NORAS OR HEAD HOLDER FLEXIBILITY

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that appears to represent three human profiles in a row. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 6, 2014 NORAS MRI Products GmbH % Mr. Zahed Sedighiani Quality and Regulatory Management Leibnizstrasse 4 Hoechberg D-97204 GERMANY Re: K133506 Trade/Device Name: NORAS OR Head Holder "Flexibility" Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS, HBL Dated: June 25, 2014 Received: June 27, 2014 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael D. O'Hara for Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. ## 510(k) Number (if known) K133506 ### Device Name NORAS OR Head Holder Flexibility 114464 ## Indications for Use (Describe) For Siemens: The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.57 / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery. The NORAS OR Head Holder is used for safely securing the patient's head during the intervention. The NORAS OR Head Holder Flexibility together with the NORAS OR Head Coil 1.5T / 3.0T are suitable for use with the MR system MAGNETOM Aera / Skyra and the Combi-Dockable-Table together with Trumpf OR Tables TrueSystem 7500 (EU/US Version) and as well as together with Maquet OR Tables Magnus (EU/US Version) and Alpha Maquet Plus (EU/US Version). For Philips: The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.5T / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery. The NORAS OR Head Holder is used for safely securing the patient's head during the intervention. The NORAS OR Head Holder Flexibility together with the NORAS OR Head Coil 1.5T / 3.0T are suitable for Philips MR system Ingenia 1.5T/3T in combination with Maguet Transfer Board together with Maquet OR table. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Michael D'Hara FORM FDA 3881 (1/14) SC Publishing Services (301) 443-6740 {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 003_Summary.docx Image /page/4/Picture/1 description: The image shows the logo for NORAS MRI products. The word "NORAS" is in bold, blue letters, with a horizontal line underneath. To the right of the word "NORAS" is a graphic of a heartbeat line, and the words "MRI products" are stacked on top of each other to the right of the heartbeat line. # 510(k) Summary NORAS OR Head Holder Flexibility Date of Summary Preparation: March 28, 2014 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 003 Summary.docx {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for NORAS. The logo is in blue and white. The word "NORAS" is in large, bold letters, and to the right of it is a heartbeat line with the words "MRI products" below it. #### 2. Contact Person Zahed Sedighiani MSc. Medical Engineering Quality Assurance & International Licensing NORAS MRI products GmbH Leibnizstr.4 97204 Hoechberg Germany Tel: (+49) 931 / 29927-17 Fax: (+49) 931 / 29927-20 zahed.sedighiani@noras.de #### Device Name and Classification 3. | Trade Name: | NORAS OR Head Holder Flexibility | |-----------------------|--------------------------------------| | Common Name: | NORAS OR Head Holder Flexibility | | Classification Name: | Magnetic Resonance Diagnostic Device | | Classification Panel: | Radiology | | CFR Number: | 21 CFR § 892.1000 | | Device Class: | II | | Product Code: | MOS, HBL | {6}------------------------------------------------ #### Device Description 4. The NORAS OR Head Holder and the NORAS OR Head Coil 1.5T / 3.0T combine the functions of a head holder for neurosurgical interventions and an MR receiving coil for intra-operative surgery. The NORAS OR Head Holder without the NORAS OR Head Coil 1.5T / 3.0T can be used for stabilizing the patient's head. It can also be used in combination with the body coil. The Head Frame of the NORAS OR Head Holder allows adjustment to heads varying in size. For optimal access to the area of intervention, the Head Frame can be swiveled and rotated. Image /page/6/Picture/6 description: The image shows a complex mechanical device, possibly a prototype or a component of a larger machine. It features a combination of curved pipes, flat plates, and cylindrical elements, all connected in an intricate arrangement. The device appears to be made of metal, with a light-colored finish. The background is a plain, light gray, which helps to isolate the device and highlight its details. Image /page/6/Picture/7 description: The image shows a complex mechanical apparatus, possibly a component of a larger machine or a specialized tool. It features a series of interconnected metal frames, gears, and adjustable parts, suggesting a high degree of precision and functionality. The device is mounted on a base, allowing for stability and controlled movement. The overall design indicates it may be used for manufacturing, scientific research, or engineering applications. Image /page/6/Picture/8 description: The image shows a medical device, possibly an MRI machine or a component of one. The top part of the image shows a person lying on a table, positioned within a large, circular device. The bottom part of the image shows a close-up of a similar circular device, which appears to be a coil or part of the imaging system, mounted on a platform. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for NORAS MRI products. The logo is in blue and white. The word "NORAS" is in large, bold letters. To the right of the word "NORAS" is a line that resembles a heart rate monitor. The words "MRI products" are stacked on top of each other to the right of the line. #### 5. Indications for Use # For Siemens: The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.5T / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery. The NORAS OR Head Holder is used for safely securing the patient's head during the intervention. The NORAS OR Head Holder Flexibility together with the NORAS OR Head Coil 1.5T / 3.0T are suitable for use with the MR system MAGNETOM Aera / Skyra and the Combi-Dockable-Table together with Trumpf OR Tables TrueSystem 7500 (EU/US Version) and as well as together with Maquet OR Tables Magnus (EU/US Version) and Alpha Maquet Plus (EU/US Version). # For Philips: The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.5T / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery. The NORAS OR Head Holder is used for safely securing the patient's head during the intervention. The NORAS OR Head Holder Flexibility together with the NORAS OR Head Coil 1.5T / 3.0T are suitable for Philips MR system Ingenia 1.5T/3T in combination with Maquet Transfer Board together with Maquet OR table. #### 6. Substantial Equivalence NORAS MRI products GmbH believes that, within the meaning of the Safe Medical Devices Act of 1990, the NORAS OR Head Holder Flexibility is substantially equivalent to the following OR Head Holder: | Predicate<br>Device Name<br>and<br>Manufacturer | 510(k)<br>Number | Clearance<br>Date | Product<br>Code | Comparable<br>Properties | |-------------------------------------------------|------------------|-------------------|-----------------|-----------------------------------| | NORAS OR Head<br>Holder | K071179 | April 27-2007 | MOS, HBL | Fixation of the<br>patient's head | {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for NORAS MRI products. The logo features the word "NORAS" in bold, blue letters, with a horizontal line extending from the right side of the word. The line then forms a heartbeat-like waveform, with the words "MRI products" stacked vertically to the right of the waveform. The logo is set against a white background, with a blue shape on the left side. ## Summary of Technological Characteristics of the Principal Device as 7. Compared with the predicate Device In comparison to the existing OR head holders, the OR Head Holder Flexibility PN: 114464 includes only some minor mechanical changes which contribute to more flexibility in patient positioning. According to our internal evaluations as well the external tests done by VDE the new components such as Z-joint meet the requirements of IEC 60601-1 3.ed (clause 9.8) and do not adversely affect the safety of the design. #### 8. General Safety and Effectiveness Concerns The NORAS OR Head Holder Flexibility combined with the NORAS OR Head Coil 1.5T / 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 Siemens MAGNETOM Aera/Skyra 1.5T/3T as well as Philips Ingenia 1.5T/3T systems. #### Conclusion as to Substantial Equivalence 9. NORAS MRI products GmbH believes that, within the definition of the Safe Medical Devices Act of 1990, the NORAS OR Head Holder Flexibility is substantially equivalent to the predicate device listed above. Zahed Sedighiani Quality and Requlatory Affairs Manager June 25, 2014 {9}------------------------------------------------