MAGNETIC RESONANCE DIAGNOSTIC SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the GE logo at the top left corner. Below the logo, the text "age 1 of 2" is visible. The text indicates that this is the first page of a two-page document. The image is a black and white scan of a document. K972296 GE Medical Systems SEP 1 5 1097 P.O. Box 414. Milwaukee, WI 53 USA ## SUMMARY OF SAFETY AND EFFECTIVENESS - This 510(k) summary of safety and effectiveness information is O submitted in accordance with the requirements of 21 CFR Part 807.87(h). - 0 Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, June 11, 1997 - o Identification of the Product Signa Profile 9 Inch Coil and Kinematic Positioner Options Manufacturer Address: GE Yokogawa Medical Systems, Ltd. 4-7-127, Asahigaoka, Hino-Shi Tokyo, 191 Japan - O Marketed Devices The Signa Profile MR System with the 9 Inch Coil and the Kinematic Positioner Options are substantially equivalent to the currently marketed Signa Profile System (software and electronics) and the Signa Profile Extremity Coil. ## o Device Description Profile 9 Inch Coil consists of a linear solenoid coil. The lt is a split two part design that has a base and a removable top to facilitate patient positioning. It is designed for use with a vertical magnetic field MR imaging system. The Kinematic Positioner provides support for the legs for MR scanning. It has two usages. One is for a scan when the scanned leg is fixed, and the other is while the scanned leg is moving down. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the text "GE Medical Systems". The text is in a bold, sans-serif font. The text is black and is on a white background. The text is centered in the image. Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The letters are connected and have a flowing, cursive appearance. The logo is black and white. age 2 of 2 P.O. Box 414, W-709 Milwaukee, WI 53201 USA # SUMMARY OF SAFETY AND EFFECTIVENESS - o Indications_for_Use The Indications for Use for the Signa Profile 9 Inch Diameter Coil and Kinematic Positioner Options expands the capability of the Signa Profile System. The Kinematic Positioner accommodates and improves imaging of the knee and surrounding structures. The 9 inch Coil is intended for imaging of the cervical spine, shoulder, knee and surrounding structures. ### 0 Comparison with Predicate The Profile 9 Inch Surface Coil is similar to the Profile Extremity Coil except that the Extremity coil is a quadrature receive only coil while the 9 inch coil is a linear receive only coil. #### Summary of Studies o The 9 Inch Surface Coil was evaluated to the appropriate NEMA performance standards. Both options were evaluated to the International safety standards IEC 601-1 and IEC 601-2-33. Both options performed to stated specifications. #### O Conclusions It is the opinion of GE that the Signa Profile System with the 9 Inch Surface Coil and Kinematic Positioner options are substantially equivalent to the presently marketed Signa Profile System and the Signa Profile Extremity Coil. These options do not result in any new potential hazards. {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Image /page/2/Picture/3 description: The image shows a partial view of a logo or emblem, featuring three stylized, curved lines stacked vertically. These lines appear to be thicker at the top and taper slightly as they descend. To the left of these lines, a portion of text is visible, arranged in a curved, vertical orientation, suggesting it is part of a circular design. The text is cut off, making it difficult to read, but it seems to be a word or phrase associated with the emblem. SEP 1 5 1997 Larry A. Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems P.O. Box 414, W-709 Milwaukee, WI 53201 Re: K972296 Signa Profile 9-Inch Coil and Kinematic Positioner Dated: June 11, 1997 Received: June 19, 1997 Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS Dear Dr. Kroger: 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, 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 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 requirement, as set forth in the Quality System Regulation (QS) 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 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 vitro 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/cdrh/dsmamain.html". Sincerely yours, h. William Yui Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health {3}------------------------------------------------ 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ 972296 Device Name: Signa Profile 9 Inch Diameter Coil and Kinematic Positioner Options Indications For Use: The Indications for Use for the Signa Profile 9 Inch Diameter Coil and Kinematic Positioner Options expands the capability of the Signa Profile System. The Kinematic Positioner accommodates and improves imaging of the knee and surrounding structures. The 9 inch Coil is intended for imaging of the cervical spine, shoulder, knee and surrounding structures. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Beynon (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number **Prescription Use** (Per 21 CFR 801.109) OR Over-The-Counter Use