NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230

K091546 · Noras Mri Products GmbH · MOS · Jun 24, 2009 · Radiology

Device Facts

Record IDK091546
Device NameNORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230
ApplicantNoras Mri Products GmbH
Product CodeMOS · Radiology
Decision DateJun 24, 2009
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 892.1000
Device ClassClass 2

Intended Use

The intended use of the Noras OR Head Coil 3T 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 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

8-channel phased array head coil; designed for 3T MRI systems. Input: radiofrequency signals from human brain during MRI scan. Operation: coil captures signals via top and bottom arrays (4 channels each) tuned to 123.2 MHz (1H Larmor frequency); connects to MAGNETOM system via cables. Output: raw signal data processed by MRI system into diagnostic images. Used in operating rooms or clinical settings; operated by trained medical staff. Provides anatomical/functional brain images for surgical guidance and diagnostic decision-making. Requires Noras OR Head Holder for operation.

Clinical Evidence

Bench testing only. Performance and safety parameters verified using NEMA standards and IEC 60601-2-33:2002. Testing conducted on MAGNETOM Trio a Tim system (software version VB15A) and deemed applicable to Verio systems.

Technological Characteristics

8-channel phased array coil; 4-channel top and bottom arrays. Tuned to 123.2 MHz (1H Larmor frequency at 3T). Connectivity: wired connection to MAGNETOM MRI systems. Compliance: NEMA standards for MRI performance; IEC 60601-2-33:2002 for safety. Form factor: curved headbands with integrated wiring.

Indications for Use

Indicated for MR examination of the human brain in patients undergoing brain surgery (pre-, intra-, and post-operative) and for standard diagnostic head imaging and fMRI. Used with 3T MAGNETOM 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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K091546 page 1 of 4 ### 510(k) Summary JUN 2 4 2009 ### Noras OR Head Coil 3T Date of Summary Preparation: April 30, 2009 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92. #### 1. General Information Importer/Distributor Name and Address Noras MRI products GmbH Leibnizstr.4 97204 Hoechberg / Germany ERN: 3004929307 Owner/Operator Number: 9071737 Manufacturing Site Name and Address Noras MRI products GmbH Leibnizstr.4 97204 Hoechberg / Germany ERN: 3004929307 Owner/Operator Number: 9071737 #### 2. Contact Person Zahed Sedighiani Regulatory Affairs Manager Noras MRI products GmbH Leibnizstr.4 97204 Hoechberg Germany Tel: (+49) 931 / 29927-17 Fax: (+49) 931 / 29927-20 zahed.sedighiani@noras.de {1}------------------------------------------------ K091546 Page 2 of 4 #### Device Name and Classification 3. Trade Name: OR Head Coil 3T Common Name: OR Head Coil 3T Classification Name: Magnetic Resonance Diagnostic Device Classification Panel: Radiology 21 CFR § 892.1000 CFR Number: Device Class: Product Code: 90MOS #### Device Description 4. The Noras OR Head Coil 3T 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 3T, 123.2 MHz. Each coil is connected to the MAGNETOM system by a separate cable. Image /page/1/Picture/5 description: The image shows two headbands with wires and connectors. The headbands are curved and appear to be made of a dark material. Each headband has a wire that extends from it, terminating in a connector. The connectors are rectangular and have multiple pins or contacts. The background is black, which makes the headbands and connectors stand out. Use of the Noras OR Head Coil 3T requires the Noras OR Head Holder (K071179 April 30, 2007). The pictures below show the complete set. Image /page/1/Figure/7 description: The image contains two separate pictures. The picture on the left shows a complex mechanical device with multiple components and wires. The picture on the right shows a similar mechanical device, but with a different configuration and a visible arrow at the bottom. Special 510(k) Noras MRI products GmbH OR Head Coil 3T April 30, 2009 {2}------------------------------------------------ K091546 Page 3 of 4 #### 5. Intended Use The intended use of the Noras OR Head Coil 3T 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 MRI products GmbH believes that, within the meaning of the Safe Medical Devices Act of 1990, the 8-channel phased array Noras OR Head Coil 3T for the Magnetom Systems is substantially equivalent to the following coil: | Predicate Device Name and<br>Manufacturer | 510(k)<br>Number | Clearance Date | Product<br>Code | Comparable<br>Properties | |-------------------------------------------------------------------------------------------------------------|------------------|------------------|-----------------|-----------------------------------------| | Noras OR Head Coil 1,5T | K060758 | March 21, 2006 | 90MOS | Proton imaging | | MRI Devices Corporation (now<br>known as Invivo Corporation)<br>High Resolution Head Coil<br>Model HRH-63-8 | K013159 | October 16, 2001 | 90MOS | High Resolution<br>Head Imaging<br>fMRI | ### 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 all top coils are substantially equivalent. #### General Safety and Effectiveness Concerns 8. The Noras OR Head Coil 3T 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 3T systems Trio a Tim and Verio. {3}------------------------------------------------ The NEMA Tests can be found in Appendix C. The NEMA Tests were done on software platform version VB15A. 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 Trio a Tim are applicable to Verio system. #### Conclusion as to Substantial Equivalence 9. Noras MRI products GmbH believes that, within the definition of the Safe Medical Devices Act of 1990, the 8-channel phased array Noras OR Head Coil 3T is substantially equivalent to the predicate device listed above. Hubert Noras Hubert Noras President 30. 9. 09 April 30, 2009 {4}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES ... . . _Public Health Service . Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # JUN 24 2009 Mr. Zahed Sedighiani Regulatory Affairs Manager Noras MRI Products GmbH Leibnizstr. 4. Hoechberg 97204 GERMANY . Re: K091546 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: April 30, 2009 Received: May 27, 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 (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 (PMA), it may be subject to 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); medical device reporting (reporting of medical {5}------------------------------------------------ device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Iarina M. Morris Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ### Indications for Use 510(k) Number (if known): Ko f 15 yc Device Name: Noras OR Head Coil 3T ### Indications for Use: The intended use of the Noras OR Head Coil 3T 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 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-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use (Part 21 CFR 801 Subpart D) | <div><img alt="Checkmark" src="checkmark.png"/></div> | |----------------------------------------------|-------------------------------------------------------| | AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) | (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices | 510(k) Number | K091546 | |---------------|---------| |---------------|---------| Special 510(k) Noras MRI products GmbH OR Head Coil 3T April 30, 2009
Innolitics
510(k) Summary
Decision Summary
Classification Order
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