NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE

{0}------------------------------------------------ page 1 # K980241 ## ATTACHMENT 5: 510(K) SUMMARY #### 1. Submitter Information MAR 17 1998 NetCo Communications Corp. NetCo Medical Data Management Division 6100 West 110th Street Minneapolis, MN 55438 Tom Quintavalle, Manager of Quality Contact: Systems and Regulatory Affairs 612-886-5403 tel Phone: 612-886-5474 fax Summary Preparation Date: January 22, 1998 ## 2. Device Names | Proprietary Name: | NetCo Medical Data Transportation Service software | |----------------------|-------------------------------------------------------------------------------------------------------------------------------| | Common/Usual Name: | medical image communications and storage device component | | Classification Name: | No formal classifications have been issued for medical image management devices or their components | | Classification: | Class I--proposed (See Federal Register Monday, December 2, 1996 Vol. 61 No. 232 p 63769 (Proposed rule) Docket No. 96-30650) | ## 3. Predicate devices - . Sectra Imageserver 2000 Picture Archiving System [K963395] - AGFA IMPAX 3000 [K934832] . ### 4. Device Description The DICOM storage service class functionality is provided by two applications that execute on the NAD platform. The applications act as proxies for DICOM storage Service Class Provider (SCP) devices and storage Service Class User (SCU) devices on either end of a transportation network connection. The storage SCP proxy is configure-able to emulate another SCP device that is the destination of DICOM data. The file is moved across the transportation network to one or more destination NADs. On the destination NAD is a proxy SCU application that is configured to emulate the original SCU that sent the data. The original DICOM message file is kept intact as it is processed through the originating NAD and transmitted via the pathway. ### 5. Intended use The NetCo MDTS software is intended to be used in the transportation, storage, and retrieval of digital patient files. #### 6. Comparison of technological characteristics The NetCo MDTS software and the predicate product software all employ proprietary software and DICOM file standards to interface with a health care subscriber's network to transmit, store and retrieve medical image data. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the top of the logo. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 17 1998 Tom Quintavalle Manager of Quality Systems and Regulatory Affairs NetCo.Communications Corp. NetCo Medical Data Management Division 6100 West 110th Street Minneapolis, MN 55438 Re: K980241 NetCo Medical Data Transporation Service Software Dated: January 22, 1998 Received: January 23, 1998 Regulatory class: Unclassified Procode: 90 LMD Dear Mr. Quintavalle: 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 receral 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 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, 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 {2}------------------------------------------------ Page_ /_ of_ / 510(k) Number (if known): ূ८९४० 24 / Device Name: NETO MECICAL DATH TRANSPORTATI Indications For Use: The NetCo MDTS software is intended to be used in the transportation, storage, and retrieval of digital patient files. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Divis active, Abdominal, ENT, and Devices 510(k) Number K980241 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)