ACCESSPOINT, MED E-MAIL, DICOM READER

{0} K963936/ BIOSOUND BEACOTE Biosound, Inc. 8000 Castleway Drive Indianapolis, IN 46250 317 849.1793 800 428.4374 tax 317 841.8616 http://www.biosound.com/ Safety and Effectiveness Summary MAR 31 1997 The following safety and effectiveness summary has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR §807.92(a). 807.92(a)(1) Submitter Information Wayne Nethercutt Director, Regulatory Affairs 8000 Castleway Drive Indianapolis, IN 46250 Phone: (317) 849-1793 Facsimile: (317) 841-8616 Contact Person: Wayne Nethercutt Date: 09/27/96 Our mission is to enhance the quality of life by providing diagnostic medical equipment and services of superior quality and value for the early detection and management of disease. {1} K963936/A1 Safety and Effectiveness Summary AccessPoint™ Biosound, Inc. 807.92(a)(2) Trade Name: AccessPoint™ Med E-mail DICOM Reader Common Name: Medical Image Reading and Transport Software Classification Name(s): Diagnostic Ultrasound 90ITX 807.92(a)(3) ## Predicate Device(s) - TomTec P90 K950279 Additional Substantial Equivalence information is provided in the attached Substantial Equivalence Comparison Table. 807.92(a)(4) ## Device Description Generally speaking, AccessPoint is a software product designed to provide the translation of different medical image formats into a form compatible to be displayed on a standard PC. Connection between sites including hospitals, out reach clinics, physician home and office are provided through the use of e-mail. The images and reports (patient studies) may be transported via e-mail in a secure manner (encryption of data) following standards used by the Internet and local LAN (Intranet), transport systems. A description of the various elements follow: The AccessPoint™ software conforms to DICOM V3 service classes in the role of Service Class Reader. {2} Safety and Effectiveness Summary AccessPoint™ Biosound, Inc. ## Communications Modems supported by Microsoft windows 95 and Windows NT Network communications utilizing TCP/IP Internet Protocol definitions E-mail utilizing POP3 and SMTP (simple mail transfer protocol) standard as implemented in the Microsoft Windows 95, and windows NT operating system Telecommunications standard Integrated Services Digital Network (ISDN) Internet Service access through TCP/IP connection. ## Storage Floppy disk, hard disk, tape, and optical storage supported by Windows 95 or NT operating system. ## Image Formats AccessPoint™ supports the requirement in the Ultrasound Application Profile (APL-US) in the role of file set - Reader as incorporated in the DICOM version 3 definition. ## Commercial Ultrasound Image Formats: Biosound/Esaote AU3 and AU4 digital formats Hewlett Packard DSR Tiff format TomTec version 5 and P90 versions MicroSonics DSR, DataVue, ImageVue formats ## Data Compression Standard compression techniques used include: Run Length encoding as published in DICOM V3 supplement 5 also referred to as Tiff Pack bits compression. ISO/IEC 10918-1 JPEG baseline lossy, and Baseline lossless Compression Audio compression ADPCM adaptive pulse code modulation supplied standard in Windows 95 and Windows NT. The compression ratio is displayed on the status bar of each window showing the operator and reader that the images displayed have been compressed. Lossy compression is noted on each display screen. {3} Safety and Effectiveness Summary AccessPoint™ Biosound, Inc. ## Workstation Monitor Standard SVGA monitors are used which comply with the requirements of the Radiation Control and Health and Safety Act. ## Processors and Storage No special image processing hardware is required. Storage requirements vary based on the source of the image data as follows: With Biosound/Esaote AU3 Ultrasound System, 128/230 MB Magneto optical 3.5" disk drive (internal) With TomTec version 5 acquisition systems, one compatible disk drive 128/230 MB Magneto optical 3.5" disk drive (internal) SCSI controller compatible with Windows 95 or 650/1.3 MB Magneto optical disk drive SCSI controller compatible with Windows 95. With MicroSonics DSR acquisition, one compatible disk drive 230 MB Magneto optical 3.5" disk drive (internal) SCSI controller compatible with Windows 95 or 650/1.3 MB Magneto optical disk drive, SCSI controller compatible with Windows 95. With Hewlett Packard DSR acquisition, one compatible disk drive, 650 MB Magneto optical disk drive, SCSI controller compatible with Windows 95. ## Operator Interface Standard input devices supported by Microsoft Windows 95, and Windows NT 3.51. No special devices are required. Common implementation includes a keyboard and MS compatible mouse. ## Software The workstation uses: - Microsoft Office Professional Edition - Microsoft Windows 95, windows NT 3.51 or greater - Microsoft Plus Pack - Microsoft Internet Explorer 3.0 807.92(a)(5) ## Intended Use(s) The AccessPoint™ software is intended to translate different medical image formats into a single format suitable for display on a standard Personal Computer. {4} Safety and Effectiveness Summary AccessPoint™ Binsound, Inc. 807.92(a)(6) # Substantial Equivalence Table | Feature | Access Point™ | TomTec P90 K950279 | | --- | --- | --- | | Real-Time Image Playback | Yes | Yes | | Slow Motion or Frame by Frame Review | Yes | Yes | | Image Zoom | Variable from .5 to SVGA size | 2X only | | Study Comparison | Windows 95, NT facilities | Windows 3.11 Facilities | | ECG Synchronized Playback | Yes | Yes | | ECG Display | Yes | Yes | | Patient Demographics Display | Window contains age, heart rate, BP, study type and date | Heart rate, BP, study phase | | Modem Transmission | Windows 95 Windows NT standard | Custom software | | E-Mail | Windows Messaging, Exchange, SMTP | No | | Network Support | Windows 95, Windows NT TCP/IP standard | Windows 3.11 | | Comprehensive Image Serial Study Review | DICOM V3.0, TomTec, Microsonics, HP, Esaote/Biosound acquired | TomTec, MicroSonics acquired | | Different Modalities Review | DICOM US, NM | Proprietary format with DICOM support | | Audio Capture & Playback | Windows 95, NT facilities | Windows | | Patient Data Storage Compression | DICOM Version 310 Lossy JPEG baseline, Lossless REL Lossless JPEG baseline | Proprietary patient roster JPEG lossy, JPEG lossless | # Differences | Feature | Access Point™ | TomTec P90 | | --- | --- | --- | | Acquisition of Ultrasound Images | Does not acquire images from analog composite video sources. Reads images formatted and acquired by other systems, i.e., TomTec P90, Nova Microsonics, DICOM, AU3, AU4, HP | Analog composite video NTSC/PAL, SVHS, RGB | | Integration Into Ultrasound System | No | All manufacturers ultrasound systems | | Proprietary Hardware | None | Digital Echo Bus™ |