MAGNETOM AERA

K132951 · Siemens Medical Solutions USA, Inc. · LNH · Nov 15, 2013 · Radiology

Device Facts

• Record ID: K132951
• Device Name: MAGNETOM AERA
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Nov 15, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

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 Story

MAGNETOM Aera is 1.5T superconducting whole-body MRI scanner; open-bore design for patient comfort. System inputs: magnetic resonance signals from patient anatomy. Transformation: MaRS (Measurement and Reconstruction System) processes signals into cross-sectional images, spectroscopic images, or spectra. Output: diagnostic images/spectra displayed on Syngo MR Workplace for physician interpretation. Used in clinical settings by trained physicians/technicians. Modifications include 24 receive channels, updated MaRS/MRAWP, syngo MR D13E software, and three new coils. Supports interventional imaging with MR-safe accessories. Benefits: provides internal structural/functional visualization to assist clinical diagnosis.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and adherence to recognized international standards (IEC, ISO, NEMA) for MR safety and performance.

Technological Characteristics

1.5T superconducting magnet; 24 receive channels; open-bore form factor. Software: syngo MR D13E. Connectivity: Syngo MR Workplace. Conforms to IEC 60601-1 series, ISO 14971:2007, and relevant FDA MR guidance documents.

Indications for Use

Indicated for patients requiring MR diagnostic imaging of head, body, or extremities; produces cross-sectional images, spectroscopic images, or spectra to assist trained physicians in diagnosis; supports interventional procedures using MR-compatible devices.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Siemens MAGNETOM Aera (1.5T) with syngo MR D13A (K121434)

Submission Summary (Full Text)

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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.<br>51 Valley Stream Parkway<br>Mail Code D02<br>Malvern, PA 19355, USA<br>Registration Number 2240869 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | January 31, 2013 |
| Registration Number | 2240869 |
| Manufacturers | Siemens AG<br>Henkestrasse 127<br>D-91052 Erlangen, Germany<br>Registration Number 3002808157<br><br>Siemens Shenzhen Magnetic Resonance Ltd.<br>Siemens MRI Center<br>Gaoxin C. Ave., 2nd<br>Hi-Tech Industrial Park,<br>Shenzhen 518057, P.R. China<br>Registration Number 3004754211 |
| Contact Person | Ms. Nadia Sookdeo<br>Regulatory Affairs Technical Specialist<br>Siemens Healthcare<br><br>Siemens Medical Solutions USA, Inc.<br>Customer Solutions Group<br>51 Valley Stream Parkway<br>Mail Code D02<br>Malvern, PA 19355, USA<br>Phone: [phone]<br>Fax: [phone] |
| Device Name | Trade Names: MAGNETOM Aera<br>Classification Name: Magnetic Resonance Diagnostic Device<br>CFR Code: 21 CFR § 892.1000<br>Product Code: LNH<br>Classification: 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

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.

#### Substantial Equivalence

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

| Predicate Device Name-<br>System | FDA Clearance<br>Number | Product<br>Code | FDA<br>Clearance<br>Date |
|------------------------------------------------------|-------------------------|-----------------|--------------------------|
| Siemens MAGNETOM<br>Aera(1.5T) with syngo MR<br>D13A | K121434 | LNH | November<br>5, 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 [phone] or [phone] 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 [phone] or [phone] 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 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.

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

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