NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH

K093693 · Noras Mri Products GmbH · MOS · Jan 19, 2010 · Radiology

Device Facts

• Record ID: K093693
• Device Name: NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH
• Applicant: Noras Mri Products GmbH
• Product Code: MOS · Radiology
• Decision Date: Jan 19, 2010
• 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 3T 7230-PH 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 3T Philips Achieva 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

Noras OR Head Coil 3T 7230-PH is a specialized radiofrequency (RF) coil designed for use with 3T Philips Achieva MRI systems. It functions as an accessory to the MRI scanner to receive MR signals from the human brain. The device is specifically engineered for use in the operating room environment, allowing for imaging before, during, and after neurosurgical procedures. It also supports standard diagnostic head imaging and fMRI. The coil captures anatomical data which is processed by the host MRI system to produce cross-sectional images. These images are reviewed by a trained physician to assist in clinical diagnosis and surgical guidance. The device benefits patients by enabling real-time or near-real-time intraoperative visualization of brain structures, potentially improving surgical precision and outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

RF head coil designed for 3T MRI systems. Form factor optimized for operating room use. Functions as a passive signal receiver for MR scanners. Compatible with Philips Achieva 3T systems. No internal software or active processing algorithms; relies on host MRI system for signal processing and image reconstruction.

Indications for Use

Indicated for patients requiring MR examination of the human brain, including intraoperative imaging during brain surgery and standard diagnostic head imaging, including fMRI. Used with 3T Philips Achieva Systems to produce transverse, sagittal, coronal, and oblique images of internal head structures for physician interpretation.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines above it, representing care and support.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - W066-G609 Silver Spring, MD 20993-0002

# JAN 1 9 2010

Mr. Zahed Sedighiani Regulatory Affairs Manager Moras MRI Products GmbH Leibnizstr. 4, Hoechberg, 97204 GERMANY

Re: K093693

Trade/Device Name: Noras OR Head Coil 3T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 20, 2009 Received: November 30, 2009

#### Dear Mr. Sedighiani:

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 (DMA). 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 2 one Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish firther 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 in 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for 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 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,

Donald J. Trump

Donald J. St Pierre 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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Indications for Use

510(k) Number (if known): _ K09 3693

Device Name: Noras OR Head Coil 3T

### Indications for Use:

The intended use of the Noras OR Head Coil 3T 7230-PH 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 3T Philips Achieva 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-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

**(Division Sign-Off)**

Division of Radiological Devices

510(k) Number K093693

Special 510(k) Noras MRI products GmbH OR Head Coil 3T 7230-PH November 20, 2009

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