MAGNETOM TRIO A TIM SYSTEM

K050200 · Siemens Medical Solutions USA, Inc. · LNH · Feb 28, 2005 · Radiology

Device Facts

• Record ID: K050200
• Device Name: MAGNETOM TRIO A TIM SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MAGNETOM Trio a Tim System is intended 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. These images and/or spectra, when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM Trio a Tim System may also be used for imaging during interventional procedures performed with MR compatible devices such as in room display and MR safe biopsy needles.

Device Story

The MAGNETOM Trio a Tim System is a 3.0 T closed superconducting magnet whole-body scanner. It acquires magnetic resonance signals to generate transverse, sagittal, coronal, and oblique cross-sectional images and spectroscopic data. Operated by trained clinicians in a clinical setting, the system displays internal anatomical structures and functions to assist in medical diagnosis. It supports interventional procedures when used with MR-compatible accessories like biopsy needles and in-room displays. The device leverages hardware components shared with existing MAGNETOM Trio and Avanto platforms to provide diagnostic imaging capabilities.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and adherence to recognized NEMA and IEC performance and safety standards for magnetic resonance diagnostic devices.

Technological Characteristics

3.0 T closed superconducting magnet whole-body scanner. Utilizes magnetic resonance imaging principles. Conforms to NEMA standards for performance and IEC standards for safety. Hardware is derived from existing MAGNETOM Trio and Avanto systems.

Indications for Use

Indicated for use as an MR diagnostic device to produce cross-sectional images and spectra of the head, body, or extremities to assist in diagnosis. May be used during interventional procedures with MR-compatible devices. No specific age or gender restrictions; contraindicated for patients incompatible with MR environments.

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 1.5 T Avanto (K032428)
• Siemens MAGNETOM 3.0 T Trio (K013586)

Submission Summary (Full Text)

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# 12 510(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

| Establishment | Siemens Medical Solutions. Inc.<br>51 Valley Stream Parkway<br>Malvern. PA 19355 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 2240869 |
| Manufacturer | Siemens AG. Bereich Med<br>Henkestrasse 127<br>D-91052 Erlangen. Germany |
| Registration Number | 8010024 |
| Contact Person | Ms. Ana Ladino<br>Technical Specialist. Regulatory Submissions<br>51 Valley Stream Parkway<br>Malvern. PA 19355<br>Phone: [phone]<br>Fax: [phone] |
| Device Name | Trade Name: MAGNETOM Trio a Tim System<br>Classification Name: Magnetic Resonance Diagnostic Device<br>CFR Code: 21 CFR § 892.1000<br>Classification: Class II |

#### Performance Standards

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

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

#### Indications for Use

The MAGNETOM Trio a Tim System is intended 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. These images and/or spectra, when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM Trio a Tim System may also be used for imaging during interventional procedures performed with MR compatible devices such as in room display and MR safe biopsy needles.

#### Device Description

The MAGNETOM Trio a Tim System is a 3.0 T closed superconducting magnet whole body designed scanner. It consists of the same types of hardware that are currently available with the MAGNETOM Trio and Avanto systems.

#### Substantial Equivalence

The system is substantially equivalent to the following cleared medical devices:

| Predicate Device Name | FDA Clearance<br>Number | FDA Clearance Date |
|-------------------------------|-------------------------|--------------------|
| Siemens MAGNETOM 1.5 T Avanto | K032428 | October 16, 2003 |
| Siemens MAGNETOM 3.0 T Trio | K013586 | December 28, 2001 |

#### General Safety and Effectiveness Concerns:

Operation of the MAGNETOM Trio a Tim System is substantially equivalent to the commercially available MAGNETOM 3.0 T Trio System and 1.5 T Avanto System.

The MAGNETOM Trio a Tim System will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Trio and Avanto systems.

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Public Health Service

Image /page/2/Picture/2 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 an abstract symbol that resembles a stylized eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.

### FEB 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ana Ladino Technical Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway MALVERN PA 19355

Re: K050200

Trade/Device Name: MAGNETOM Trio a Tim System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: January 25, 2005 Received: January 28, 2005

Dear Ms. Ladino:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your becalled by equivalent (for the indications for use stated in above and nave deceminearketed predicate devices marketed in interstate commerce prior to the enclosure) to tegally manelou produced Device Amendments, or to devices that have been May 20, 1770, the onlinement active and of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accondation warmarket approval application (PMA). You may, therefore, market the do not require approval of a promance of the Act. The general controls provisions of the Act device, subject to the general version, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is other the (see and additional controls. Existing major regulations affecting your Apploval), It inay of our 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 I Tcase be advised that 1991 to issual your device complies with other requirements of the Act or any FTA has made a decemmation mad your were rederal agencies. You must comply with all the r cacral statues and regulation but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 8017, good manakelif applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the supplied of a line of a latestial againsteals This letter will allow you to begin market as walness of your device of your device to a legally
premarket notification. The FDA finding of substantial equise of your device premarket notification. The FDA Inding of substantial equiratelie of your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleased
on the regulation of the fillers for af Hearing numbers, based on the r If you desire specific advice for your device on but facemig regarities. (even the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoraniality of your responsibilities under the Act from the 807.97). You may obtain other general informations on your responsibility of the number (800)
Division of Small Manufacturers, International and Consumer Assistance at its t DAVIsion of Sman Man-6597 or at its Internet address 056-2011-01-11-01-12-2017-01-11 11:11:11 11-01-2017

Sincerely yours,

Nanay C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 3 Indications for Use Statement

510(k) Number (if known) _Ko So2 00

Device Name: MAGNETOM Trio a Tim System

Indications for Use:

The MAGNETOM Trio a Tim System 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. These images and/or spectra, when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM Trio a Tim System may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room display and MR safe biopsy needles.

(please do not write below this line- continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation

| Prescription Use | <span style="text-decoration: underline;">✓</span> | OR | Over-The-Counter Use | <span style="text-decoration: underline;"></span> |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|----------------------|---------------------------------------------------|
| | <div> <span style="text-decoration: underline;">David A. Legmann</span> </div> <div>(Division Sign-Off)</div> <div>Division of Reproductive, Abdominal,</div> <div>and Radiological Devices</div> | | | |
| 510(k) Number | <span style="text-decoration: underline;">K050200</span> | | | |

Siemens 510(k) Premarket Notification MAGNETOM Trio a Tim System

January 25, 2005

CONFIDENTIAL