WINSCAN AUTOMATED IMAGING SYSTEM

{0}------------------------------------------------ K980375 ## Summary of Safety and Effectiveness #### Submitter Applied Imaging 2380 Walsh Avenue, Building B Santa Clara, California 95051 Phone: 408-562-0250 Fax: 408-562-0264 #### Date summary was prepared January 27, 1998 #### Name of the device WinSCAN Automated Imaging System #### Identification of predicate device Micro 21 System (also known as IMS-200): K925670 #### Description of the device The WinSCAN System is an automated imaging system that scans peripheral blood smears for nucleated blood cells. WinSCAN software provides for operator interaction and decision making to identify nucleated red blood cells (nRBC), and enumerate them as #nRBC/100 white blood cells (WBC). The operator selects the recommended parameters for nucleated cells, starts the scan and can walk away. The system locates and stores color images of the nucleated cells for each slide, the operator reviews the data on the WinSCAN monitor, and classifies the nucleated cells as nRBC or WBC based on stain and nuclear characteristics. Identification parameters include light adsorption, size and shape. {1}------------------------------------------------ Automatic relocation, capture and archiving of the cell images are performed by the instrument based upon operator selection. The instrument also can be used in the manual mode to systematically scan a slide and examine each field. The WinSCAN System consists of the following components: - Intel-based PC with Windows operating system . - Monitor, kevboard, mouse . - Switchstick control unit t - Color printer for images and texts . - Microscope with brightfield capability and 10x, 20x, 40x and 50x . objectives - Set of transmission and excitation filters . - Camera and image acquisition board t - Motorized devices: stage, filter wheels, focus drive 0 - Motor controller unit and manual controls . The Intel-based PC operates the instrument through the software program that coordinates control of the automated microscope. The base operating system of the PC consists of MicroSoft Windows 3.1 and DOS version 6.0. When the WinSCAN icon is selected from the Program Manager, WinSCAN software is downloaded and operation of the system can begin. The WinSCAN program includes all facilities to scan, relocate, and acquire images from a microscope slide. The WinSCAN software also performs image acquisition and scan functions, as well as archiving and relocation of images and facilitates operator review of cells. Classification of cells is performed by the operator. The Monitor. Kevboard, Mouse, and switchstick control unit provide user interfaces to the system. The monitor displays all information to the user, including menus for navigating through the WinSCAN operation, image acquisition results and allows for operator visual review for operator classification of the nucleated cells found on a slide. The keyboard allows for user entry of scan parameters, slide numbers, user identification, comments, and annotation of results. The mouse/keyboard is used to interact with the instrument and software, including selecting menus and functions of the WinSCAN software and instrument. A color printer is included with the system that allows the user to print results of scanning or acquired images of cells. {2}------------------------------------------------ ### Intended Use The WinSCAN System is an automated imaging system that scans peripheral blood smears for nucleated blood cells. WinSCAN software provides for operator interaction and decision making to identify nucleated red blood cells (nRBC) and enumerate them as #nRBC/100 white blood cells (WBC). ### Comparison of device characteristics to predicate The WinSCAN instrument is substantially equivalent to the Micro 21 system. Both instruments can automatically scan a slide, both instruments allow for operator review, and both instruments allow for viewing images on a computer monitor. Unlike the Micro 21 system, the WinSCAN system includes a manual microscope that allows the user to view slides manually for verification. Both systems can relocate a cell or object on a slide, even upon its removal and replacement. ### Testing Results of studies demonstrate that WinSCAN is an effective tool that aids the operator in locating and classifying nucleated cells. The test results demonstrate that the WinSCAN is able to scan slides prepared from peripheral blood and aid the operator in locating white blood cells and nucleated red blood cells. When compared to the standard manual microscope method, the correlation coefficient is >/= 0.98. Additionally, precision testing using replicate counts of 30 samples demonstrates that WinSCAN performs in a repeatable manner, with a mean coefficient of variation of 24% - 26% over multiple samples, instruments and operators, as compared to 23% CV% precision demonstrated by manual microscopy. ### Conclusion The WinSCAN instrument is substantially equivalent to the Micro 21 system. Both instruments can automatically scan a slide for nucleated cells, both instruments allow for operator review, and both instruments allow for viewing images on a computer monitor. Unlike the Micro 21, WinSCAN includes a manual microscope that the user can use to view nucleated cells on a slide manually for verification. Both systems can relocate a cell or object on a slide, even upon its removal and replacement. Both systems require operator interaction for cell classification and for the enumeration of nRBCs/100 WBCs. {3}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right. Public Health Service JUN - 9 1998 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Patricia A. Milbank, JD, RAC Vice President, Requlatory Affairs and Quality Assurance Applied Imaqinq 2380 Walsh Avenue, Bldg. B Santa Clara, California 95051 K980375/S1 Re : WinSCAN Automated Imaging System Trade Name: Requlatory Class: II Product Code: JOY Dated: May 6, 1998 Received: May 7, 1998 Dear Ms. Milbank: 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 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 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 the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations. {4}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655. 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) 594-4588. 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" Sincerely yours, Steven Putman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure ............ {5}------------------------------------------------ Page of of ___ | 510(k) Number (if known): | K980375 | |---------------------------|----------------------------------| | Device Name: | WinSCAN Automated Imaging System | # Indications For Use: Intended Use WinSCAN is an automated imaging system that scans peripheral blood smears for nucleated blood cells. WinSCAN software provides for operator interaction and decision making to identify nucleated red blood cells (nRBC), and enumerate them as #nRBC/100 white blood cells (WBC). (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Deborah Morie for Dr. Peter Massim (Division Sign-Ofm Division of Clinical Laboratory Devices 510(k) Numbor. Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)