The MAGNETOM Aera with syngo MR D13E 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.

The MAGNETOM Aera 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 MAGNETOM Aera is a 1.5T, utilizing a superconducting magnet design. The open bore, whole body scanner is designed for increased patient comfort The MAGNETOM Aera is being modified to include another configuration to the MAGNETOM portfolio to be available for Ex-factory (new) systems. The full modifications for the new MAGNETOM Aera configuration include 24 receive channels, modified Measurement and Reconstruction System (MaRS) and Syngo Acquisition Workplace (MRAWP)/Syngo MR Workplace(MRWP), an update to the software syngo MR D13E and the addition of three new coils to the existing MAGNETOM Aera Magnetic Resonance System.

AI/ML Overview

This is a 510(k) summary for a Siemens MAGNETOM Aera 1.5T System, which is a magnetic resonance diagnostic device. The documentation provided does not include specific acceptance criteria or performance study data as would typically be found in a medical device submission for a new or significantly modified device.

The submission is a Special 510(k), indicating that it is for a modification to a previously cleared device (MAGNETOM Aera with syngo MR D13A, K121434). In such cases, the primary goal is often to demonstrate substantial equivalence to the predicate device, rather than to conduct new clinical performance studies with detailed acceptance criteria.

The document states:

"The MAGNETOM Aera with syngo MR D13E 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."
"The MAGNETOM Aera with software syngo MR D13E conforms to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety..."

Without specific performance study data, it is not possible to fill out the table or answer most of the questions. However, based on the nature of the submission and the provided text:

1. A table of acceptance criteria and the reported device performance:

No specific acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy for a particular diagnostic task) are provided in the document. The device is a diagnostic imaging system, and its performance is generally evaluated against its ability to acquire high-quality images and spectra, and this submission focuses on demonstrating that the modified system maintains performance equivalent to the predicate.

Acceptance Criteria	Reported Device Performance
Not specified in document	Not specified in document

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

No information about a specific test set or data provenance is provided. Given that this is a Special 510(k) for a modification to an existing MRI system, the primary argument for substantial equivalence likely relies on technical specifications, verification and validation testing (e.g., image quality phantoms, electrical safety, software testing), and comparison to the predicate device's established performance, rather than a new clinical study with a specific patient test set.

3. 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 applicable, as no clinical test set or ground truth establishment by experts is described in this submission.

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

Not applicable, as no clinical test set or adjudication process is described in this submission.

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:

Not applicable. This document describes an MRI hardware and software upgrade, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

Not applicable. This is an MRI system, not a standalone algorithm.

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

Not applicable, as no clinical study requiring ground truth is described. The "ground truth" for an MRI system's performance would primarily be related to its physical and image quality metrics (e.g., signal-to-noise ratio, spatial resolution, contrast, artifact levels), which are typically assessed using phantoms and technical specifications.

8. The sample size for the training set:

Not applicable. This document is for an MRI system, not an AI model requiring a training set in the conventional sense. The "training" for such a system would involve engineering and development, not data-driven machine learning model training.

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

Not applicable, as there is no training set mentioned or implied for an AI model.

Summary

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Special 510(k) Submission: MAGNETOM Aera 1.5T System

Section 5 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act 1990 and 21 CFR § 807.92. The 510(k) Summary is provided on the next page and is suitable for publication on the FDA website.

I. General Information

SIEMENS

Establishment	Siemens Medical Solutions USA. Inc.51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USARegistration Number 2240869
Date Prepared	January 31, 2013
Registration Number	2240869
Manufacturers	Siemens AGHenkestrasse 127D-91052 Erlangen, GermanyRegistration Number 3002808157Siemens Shenzhen Magnetic Resonance Ltd.Siemens MRI CenterGaoxin C. Ave., 2ndHi-Tech Industrial Park,Shenzhen 518057, P.R. ChinaRegistration Number 3004754211
Contact Person	Ms. Nadia SookdeoRegulatory Affairs Technical SpecialistSiemens HealthcareSiemens Medical Solutions USA, Inc.Customer Solutions Group51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USAPhone: (610) 448-4918Fax: (610) 448-1787
Device Name	Trade Names: MAGNETOM AeraClassification Name: Magnetic Resonance Diagnostic DeviceCFR Code: 21 CFR § 892.1000Product Code: LNHClassification: Class II

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SIEMENS

II. Safety and Effectiveness Information Supporting Substantial Equivalence

Intended Use

The intended use for the MAGNETOM Aera with syngo MR D13E is the same as MAGNETOM Aera with syngo MR D13A that is described in K121434 and cleared on November 05, 2012.

The MAGNETOM Aera with syngo MR D13E 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 atrained physician vield information that may assist in diagnosis.

The MAGNETOM Aera 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

Substantial Equivalence

Siemens feels that the new system is substantially equivalent to the following predicate devices:

Predicate Device Name-System	FDA ClearanceNumber	ProductCode	FDAClearanceDate
Siemens MAGNETOMAera(1.5T) with syngo MRD13A	K121434	LNH	November5, 2012

General Safety and Effectiveness Concerns:

The MAGNETOM Aera with software syngo MR D13E conforms to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to

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Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in bold, black letters. The letters are large and evenly spaced, with a thick black line underlining the entire word. The font appears to be sans-serif, giving the word a clean and modern look.

Special 510(k) Submission: MAGNETOM Aera 1.5T System

performance and safety as recommended by the respective MR FDA Guidance Document.

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 to potential hazards beginning early in the design cycle and continuing throughout the development of the product.

Siemens adheres to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three wavy lines representing snakes intertwined around a staff.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 15, 2013

Siemens Medical Solutions USA, Inc. % Ms. Nadia Sookdeo Technical Specialist, Regulatory Affairs 51 Valley Stream Parkway, D 02 MALVERN PA 19355

Re: K132951

Trade/Device Name: MAGNETOM Aera Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: October 23, 2013 Received: October 24, 2013

Dear Ms. Sookdeo:

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. Sookdeo

... .

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Special 510(k) Submission: MAGNETOM Aera 1.5T System

Section 4 Indications for Use Statement

510(k) Number (if known): K132951

Device Names: MAGNETOM Aera

Indications for Use:

The MAGNETOM Aera 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.

Prescription Use x (Part 21 CFR 80) Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) 12 - 11 - 1

-------------------- (Division Sign Off) Division of Radiological Health Office of In Firo Diagnostic and Radiological Health 510kk) K 13295 I

Page 1 of 1

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.