(54 days)
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.
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. ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It is designed with intuitive graphical user interfaces (GUIs) and is based on Microsoft Windows® with defined hardware requirements.
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 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/browser - 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.
ViewPoint 6 software is a server-based application with client-server architecture, accessed via client computers or mobile devices as well as browser-based systems. Viewpoint 6 is installed on client provided servers within a hospital network.
The software comes with features to view, annotate, measure, calculate, save and retrieve clinical data (including images via DICOM format) to support patient documentation and record keeping related to ultrasound image scans. Additionally, the software is available for patient administrative tasks such as appointment scheduling and exam billing.
This product does not control or alter any of the medical devices providing data across the hospital network.
The provided text is a 510(k) Summary for a medical device called "ViewPoint 6." This type of document focuses on demonstrating substantial equivalence to a predicate device and typically does not contain detailed primary study results with acceptance criteria and specific performance metrics as would be found in a clinical study report. It primarily outlines the scope of V&V activities and voluntary standards adhered to.
Based on the provided text, the following information can be extracted regarding the device performance and acceptance criteria:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with corresponding reported device performance values in terms of clinical accuracy (e.g., sensitivity, specificity). Instead, it states that:
"Successful completion of design verification and validation testing was performed to confirm that software and user requirements have been met."
This implies that the acceptance criteria are tied to the fulfillment of software and user requirements, which are assessed through various testing activities, but the specific numerical performance metrics are not detailed in this summary. The general statement about "Performance dependent on customer hardware but minimum hardware requirements for acceptable performance are defined in the System Requirements" suggests that performance acceptance is related to system specifications rather than clinical efficacy metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify any sample sizes for a clinical test set, nor does it provide data provenance (e.g., country of origin, retrospective or prospective nature). The V&V activities mentioned (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Performance testing, Safety testing) are typically software engineering and system-level tests and do not involve a clinical test set with patient data for performance evaluation in the context of diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
No clinical test set is described, and therefore, there is no information about the number or qualifications of experts used to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No clinical test set is described, so no adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document states:
"The similarities and differences between the subject device and the predicate device, were determined not to have a significant impact on the device's performance, the clinical performance, and the actual use scenarios. Therefore, the subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence."
This explicitly indicates that no MRMC comparative effectiveness study, or any clinical study, was conducted or deemed necessary for this 510(k) submission. Therefore, there is no information about AI assistance or its effect size on human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is described as "an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data." The indications for use state it "is not intended to be used as an automated diagnosis system." This confirms it's a tool to assist clinicians, not a standalone diagnostic algorithm. No standalone algorithmic performance study was conducted or mentioned.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As no clinical studies were performed for diagnostic accuracy, no specific ground truth type (expert consensus, pathology, outcomes data, etc.) is mentioned. The V&V activities focused on software and system requirements.
8. The sample size for the training set
The document does not refer to any AI/ML components that would require a training set. Therefore, no training set sample size is provided.
9. How the ground truth for the training set was established
Since no training set is mentioned for AI/ML, there is no information on how its ground truth would be established.
In summary:
This 510(k) submission for ViewPoint 6 primarily relies on demonstrating substantial equivalence to a predicate device (ViewPoint 6 v6.12 K203677) through software validation and verification activities, adherence to voluntary standards, and a comparison of technological characteristics. It explicitly states that clinical studies were not required because the changes from the predicate device were not deemed to have a significant impact on clinical performance. Therefore, detailed information regarding clinical performance acceptance criteria, sample sizes for test or training sets, expert adjudication, or AI performance metrics is not present in this document.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GE Healthcare GmbH % Brandon O'Shea Sr. Regulatory Affairs Manager GE HealthCare 9900 Innovation Drive Wauwatosa, WI 53225
July 2, 2024
Re: K241300
Trade/Device Name: ViewPoint 6 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: May 8, 2024 Received: May 9, 2024
Dear Brandon O'Shea:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
{1}------------------------------------------------
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Jessica Lamb
Jessica Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
{2}------------------------------------------------
Indications for Use
Submission Number (if known)
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 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
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}------------------------------------------------
Image /page/3/Picture/0 description: The image contains the GE HealthCare logo. The logo consists of the GE monogram on the left and the text "GE HealthCare" on the right. The monogram and text are both in a purple color.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| 807.92(a)(1) – Submitter Information | |
|---|---|
| Date | 08 May 2024 |
| Submitter | GE Healthcare GmbHOskar-Schlemmer-Straße 1180807 München, Germany |
| Primary Contact Person | Brandon O'SheaSr. Regulatory Affairs ManagerGE HealthCare, UltrasoundEmail: brandon.oshea@gehealthcare.comPh: (414) 323-3147 |
| Secondary Contact Person | Gabriel CarnielRegulatory Affairs SpecialistGE HealthCare, UltrasoundEmail: gabriel.carniel@gehealthcare.com |
| 807.92(a)(2) – Device Information | |
| Device Trade Name | ViewPoint 6 |
| Common/Usual Name | System, Image Processing, Radiological |
| Regulation Name | Medical image management and processing system |
| Regulation Number | 21 CFR 892.2050 |
| Regulation Class | Class II |
| Product Code | LLZ |
| Review Panel | Radiology |
| 807.92(a)(3) – Predicate Device | |
| 510(k) Number | K203677 |
| Manufacturer | GE Healthcare GmbH |
| Predicate Device(s) | ViewPoint 6 |
| The predicate device has not been subject to a design-related recall | |
| 807.92(a)(4) – Device Description |
Device Design
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. ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It is designed with intuitive graphical user interfaces (GUIs) and is based on Microsoft Windows® with defined hardware requirements.
