(101 days)
ViewPoint 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 provides the user the ability to including images, drawings, and charts into medical reports. ViewPoint 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 displays to the user, can be used for diagnostic purposes.
ViewPoint is intended for professional use only. ViewPoint is not intended to be used as an automated diagnosis system.
ViewPoint is not intended to operate medical devices in surgery related procedures.
GE ViewPoint 6 is an-image-archiving and reporting software for medical practices and clinical radiological departments used for diagnostic purpose. It incorporates basic features of administration, image and data acquisition from medical devices via DICOM or proprietary interface, data transfer from third party systems, reporting of medical findings, report generation, network interfacing and archiving. Image processing and calculations capabilities are available for images.
The basis for this submission is a modification to a legally marketed device to incorporate additional features and to modify the wording of the indications for use statement for clarification purposes. The proposed indications for use statement is equivalent to the one from the predicate device. The intended use is identical to the predicate device.
The device modifications mainly consist of:
- Enhancements to the User Interface for improved usability;
- Additional customization capabilities;
- Configurable User Interface language.
The provided document is a 510(k) Premarket Notification for GE Healthcare's ViewPoint 6, an image archiving and reporting software for medical practices and clinical radiological departments. The document focuses on demonstrating substantial equivalence to a predicate device (ViewPoint 5) and does not describe a study involving AI or specific acceptance criteria for a device's performance in terms of diagnostic accuracy or a similar clinical metric.
Therefore, many of the requested details, such as a table of acceptance criteria and reported device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable or not available in this document.
Here's what can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable / Not available. The document states that ViewPoint 6 did not require clinical studies. The "acceptance criteria" here are related to regulatory compliance and demonstrating substantial equivalence to a predicate device, rather than specific performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic AI device. The study performed involved non-clinical tests to verify compliance with voluntary standards and ensure quality assurance.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not available. As no clinical studies were performed, there is no test set in the context of diagnostic performance evaluation. The "tests" mentioned are for software verification and validation (e.g., unit, integration, performance, safety, simulated use testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable / Not available. No ground truth for diagnostic performance was established for a test set as no clinical studies were performed.
4. Adjudication Method for the Test Set:
- Not applicable / Not available.
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:
- Not applicable. This device is an image archiving and reporting software, not an AI-powered diagnostic tool for assisting human readers. The document explicitly states it "is not intended to be used as an automated diagnosis system."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is software for image management and reporting, not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No clinical ground truth was established for diagnostic performance. The "ground truth" in the context of this submission refers to the successful completion of software development lifecycle activities and adherence to established standards and requirements for software functionality and safety.
8. The Sample Size for the Training Set:
- Not applicable / Not available. This is not an AI/machine learning device that relies on a training set for model development.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / Not available.
Summary of the Study and Device Information (as per document):
- Device Name: ViewPoint 6
- Device Type: Image archiving and reporting software for medical practices and clinical radiological departments.
- Intended Use: "To accept, transfer, display, store and process medical images and data, including the ability to measure, calculate, annotate and prepare and print patient examination reports primarily for diagnostic ultrasound." It also explicitly states: "ViewPoint is not intended to be used as an automated diagnosis system."
- Study Performed: Non-clinical tests were conducted to comply with voluntary standards and apply quality assurance measures to the development of the system. These included:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
- Conclusion of Study: "The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence." The non-clinical tests were deemed sufficient to demonstrate that ViewPoint 6 is as safe, as effective, and its performance is substantially equivalent to the predicate device (ViewPoint 5).
In essence, the ViewPoint 6 submission is for a software update to an existing PACS (Picture Archiving and Communications System) type device, not for an AI diagnostic device. Its regulatory pathway leveraging substantial equivalence to a predicate device and focusing on non-clinical software testing reflects its classification and intended use as a medical image management system, not a device making diagnostic interpretations.
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Image /page/0/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is slightly distorted and has some artifacts, possibly due to the image quality or compression.
