OR HEAD COIL 1.5 T

K060758 · Siemens Medical Solutions USA, Inc. · MOS · May 5, 2006 · Radiology

Device Facts

• Record ID: K060758
• Device Name: OR HEAD COIL 1.5 T
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: MOS · Radiology
• Decision Date: May 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The intended use of the Noras OR head coil 1.5 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging). Used in the 1.5T MAGNETOM Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Device Story

OR Head Coil 1.5T is an 8-channel phased array coil designed for 1.5T MRI systems; consists of top and bottom arrays (4 channels each) tuned to 63.6 MHz (1H spin). Used in operating rooms for brain surgery imaging and standard diagnostic/fMRI head exams; requires Siemens OR Head Holder. Device captures MR signals from the head; transmits data via cables to MAGNETOM system for image reconstruction. Physician interprets resulting transverse, sagittal, coronal, and oblique images to assist in clinical diagnosis. Benefits include enabling intra-operative visualization of brain structures during neurosurgical procedures.

Clinical Evidence

Bench testing only. Performance and safety parameters verified against NEMA standards and IEC 60601-2-33:2002. Testing conducted on syngo MR2004A software platform, with risk analysis confirming applicability to syngo MR2006A and MAGNETOM 1.5T systems.

Technological Characteristics

8-channel phased array coil; 1.5T magnetic field strength; 63.6 MHz resonant frequency. Comprised of top and bottom arrays. Connectivity via dedicated cables to MAGNETOM MRI systems. Conforms to NEMA standards and IEC 60601-2-33:2002.

Indications for Use

Indicated for patients requiring MR examination of the human brain, including pre-operative, intra-operative, and post-operative brain surgery assessment, as well as standard diagnostic head examinations and fMRI.

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

• MRI Devices Corporation (Now Known as Invivo Corporation) High Resolution Head Coil -Model HRH-63-8 (K013159)

Submission Summary (Full Text)

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### 510(k) Summary

## OR Head Coil 1.5T

MAY - 5 2006

Date of Summary Preparation: March 15, 2006

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

- General Information 1.
- Importer/Distributor Name and Address Siemens Medical Solutions, Inc. 51 Valley Stream Parkway Malvern, PA 19355

Establishment Registration Number 2240869

Manufacturing Site Name and Address Noras Röntgen- und Medizintechnik GmbH Leibnizstrasse 4 97204 Höchberg Germany

Establishment Registration Number Establishment Registration 3004929307

Owner/Operator 9071737

#### Contact Person 2.

Judy Campbell Siemens Medical Solutions, Inc. 51 Valley Stream Parkway, E-50 Malvern, PA 19355 Telephone: [phone] [phone] Fax: Email Address: [e-mail]

CONFIDENTIAL

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Trade Name: Common Name: Classification Name: Classification Panel: CFR Number: Device Class: Product Code:

OR Head Coil 1. OR Head Coil 1.5 Magnetic Resonance Diagnostic Device Radiology 21 CFR § 892.1000 ============================================================================================================================================================================== 90MOS

#### 4. Device Description

The OR Head Coil 1.5T is an 8-channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. Each channel is tuned to the Larmor frequency of the 1H spin in a magnetic field of 1.5T, 63.6 MHz. Each coil is connected to the MAGNETOM system by a separate cable.

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Use of the OR Head Coil 1.5T requires the Siemens OR Head Holder. The pictures below show the complete set.

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Traditional 510(k) Noras Rontgen- Und Medizintechnik GmbH OR Head Coil 1.5T March 16, 2006

CONFIDENTIAL

000 05

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Image /page/2/Picture/0 description: The image shows a logo with the text "RÖNTGEN- UND MEDIZINTECHNIK" in bold, black letters. The text is stacked in two lines, with "RÖNTGEN- UND" on the top line and "MEDIZINTECHNIK" on the bottom line. To the left of the text is a stylized graphic that resembles a triangle with a horizontal line extending from its base. The logo appears to be for a company or organization related to X-ray and medical technology.

The intended use of the Noras OR Head Coil ST is the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. It can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI.

#### 6. Substantial Equivalence

Noras and Siemens believe that, within the meaning of the Safe Medical Devices Act of 1990, the 8-channel phased array OR head coil 1.5T for the Magnetom Systems is substantially equivalent to the following coil:

| Coil Name | Pemarket Notification | Clearance Date |
|--------------------------------------------------------------------------------------------------------------------|-----------------------|------------------|
| MRI Devices<br>Corporation (Now<br>Known as Invivo<br>Corporation)<br>High Resolution Head<br>Coil -Model HRH-63-8 | K013159 | October 16, 2001 |

### Summary of Technological Characteristics of the Principal Device as 7. Compared with the predicate Device

Although the MRI Devices High Resolution Head Coil is limited for use outside the operating room, we believe that both coils are substantially equivalent.

#### General Safety and Effectiveness Concerns 8.

The OR Head Coil 1.5T will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the IEC standards for safety issues with the Magnetic Resonance Imaging Devices, IEC 60601-2-33: 2002. This will assure that the performance of this device can be considered safe and effective when used with the currently available MAGNETOM 1.5T systems.

The NEMA Tests can be found in Appendix C. The NEMA Tests were done on Software platform syngo MR2004A. We have included the Common Risk Analysis for syngo MR2006A, which is the same functionality as syngo platform MR 2004A. We believe the NEMA tests on the Symphony are applicable to all MAGNETOM 1.5T systems.

Traditional 510(k) Noras Rontgen- Und Medizintechnik GmbH OR Head Coil 1.5T March 16, 2006

CONFIDENTIAL

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Image /page/3/Picture/0 description: The image shows the logo for NORAS Röntgen- und Medizintechnik. The word "NORAS" is in large, bold, black letters. To the right of "NORAS" is a black line that forms a V shape, and to the right of that is the text "RÖNTGEN- UND MEDIZINTECHNIK" in smaller, bold, black letters. A black line underlines the text.

#### Conclusion as to Substantial Equivalence 9.

Noras and Siemens believe that, within the definition of the Safe Medical Devices Act of 1990, the Noras 8-channel phased array OR head coil 1.5T is substantially equivalent to the predicate device listed above.

Auebert Wares

Hubert Noras President

March 16, 2006

Traditional 510(k) Noras Rontgen- Und Medizintechnik GmbH OR Head Coil 1.5T March 16, 2006

CONFIDENTIAL

000 07

7

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY - 5 2006

Ms. Judith Campbell Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, E-50 MALVERN PA 19355

Re: K060758

Trade/Device Name: Noras OR Head Coil 1.5 T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 16, 2006 Received: March 21, 2006

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.

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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 prumber 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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510(k) Number (if known):

Device Name:

Noras OR Head Coil 1.5 T

Indications for Use:

The intended use of the Noras OR head coil 1.5 T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging).

Used in the 1.5T MAGNETOM Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head.

When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONT NUE ON ANOTHER PAGE OF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--------|
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | ✓ |
| | AND/OR |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

*(Division Sign-Off)*

Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K060258 |
|---------------|---------|
| Page | of |

Traditional 510(k)

Noras Rontgen- Und Medizintechnik GmbH

CONFIDENTIAL
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March 16, 200€

**CONFIDENTIAL**