MAGNETOM SPECTRA

K121160 · Siemens Medical Solutions USA, Inc. · LNH · Jul 16, 2012 · Radiology

Device Facts

• Record ID: K121160
• Device Name: MAGNETOM SPECTRA
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jul 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MAGNETOM Spectra 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 Spectra may also be used for imaging during interventional procedures when performed with MR compatible devices such as inroom display and MR-safe biopsy needles.

Device Story

MAGNETOM Spectra is a 3T superconducting whole-body MRI scanner; utilizes magnetic resonance physics to acquire cross-sectional images, spectroscopic images, and spectra of head, body, and extremities. System features open-bore design for patient comfort; fixed configuration. Operated by trained clinicians/technicians in clinical settings; supports interventional procedures via MR-compatible accessories (e.g., biopsy needles). Output consists of visual images and derived physical parameters; interpreted by physicians to assist in clinical diagnosis. System workflow emphasizes ergonomics and usability. Benefits include non-invasive diagnostic visualization of internal structures and function.

Clinical Evidence

Bench testing only. Performance and safety data measured per NEMA, IEC, and ISO standards, including static field, RF power deposition, acoustic noise, signal-to-noise ratio, image uniformity, geometric distortion, slice profile, and spatial resolution. No clinical data presented.

Technological Characteristics

3T superconducting magnet; open-bore whole-body scanner. Conforms to IEC, ISO, and NEMA standards for MR safety and performance. Fixed configuration. Software-based image reconstruction and processing.

Indications for Use

Indicated for patients requiring diagnostic MR imaging of the head, body, or extremities; produces cross-sectional images, spectroscopic images, and spectra to assist in diagnosis; supports interventional procedures using MR-compatible devices. Contraindications include presence of non-MR-safe implants or 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 Skyra (3T) (K101347)
• Siemens MAGNETOM Verio (3T) (K072237)
• syngo® MR B17 Software update (K082427)
• Hardware and Software Updates to MAGNETOM Aera (1.5T) and Skyra (3T) (K111242)

Submission Summary (Full Text)

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510K Summary

# SIEMENS

#### Traditional 510(k) Submission: MAGNETOM Spectra 3T System

# I. General Information

Establishment

Siemens Medical Solutions USA. Inc. 51 Valley Stream Parkway Mail Code G01 Malvern, PA 19355, USA

JUL 16 2012

Date Prepared

April 13, 2012

2240869

Registration Number

Manufacturer

Siemens Shenzhen Magnetic Resonance Ltd. Siemens MRI Center Gaoxin C. Ave., 2nd Hi-Tech Industrial Park, Shenzhen 518057, P.R. China

### Registration Number

Contact Person

3004754211

Ms. Nadia Sookdeo Regulatory Affairs Technical Specialist Siemens Healthcare

Siemens Medical Solutions USA, Inc. Customer Solutions Group 51 Valley Stream Parkway Mail Code G01 Malvern, PA 19355, USA Phone: [phone] Fax: [phone]

Device Name

Trade Names: MAGNETOM Spectra Classification Name: Magnetic Resonance Diagnostic Device CFR Code: 21 CFR § 892.1000 Classification: Class II

#### Performance Standards

None established under Section 514 the Food, Drug and Cosmetic Act.

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SIEMENS

Traditional 510(k) Submission: MAGNETOM Spectra 3T System

### II. Safety and Effectiveness Information Supporting Substantial Equivalence

### Intended Use

The MAGNETOM Spectra 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 Spectra may also be used for imaging during interventional procedures when performed with MR compatible devices such as inroom display and MR-safe biopsy needles.

#### Device Description

MAGNETOM Spectra (3T) is similar to the previously cleared MAGNETOM Skyra and MAGNETOM Verio, utilizing a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to simplify the MR workflow.

The MAGNETOM Spectra systems will be available in a fixed configuration.

