MEDSTREAMING MEDICAL OFFICE SOFTWARE

{0}------------------------------------------------ K072972 Page 1 of 2 ## 510(k) Summary of Safety and Effectiveness This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21CFR. Part 807, Subpart E. Section 807.92 #### 1) Submitter's name, address, telephone number, contact person Karla Patten 4320 Leavelle Street NW Olympia, WA. 98502 Telephone: 425-239-1240 E-mail: kspatten@msn.com NOV - 8 2017 2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known: | Common/Usual Name: | Picture Archiving and Communications Systems (PACS) | |----------------------|-------------------------------------------------------| | Proprietary Name: | MEDStreaming Medical Office | | Classification Name: | Picture Archiving and Communications System, Class II | #### 3) Device Description The MEDStreaming Medical Office software provides a means of opening and displaying image files. The MEDStreaming Medical Office software provides a means of transferring medical image files using a DICOM network method from the modality acquisition devices to the MEDStreaming Medical Office server. MEDStreaming's Medical Office provides a means for transferring the acquired studies to a DICOM compliant archive device using standard networking methods. The MEDStreaming Medical Office software provides a means to retrieve and view image data located on an acquisition or archive device using a standard network connection. The MEDStreaming Medical Office software provides a means for querving and retrieving patient studies from a networked DICOM server device. The MEDStreaming Medical Office software provides a means of creating AVI, BMP and JPG graphic files from the image data displayed by the software. The MEDStreaming Medical Office software provides a means of quantifying the image data using standard measurement tools. The MEDStreaming Medical Office software provides a means of transferring the DICOM Structured Reporting components provided by a connected acquisition device. MEDStreaming's Medical Office provides a means of transferring labeled measurements using a serial gateway from modality devices that support a serial data transfer method. MEDStreaming's Medical Office provides a means of generating an examination report for patient studies reviewed on the Medical Office workstation utilizing Microsoft standard text, spreadsheet and database programs. MEDStreaming's Medical Office provides a means for export results in HL7 or standard graphic file format. MEDStreaming's Medical Office provides a method for generating utilization reports for data contained within the MEDStreaming patient database using standard Microsoft database tools. #### 4) Performance Standards No performance standards for PACS systems or components have been issued under the authority of Section 514. {1}------------------------------------------------ KC72972 Page 2 of 2 The MEDStreaming Medical Office software has been designed to comply with the following voluntary standards: ISO Joint Photographic Experts Group (JPEG) Image Compression Standard DICOM Standard 3.0 ICD-9 Finding Codes Exam Type CPT Codes Health Language 7 Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL) Intersocietal Commission for the Accreditation of Echocardiographic Laboratories (ICAEL) Microsoft Office Interoperability Engine ## 5) General Safety and Effectiveness Concerns The device labeling contains operating instructions for the safe and effective use of the MEDStreaming Medical Office software. ## 6) Substantially Equivalent Devices MEDStreaming LLC believes that the capability and features of the MEDStreaming Medical Office software makes it substantially equivalent to other image display products commercially available. specifically the ProSolv Cardiovascular Viewer, Analyzer and Server. #### 7) Software Software development for the MEDStreaming Medical Office software follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the software. Appropriate steps have been taken to control all identified risks for this type of image display and communication product. #### 8) Conclusions The MEDStreaming Medical Office software is designed and manufactured to meet United States and international standards for the display and transmission of images acquired on medical imaging devices. The system is designed to incorporate components common to all image viewing systems for the display, manipulation and image transmission within a clinical setting. The MEDStreaming Medical Office software incorporates features of predicate devices cleared through premarket notification and no new issues of safety or effectiveness are raised. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The text is in all caps and is smaller than the eagle symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## NOV - 6 2007 MEDStreaming LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313 Re: K072972 Trade/Device Name: MEDStreaming Medical Offices Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 20, 2007 Received: October 22, 2007 #### · Dear Mr. Job: 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. Ilsting 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 such 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. {3}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean 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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter. | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours, Nancy Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K072973 Device Name: 3 MEDStreaming Medical Office Software Indications for Use: The MEDStreaming Medical Office software provides a means of opening and displaying image files. The MEDStreaming Medical Office software provides a means of transferring medical image files using a DICOM network method from the modality acquisition devices to the MEDStreaming Medical Office server. MEDStreaming's Medical Office provides a means for transferring the acquired studies to a DICOM compliant archive device using standard networking methods. The MEDStreaming Medical Office software provides a means to retrieve and view image data located on an acquisition or archive device using a standard network connection. The MEDStreaming Medical Office software provides a means for querying and retrieving patient studies from a networked DICOM server device. MEDStreaming's Medical Office provides a means to digitize video information from connected imaging modalities using a standard video digitizing engine. The MEDStreaming Medical Office software provides a means of creating AVI, BMP and JPG graphic files from the image data displayed by the software. The MEDStreaming Medical Office software provides a means of quantifying the image data using standard measurement tools. The MEDStreaming Medical Office software provides a means of transferring the DICOM Structured Reporting components provided by a connected acquisition device. MEDStreaming's Medical Office provides a means of transferring labeled measurements using a serial gateway from modality devices that support a serial data transfer method. MEDStreaming's Medical Office provides a means of generating an examination report for patient studies reviewed on Medical Office utilizing Microsoft standard text, spreadsheet and database programs. MEDStreaming's Medical Office provides a means for importing and exporting patient information in HL7 format. MEDStreaming's Medical Office provides a method for generating utilization reports for data contained within the MEDStreaming patient database using standard Microsoft database tools. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Page 1 of 1 Division of Reproductive, Abdominal and Radiological Devices 510(k) Number