The MAGNETOM MR system [Aera / Skyra] 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 MR system [Aera / Skyra] 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

The MAGNETOM MR system is a magnetic resonance device (MRDD) producing transverse, sagittal, coronal, and oblique sectional images, spectroscopic images and/or spectra, and displaying 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.

The 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.

The software syngo MR D13A is the latest software for the Siemens MAGNETOM scanners including software sequences, applications, coils and other hardware for the MAGNETOM scanners. This software was previously cleared under K121434.

New scanners are manufactured with syngo MR D13A: existing scanners can be upgraded to this software version.

This filing describes additional local coils intended to be used with the MAGNETOM Aera and MAGNETOM Skyra.

For MAGNETOM Skyra the Head/Neck 64, the Breast 18 and the Body 18 long are new coils. For MAGNETOM Aera the Breast 18 and the Body 18 long are new coils.

AI/ML Overview

The provided text is a 510(k) summary for the Siemens MAGNETOM Aera/Skyra MR system with additional local coils. This document describes a submission for a modification to an existing medical device, specifically the addition of new coils to an already cleared MR system.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

Acceptance Criteria	Reported Device Performance
SNR (Signal-to-Noise Ratio)	Tested; results demonstrate the device performs as intended.
Image Uniformity	Tested; results demonstrate the device performs as intended.
Heating (Safety)	Tested; results demonstrate the device performs as intended.
Compliance with NEMA standards	Tested per applicable NEMA standards.
Compliance with IEC standards	Tested per applicable IEC standards.
Substantial Equivalence to Predicate Device	Established through non-clinical testing and comparison.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. No clinical tests were conducted. The non-clinical tests were performed on the new coils themselves.
Data Provenance: Not applicable. No human subject data (clinical data) was used. The tests were non-clinical, likely engineering and performance tests on the hardware.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. No clinical ground truth was established by experts for this specific submission as no clinical tests were performed.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. No clinical ground truth was established.

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

MRMC Study: No. This submission is for modifications to a magnetic resonance diagnostic device (MRDD) through the addition of new coils. It does not involve AI or algorithms requiring MRMC studies for comparative effectiveness with human readers.

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

Standalone Study: No. This submission focused on the physical performance and safety of new hardware (MR coils), not on the performance of a standalone algorithm.

7. The type of ground truth used

Type of Ground Truth: Not applicable for clinical ground truth. The "ground truth" for the non-clinical tests was likely established by reference to engineering specifications, NEMA/IEC standards, and direct measurements with calibrated equipment.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This submission concerns hardware additions (coils) and their physical performance, not machine learning algorithms that require training sets.

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

How Ground Truth for Training Set was Established: Not applicable.

Summary of the Study and Why the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria was non-clinical performance testing conducted on the newly added local coils (Head/Neck 64, Breast 18, and Body 18 long) for the MAGNETOM Aera and Skyra MR systems.

The acceptance criteria focused on the fundamental performance characteristics of MR coils:

Signal-to-Noise Ratio (SNR): A measure of image quality.
Image Uniformity: Ensuring consistent image quality across the scanned area.
Heating: A critical safety parameter, ensuring the coils do not generate excessive heat during operation.

These tests were performed "per applicable NEMA and IEC standards." These standards provide established, rigorous methodologies for evaluating the performance and safety of MR devices and components.

The report explicitly states: "The test results demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared." This indicates that the coils' performance met the predefined thresholds or expectations set by these standards and compared favorably to the performance of previously cleared coils or the system as a whole.

No clinical studies were conducted because this was a Special 510(k) submission for a minor change (new coils) to an already cleared predicate device (syngo MR D13A software for various MAGNETOM systems, K121434). The FDA determined that the non-clinical tests were sufficient to establish substantial equivalence for the new coils, given that there were "no system change and no software change" to the core MR system. The safety and effectiveness were further supported by compliance with risk management standard ISO 14971:2007 and general medical electrical equipment standards like IEC 60601-1.

Summary

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SIEMENS

K133435
Page 1 of 3
0(k) Submission

Special 510(k) Submission

Section 5 510(k) Summary

DEC 1222013

This 510(k) summary is being submitted in accordance with 21 CFR § 807.92.

