QUIET/SILENT SCANNING SUITE

K132831 · Siemens Medical Solutions USA, Inc. · LNH · Nov 1, 2013 · Radiology

Device Facts

• Record ID: K132831
• Device Name: QUIET/SILENT SCANNING SUITE
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Nov 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

The MAGNETOM systems Aera and Skyra with the updated software syngo MR D13A are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display 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 systems Aera and Skyra with the updated software syngo MR D13A may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MRsafe biopsy needles.

Device Story

Software update for MAGNETOM Aera (1.5T) and Skyra (3T) MRI systems. Modifies existing imaging sequences, specifically introducing 'Quiet' sequences and VIBE sequence improvements. Operates in clinical settings; managed by trained physicians and technologists. Input consists of raw MR signal data; software processes these signals to reconstruct transverse, sagittal, coronal, and oblique images or spectra. Output displayed on system monitors for clinical interpretation. Enhancements aim to reduce acoustic noise, improve workflow, and provide additional diagnostic options. Benefits include improved patient comfort via noise reduction and enhanced diagnostic utility for clinicians.

Clinical Evidence

No clinical trials conducted. Evidence consists of bench testing, including acoustic noise testing, and verification/validation of software features. Clinical images provided to demonstrate the performance of modified software sequences.

Technological Characteristics

Software update for 1.5T (Aera) and 3T (Skyra) MRI systems. Utilizes standard MR physics (RF pulses, magnetic field gradients). Conforms to IEC 60601-1 series, ISO 14971:2007, and NEMA standards for MR safety and performance. Software-based sequence control.

Indications for Use

Indicated for use as magnetic resonance diagnostic devices to produce cross-sectional images and spectra of the head, body, or extremities for diagnostic purposes. Applicable to patients requiring MR imaging, including interventional procedures using MR-compatible devices. No specific age or gender contraindications stated beyond standard MR safety precautions.

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 Aera, Skyra, Avanto, and Verio with syngo® MR D13A (K121434)

Submission Summary (Full Text)

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NOV 0 1 2013

Traditional 510(k) Submission

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This 510(k) summary is being submitted in accordance with 21 CFR § 807.92.

# 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 |
| | 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 | 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: Nadia. [e-mail] |
| Device Name | Software update syngo MR D13A-AP-AA to the<br>commercially available software version syngo MR D13A<br>for MAGNETOM Aera and MAGNETOM Skyra |
| CFR Code | 21 CFR § 892.1000 |
| Classification | Class II |
| Product Codes | LNH, LNI, MOS |
| Classification Name | Magnetic Resonance Diagnostic Device,<br>MR Spectroscopy, MR Coils |

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SIEMENS

K132831
page 2 of 4

Traditional 510(k) Submission

# Information Supporting Substantial Equivalence

## DEVICE DESCRIPTION

The software version syngo MR D13A is updated for two Siemens MR systems:

- o MAGNETOM Aera (1.5T)
- o MAGNETOM Skyra (3T)

Systems that are already in clinical use and at customer sites can be updated with this software update; both MAGNETOM systems can be manufactured with this software update.

This software update includes modified software sequences for MAGNETOM Aera and MAGNETOM Skyra.

MAGNETOM Aera and MAGNETOM Skyra with software syngo MR D13A were previously cleared under K121434 (November 5, 2012).

Summary of Features New with the Software Update compared to the commercially available Software Version syngo MR D13A:

#### Software

- Modified sequences: .
- Quiet sequences o
- VIBE sequence improvements o

#### INTENDED USE

The MAGNETOM systems Aera and Skyra with the updated software syngo MR D13A are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display 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 systems Aera and Skyra with the updated software syngo MR D13A may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MRsafe biopsy needles.

## NONCLINICAL TESTS

Software Update syngo MR D13A for MAGNETOM Aera/Skyra

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K132831
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# SIEMENS

Performance testing such as acoustic noise testing was conducted on the subject device. Additionally, all 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

There were not any clinical tests conducted to support the subject device and the substantial equivalence argument, however clinical images are provided to support the modified software features of the subject device.

## SUBSTANTIAL EQUIVALENCE

Software update to the commercially available software version syngo MR D13A for MAGNETOM Aera and MAGNETOM Skyra is substantially equivalent to the following predicate devices:

| Predicate Device Name | FDA<br>Clearance<br>Number | FDA Clearance<br>Date | Main<br>Product<br>Code |
|-------------------------------------------------------------------|----------------------------|-----------------------|-------------------------|
| MAGNETOM Aera, Skyra,<br>Avanto, and Verio with syngo®<br>MR D13A | K121434 | November 5, 2012 | LNH |

Predicate device for Software Update to the commercially available software version Table 1 syngo MR D13A for MAGNETOM Aera and MAGNETOM 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 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.

MAGNETOM systems Aera and Skyra with the updated software syngo MR D13A 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.

## SUBSTANTIAL EQUIVALENCE CONCLUSION

There are no changes to the Indications for Use for the subject device, compared to that of the predicate MAGNETOM scanners with software syngo MR D13A.

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SIEMENS

Traditional 510(k) Submission

While the updated software provides the user with additional capabilities compared to the two subject MAGNETOM systems with the previous software version syngo MR D13A, it has the same technological characteristics as that of the predicate devices. The modifications of the updated software version make the systems and software more user- and patient-friendly - providing imaging techniques with lower noise towards the patient: improving the user's workflow: providing additional information and options to the user.

The differences between the subject device and the predicate devices, which include the aforementioned modified sequences, give the systems greater capabilities than the predicate devices, but have the same technological characteristics as the predicate devices, are similar to the functionalities of the predicate devices, and do not introduce any new issues of safety or effectiveness.

Therefore. Siemens believes that the subject device, the updated software version syngo MR D13A for MAGNETOM systems Aera and Skyra is substantially equivalent to the predicate devices listed above.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 1. 2013

Siemens Medical Solutions USA, Inc. % Ms. Nadia Sookdeo Regulatory Affairs Technical Specialist 51 Valley Stream Parkway, MC D02 MALVERN PA 19355

Re: K132831

Trade/Device Name: Syngo MR D13A-AP-AA software update Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: September 25, 2013 Received: September 26, 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. Iisting 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

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forth in the quality systems (OS) 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 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" (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/ReportalProblem/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,

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): K132831

Device Name: Syngo MR D13A-AP-AA software update for MAGNETOM Aera and MAGNETOM Skyra

Indications for Use:

The MAGNETOM systems Aera and Skyra with the updated software syngo MR DI3A are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse. sagittal. coronal and oblique cross sectional images. spectroscopic images and/or spectra, and that display 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, vield information that may assist in diagnosis.

The MAGNETOM systems Aera and Skyra with the updated software syngo MR D13A 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 × (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

210(k) K 13283 1

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