STRAIT'MAP OPTION

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a black circle on a white background. The circle is not perfectly round, and it has some irregularities in its shape. The black color of the circle contrasts sharply with the white background, making it stand out. The image is simple and minimalist, with no other objects or details present. Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and a symbol. The sequence starts with a symbol that resembles a less-than sign, followed by the numbers 9, 7, 3, 3, 6, and 8. The numbers are written in a cursive style, with some of the digits connected to each other. GE Medical Systems P.O. Box 414. W-709 Milwaukee, WI 53201 USA ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 5 September, 1997 OCT 17 1997 This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h). | Contact: | Larry A. Kroger, Ph.D | | |----------|-----------------------|--------------| | | Phone: | 414-544-3894 | | | Fax: | 414-544-3863 | ### Identification of Product The Strait'Map is an optional accessory consisting of a software program and a grid to provide distortionfree digital x-ray images that can be used in x-ray angiography in stereotactic conditions. It is manufactured by GE Medical Systems - Europe, 283, rue de la Miniere, 78530 BUC, France, and is distributed by GE Medical Systems, Milwaukee, WI. ### Device Description This optional software is run after the acquisition of patient images is completed and has no affect on the acquisitions. Two orthogonal acquisitions are required to obtain accurate localization in the region of interest. The image correction is based on distortion calibration using a straight grid image, with the patient removed from the imaging field. A separate callbration is performed for each patient series to be corrected. ### Indications for Use The Strait'Map is intended to permit digital x-ray systems to produce distortion-free images for stereotaxy without the use of a film changer. Strait' Map corrects the geometric distortion in the digital images caused by the image intensifier. The corrected images are then sent to a laser imager for use in neuroangiographic examinations requiring the use of a stereotactic frame. The correction procedure can be used in either monoplane or biplane configuration. ## Comparison with Predicate Strait Map permits the production of images free of the geometrical distortion which are comparable to those produced by film changers. Strait 'Map corrects the distortion caused by the image intensifier in the image chain of digital images to accomplish the same geometrical accuracy as image taken with film changers that do not utilize an image intensifier. ### Conclusion It is the opinion of GE Medical Systems that Strait Map is safe and potential hazards (less accurate image correction) are controlled by a risk management plan including hazards analysis, software development process, and external evaluation by different hospitals. The use of the Strait'Map option does not change the intended use of the angiographic systems with which it is used. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the 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 image of an eagle with its wings spread, facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Image /page/1/Picture/4 description: The image shows the date October 17, 1997. The month is abbreviated to OCT. The numbers are written in a bold, sans-serif font. The date is written in a single line. Larry A. Kroger, Ph.D. Regulatory Affairs Program Manager GE Medical Systems, Inc. P.O. Box 414 Milwaukee, WI 53201 Re: K973368 Strait' Map Option (Angiographic X-Ray System) Dated: September 5, 1997 Received: September 8, 1997 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI Dear Dr. Kroger: We have reviewed your Section 510(k) notification of intent to market the device 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 (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 question 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, N. Hiau Yri 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 Enclosure {2}------------------------------------------------ # 510(k) Number (if known): Device Name: Strait'Map Indications For Use: #### Indications for Use The Strait'Map is intended to permit digital x-ray systems to produce distortion-free images for stereotaxy without the use of a film changer. Strait'map corrects the geometric distortion in the digital images caused by the image intensifier. The corrected images are then sent to a laser imager for use in neuroangiographic examinations requiring the use of a stereotactic frame. The correction procedure can be used in either monoplane or biplane configuration. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801-109) OR Over-The-Counter Use_ Gerrit h. Seym (Division Sign-Off) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number