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.

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.

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 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 clientserver 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.

AI/ML Overview

The provided text contains information about a 510(k) submission for the ViewPoint 6 device, which is a Picture Archiving and Communications System (PACS). However, it explicitly states, "The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence."

Therefore, the document does not contain information regarding acceptance criteria, device performance from a clinical study, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance. It focuses on non-clinical tests (compliance with standards, quality assurance measures).

Here's what can be extracted based on the prompt's requirements, highlighting the lack of relevant clinical study data:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission states that clinical studies were not required to support substantial equivalence. Therefore, there are no reported acceptance criteria or device performance metrics from a clinical study.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical test set was used as clinical studies were not required.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No clinical test set requiring ground truth established by experts was used.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. A MRMC comparative effectiveness study was not performed as clinical studies were not required.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-loop Performance) was Done

Not applicable. The device is a PACS system for diagnostic interpretation and reporting, not an automated diagnosis system. The submission explicitly states: "ViewPoint 6 is not intended to be used as an automated diagnosis system." Therefore, a standalone algorithm performance study is not relevant in the context of this device.

7. The Type of Ground Truth Used

Not applicable. No clinical test set requiring ground truth was used.

8. The Sample Size for the Training Set

Not applicable. The device is a PACS software, not an AI/ML diagnostic algorithm that would typically involve a "training set" for model development.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As explained above, there is no mention of a training set or associated ground truth.

Summary of Non-Clinical Tests and Quality Assurance (as provided in the document):

The device complies with the following voluntary standards:

IEC 62366-1:2015 Medical devices Application of usability engineering to medical devices
IEC 62304:2006, Medical device software Software life cycle process
NEMA PS 3.1 - 3.20 (2016), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
ISO 14971:2012 Medical Devices Application of risk management to medical devices

Quality assurance measures applied to the development of the system include:

Risk Analysis
Requirements Reviews
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
Final Acceptance Testing (Design Validation and Service Validation)
Performance testing (Verification)
Safety testing (Verification)

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 22, 2016

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Ms. Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226

Re: K162743

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: September 28, 2016 Received: September 30, 2016

Dear Ms. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Robert Ochs

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use		Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K162743

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 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)

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."

FORM FDA 3881 (8/14)

EF PSC Publishing Services (301) 443-6740

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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: September 28, 2016 Date: GE Medical Systems Ultrasound and Primary Care Diagnostics, Submitter: 9900 Innovation Drive Wauwatosa, WI 53226

Primary Contact Person: Tracey Ortiz Regulatory Affairs Director GE Healthcare T:(262)676-6120 F:(414)918-8275
- Secondary Contact Nadine Gebhard- Höflinger Requlatory Affairs Person: GE Healthcare Austria GmbH & Co OG

Trade Name:	ViewPoint 6
Common/Usual Name:	PACS / Picture archiving and communications system
Classification Names:	Class II

Product Code: Picture archiving and communications system, 21 CFR 892.2050, LLZ
Primary Predicate ViewPoint 6 (K103458) Device(s):
Reference Predicate none Device(s):

ViewPoint 6 is an image archiving and reporting software for Device Description: 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 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

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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. The frame has decorative swirls or flourishes around the letters. The logo is presented in a light blue color.

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.

Intended Use/ Indication for Use:

Indications for Use of ViewPoint 6

Technology: ViewPoint 6 employs the same fundamental scientific technology as its predicate device.

Determination of Comparison to Predicates

Substantial Equivalence:

The proposed ViewPoint 6 is substantially equivalent to the predicate ViewPoint 6 with regards to intended use. capabilities, technological characteristics, safety and effectiveness. There was no change in the indication for use.

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo, which is a stylized monogram of the letters 'g' and 'e' enclosed within a circular shape. The monogram is rendered in a cursive style, with the 'g' and 'e' intertwined. The logo is colored in a light blue hue, and the circular shape has a double-line border, also in the same blue color.

Following changes were done compared to the predicate device:

Distribution changed from physical DVD to an access controlled cloud based solution (e-distribution)
Labelling updates made as needed to alian with the o product changes
Expanded capabilities for image review/compare, ● measure, annotate, and adjust
o Added organization features – auto log off tracking, smartcard authentication, clinical scheduler, resource manager, spell check, code lists for billing, HL7 order management
Added options for export of data and reports with an o encrypted database
Added adaptable lighting environment setting ( lightson/lights-off mode)
Added workflow features for exam type definition, ● exam auto lock, multi-monitor support and new report forms

Summary of Non-Clinical Tests:

The ViewPoint 6 and its applications comply with voluntary standards:

1. IEC 62366-1:2015 Medical devices Application of usability engineering to medical devices
1. IEC 62304:2006, Medical device software Software life cycle process
1. NEMA PS 3.1 3.20 (2016), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
1. ISO 14971:2012 Medical Devices Application of risk management to medical devices

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Image /page/6/Picture/0 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. There are decorative swirls around the outer edge of the circle, giving it a classic and recognizable appearance.

The following quality assurance measures are applied to the development of the system:

Risk Analysis
Requirements Reviews ●
. Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
Final Acceptance Testing (Design Validation and ● Service Validation)
o Performance testing (Verification)
Safety testing (Verification) ●

Summary of Clinical Tests:

The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the proposed ViewPoint 6 to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).