MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION

K052423 · Siemens Medi Cal Solutions, Inc. · LNH · Jan 13, 2006 · Radiology

Device Facts

• Record ID: K052423
• Device Name: MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION
• Applicant: Siemens Medi Cal Solutions, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jan 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The following MAGNETOM systems: MAGNETOM 1.5 T Avanto MAGNETOM 1.5 T Espree MAGNETOM 1.5 T Symphony a Tim System MAGNETOM 3.0 T Trio a Tim System MAGNETOM 1.0 T Harmony MAGNETOM 1.5 T Symphony MAGNETOM 1.5 T Sonata MAGNETOM 0.2 T Concerto MAGNETOM 3.0 T Trio with syngo Expert—i option described in this premarket notification 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. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. They 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 syngo Expert-i option is a software feature for Siemens MAGNETOM MRI systems; it enables remote access to the MRI main or satellite console by authorized personnel within the local radiology department network. The system allows a remote user (e.g., physician or technician) to assist the local operator (e.g., technician) in real-time during scanning. This collaborative workflow aims to improve scan speed and image quality by facilitating expert guidance. The device does not alter the fundamental MR imaging physics or hardware of the predicate systems; it functions as a communication and remote-control interface for the existing console software. Healthcare providers use the remote access to provide guidance, which may influence scan parameters or procedural decisions, potentially benefiting patients through optimized imaging protocols and reduced scan times.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and risk analysis regarding the safety of the remote access software feature.

Technological Characteristics

Software option for existing MAGNETOM MRI systems. Connectivity: Local area network (LAN) integration for remote console access. Hardware: Unchanged from predicate systems. Safety: Risk analysis performed for remote access functionality.

Indications for Use

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

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 1.5 T Avanto (K032428)
• MAGNETOM 1.5 T Espree (K041112)
• MAGNETOM 1.5 T Symphony a Tim System (K050199)
• MAGNETOM 3.0 T Trio a Tim System (K050200)
• MAGNETOM 1.0 T Harmony (K970852)
• MAGNETOM 1.5 T Symphony (K971684)
• MAGNETOM 1.5 T Sonata (K993731)
• MAGNETOM 0.2 T Concerto (K003192)
• MAGNETOM 3.0 T Trio (K013586)

Submission Summary (Full Text)

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## JAN I 3 2006 (052423 Section 1 - 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 Medical Solutions<br>Henkestrasse 127<br>D91052 Erlangen, Germany |
| Registration Number | 8010024 |
| Contact Person | Ms. Judy Campbell<br>Technical Specialist, Regulatory Submissions<br>51 Valley Stream Parkway<br>Malvern. PA 19355<br>Phone: [phone]<br>Fax: [phone] |
| Device Name | Trade Name:<br>MAGNETOM Systems with <i>syngo</i> Expert—i option |
| Classification Name:<br>CFR Section:<br>Classification: | Magnetic Resonance Diagnostic Device<br>21 CFR § 892.1000<br>Class II |

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

H. Safety and Effectiveness Information Supporting Substantial Equivalence.

Intended Use The following MAGNETOM systems:

MAGNETOM 1.5 T Avanto MAGNETOM 1.5 T Espree MAGNETOM 1.5 T Symphony a Tim System MAGNETOM 3.0 T Trio a Tim System

Siemens 510(k) Premarket Notiification 1 Syngo Expert-I Option for MAGNETOM Systerns CONFIDENTIAL

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K05 2423

MAGNETOM 1.0 T Harmony MAGNETOM 1.5 T Symphony MAGNETOM 1.5 T Sonata MAGNETOM 0.2 T Concerto MAGNETOM 3.0 T Trio

with syngo Expert—i option described in this premarket notification 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. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.

They may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room display and MR safe biopsy needles.

Siemens Medical Solutions, Inc., intends to offer a software option called syngo Expert—i. The indications for use will stay exactly the same, with respect to the previous > oftware versions mentioned in the comparison matrix.