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 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.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image contains the logo for GE HealthCare. The logo consists of the GE monogram in purple on the left, followed by the text "GE HealthCare" in a sans-serif font, also in purple. The text is aligned horizontally with the monogram, creating a unified brand representation.
ViewPoint 6 supports both a single workstation and a client/browser - 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.
Environment of Use
ViewPoint 6 is intended to be utilized across ultrasound care areas and environments.
Principle of Operation and Deployment
ViewPoint 6 software is a server-based application with client-server architecture, accessed via client computers or mobile devices as well as browser-based systems. Viewpoint 6 is installed on client provided servers within a hospital network.
The software comes with features to view, annotate, measure, calculate, save and retrieve clinical data (including images via DICOM format) to support patient documentation and record keeping related to ultrasound image scans. Additionally, the software is available for patient administrative tasks such as appointment scheduling and exam billing.
This product does not control or alter any of the medical devices providing data across the hospital network.
807.92(a)(5) - Indications 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.
807.92(a)(6) - Comparison of Intended Use and Technological Characteristics
The table below compares the intended use and technological characteristics of the subject and predicate device.
| Specification | Predicate DeviceViewPoint 6 (v6.12)K203677 | Subject DeviceViewPoint 6 (v6.15)K241300 |
|---|---|---|
| Patient Population | All patient types | All patient types |
| Environment of Use | ViewPoint 6 is intended to be used in medicalpractices and in clinical departments | ViewPoint 6 is intended to be used in medicalpractices and in clinical departments as well asremote support locations with MobileConnect |
| Design | System is based on Windows operating system Central SQL database Native Client to Server System Client communicates to server via CORBA, SQL and files One Software version with configurable languages | System is based on Windows operating system Central SQL database Native Client and Browser Client(s) to Server System Client communicates to server via REST API, SQL and files One Software version with configurable languages |
| Performance | Performance dependent on customer hardware but minimum hardware requirements for acceptable performance are defined in the System Requirements | Performance dependent on customer hardware but minimum hardware requirements for acceptable performance are defined in the System Requirements |
| Compatibility with other devices / Accessories | Compatibility with other devices: EchoPAC Plug-in (K200852) 4D View (K182750) | Compatibility with other devices: EchoPAC Plug-in (K220940) 4D View (K182750) |
| Interfaces | Public (bidirectional interfaces) DICOM Interface to the imaging modality (scanners) DICOM Interface to PACS HL7 Interface HL7 exam data import interface to a laboratory system or Trium CTG Online BDT/GDT Interface HTTPS+SOAP (only available in Sweden) Private (service/non-public interfaces) TCP+TLS (SQL) TCP (DICOM Fast Routing) | Public (bidirectional interfaces) DICOM + DICOM (TLS) Interface to the imaging modality (scanners) DICOM Interface to PACS HL7 Interface HL7 exam data import interface to a laboratory system or Trium CTG Online BDT/GDT Interface HTTPS+SOAP (only available in Sweden) Private (service/non-public interfaces) TCP+TLS (SQL) TCP (DICOM Fast Routing) FHIR Interface (service/non-public) HTTPS (REST, WAMP, WS, WebDAV) |
| Data Sources /Connectivity / Outputs | Data Sources (inputs) Imaging Modalities (scanners) Electronic Health Record (EHR/HIS) Picture Archiving and Communication System (PACS) General HL7 connected health systems Connectivity & Output Fax Device Network Attached Storage Imaging Modalities (Scanners) Electronic Health Record (EHR/HIS) Picture Archiving and Communication System (PACS) | Data Sources (inputs) Imaging Modalities (scanners) Electronic Health Record (EHR/HIS) Picture Archiving and Communication System (PACS) General HL7 connected health systems Connectivity & Output Fax Device Network Attached Storage Imaging Modalities (Scanners) Electronic Health Record (EHR/HIS) Picture Archiving and Communication System (PACS) |