#### Substantial Equivalence

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

| Predicate Device Name | FDA<br>Clearance<br>Number | FDA Clearance<br>Date |
|-------------------------------------------------------------------------|----------------------------|-----------------------|
| Siemens MAGNETOM Skyra (3T) | K101347 | October 1, 2010 |
| Siemens MAGNETOM Verio (3T) | K072237 | October 10, 2007 |
| syngo® MR B17 Software update | K082427 | November 7, 2008 |
| Hardware and Software Updates to<br>MAGNETOM Aera (1.5T) and Skyra (3T) | K111242 | November 23, 2011 |

#### General Safety and Effectiveness Concerns:

Operation of the MAGNETOM Spectra system is substantially equivalent to the commercially available MAGNETOM Skyra and MAGNETOM Verio System.

# Siemens 510(k) for MAGNETOM Spectra

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Traditional 510(k) Submission: MAGNETOM Spectra 3T System

As specified in the FDA guidance document "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Devices" (released Nov. 1998) the following measurements of performance and safety data have been performed following NEMA or equivalent IEC and ISO standards:

### Safety:

- Maximum Static Field
- · Rate of Change of Magnetic Field

SIEMENS

- · RF Power Deposition
- · Acoustic Noise Levels

#### Performance:

- · Specification Volume
- · Signal to Noise
- · Image Uniformity
- · Geometric Distortion
- · Slice Profile. Thickness and Gap
- High Contrast Spatial Resolution

The MAGNETOM Spectra also conforms to the measurements of safety parameters to the international IEC, ISO and NEMA standards for safety issues with Magnetic Resonance Imaging Diagnostic Devices.

Furthermore performance measurements have been done on the predicate devices MAGNETOM Skyra and MAGNETOM Verio to show that the performance of the MAGNETOM Spectra is equivalent with respect to the predicate devices, assuring that the performance of these devices can be considered safe and effective with respect to the currently available MAGNETOM Skyra and MAGNETOM Verio systems.

# Siemens 510(k) for MAGNETOM Spectra

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

Re: K121160

Trade/Device Name: MAGNETOM Spectra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, KNI, and MOS Dated: April 13, 2012 Received: April 16, 2012

JUL 16 2012

#### Dear Ms. Sookdeo:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section >10(x) promative is substantialy enuivalent (for the indications
referenced above and have determined the device is substantialy marketed in int referenced above and have ustemmed the actives marketed in interstate for use stated in the encrosure) to regary manation to the Medical Device Ameralments, or to commerce prof to May 28, 1970, the cidemic and of the provisions of the Federal Food, Drug, devices that have been reciassified in accordance with the provisions of the Act. The and Cosmetic Act (Act) that do not require apper of the general controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject equirements for annual registration, listing of
general controls provisions of the Act include requirements for annual registra general controls provisions of the necessor squals would the sugainst misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (see above) and class affecting your device , an be found in Title 21 ,
additional controls. Existing major regulations , 2005 , also supplish fu additional controls. Existing major regulations and to 195. In addition, FDA may publish further
Code of Federal Regulations (CFR), Parts 800 to 195. In and 195 Couc of I ederal regaration your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substitive with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has made a determination and your corred by other Federal agencies: You must or any Federal statutes and regulances and including, but not limited to: registing (21)
comply with all the Act's requirements, and act and section (reporting (reporting of comply with an the Act s requirements, theracing, our november of the reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related adverse cromby (21 cegulation (21 CFR Part 820). This letter requirents as set form in the quality of evice as described in your Section 510(k) premaket will anow you to begin marketing your as not equivalence of your device to a legally marketed notification. The FDA imanig of subbantial organ device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and II you uesne specific advice for your covice earonstic Device Evaluation and Safety at (301) 796-007), promote 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

under the MDA regulation (21 Of Ferrare 60) personal of 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 Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# SIEMENS

Traditional 510(k) Submission: MAGNETOM Spectra 3T System

# Section 4 Indications for Use Statement

510(k) Number (if known)

MAGNETOM Spectra Device Names:

## Indications for Use:

The MAGNETOM Spectra 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 cross socional images, are function of the head, body, or extremities.

Other physical parameters derived from the images and/or spectra may also be other priysiour paramotions on the region of interest, contrast agents may be used. produce. Boponaing 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 Spectra may also be used for imaging during interventional The MAGNETOm opeona with MR compatible devices such as inroom 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 Diagnostic Devices (OVID)

.A.D.N.

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K12160

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