MAGNETOM SKYRA

K123510 · Siemens Medical Solutions USA, Inc. · LNH · May 17, 2013 · Radiology

Device Facts

• Record ID: K123510
• Device Name: MAGNETOM SKYRA
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: May 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MAGNETOM 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 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 Skyra is an MRI system utilizing TimTX TrueShape and syngo MR D13C software. TimTX TrueShape enables parallel RF transmission, allowing local shaping of the RF excitation field for selective excitation. The syngo ZOOMit application uses this technology to perform selective excitation, effectively 'zooming' into specific body regions. The system includes two independent RF transmit paths, a modified whole-body RF coil, B1 shimming options, and inline RF pulse generation. Pulse sequences are derived from EPI and SPACE. Operated by healthcare professionals in clinical settings, the system acquires MR images and spectra to assist in diagnosis. It supports neurological, musculoskeletal, angiographic, and oncological imaging protocols. The output consists of cross-sectional images and spectroscopic data, which physicians interpret to inform clinical decision-making. The device also supports interventional procedures using MR-compatible accessories.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including software verification and validation, and adherence to recognized international standards (IEC 60601-1 series, ISO 14971:2009).

Technological Characteristics

Magnetic resonance diagnostic device; parallel RF transmission; modified whole-body RF coil; B1 shimming; inline RF pulse generation; EPI and SPACE-derived pulse sequences. Conforms to IEC, ISO, and NEMA standards. Software-controlled operation.

Indications for Use

Indicated for patients requiring diagnostic MR imaging of head, body, or extremities; produces cross-sectional images, spectroscopic images, and spectra; used for 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

• MAGNETOM Skyra with syngo MR D13A (K121434)

Submission Summary (Full Text)

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MAY 1 7 2013

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SIEMENS

Traditional 510(k) Submission: TimTX TrueShape and syngo MR D13C for MAGNETOM Skyra

#### TimTX TrueShape and syngo MR D13C for 510(k) Summary: MAGNETOM Skyra

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.

Date of Summary Preparation: November 9, 2012

l. General Information

| Importer/Distributor | Siemens Medical Solutions USA, Inc. |
|----------------------|-------------------------------------|
| | 51 Valley Stream Pkwy |
| | Mail Code D02 |
| | Malvern, PA 19355, USA |
| Registration Number: | 2240869 |
| Manufacturer | Siemens AG |
| | Medical Solutions |
| | Henkestrasse 127 |
| | D-91052 Erlangen, Germany |
| Registration Number: | 8010024 |

SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. Siemens MRI Center, Hi-Tech Industrial park (middle) Gaoxin C. Ave., 2nd Shenzhen 518057, P.R. CHINA 3004754211

Registration Number:

Contact Person Nadia Sookdeo

Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Pkwy Mail Code D02 Malvern, PA 19355, USA Phone: [phone] Fax: [phone] Email: [e-mail]

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#### Traditional 510(k) Submission:

#### TimTX TrueShape and syngo MR D13C for MAGNETOM Skyra

e Name and Classification

| Data | Details |
|---------------------------|--------------------------------------------------------------------------|
| Trade name /<br>Device | MAGNETOM Skyra |
| Proprietary<br>Name: | option TimTX TrueShape with syngo MR D13C |
| Classification<br>Name: | Regulation Description:<br>- Magnetic Resonance Diagnostic Device (MRDD) |
| Classification<br>Panel: | Radiology |
| Device<br>Classification: | Class II devices |
| Regulation<br>number: | 21 CFR § 892.1000 |
| Product<br>Code: | LNH |

# II. Safety and Effectiveness Information Supporting Substantial Equivalence

#### Intended Use

The MAGNETOM 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 diaqnosis.

The MAGNETOM 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

TimTX TrueShape, an option for the MR system MAGNETOM Skyra, allows parallel transmission of RF pulses, shaping the RF excitation field locally and thus enabling selective excitation.

syngo ZOOMit (introduced with the software version syngo MR D13C) is the application that utilizes TimTX TrueShape. It allows "zooming into" a part of the human body by selective excitation.

The option TimTX TrueShape and syngo ZOOMit include two independent RF transmit paths fully integrated with the system, a modified whole-body RF coil, new options for

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# SIEMENS

### Traditional 510(k) Submission:

TimTX TrueShape and syngo MR D13C for MAGNETOM Skyra B1 shimming, as well as new inline RF pulse generation. Pulse sequences allowing for different kinds of excitation, or zooming are derived from EPI and SPACE sequences. Protocol optimization for neurological, musculoskeletal, angiographic and oncological imaging is also inherent to the TimTX TrueShape option.

# General Safety and Effectiveness Concerns

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.

Product Risk Management is accomplished through a process in compliance with ISO 14971:2009 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.

The MAGNETOM Skyra with option TimTX TrueShape and software syngo MR D13C 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

MAGNETOM Skyra with TimTX TrueShape and software syngo MR D13C is a magnetic resonance diagnostic device that includes all of the features of MAGNETOM Skyra with syngo MR D13A. Therefore, the MAGNETOM Skyra with the option TimTX TrueShape and software syngo MR D13C is substantially equivalent to the following current legally marketed device (please refer to Table 1):

| Predicate Device Name | FDA<br>Clearance<br>Number | FDA Clearance Date |
|--------------------------------------|----------------------------|--------------------|
| MAGNETOM Skyra with syngo MR<br>D13A | K121434 | November 05, 2012. |

#### Table 1: Predicate device for MAGNETOM Skyra with TimTX TrueShape and software syngo MR D13C

# Conclusion as to Substantial Equivalence

MAGNETOM Skyra with option TimTX TrueShape and software syngo MR D13C has the same intended use and the same basic technical characteristics as the predecessor device MAGNETOM Skyra with syngo MR D13A, with respect to the magnetic resonance features and functionalities. MAGNETOM Skyra with option TimTX TrueShape and software syngo MR D13C will be used for acquiring MR images (transverse, sagittal, coronal and obligue cross sectional images, spectroscopic

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K123510

# SIEMENS

#### Traditional 510(k) Submission:

TimTX TrueShape and syngo MR D13C for MAGNETOM Skyra images and/or spectra). The predicate device, MAGNETOM Skyra with software syngo MR D13A, is also capable of acquiring MR images (transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra). The differences between the subject device and the predicate device, which include the aforementioned new / modified technology and software version, give the subject device greater capabilities than the predicate device, but have the enhanced technological characteristics as the predicate device. MAGNETOM Skyra with option TimTX TrueShape and software syngo MR D13C is similar to the functionalities of the predicate device, and does not introduce any new issues of safety or effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

May 17. 2013

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

Re: K123510

Trade/Device Name: MAGNETOM Skyra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: May 13, 2013 Received: May 15, 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 vour 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/Safcty/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.lda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara 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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# Indications for Use

### 510(k) Number (if known): K123510

Device Name: MAGNETOM Skyra

Indications for Use:

The MAGNETOM 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 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K123510 510(k)

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