| Image Management | Ability to capture and view images Ability to handle DICOM and other image formats (JPG and TIF) but convert all images to DICOM for archiving Manage single images as well as image sequences and volume data Arrange images in an exam Select images to include in a report Take measurements on images Add annotations to images Adjust image parameters | Ability to capture and view images Ability to handle DICOM and other image formats (JPG and TIF) but convert all images to DICOM for archiving Manage single images as well as image sequences and volume data Arrange images in an exam Select images to include in a report Take measurements on images Add annotations to images Adjust image parameters |
| EchoPAC | EchoPAC | |
| Reporting Module Areas | Reporting Module Areas | |
| • Obstetrics | • Obstetrics | |
| • Maternity Documentation | • Maternity Documentation | |
| ExaminationManagement | • Gynecology | • Gynecology |
| • Breast Ultrasound | • Breast Ultrasound | |
| • Abdomen and Small Parts | • Abdomen and Small Parts | |
| • Endoscopy | • Endoscopy | |
| • Vascular | • Vascular | |
| • Echocardiography | • Echocardiography | |
| • General Report | • General Report | |
| Point of Care Ultrasound (POCUS) | ||
| • Ability to generate reports which includeexam results, images and graphs | • Ability to generate reports which includeexam results, images and graphs | |
| • Ability to create exam templates for examtypes and care areas or specific departments | • Ability to create exam templates for examtypes and care areas or specific departments | |
| • Ability to set default templates for specificexam types | • Ability to set default templates for specificexam types | |
| Report Editing andManagement | • Capability to print or fax reports to specificcontact lists | • Capability to print or fax reports to specificcontact lists |
| • Ability to auto-fill a report with selectedinformation from a prior study or other valueswithin a report | • Ability to auto-fill a report with selectedinformation from a prior study or other valueswithin a report | |
| • Dark mode reports for light-reducedenvironments | • Dark mode reports for light-reducedenvironments | |
| • Gestational age | • Gestational age | |
| • Physical patient status calculations (BMI,PI/RI for Doppler values, etc.) | • Physical patient status calculations (BMI,PI/RI for Doppler values, expandedautomated calculation for Surface Area byHaycock BSA formula, etc.) | |
| • Gynecology reporting | • Gynecology reporting | |
| o Ovarian tumor classification according toIOTA LR2 Model | o Ovarian tumor classification according toIOTA LR2 Model | |
| o Ovarian tumor classification according toIOTA Simple Rules Model | o Ovarian tumor classification according toIOTA Simple Rules Model | |
| o IOTA ADNEX Model (Ovarian TumorAnalysis Model of IOTA medical group) | o IOTA ADNEX Model (Ovarian TumorAnalysis Model of IOTA medical group) | |
| o Carotid arteries ultrasound exam(extracranial): Automated calculation basedon Peak systolic and End-diastolicvelocities index | o Carotid arteries ultrasound exam(extracranial): Automated calculation basedon Peak systolic and End-diastolicvelocities index (including Sr. MaryRatio; ICA prox PSV/CCA distal EDVratio) | |
| Calculation & Analysis(within ExaminationManagement) | • Echocardiography and Vascular ultrasoundreporting: | • Echocardiography and Vascular ultrasoundreporting: |
| o Standard calculations likeEchocardiography and Doppler automatedcalculation | o Standard calculations likeEchocardiography and Doppler automatedcalculation | |
| o Echocardiography Reporting■ Support of Z-Scores | o Echocardiography Reporting■ Support of Z-Scores (includingpublications from Pediatric HeartNetwork) | |
| • Head and Neck Reporting | ■ Automated simpleEchocardiography measurementcalculations such as indexed values(over BSA) | |
| o Automated calculations | ■ Automated report generation forechocardiography reporting basedon normalized value references | |
| o ACR TI-RADS Thyroid Risk-StratificationSystem | ||
| • Obstetrics reporting | ||
| Head and Neck Reporting Automated calculations ACR TI-RADS Thyroid Risk-Stratification System Thyroid nodules overview table (trending table for thyroid lesion sizes, location and TI-RADS grading) Obstetrics reporting (with extended fetal biometry charts and graphs) | ||
| Data Privacy andSecurity | Centralized user management through link to Microsoft Active Directory by LDAP Database Encryption SmartCard authentication Clear short time store (STS) per station on user logoff LDAP Support FileShare CORBA | Centralized user management through link to Microsoft Active Directory by LDAP Database Encryption SmartCard authentication Clear short time store (STS) per station on user logoff LDAP Support REST API DICOM (TLS) support enabled |
| Other Functions(non-device functions) | Administrate Appointments (ability to schedule appointments) Coding and billing Order Management Contact Management User Management Analytics | Administrate Appointments (ability to schedule appointments) Coding and Billing Order Management Contact Management User Management Analytics Automatic Assignment of Studies to an Exam |
