VR NETSERVE

{0}------------------------------------------------ S 10(k) Premarket Notification ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------........... | MAY 6 1998 | 510(k) Summary of Safety and Effectiveness | K980684 | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Submitter: | I.S.G. Technologies, Inc. | | | Address: | 6509 Airport Road<br>Mississauga, Ontario<br>Canada L4V 1S7 | | | Contact: | Carol Nakagawa, Clinical Scientist | | | Telephone: | (905) 672-2100 | | | Date: | February 20, 1998 | | | Trade Name: | VR NetServe | | | Common Name: | Picture Archiving and Communication System (PACS) component<br>software. | | | Classification Name: | PACS: Image Storage Device. | | | Predicate Device: | VR SOFTSTORE (ID.Store) image archive software device. | | | Device Description: | The VR NetServe software module is an addition to the VR<br>SOFTSTORE medical image archive system which allows the user<br>to access patient images using web server technology to query the<br>database and display retrieved images. The intended use of the VR<br>SOFTSTORE system containing this module has not been<br>modified by this addition. | | | Intended Use: | VR SOFTSTORE is a software device intended to direct the<br>lossless archival storage and retrieval, including the use of pre-<br>fetching and auto-routing capabilities, of digital medical images<br>within a Picture Archiving and Communications System (PACS). | | | Comparison to<br>Predicate: | The intended use and technological characteristics of the VR<br>SOFTSTORE (ID.Store) device containing the VR NetServe<br>module are substantially equivalent, in the opinion of I.S.G.<br>Technologies, to those of the predicate device and do not pose any<br>new issues of safety and effectiveness. | | 다. . {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 stylized eagle with three human figures inside of it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 6 1998 Carol Nakagawa Clinical Specialist I.S.G. Technologies, Inc. 6509 Airport Road Mississauga, Ontario Canada L4V 1S7 Dear Ms. Nakagawa: Re: K980684 VR NetServe, PACS Web Access Software Module Dated: February 20, 1998 Received: February 23, 1998 Regulatory class: Unclassified Procode: 90 LMD 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, 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 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/dsmallsmamain.html". Sincerely yours, Kilian Yin 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): K980684 VR SOFTSTORE Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use: VR SOFTSTORE may be used for the permanent storage and subsequent retrieval of any medical imaging data presented in DICOM or other supported format, within a Picture Archiving and Communications System (PACS). (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Ehmil A. Glynn (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number Prescription Use (Per 21 CFR 801.109) ✓ OR Over-The-Counter Use \$