5.1 General Information

Establishment	Siemens Medical Solutions USA, Inc.51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USARegistration Number: 2240869
Manufacturer	Siemens AGHenkestrasse 127D-91052 Erlangen, GermanyRegistration Number: 3002808157
Contact Person	Ms. Nadia SookdeoRegulatory Affairs Technical SpecialistSiemens Medical Solutions USA, Inc.51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USAPhone: (610) 448-4918E-mail: Nadia.Sookdeo@siemens.com
Device Name	MAGNETOM Aera/Skyra
CFR Code	21 CFR § 892.1200
Classification	Class II
Product Codes	LNH
Classification Name	Magnetic Resonance Diagnostic Device (MRDD),Emission Computed Tomography System, MR Coils

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5.2 Information Supporting Substantial Equivalence

DEVICE DESCRIPTION

The 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.

New scanners are manufactured with syngo MR D13A: existing scanners can be upgraded to this software version.

This filing describes additional local coils intended to be used with the MAGNETOM Aera and MAGNETOM Skyra.

For MAGNETOM Skyra the Head/Neck 64, the Breast 18 and the Body 18 long are new coils. For MAGNETOM Aera the Breast 18 and the Body 18 long are new coils.

INTENDED USE

The MAGNETOM MR system [Aera / Skyra] 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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NONCLINICAL TESTS

The following performance testing was conducted on the subject device:

The coils were tested for SNR, image uniformity, and heating per . applicable NEMA and IEC standards.
The test results demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.

CLINICAL TESTS

There were no clinical tests conducted to support the subject device and the substantial equivalence argument, however sample images of the now local coils of the subject devices are provided to support the descriptions in Section 11.

SUBSTANTIAL EQUIVALENCE

The MAGNETOM Aera/Skyra with software syngo MR D13A including the additional local coils Head/Neck 64, Breast 18 and Body 18 long is substantially equivalent to the following predicate device, described in Table 1.

Table 1: Predicate device for MAGNETOM Aera/Skyra

Predicate Device Name	FDAClearanceNumber	FDA ClearanceDate	MainProductCode
Software syngo MR D13Afor the MAGNETOMSystems Aera / Skyra /Avanto / Verio	K121434	Nov 5, 2012	LNH

There is no system change and no software change. The only difference between the subject and the predicate device are the additional new local coils for the systems.

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 to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Siemens Medical Solutions USA. Inc. and Siemens AG adhere 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 contains a logo and some text. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle. To the right of the logo is the letter "D" in a large font. The rest of the text is not clear enough to read.

Public Health Service

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

December 12, 2013

Siemens Medical Solutions USA, Inc. % Ms. Nadia Sookdeo Regulatory Affairs Technical Specialist 51 Valley Stream Parkway Mail Code D02 MALVERN PA 19355

Re: K133435

Trade/Device Name: MAGNETOM Aera/Skyra syngo MR D13A Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 7, 2013 Received: November 8, 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/Resources/orYou/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,

Smh.7)

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31. 2013 See PRA Statement on last page.

510(k) Number (if known) K133435

Device Name

MAGNETOM Aera Skyra syngo MR. D13A with additional local couls

Indications for Use (Describe)

The MAGNETOM SE system (Aera Skym) is indicated for use as a maggeour darice (MRDD) that produces transverse, segmal and oblique cross sections unsges. spectroscopic coasges and condition the manal structure and or function of the head. body, or extremines.

Other playical parameers darived from the spects may also be produced. Depending on the region of inzers. contast agent may be used. These unages and the physical paraneters derived from the mages and or spectar when internet by a trained physician yield information that may assist in diagnosis.

The MAGNETON MR system (Aen Skyrs) may also be used for imaging darner siben performed anti MR companible device: such as in-room displays and MR-Safe bropsy needles.

Type of Use (Select one or both. as applicable)

Prescription Use : Part 21 CFR 501 Subpan Di

Over-The-Counter Use (21 CFR 50) Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radictor car Health (CORH) (Signature)

Smh.7)

FORM FDA 3881 (9/13)

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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.