MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE

K140253 · Siemens Medical Solutions USA, Inc. · LNH · Mar 20, 2014 · Radiology

Device Facts

• Record ID: K140253
• Device Name: MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Mar 20, 2014
• Decision: SESE
• Submission Type: Traditional
• 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 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 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 with MR compatible devices such as in-room displays and MR Safe biopsy needles.

Device Story

MAGNETOM Artis Combi Suite is a hardware modification for MAGNETOM Aera and Skyra MR scanners; enables patient transfer workflow between Siemens Artis angiography systems and MR scanners via a patient transfer board. System allows movement of patients between imaging modalities; intended for clinical environments where interventional angiography and MR imaging are integrated. Physicians use resulting images for diagnostic purposes; system maintains existing MR imaging capabilities; benefits include streamlined patient handling during multi-modality procedures.

Clinical Evidence

No clinical data. Safety and effectiveness supported by risk management per ISO 14971:2007 and adherence to recognized standards including IEC 60601-1 series and NEMA standards for MR performance and safety.

Technological Characteristics

Hardware modification to MAGNETOM Aera/Skyra MR systems; includes dockable table and patient transfer board. Complies with IEC 60601-1 series, ISO, and NEMA standards. Operates as an MR diagnostic device; connectivity and software remain consistent with predicate MR systems.

Indications for Use

Indicated for patients requiring diagnostic MR imaging of head, body, or extremities; produces cross-sectional images/spectra for interpretation by trained physicians; 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

• syngo MR D 13A for MAGNETOM Aera, Skyra, Verio and Avanto (K121434)
• MAGNETOM Skyra with TimTX TrueShape and syngo MR D13C (K123510)

Submission Summary (Full Text)

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SIEMENS

**MAR 2 0 2014**

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# 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.

# I General Information

Date Prepared: January 30, 2014

| 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 |
| | SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.<br>Siemens MRI Center<br>Hi-Tech Industrial park (middle)<br>Gaoxin C. Ave., 2nd<br>Shenzhen 518057, P.R. CHINA<br>Registration Number: 3004754211 |
| Contact Person | Cordell L. Fields, Esq.<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>Fax: [phone]<br>E-mail: [e-mail] |

#### Classification and Device Name

| Trade name: | MAGNETOM Artis Combi Suite for the MAGNETOM systems Aera and Skyra. |
|-----------------------|--------------------------------------------------------------------------|
| Classification Name: | Regulation Description:<br>- Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| Regulation number: | 21 CFR § 892.1000 |
| Device Class: | II |
| Product Code: | Primary: LNH; Secondary: MOS |

## MAGNETOM Artis Combi Suite for the MAGNETOM systems Aera/Skyra

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# II Safety and Effectiveness Information Supporting Substantial Equivalence

## Device Description

MAGNETOM Artis Combi Suite is the marketing name for the modification of MAGNETOM Aera and MAGNETOM Skyra to include a modified dockable table for use with a standalone Artis system in a clinical workflow. The market name, MAGNETOM Artis Combi Suite, refers to a sales bundle of single items that have been combined to build up a patient transfer workflow from one medical device to another.

MAGNETOM Artis Combi Suite enables the user to move a patient via a patient transfer board from the patient table of a angiography system of the Siemens Artis family to the MR scanner.

The intended use of the MAGNETOM Aera and MAGNETOM Skyra as well as Artis imaging systems remains unchanged.

The MAGNETOM Artis Combi Suite will only be available for MAGNETOM systems Aera and Skyra and will be available as an option to new manufactured scanners; existing scanners can be upgraded to this sales bundle. The sales bundles include new hardware for the MAGNETOM systems Aera and Skyra.

## Substantial Equivalence

Sales bundle MAGNETOM Artis Combi Suite for the MAGNETOM systems Aera and Skyra is substantially equivalent to the following current legally marketed devices (please refer to Table 1):

| Predicate Device Name | FDA Clearance Number / Date | Manufacturer | Manufacturer, Product Code | Claim Substantial Equivalence to |
|--------------------------------------------------------------|-----------------------------------------|--------------|----------------------------|-------------------------------------------------------------------------|
| syngo MR D 13A for<br>MAGNETOM Aera, Skyra, Verio and Avanto | K121434,<br>cleared<br>November 5, 2012 | Siemens AG | LNH | - MAGNETOM Aera and<br>Skyra with syngo MR D13A<br>- Tim Dockable Table |
| MAGNETOM Skyra with<br>TimTX TrueShape and<br>syngo MR D13C | K123510,<br>cleared May<br>17, 2013 | Siemens AG | LNH | - MAGNETOM Skyra with<br>syngo MR D13C<br>- Tim Dockable Table |

| Table 1: | Predicate device(s) for MAGNETOM Artis Combi Suite for the<br>MAGNETOM systems Aera and Skyra |
|----------|-----------------------------------------------------------------------------------------------|
|----------|-----------------------------------------------------------------------------------------------|

### 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

MAGNETOM Artis Combi Suite for the MAGNETOM systems Aera/Skyra

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# SIEMENS

K140253
Page 3 of 3

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.

The MAGNETOM systems Aera and Skyra with sales bundle MAGNETOM Artis Combi Suite conform 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.

#### Indications for Use

Your 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.

Your 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.

### Conclusion as to Substantial Equivalence

MAGNETOM Aera and MAGNETOM Skyra and software syngo MR D13A with MAGNETOM Artis Combi Suite as well as MAGNETOM Skyra and software syngo MR D13C with MAGNETOM Artis Combi Suite has the same intended use and the same technical characteristics as the predicate devices with respect to the magnetic resonance features and functionalities. The differences between the subject device and the predicate devices, which include the aforementioned hardware, give the systems MAGNETOM Aera and MAGNETOM Skyra with SW syngo MR D13 and Artis family additional capabilities by allowing the user to move a patient transfer board from the patient table of a angiography system of the Siemens Artis family to the MR scanner. There are no new issues of safety or effectiveness introduced with the MAGNETOM Artis Combi Suite. The functionality of MAGNETOM Artis Combi Suite remains similar to that of the predicate devices, MAGNETOM Aera and MAGNETOM Skyra with software syngo MR D13A and syngo MR D13C for MAGNETOM Skyra.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. In the center of the seal is a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

#### Public Health Service

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

March 20, 2014

Siemens Medical Solutions USA, Inc. % Cordell L. Fields, Esa. Regulatory Affairs Technical Specialist 51 Valley Stream Parkway, Mail Code D02 MALVERN PA 19355

Re: K140253

Trade/Device Name: MAGNETOM Artis Combi Suite for the MAGNETOM systems Aera and Skyra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH Dated: January 30, 2014 Received: January 31, 2014

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 (2 l 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

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Page 2- Cordell L. Fields, Esq.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/default.htmfor 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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#### 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 on last page.

510(k) Number (if known)

# k140253

#### Device Name

"MAGNETOM Artis Combi Suite" for the MAGNETOM systems Acra and Skyra

#### Indications for Use (Describe)

The MAGNETOM MR system [Acra/Skyra] is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional 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 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 | Acra/Skyra] may also be used for imaging during interventional procedures with MR compatible devices such as in-room displays and MR Safe biopsy needles.

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

[x] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 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 Radiological Health (CDRH) (Signalure)

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FORM FDA 3881 (1/14)

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