MAR - 4 2011
GE Healthcare ViewPoint 6 - 510(k) Premarket Notification
510(k) Summary
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In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | November 20, 2010 |
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| Submitter: | GE Healthcare [ViewPoint Bildverarbeitung GmbH]Argelsrieder Feld 12Wessling, Germany, 82234T: +49 8153 931191F: +49 8153 931130 |
| Primary Contact Person: | Nicole LandrevilleUSA Premarket Regulatory Affairs LeaderGE Healthcare, QARA Regions - Americas3000 North Grandview Boulevard #W450Waukesha, WI, USA, 53188T: (289) 208-2365F: (414) 918-4498 |
| Secondary Contact Person: | Erich ZannerSite QA & Regulatory Affairs Leader.GE Healthcare [ViewPoint Bildverarbeitung GmbH]Argelsrieder Feld 12Wessling, Germany, 82234T: +49 8153 931191F: +49 8153 931130 |
| Device/Trade Name: | ViewPoint 6 |
| Common/Usual Name: | ViewPoint |
| Classification Names:Product Code: | PACS - Picture archiving and communications systemLLZ, 892.2050 |
| Predicate Device(s): | ViewPoint 5 [K050943] |
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GE Healthcare
ViewPoint 6 - 510(k) Premarket Notification
in the
| Device-Description: | GE ViewPoint 6 is an-image-archiving and reporting software formedical practices and clinical radiological departments used fordiagnostic purpose. It incorporates basic features ofadministration, image and data acquisition from medical devicesvia DICOM or proprietary interface, data transfer from third partysystems, reporting of medical findings, report generation, networkinterfacing and archiving. Image processing and calculationscapabilities are available for images. |
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| The basis for this submission is a modification to a legally marketeddevice to incorporate additional features and to modify the wordingof the indications for use statement for clarification purposes. Theproposed indications for use statement is equivalent to the one fromthe predicate device. The intended use is identical to the predicatedevice.The device modifications mainly consist of:- Enhancements to the User Interface for improved usability;- Additional customization capabilities;- Configurable User Interface language. | |
| Intended Use: | The GE ViewPoint is intended to accept, transfer, display, store andprocess medical images and data, including the ability to measure,calculate, annotate and prepare and print patient examinationreports primarily for diagnostic ultrasound. |
| Technology: | The ViewPoint 6 employs the same fundamental scientifictechnology as its predicate devices. |
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GE Healthcare ViewPoint 6 - 510(k) Premarket Notification
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| Determination of SubstantialEquivalence: | Summary of Non-Clinical Tests:The ViewPoint 6 and its sub-applications comply with voluntarystandards as detailed in Section 9 of this premarket submission. Thefollowing quality assurance measures were applied to thedevelopment of the system:Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation)Summary of Clinical Tests:The subject of this premarket submission, ViewPoint 6, did notrequire clinical studies to support substantial equiva nce. |
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| Conclusion: | GE Healthcare considers the ViewPoint 6 to be as safe, as effective,and performance is substantially equivalent to the predicatedevices. |
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its wings and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration · 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
GE Healthcare % Ms. Nicole Landreville USA Premarket Regulatory Affairs Leader 3000 North Grandview Boulevard #W450 WAUKESHA WI 53188
MAR - 4 2011
Re: K103458
Trade/Device Name: ViewPoint 6 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 20, 2010 Received: December 20, 2010
Dear Ms. Landreville:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary S Pastel
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: ViewPoint 6
Indications for Use:
ViewPoint 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 provides the user the ability to including images, drawings, and charts into medical reports. ViewPoint 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 displays to the user, can be used for diagnostic purposes.
ViewPoint is intended for professional use only. ViewPoint is not intended to be used as an automated diagnosis system.
ViewPoint is not intended to operate medical devices in surgery related procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Mry. Slatel
(Division Sign-Off)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K103458
Prescription Use (Per 21 CFR 801.109)
§ 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).