MAGNETOM ESSENZA

K071925 · Siemens Medical Solutions USA, Inc. · LNH · Aug 14, 2007 · Radiology

Device Facts

• Record ID: K071925
• Device Name: MAGNETOM ESSENZA
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Aug 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MAGNETOM Essenza 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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis. The MAGNETOM Essenza 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.

Device Story

1.5T closed superconducting MRI scanner; utilizes Matrix Coils and Total Imaging Matrix (Tim) technology. Inputs: magnetic resonance signals from patient anatomy. Transformation: spatial encoding and signal processing to generate cross-sectional images and spectra. Output: diagnostic images/spectra displayed for physician interpretation. Used in clinical settings by trained physicians/technicians. Supports interventional procedures via MR-compatible accessories (e.g., biopsy needles, in-room displays). Assists in clinical diagnosis by visualizing internal structures and function.

Clinical Evidence

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

Technological Characteristics

1.5T closed superconducting magnet; utilizes Matrix Coils and Total Imaging Matrix (Tim) technology. Modified gradient coil and RF body resonator. Conforms to NEMA performance standards and IEC safety standards for MRI devices.

Indications for Use

Indicated for patients requiring diagnostic MR imaging or spectroscopy of the head, body, or extremities, including interventional procedures. No specific age or gender contraindications provided.

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)
• Software syngo MR VB15 (K062454)
• Siemens MAGNETOM 1.5 T Symphony (MAGNETOM Project 047) (K971684)

Submission Summary (Full Text)

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K07/925

Section 5: 510(k) Summary

# 5 510(k) Summary

AUG 1 4 2007

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 Mindit Magnetic Resonance Ltd.<br>Siemens MRI Center,<br>Gaoxin C. Ave. 2nd<br>Hi-Tech Industrial Park,<br>ShenZhen 518057, PR. China |
| Registration Number | 3004754211 |
| 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: MAGNETOM Essenza<br>Classification Name: Magnetic Resonance Diagnostic Device<br>CFR Code:<br>21 CFR § 892.1000<br>Classification:<br>Class II |

#### Performance Standards

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

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### Section 5: 510(k) Summary

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

#### Intended Use

The MAGNETOM Essenza is indicated for use as magnetic resonance diagnostic devices (MRDD) that produces 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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.

The MAGNETOM Essenza 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.

#### Device Description

The MAGNETOM Essenza System is a 1.5 T closed superconducting magnet designed scanner. It consists of the same types of hardware (with a modified gradient coil, RF body resonator and magnet) that are currently available with the MAGNETOM Avanto Systems, including Matrix Coils and Total Imaging Matrix (Tim) Technolgy.

#### Substantial Equivalence

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

| Predicate Device Name | FDA Clearance<br>Number | FDA Clearance<br>Date |
|-----------------------------------------------------------|-------------------------|-----------------------|
| Siemens MAGNETOM 1.5 T Avanto | K032428 | Oct 16, 2003 |
| Software syngo MR VB15 | K062454 | Nov 3, 2006 |
| Siemens MAGNETOM 1.5 T<br>Symphony (MAGNETOM Project 047) | K971684 | Aug 5, 1997 |

#### General Safety and Effectiveness Concerns:

The MAGNETOM Essenza 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 Avanto and MAGNETOM Symphony 1.5 T systems.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### AUG 1 4 2007

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

Re: K071925

Trade/Device Name: MAGNETOM Essenza Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 11, 2007 Received: July 12, 2007

#### 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.

Image /page/2/Picture/9 description: The image is a circular seal with the text "1906-2006" at the top. The letters "FDA" are in the center of the seal in a bold, sans-serif font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The seal appears to be a commemorative emblem for the centennial anniversary of the FDA.

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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.

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 to 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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Chogdon

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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## 4 Indications for Use Statement

510(k) Number (if known)_ Kひフ/ 9 2 5

Device Name: MAGNETOM Essenza

#### Indications for Use:

The MAGNETOM Essenza 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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM Essenza may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR-safe biops y needles.

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

| Concurrence of CDRH, Office of Device Evaluation | |
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Prescription Use

Over-The-Counter Use

J.L. Hanz
(Division Sign-Off)

OR

of Reproductive. Ab