| User Interfaces | ViewPoint 6 Native Client (PC) | ViewPoint 6 Native Client (PC) ViewPoint 6 Browser Client(s) WebConnect Client (PC/Tablet) MobileConnect Client (Tablet/Phone) |
| Supported OperatingSystem(s) | Operating System(s) Native Client: Windows 8.1, Windows 10, Windows Server 2012, Windows Server 2016, Windows Server 2019 | Operating System(s) Native Client: Windows 10, Windows 11, Windows Server 2016, Windows Server 2019, Windows Server 2022 Operating System(s) Browser Client (WebConnect): Mozilla Firefox (minimum version 103.2) Microsoft Edge Extended Stable Channel: Version 105.0.1343.42 Google Chrome Version 105.0.5195.127 Operating System(s) Browser Client (MobileConnect): iOS - Apple Safari: Version 16.3 and above Android - Google Chrome Version 111 and above |
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the GE HealthCare logo. The logo consists of a circular symbol with intertwined letters on the left and the text "GE HealthCare" on the right. The color of the logo is a shade of purple.
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the text "GE HealthCare" is written in a simple, sans-serif font, also in purple. The logo is clean and modern, reflecting the company's focus on healthcare technology and innovation.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image contains the GE HealthCare logo. The logo consists of the GE monogram on the left and the text "GE HealthCare" on the right. The monogram and text are both in a purple color.
The proposed ViewPoint 6 application is substantially equivalent to the ViewPoint 6 (K203677) application with regards to intended use, capabilities, technological characteristics, security characteristics, safety and effectiveness.
The proposed ViewPoint 6 application employs the same fundamental scientific technology as its predicate device.
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem with a stylized "GE" monogram on the left. To the right of the emblem is the text "GE HealthCare" in a simple, sans-serif font. The color of the logo and text is a shade of purple.
| 807.92(b)(1) - Performance Testing | |
|---|---|
| Summary of Non-ClinicalTests | Software was evaluated as recommended in the 2023 FDA guidancedocument "Content of Premarket Submissions for Device SoftwareFunctions." The ViewPoint 6 application was developed followingthe GE HealthCare Quality Management System. The followingactivities were successfully completed: |
| Risk Analysis / Management Requirements Reviews Design Reviews Testing on unit level (Module Verification) Integration testing (System Verification) Performance testing (Verification & Validation) Safety testing (Verification) | |
| The ViewPoint 6 application has also been subject to the followingvoluntary standards / non-clinical V&V activities: | |
| IEC 62366-1:2016-10, Medical devices – Part1: Applicationof usability engineering to medical devices IEC 62304:2015-06, Medical device software – Software lifecycle processes NEMA PS 3.1-3.20 (2023e), Digital Imaging andCommunications in Medicine (DICOM) Set (Radiology) ISO 14971:2019-12, Medical devices - Application of riskmanagement to medical devices IEC 82304-1:2016-10, Health software - Part 1: Generalrequirement for product safety ISO 15223-1:2021-07, Medical devices – Symbols to be usedwith information to be supplied by the manufacturer ISO 20417:2021-04, Medical devices – Information to besupplied by the manufacturer | |
| Successful completion of design verification and validation testingwas performed to confirm that software and user requirements havebeen met. | |
| Cybersecurity was evaluated as recommended in the 2023 FDAguidance document “Cybersecurity in Medical Devices: QualitySystems Considerations and Content of Premarket Submissions." | |
| Interoperability was evaluated as recommended in the 2017 FDAguidance document "Design Considerations and Pre-marketSubmission Recommendations for Interoperable Medical Devices." |
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized, circular design, and the text is in a clean, sans-serif font.
| No additional testing was required beyond the testing per thestandards and the verification testing from the Software/FirmwareSection to support substantial equivalence. | |
|---|---|
| 807.92(b)(2) – Summary of Clinical Tests | |
| Summary of Clinical Tests | The similarities and differences between the subject device and thepredicate device, were determined not to have a significant impacton the device's performance, the clinical performance, and the actualuse scenarios.Therefore, the subject of this premarket submission, ViewPoint 6,did not require clinical studies to support substantial equivalence. |
| 807.92(b)(3) - Conclusion |
The performance data described above demonstrate that the proposed ViewPoint 6 application is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).