MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC

{0}------------------------------------------------ NOV 2 1998 ### 510(k) SUMMARY MEDRAD 1.0T, 1.5T ANTERIOR NECK COILS | OFFICIAL CONTACT: | Jim Ferguson, Jr.<br>Sr. Regulatory Affairs Associate<br>Medrad, Inc.<br>One Medrad Drive<br>Indianola, PA 15051<br>(412) 767-2400 Ext. 3326 | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------| | CLASSIFICATION NAME: | Magnetic Resonance Diagnostic Accessory<br>[21 CFR 892.1000} | | COMMON/USUAL NAME: | MR Imaging Surface Coil | | PROPRIETARY NAME: | Medrad Anterior Neck Coil | | PREDICATE DEVICES: | General Electric (GE) Anterior Neck Coil | ## DEVICE DESCRIPTION: The Medrad Anterior Neck Coil is a receive only coil designed to enhance the MR Imaging of the area superior to the oral pharynx and inferior to the brachial plexus. This area includes the pharynx, throat, tongue, larynx and thyroid regions. ### INTENDED USE: The Medrad Anterior Neck Coil is a receive only coil intended to be used with the General Electric Superconducting MRI Scanners. This coil is intended to facilitate complete MR imaging of the area superior to the oral pharynx and inferior to the brachial plexus. This area includes the pharynx, throat, tongue, larynx and thyroid regions anatomy. | Anatomical Region: | The area superior to the oral pharynx and<br>inferior to the brachial plexus. This area<br>includes the pharynx, throat, tongue, larynx and<br>thyroid regions anatomy. | |--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Nuclei Excited: | Hydrogen | | Diagnostic Uses: | 2D and 3D Imaging | {1}------------------------------------------------ 510(k) Summary Medrad Anterior Neck Coil Page 2 of 3 # PROPOSED MEDRAD ANTERIOR NECK COIL TECHNICAL COMPARISON TO PREDICATE DEVICES: The following table compares the predicate GE Anterior Neck Coil and the proposed Medrad Anterior Neck Coil. | GE Anterior Neck Coil<br>(PMA P830074) | Medrad Anterior Neck Coil | |----------------------------------------|---------------------------| | GE labeling | Medrad labeling | Medrad was responsible for the design and manufacturing of the predicate device, and will remain responsible for the design and manufacturing for the proposed device. The device will be labeled and marketed as "Medrad Product". This is the only change to the device. # PROPOSED MEDRAD ANTERIOR NECK TECHNICAL COMPARISON TO PREDICATE DEVICES | Patient contacting materials comparison information | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | GE Anterior Neck Coil | Medrad Anterior Neck Coil | | Reference PMA P830074<br>for material information | All materials used are the<br>same as the GE Anterior Neck coil. (Predicate<br>device) | | Certification: Medrad, Inc. certifies that the patient<br>contacting materials and formulations for<br>the proposed Medrad Anterior Neck Coils<br>are unchanged from currently marketed<br>devices. | | {2}------------------------------------------------ #### PERFORMANCE TEST DATA: #### SIGNAL TO NOISE RATIO (SNR) A Signal to Noise Ratio(SNR) study was conducted to generate a Signal -To-Noise ratio comparison between the proposed Medrad Anterior Neck coil and the predicate GE Anterior Neck Coil. IMAGE UNIFORMITY - The Medrad Anterior Neck Coil was evaluated using NEMA Standards to characterize the non-uniformity of the proposed coil. Contours of the images obtained with the coil were constructed for the axial image and sagittal image. GEOMETRIC DISTORTION: None. Static magnetic field distortion results from the use of magnetic materials in the construction of a surface coil. This device contains slightly magnetic materials or components. However, such components have been positioned within the surface coil so that no observable distortion of the static magnetic field is present. TRANSMIT RF FIELD IB11 DISTORTION - Analysis of the electrical design of the coil and its blocking network demonstrates that no significant currents are induced. No artifacts of any type were observed during imaging. RESOLUTION, SLICE THICKNESS, AND CONTRAST - These performance parameters are not affected by the use of a surface coil and were not separately tested in the performance evaluation of the proposed Medrad Anterior Neck Coil. CLINICAL EVALUATION - Clinical images for the proposed 1.5T Anterior Neck Coil have been provided with this submission to demonstrate the clinical effectiveness of the Anterior Neck coils. Based on these results, and the SNR results for the 1.0T Anterior Neck Coil, Medrad concludes that the proposed 1.0T Anterior Neck Coil will produce similar clinical image results. CONCLUSION - Extensive safety, verification, durability and clinical testing was conducted on the predicate GE device (PMA P830074). This device is exactly the same as the proposed device except for the labeling. The proposed device is deemed by Medrad to be substantially equivalent. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. Re: · Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 2 1998 Jim Ferguson, Jr. Sr. Regulatory Affairs Associate Medrad, Inc. One Medrad Drive Indianola, PA 15051 K982932 Medrad Anterior Neck Coil Dated: August 19, 1998 Received: August 20, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH Dear Mr. Ferguson: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in ritto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdri/dsmadsmamain.html". Sincerely yours, Lillian Yin, Ph.D. Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) NUMBER (IF KNOWN): K982932 Medrad Anterior Neck Coil DEVICE NAME: INDICATIONS FOR USE: The Medrad Anterior Neck Coil is a receive only coil intended to be used in MRI Scanner Systems for imaging of the area superior to the oral pharynx and inferior to the brachial plexus. The Medrad Anterior Neck Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Magnetic Resonance Imaging. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) √ OR Over-The-Counter-Use (Optional Format 1-2-96) Vivid G. Segura --- (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number K982432