MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A

K133435 · Siemens Medical Solutions USA, Inc. · LNH · Dec 12, 2013 · Radiology

Device Facts

• Record ID: K133435
• Device Name: MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Dec 12, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

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 Story

MAGNETOM Aera/Skyra are magnetic resonance diagnostic devices (MRDD) producing transverse, sagittal, coronal, and oblique sectional images and spectroscopic data. Input consists of MR signals captured via local coils (Head/Neck 64, Breast 18, Body 18 long); system transforms signals into internal structural/functional images. Used in clinical settings by trained physicians to assist in diagnosis; supports interventional procedures using MR-safe accessories. Output viewed by clinicians to inform diagnostic decision-making. Benefits include non-invasive visualization of internal anatomy and pathology.

Clinical Evidence

No clinical tests conducted. Substantial equivalence supported by bench testing of new coils for SNR, image uniformity, and heating per NEMA and IEC standards.

Technological Characteristics

MR diagnostic system; includes new local coils (Head/Neck 64, Breast 18, Body 18 long). Operates via magnetic resonance imaging principles. Compliance with IEC 60601-1 series for electrical/mechanical safety and ISO 14971:2007 for risk management. Software version syngo MR D13A.

Indications for Use

Indicated for use as a magnetic resonance diagnostic device (MRDD) to produce cross-sectional images and spectra of the head, body, or extremities for diagnostic purposes. May be used with contrast agents and during interventional procedures with MR-compatible devices. Intended for use by trained physicians.

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

• Software syngo MR D13A for the MAGNETOM Systems Aera / Skyra / Avanto / Verio (K121434)

Submission Summary (Full Text)

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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.<br>51 Valley Stream Parkway<br>Mail Code D02<br>Malvern, PA 19355, USA<br>Registration Number: 2240869 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Siemens AG<br>Henkestrasse 127<br>D-91052 Erlangen, Germany<br>Registration Number: 3002808157 |
| Contact Person | Ms. Nadia Sookdeo<br>Regulatory Affairs Technical Specialist<br>Siemens Medical Solutions USA, Inc.<br>51 Valley Stream Parkway<br>Mail Code D02<br>Malvern, PA 19355, USA<br>Phone: [phone]<br>E-mail: [e-mail] |
| Device Name | MAGNETOM Aera/Skyra |
| CFR Code | 21 CFR § 892.1200 |
| Classification | Class II |
| Product Codes | LNH |
| Classification Name | Magnetic Resonance Diagnostic Device (MRDD),<br>Emission Computed Tomography System, MR Coils |

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# 5.2 Information Supporting Substantial Equivalence

# 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.

# INTENDED USE

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.

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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 | FDA<br>Clearance<br>Number | FDA Clearance<br>Date | Main<br>Product<br>Code |
|----------------------------------------------------------------------------------------|----------------------------|-----------------------|-------------------------|
| Software syngo MR D13A<br>for the MAGNETOM<br>Systems Aera / Skyra /<br>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 [phone] or [phone] 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 [phone] or [phone] 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)

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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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