ADVANTAGE WORKSTATION PASTING 1.1

{0}------------------------------------------------ K031396 MAY 1 3 2003 ್ತ ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h). Submitter Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager Telephone: (262) 544-3894 Fax: (262) 548-4768 GE Medical Systems W-400 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: April 7, 2003. K973270 ## PRODUCT IDENTIFICATION | Name: | Advantage Workstation Pasting 1.1 | |----------------------|---------------------------------------------------------------------------------------| | Classification Name: | Accessory to Magnetic Resonance Diagnostic Device | | Manufacturer : | General Electric Medical Systems<br>283, rue de la Minière<br>78533 Buc Cedex, FRANCE | | Distributor: | General Electric Medical Systems, Buc, France. | | Marketed Devices | The AW Pasting 1.1 is substantially equivalent to the devices listed below: | | Model: | AW X-Ray Pasting (Leg'Map) | | Manufacturer: | General Electric Medical Systems. Milwaukee. WI | #### Device Description: 510(k) #: The GEMS AW Pasting 1.1 software package is a display option, which provides the convenience of viewing a single image resulting from the automatic pasting of multiple images acquired in different stations of the body. {1}------------------------------------------------ ### Indications for Use: The GEMS AW Pasting 1.1 software package is a display option, which combines a series of MR images acquired in multiple stations of the body into a single image. AW Pasting 1.1 provides the convenience of viewing a single image rather than several images. 1. 1. 2.2 #### Comparison with Predicate: The functional features of the AW Pasting 1.1 software package are substantially equivalent to that of the following device: | Device Name | 010 A<br>learance Number | |------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | . A W Y V Y<br>11 BUISEA<br>120 H<br>eo<br>Man | 120000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | ### Adverse Effects on Health: The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by: - · Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements. - · Adherence to industry and international standards. ### Conclusions: The AW Pasting does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the AW Pasting 1.1 to be equivalent to those of AW X-Ray Pasting (K973270). {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 3 2003 GE Medical Systems-Europe % Mr. Heinz-Joerg Steneberg Division Manager Medical Division TUV Rheinland of North America 12 Commerce Road NEWTON CT 06470 Re: K031396 Trade/Device Name: Pasting 1.1 Software Option for MRI Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: May 1, 2003 Received: May 2, 2003 Dear Mr. Steneberg: 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 (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 r 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. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter: | 8xx. 1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html. Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure Page 2 {4}------------------------------------------------ K03 1394 Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with curved lines and flourishes, giving them a classic and recognizable appearance. The logo is in black and white. General Electric Medical Systems # STATEMENT OF INTENDED USE Device name: Advantage Workstation Pasting 1.1 Intended Use: The GEMS AW Pasting 1.1 software package is a display option, which combines a series of MR images acquired in multiple stations of the body into a single image. AW Pasting 1.1 provides the convenience of viewing a single image rather than several images. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use \$\surd\$ 1. 1. string and Ra 3 | O(K) Nt