ViewPoint 6

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue. GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC % Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226 Re: K203677 Trade/Device Name: ViewPoint 6 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 16, 2020 Received: December 17, 2020 Dear Tracey Ortiz: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see January 15, 2021 {1}------------------------------------------------ 2 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) #### K203677 Device Name ViewPoint 6 #### Indications for Use (Describe) ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purpostic interpretation of images, electronic documentations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound. ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images, The medical images, which ViewPoint 6 displays to the used for diagnostic purposes. ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system. ViewPoint 6 is not intended to operate medical devices in surgery related procedures. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # GE Healthcare 510(k) Premarket Notification Submission Image /page/3/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls or flourishes around its perimeter, giving it a classic and recognizable appearance. ### 510(k) Summary K203677 In accordance with 21 CFR 807.92 the following summary of information is provided: Date: December 16, 2020 | Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics | |-----------------------|------------------------------------------------------------| | 9900 Innovation Drive | | | Wauwatosa, WI 53226 | | - Primary Contact Person: Tracey Ortiz Regulatory Affairs Director GE Healthcare T:(262)470-1003 Secondary Contact Bryan Behn Regulatory Affairs Leader Person: GE Healthcare | Trade Name: | ViewPoint 6 | |-----------------------|------------------------------------------------------------------------------| | Common/Usual Name: | PACS-Picture archiving and communications system | | Classification Names: | Class II | | Product Code: | LLZ, Picture archiving and communications system, 21 CFR<br>892.2050, 90-LLZ | | Predicate Device: | ViewPoint 6 (K192917) | | Product Code: | LLZ, Picture archiving and communications system, 21 CFR<br>892.2050, 90-LLZ | | Reference Device: | EchoPAC Software Only (K200852) | | Product Code: | LLZ, Picture archiving and communications system, 21 CFR<br>892.2050, 90-LLZ | #### Device Description: ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data. It provides different calculations and tools to allow for the assessment of the images and data. ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It has an intuitive graphical user interface (GUI) and is based on Microsoft Windows® with defined hardware requirements for the user to install on their computer. ViewPoint 6 provides exam type specific reporting forms for various medical care areas. Forms are composed of different sections with data entry fields. The documentation {4}------------------------------------------------ ## GE Healthcare 510(k) Premarket Notification Submission Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company. can include measurements, exam findings, images, and graphs. All data is saved in the ViewPoint 6 database and can be compiled to a professional report. Images and image sequences can be reviewed in the ViewPoint 6 display area based on user preference. ViewPoint 6 supports both a single workstation and a client - server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read - only functionality ### Intended Use/Indication for Use: ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound. ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes. ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system. ViewPoint 6 is not intended to operate medical devices in surgery related procedures. #### Technology: ViewPoint 6 employs the same fundamental scientific technology as its predicate device. #### Determination of Substantial Equivalence: #### Comparison to Predicate Devices The proposed ViewPoint 6 system is substantially equivalent to the ViewPoint 6 (K192917) with regards to intended use, capabilities, technological characteristics, safety and effectiveness. | Feature | Predicate Device<br>ViewPoint6 cleared<br>(K192917) | Proposed Device<br>ViewPoint 6 | Discussion of<br>Differences | |------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | Intended use | Identical | Identical | n/a | | Indications for Use | Identical | Identical | n/a | | Contra-indications | Identical | Identical | n/a | | Patient population | Identical | Identical | n/a | | Environment of use | Identical | Identical | n/a | | Human Factors | Identical | Identical | n/a | | Design | Identical | Identical | n/a | | Performance | Identical | Identical | n/a | | Standards met | Identical | Identical | n/a | | Compatibility with<br>other devices/<br>Connectivity | Added:<br>• Full Image Export CVUS - Send<br>Images for IACEL Accreditation<br>• Migrate patient and study data<br>from EchoPAC to ViewPoint 6<br>• Encapsulated PDF Document<br>Export<br>• Export to standard DICOM DIR | Similar function has been<br>cleared in reference<br>device EchoPAC<br>software only (K200852)<br>The difference has no<br>impact to ViewPoint 6<br>safety and effectiveness.<br>Other capabilities are<br>similar to predicate. | | | Image Editing and<br>Management | Added:<br>• Export of anonymized<br>multi-frames available<br>• Message upon opening<br>several exams in EchoPAC<br>regarding DICOM SR data | Equivalent<br>The difference has<br>no impact to<br>ViewPoint 6 safety<br>and effectiveness. | | | Report editing and<br>management | Added:<br>• User configured units of<br>measurements<br>• User Masks - New Control<br>Types<br>• Keep list item and field<br>visibility during update<br>• Additional Exam Locked<br>States<br>• For radio buttons, 'hide in<br>report' shall work individually<br>• Option to calculate and print<br>next appointment date<br>• Enhancements for<br>Echocardiography<br>• Extend OB/Gyn Reporting<br>Content<br>• Enhanced Fetal Anatomy and<br>Placenta Section<br>• Enhanced Reporting in<br>Multiple Pregnancies<br>• Vascular Enhancements | Equivalent<br>The difference has<br>no impact to<br>ViewPoint 6 safety<br>and effectiveness. | | | Calculation | Identical | n/a | | | Data Mining | Identical | n/a | | | Coding for<br>Billing | Added:<br>• Unify and simplify medical<br>coding | Equivalent<br>The difference has no<br>impact to ViewPoint 6<br>safety and effectiveness. | | | Data Privacy<br>and Security | Identical | n/a | | | Scheduler | Identical | n/a | | {5}------------------------------------------------ # GE Healthcare 510(k) Premarket Notification Submission Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance. {6}------------------------------------------------ Image /page/6/Picture/22 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by a swirling, wave-like pattern, also in blue. The logo is simple, clean, and easily recognizable. 510(k) Premarket Notification Submission ### Summary of Non-Clinical Tests: ViewPoint 6 and its applications comply with voluntary standards: - IEC 62366-1:2015 Medical devices-Application of usability engineering to medical devices - IEC 62304:2006+A1:2015, Medical device software-Software life cycle process ● - NEMA PS 3.1-3.20 (2016), Digital Imaging and Communications in Medicine ● (DICOM) Set. (Radiology) - ISO 14971:2019 Medical Devices-Application of risk management to medical devices - IEC 82304-1:2016, Health software-General requirements for product safety ● The following quality assurance measures are applied to the development of the system: - Risk Analysis - Requirements Reviews ● - Design Reviews ● - o Testing on unit level (Module verification) - Integration testing (System verification) 0 - o Performance testing (Verification & Validation) - Safety testing (Verification) ## Summary of Clinical Tests: The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence. ## Conclusion: GE Healthcare considers the ViewPoint 6 to be as safe, as effective, and performance is substantially equivalent to the predicate device.