## Substantial Equivalence

Within the definition of the Safe Medical Devices Act of 1990, the

MAGNETOM 1.5 T Avanto MAGNETOM 1.5 T Esprec MAGNETOM 1.5 T Symphony a Tim System MAGNETOM 3.0 T Trio a Tim System MAGNETOM 1.0 T Harmony MAGNETOM 1.5 T Symphony MAGNETOM 1.5 T Sonata MAGNETOM 0.2 T Concerto MAGNETOM 3.0 T Trio

with syngo Expert-i Option are substantially equivalent to the following cleared medical devices:

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Section 2: Required Forms and Documents

| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|--------------------------------------|----------------------|--------------------|
| MAGNETOM 1.5 T Avanto | K032428 | October 16, 2003 |
| MAGNETOM 1.5 T Espree | K041112 | July 21, 2004 |
| MAGNETOM 1.5 T Symphony a Tim System | K050199 | February 18, 2005 |
| MAGNETOM 3.0 T Trio a Tim System | K050200 | February 28, 2005 |
| MAGNETOM 1.0 T Harmony | K970852 | June 5, 1997 |
| MAGNETOM 1.5 T Symphony | K971684 | August 5, 1997 |
| MAGNETOM 1.5 T Sonata | K993731 | December 23, 1999 |
| MAGNETOM 0.2 T Concerto | K003192 | December 21, 2000 |
| MAGNETOM 3.0 T Trio | K013586 | December 28, 2001 |

KOSZ

General Safety and Effectiveness Concerns:

The introduction of the syngo Expert—i Option has effect on the MR safety. Therefore a risk analysis has been performed including new safety measures to reduce the residual risks to an acceptable level.

The MRI systems are exactly the same as what was described and cleared in the predicate premarket notifications. Safety testing will be completed before commercial introduction to the market.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2006

Ms. Judith Campbell Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355

Re: K052423

Trade/Device Name: MAGNETOM Systems with syngo Expert-i option Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: December 22, 2005 Received: December 30, 2005

Dear Ms. Campbell:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device (o proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on 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 807.97). 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/cdrh/industry/support/index.html

Sincerely yours,

Nancy 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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## Kos 2423 Section 3 - Indications for Use

| Device Name | FDA Clearance Number |
|--------------------------------------|----------------------|
| MAGNETOM 1.5 T Avanto | K032428 |
| MAGNETOM 1.5 T Espree | K0411-12 |
| MAGNETOM 1.5 T Symphony a Tim System | K050199 |
| MAGNETOM 3.0 T Trio a Tim System | K050200 |
| MAGNETOM 1.0 T Harmony | K970852 |
| MAGNETOM 1.5 T Symphony | K971684 |
| MAGNETOM 1.5 T Sonata | K993731 |
| MAGNETOM 0.2 T Concerto | K003192 |
| MAGNETOM 3.0 T Trio | K013586 |

The above listed MAGNETOM systems are 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.

They may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room display and MR safe biopsy needles.

The syngo Expert-i feature allows the local user of the MRI (e.g. tech) to get help and assistance from other personnel of the radiology department (e.g. other tech or physician) to perform scans faster and with better quality. For this purpose, a remote user within the local network of the MRI (i.e. the network of the radiology) can log onto the MR main or satellite console.

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| | Concurrence of CDRH, Office of Device Evaluation |
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|--|--------------------------------------------------|

| Prescription Use | |
|----------------------|--|
| OR | |
| Over-The-Counter Use | |

| | <div align="center">(Division Sign-Off)</div> |
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| Siemens 510(k) Premarket Notification | Division of Reproductive, Abdominal, and Radiological Devices |
|--------------------------------------------|---------------------------------------------------------------|
| Syngo Expert-I Option for MAGNETOM Systems | (k) Number K052473 CONFIDENTIAL |

Syngo Expert-I Option for MAGNETOM Systems(k) Number _