MAGNETOM Amira 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.

MAGNETOM Amira 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 Amira (1.5T) is an MRI svstem that is substantially equivalent to the previously cleared primary predicate device MAGNETOM Aera (K141977, cleared November 19, 2014) and secondary predicate device MAGNETOM ESSENZA (K130262, cleared Mach 1, 2013).

The MAGNETOM Amira utilizes a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to simplify the MR workflow.

The MAGNETOM Amira systems will be available in a fixed configuration.

AI/ML Overview

This document describes the FDA 510(k) clearance for the Siemens MAGNETOM Amira with Software syngo MR E11, a magnetic resonance diagnostic device (MRDD). It does not contain information about acceptance criteria for an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (MAGNETOM Aera and MAGNETOM ESSENZA) based on its intended use and technological characteristics, not on the performance of an AI-powered component.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, or MRMC studies related to an AI component, as this information is not present in the provided text.

The information provided pertains to the device itself (MAGNETOM Amira) as a magnetic resonance diagnostic device, and not to an AI/ML algorithm within or associated with it.

Summary

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

December 24, 2015

Siemens Medical Solutions USA, Inc. % Cordell Fields, Esq. Regulatory Affairs Specialist 51 Valley Stream Parkway MALVERN PA 19355

Re: K152283

Trade/Device Name: MAGNETOM Amira Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, MOS Dated: November 23, 2015 Received: November 24, 2015

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. 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 devicerelated 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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.

Michael D'Hara For

Robert Ochs, Ph.D. 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: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

к152283

Device Name MAGNETOM Amira

Indications for Use (Describe)

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.

MAGNETOM Amira 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)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5 510(k) Summary

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

l. General Information

Establishment	Siemens Medical Solutions USA, Inc.51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USA
Registration Number	2240869
Date Prepared	August 10, 2015
Manufacturer	Siemens Shenzhen Magnetic Resonance Ltd.Siemens MRI Center, Gaoxin C. Ave., 2ndHi-Tech Industrial Park518057 ShenzhenChinaRegistration Number: 3004754211
Contact Person	Mr. Cordell L. Fields, Esq.Regulatory Affairs Technical SpecialistSiemens HealthcareSiemens Medical Solutions USA, Inc.40 Liberty BlvdMail Code 65-1AMalvern, PA 19355, USAPhone: (610) 219-8518Fax: (610) 448-1787
Device Name	MAGNETOM Amira with Software syngo MR E11
Trade Names:	MAGNETOM Amira
Classification Name:Classification Panel:CFR Code:Classification:Product Code:	Magnetic Resonance Diagnostic Device (MRDD)Radiology21 CFR § 892.1000Class IIPrimary: LNH, Secondary: LNI, MOS

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II. Safety and Effectiveness Information Supporting Substantial Equivalence

Indications for Use

The MAGNETOM Amira 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 Amira 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 Amira systems will be available in a fixed configuration.

Technological Characteristics

While the MAGNETOM Amira with Software syngo MR E11N, the subject device, has the same basic technological characteristics as the predicate devices, there are some differences which do not affect safety or effectiveness. These differences are summarized below and are also addressed in further detail in this submission (Section 12.4).

The MAGNETOM Amira system has some different technological characteristics in comparison to the predicate devices which include:

Different bore diameter and length of the magnet
Different current output and power supply of the gradient system
Differences in the RF system concerning the maximum number of RF ● channels and the maximum number of receiving coil elements
Patient table maximum vertical and horizontal range difference
New coils to be used with the subject device .
- o Head/Neck 10
- o Spine 18
- Body 13 o

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Peripheral Angio 16 O
Breast 4 о
Extremity 12 O
iTX Extremity 18 O
Shoulder Small/Large 6 O
o Wrist 8
o Foot/Ankle 10
10 minute exam application/feature .

The subject and the primary predicate device. MAGNETOM Aera (K141977. cleared November 19, 2014) are substantially equivalent with regard to the following:

MR image acquisition steps/features
Operational environment, programming language, operating system . and performance
Conformance to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.

Nonclinical Tests

The following performance testing was conducted on the subject device:

The coils were tested for SNR, image uniformity, and heating. .
All other software features were verified and validated. ●

The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate devices to which it has been compared.

Clinical Tests

No clinical tests were conducted to support the subject device and the substantial equivalence argument; however, clinical images were provided to support the new coils for the subject device.

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 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 software development, SW 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 operators are healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.

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The MAGNETOM Amira with software synqo MR E11N conforms to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document.

Substantial Equivalence

The MAGNETOM Amira with software syngo MR E11N is substantially equivalent to the following devices:

Predicate Device Name	FDA ClearanceNumber	FDA ClearanceDate	ProductCode
Siemens MAGNETOM Aera (1.5T)(Primary Predicate)	K141977	Nov 19th 2014	LNH, LNI,MOS
Siemens MAGNETOM ESSENZA(1.5T)(Secondary Predicate)	K130262	Mar 1st 2013	LNH

Reference Device:

Reference Device Name	FDAClearanceNumber	FDAClearanceDate	ProductCode
MAGNETOM Spectra	K121160	July 16th 2012	LNH, LNI,MOS

Conclusion as to Substantial Equivalence

MAGNETOM Amira with Software syngo MR E11N has the same intended use and the same basic technical characteristics as the predicate devices: MAGNETOM Aera (K141977, cleared November 19, 2014) and MAGNETOM ESSENZA (K130262, cleared March 1, 2013), with respect to the magnetic resonance features and functionalities.

MAGNETOM Amira with Software syngo MR E11N will be used for acquiring MR images (transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra). The predicate devices, MAGNETOM Aera (K141977) and MAGNETOM ESSENZA (K130262), are also capable of acquiring MR images (transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra). Though there are differences between the subject device and the predicate devices, which include the new and modified software and hardware features, the conclusions from the nonclinical data suggest that the features (of different technological characteristics with respect to the predicate devices) bear an equivalent safety and performance profile as that of the predicate and reference device.

MAGNETOM Amira with Software syngo MR E11N has similar functionality as the predicate devices, and does not introduce new issues of safety or effectiveness. Therefore, Siemens is of the opinion that MAGNETOM Amira with Software syngo MR E11N does not raise new questions of safety or effectiveness and is substantially equivalent to the currently marketed devices, MAGNETOM Aera (K141977) and MAGNETOM ESSENZA (K130262).

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.