GE OEC ALTITUDE

{0}------------------------------------------------ # AUG 1 1 2005 ### 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. | Date: | July 22, 2005 | | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------|--| | Name of Submitter: | GE OEC Medical Systems, Inc.<br>384 Wright Brothers Drive<br>Salt Lake City, UT 84116<br>801-328-9300 | | | Corresponding Official: | Susan Schmidt,<br>Engineer - Safety & Regulatory | | | Device Proprietary Name: | GE OEC Altitude | | | Classification Name: | Image Intensified Fluoroscopic X-ray System with Image<br>Processing System | | | Common/Usual Names: | Fluoroscopic Imaging System | | | Substantial Equivalence: | The GE OEC Altitude is substantially equivalent to the: | | | | • AngioSpeed VC marketed by Shimadzu Corporation which<br>consists of the MH-200S (K943545) and DAR-2400-15B/30B<br>(K955395). | | : : - ! {1}------------------------------------------------ #### Indications for Use GE OEC Altitude is a Fluoroscopic Imaging System designed to provide fluoroscopic images of the patient during diagnostic, surgical and interventional angiography and cardiology procedures. #### General Description GE OEC Altitude is an image intensified fluoroscopic fixed C-arm system. It consists of a C-arm that supports a high-voltage generator, x-ray controls, image intensifier and flat panel display monitors. The system consists of a Ceiling suspended C-arm support (MH-200S), digital substraction system (DAR-9000) and a High Voltage generator (UD150B-40). It is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient, and supports image processing and recording devices. This system can be used in conjunction with a mobile or fixed surgical table. Interfaces are provided for optional peripheral devices such as thermal or laser printers, VCR's, and monitors. Video outputs are compatible with CCIR format for international markets and DICOM 3.0 (optional). GE OEC Medical Systems, Inc. intends to market, install and distribute the OEC Altitude. Shimadzu will be acting as the contract manufacturer designing, fabricating and assembling the MH-200S, DAR-9000 and UD150B-40 components of the OEC Altitude. #### Summary of Studies GE OEC Altitude was evaluated to the appropriate performance standards and IEC 60601-1 International Medical Equipment Safety standard, IEC 60601-2-28 Particular Requirements of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis and IEC 60601-2-32 Particular Requirements of Associated Equipment for X-Ray Equipment for Safety of GE OEC Altitude. The Product OEC Altitude is comparable to the currently marketed AngioSpeed VC which consists of the MH-200S (K943545) and DAR-2400-15B/30B (K955395). #### Conclusion It is the opinion of GE that GE OEC Altitude is substantially equivalent to the Predicate Product Shimadzu AngioSpeed VC which consists of the MH-200S (K943545) and DAR-2400-15B/30B (K955395). Usage of GE OEC Altitude does not result in any new potential hazards. {2}------------------------------------------------ f Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines extending from its head, resembling feathers or wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Susan Schmidt, RAC Engineer - Safety & Regulatory GE OEC Medical Systems, Inc. 384 Write Brothers Drive SALT LAKE CITY UT 84116 Re: K052039 Trade/Device Name: GE OEC Altitude Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: July 22, 2005 Received: July 28, 2005 Dear Ms. Schnidt: 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 (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 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); 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. AUG 1 1 2005 {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and a your finding of substantial equivalence of your device to a legally prematics notified 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. Hogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Indications For Use Statement GE OEC Medical Systems, Inc. Applicant: 510(k) No. (if known): K.052039 GE OEC Altitude Device name: GE OEC Altitude is a Fluoroscopic Imaging System designed to Indications for use: provide fluoroscopic images of the patient during diagnostic, surgical and interventional angiography and cardiology procedures. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH Office of Device Evaluation (ODE) | | | | |-------------------------------------------------------|---------------------------------------------------------------|----|--------------------------| | Prescription Use | <div></div> | OR | Over-The-Counter | | (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) | | | (Division Sign-Off) | | | | | Division of Reproductive, Abdominal, and Radiological Devices | | | | 510(k) Number | | | | GE OEC Medical Systems Company Confidential