details are lacking.

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

The document states that "clinical images were provided to support the imaging performance of the device when using the limitations of the new 'Implant Suite' feature." It also mentions that images "when interpreted by a trained physician, yield information that may assist in diagnosis." However, it does not specify the number of experts, their qualifications (e.g., years of experience as a radiologist), or their role in establishing a formal ground truth for the test set used in the performance evaluation.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for interpreting the clinical images or evaluating the performance of the device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document explicitly states: "No clinical tests were conducted to support substantial equivalence for the subject device." Therefore, no MRMC comparative effectiveness study involving human readers with and without AI assistance was performed or reported. The regulatory submission relies on non-clinical tests and demonstration of equivalent technical characteristics for safety and performance to the predicate device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This device is an MR scanner with updated software and hardware, not an AI algorithm that acts as a standalone diagnostic tool. The "Implant Suite" is a feature that modifies the scanner's operational parameters. Therefore, a standalone algorithm-only performance study (as would be typical for an AI-based diagnostic tool) is not applicable here and was not reported. The "software verification and validation testing" evaluates the correct functioning of the software features, including the new safety mechanisms, but not in the context of a standalone diagnostic algorithm.

7. Type of Ground Truth Used:

For the non-clinical tests (FPO verification, software V&V), the "ground truth" would be the expected behavior based on engineering specifications and safety requirements.
For the "clinical images," the implicit ground truth for evaluating "imaging performance" would likely be the diagnostic interpretation by a trained physician, but no formal process for establishing this ground truth is described. It is not pathology, outcomes data, or an expert consensus process in the way these are typically defined for diagnostic accuracy studies.

8. Sample Size for the Training Set:

The document does not describe the development of a machine learning or AI model with a distinct "training set." The changes are primarily software modifications for safety features and operational limitations, along with associated hardware changes. Therefore, the concept of a "training set" in the context of machine learning is not directly applicable to this submission.

9. How the Ground Truth for the Training Set Was Established:

As the device's modifications are not described as involving machine learning from a training set, the question of how ground truth for a training set was established is not relevant to this submission.

Summary

{0}------------------------------------------------

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. Martin Rajchel Regulatory Affairs Specialist 40 Liberty Boulevard, Mail Code 65-IA Malvern, Pennsylvania 19355

October 26, 2018

Re: K182299

Trade/Device Name: MAGNETOM Aera Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: August 23, 2018 Received: August 24, 2018

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

{1}------------------------------------------------

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,

Image /page/1/Picture/5 description: The image shows the name "Michael D. O'hara -S" in large, bold font on the left side of the image. On the right side of the image, there is a digital signature from Michael D. O'hara, including the date 2018.10.26 08:34:51 -04'00'. The signature also includes information such as DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, and 0.9.2342.19200300.100.1.1=1300226 759, cn=Michael D. O'hara -S.

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

{2}------------------------------------------------

Indications for Use

K182299

Device Name

MAGNETOM Aera

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 display 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)

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."

{3}------------------------------------------------

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 of 1990 and 21 CFR § 807.92.

Company:	Siemens Medical Solutions USA, Inc.40 Liberty Boulevard, 65-1AMalvern, PA 19355
----------	-----------------------------------------------------------------------------------------

August 23, 2018 Date Prepared:

General Information 1.

lmporter/Distributor:

Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mail Code 65-1A Malvern, PA 19355, USA Establishment Registration Number: 2240869

Manufacturing Sites:

Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen. Germany Establishment Registration Number: 3002808157

SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. Siemens MRI Center Hi-Tech Industrial park (middle) Gaoxin C. Ave., 2nd Shenzhen 518057, P.R. CHINA Establishment Registration Number: 3004754211

2. Contact Person:

Martin Rajchel Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, USA Phone: (610) 448-6545 Fax: (610) 640-4481 E-mail: martin.rajchel@siemens-healthineers.com

{4}------------------------------------------------

3. Device Name and Classification:

Device Name	MAGNETOM Aera with syngo MR E11C-AP01software
Trade Name	MAGNETOM Aera
Classification Name	Magnetic Resonance Diagnostic Device(MRDD)
Classification Panel:	Radiology
Regulation Number:	21 CFR § 892.1000
Device Class:	II
Primary Product Code:	LNH
Secondary Product Code:	LNI, MOS

Legally Marketed Predicate Device: 4.

Device Name	MAGNETOM Aera, MAGNETOM Skyra / Skyrafit,MAGNETOM Prisma / Prismafit and MAGNETOMAvantofit with syngo MR E11C - AP04 software
Trade Names:	MAGNETOM Aera, MAGNETOM Skyra / Skyrafit,MAGNETOM Prisma / Prismafit and MAGNETOM
510(k) Number:	K173592, cleared February 13, 2018
Classification Name	Magnetic Resonance Diagnostic Device(MRDD)
Classification Panel:	Radiology
Regulation Number:	21 CFR § 892.1000
Device Class:	II
Primary Product Code:	LNH
Secondary Product Code:	LNI, MOS

5. Intended Use

The indications for use for the subject device are 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 display and MR-Safe biopsy needles.

{5}------------------------------------------------

Device Description: 6.

Fixed ParameterOptions	B1+ peak	B1+ rms	WB SAR	dB/dtpeak	dB/dt rms	Slew rate
Scan Limits 1	-	-	≤ 2 W/kg	-	-	≤ 200T/m/s
Scan Limits 2	-	≤ 2.0 μT	≤ 0.8 W/kg	-	-	≤ 200T/m/s
Scan Limits 3	≤ 30 μT	≤ 2.0 μT	≤ 0.8 W/kg	≤ 50 T/s	≤ 56 T/s	≤ 125T/m/s

Without a scan limitation selected, the subject device operates identically to the predicate device. The AP01 application package, "Implant Suite", is an optional feature.

With application package AP01, "Implant Suite" for MAGNETOM Aera, the following changes are introduced:

Hardware	ModifiedHardware	- Additional segregated control path to safelyswitch-off the gradient power in case the limits arereached during a scan- Additional supply-voltage supervisions in thegradient amplifier- Additional measures to ensure permanent activeRF sensor data communication- Additional segregated TX- switch-off path (TSObox)- New computer hardware for MRAWP and MRWPdue to obsolescence
Software	New Featuresand Applications	- Implant Suite (syngo MR E11C-AP01)Including:- New Online Patient Safety supervision (OPS)interface- New safe reaction (switch-off) path for whenimplant related limits are exceeded- Extended look-ahead functionality (prediction)to avoid starting sequences that couldpotentially exceed implant-related limits- New internal supervision to detect latentfailures in the control path- New Implant Suite UI (IUI)- New means to control coil usage- Adapted pulse sequences with restrictedoperation mode

{6}------------------------------------------------

7. Technological Characteristics

The subject device, MAGNETOM Aera with syngo MR E11C-AP01, has the same fundamental technological characteristics as the predicate device, MAGNETOM Aera with syngo MR E11C-AP04, (K173592 cleared February 13. 2018) with regard to the operational environment, programming language, operating system, and performance.

The software was modified to implement a new user interface and limitations for scanning patients with MR Conditional implants. Additionally the hardware was modified to implement safe communication channels and a safe cut-off path for RF power.

The MAGNETOM Aera with syngo MR E11C-AP01 conforms to the standard for software medical devices (IEC 62304:2015) 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 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:

Image quality assessments of the modified measurement protocols
Verification testing of the new Fixed Parameter Options (FPO) and respective limitations
Software verification and validation testing was completed in accordance with the FDA quidance document. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005)

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 9.

No clinical tests were conducted to support substantial equivalence for the subject device: however, clinical images were provided to support the imaging performance of the device when using the limitations of the new "Implant Suite" feature.

{7}------------------------------------------------

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 to potential hazards in a risk analysis beginning early in the design phase and continuing 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. Software development is carried out according to the IEC 62304 standard for medical device software. Furthermore, the device is intended for healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.

The MAGNETOM Aera with syngo MR E11C-AP01 software conforms to the applicable FDA recognized and international IEC, ISO and NEMA.

RecognitionNumber	ProductArea	Title of Standard	ReferenceNumber and date	StandardsDevelopmentOrganization
19-4	General	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: Electromagnetic disturbances- Requirements and tests	60601-1-2Edition 4.02014-02	IEC
12-295	Radiology	Medical electrical equipment - Part 2-33:Particular requirements for the basicsafety and essential performance ofmagnetic resonance equipment formedical diagnostic	60601-2-33 Ed.3.2 B:2015	IEC
5-40	General	Medical devices - Application of riskmanagement to medical devices	14971 Secondedition 2007-03-01	ISO
5-89	General	Medical electrical equipment - Part 1-6:General requirements for basic safetyand essential performance - Collateralstandard: Usability	60601-1-6Edition 3.12013-10	IEC
5-96	General	Medical devices - Application of usabilityengineering to medical devices	62366-1:2015	AAMI ANSIIEC
13-79	Software	Medical device software - Software lifecycle processes	62304 Edition1.1 2015-06	IEC
12-300	Radiology	Digital Imaging and Communications inMedicine (DICOM) Set 03/16/2012Radiology	PS 3.1 - 3.20(2016)	NEMA

{8}------------------------------------------------

11. Substantial Equivalence and Conclusion

The subject device, MAGNETOM Aera with syngo MR E11C-AP01, has the same intended use, indications for use, and fundamental technological characteristics as the predicate device, MAGNETOM Aera with syngo MR E11C-AP04, (K173592).

The software was modified to implement a user interface with selectable limitations for scanning patients with MR Conditional implants. Additionally the hardware was modified to implement safe communication channels and a safe cut-off path for RF power.

While there are differences in technological characteristics between the subject device and predicate device, including new and modified software applications and hardware additions, these differences have been tested and the conclusions from the non-clinical tests have shown that there were no additional questions of safety and effectiveness raised.

believes that the subiect device. MAGNETOM Aera with Siemens syngo MR E11C-AP01 is substantially equivalent to the predicate device, MAGNETOM Aera with 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.