(39 days)
The GE ViewPoint is intended 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.
GE ViewPoint is a software based medical image management system providing the ability to review exam images and data, prepare and printing reports and communicate with ultrasound scanners and other PACS devices via DICOM or other network protocol. It is sold with or without the designated computer hardware.
This document is a 510(k) premarket notification for the GE ViewPoint Image Management and Reporting System, submitted on April 12, 2005. It provides general information about the device and asserts its substantial equivalence to a predicate device. However, it does not contain any specific acceptance criteria or details of a study demonstrating the device meets such criteria in terms of performance metrics.
The document explicitly states:
- "Clinical Tests: None required to confirm safety and effectiveness. However, evaluation in a clinical setting is performed to help assure reliability and compatibility within the intended network environment."
Therefore, based solely on the provided text, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence based on intended use and technological characteristics to a predicate device, not on specific performance metrics against defined acceptance criteria.
- Sample sizes used for the test set and data provenance: Not applicable as no performance testing study against acceptance criteria is described.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided document:
The GE ViewPoint system is described as a software-based medical image management system designed to accept, transfer, display, store, and process ultrasound images and data. It allows for measurement, calculation, annotation, and preparation/printing of patient examination reports.
The manufacturer asserts that the device is substantially equivalent to the KinetDx® Diagnostic Workstation for Radiology (K041029). The basis for this equivalence is stated to be:
- Equivalent technological characteristics
- Key safety and effectiveness features
- Physical design, construction, and materials
- Essentially the same intended uses
The submission highlights non-clinical tests for conformance to design specifications and software development, and system compatibility. It also mentions an evaluation in a clinical setting "to help assure reliability and compatibility within the intended network environment," but explicitly states that clinical tests were "None required to confirm safety and effectiveness."
Therefore, the document relies on the concept of substantial equivalence to a legally marketed predicate device rather than demonstrating performance against specific acceptance criteria through a detailed study.
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Medical Image Management Device 510(k) Premarket Notification GE ViewPoint Image Management and Reporting System April 12, 2005
MAY 2 3 2005
Attachment B:
Summary of Safety and Effectiveness
Prepared in accordance with 21 CFR Part 807.92(c).
Image /page/0/Picture/6 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a circular border. The letters and the border are black, creating a strong contrast against the white background.
GE Healthcare
General Electric Company P.O. Box 414, Milwaukee, WI 53201
Section a):
| 1. | Submitter: | GE Medical Systems, Ultrasound and Primary Care DiagnosticsPO Box 414Milwaukee, WI 53201 |
|---|---|---|
| Contact Person: | Allen Schuh,Manager, Safety and Regulatory EngineeringTelephone: 414-647-4385; Fax: 414-647-4090 | |
| Date Prepared: | April 12, 2005 | |
| 2. | Device Name: | ViewPoint V5 Ultrasound Image Management and Reporting SystemSystem, Image Processing, Radiological , 21 CFR 892.2050, 90-LLZ |
| 3. | Marketed Device: | KinetDx® Diagnostic Workstation for Radiology - K041029, 6/8/2004, 90-LLZCurrently placed in commercial distribution by Siemens Medical Solutions. |
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Device Description: GE ViewPoint is a software based medical image management system providing 4. Desomblight. OE viow ontrolew exam images and data, prepare and printing reports and communicate with ultrasound scanners and other PACS devices via DICOM or other network protocol. It is sold with or without the designated computer hardware.
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Indications for Use: The GE ViewPoint is intended to accept, transfer, display, store and process of indicalliens for bot. The ability to measure, calculate, annotate and prepare and print patient examination reports primarily for diagnostic ultrasound.
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Comparison with Predicate Device: The GE ViewPoint is of a comparable type and substantially equivalent to the KinetDx Diagnostic Workstation. It has equivalent technological characteristics, key safety and effectiveness features, physical design, construction, and materials, and has essentially the same intended uses as the predicate device.
Section b):
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Non-clinical Tests: The device has been evaluated for conformance to its design specifications and 1. Northernoar roots. The downed to software development. It is further verified for system compatibility with applicable industry othination of to computer hardware is certified to applicable safety standards.
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Clinical Tests: None required to confirm safety and effectiveness. However, evaluation in a clinical setting is performed to help assure reliability and compatibility within the intended network environment.
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Conclusion: Intended uses and other key features of the device are consistent with traditional clinical ാ. Onlines and established methods of handling patient examination images and data. The practice, I DA galocines are setablished menufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485:2000 quality systems. The device conforms to applicable medical device safety standards 130 15403.2000 quality Systems: The admise content quality system audit. PACS devices and medical information management systems in general have accumulated a long history of safe and medical mormation management of GE Healthcare that GE ViewPoint is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Allen Schuh Manager, GE Ultrasound Safety and Regulatory Engineering General Electric Company GE Healthcare P.O. Box 414 MILWAUKEE WI 53201
MAY 2 3 2005
, ਕਾ
Re: K050943
Trade/Device Name: GE ViewPoint Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 12, 2005 Received: April 14, 2005
Dear Mr. Schuh:
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 either class II (Special Controls) or class III (Premarket Approval), 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.
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.
Image /page/1/Picture/11 description: The image shows a logo for the Department of Health & Human Services. The logo is circular with text around the perimeter. Inside the circle is an abstract image of an eagle.
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This letter will allow you to begin marketing your device as described in your Section 510(k)
10 alcades and and and one of the supplement of your device to a legally This letter will allow you to begin harketing your antiel equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, premarket notification. The FDA miding of substantial equil 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 If you desire specific advice for your device on our labering regarded. (2.2.
contact the Office of Compliance at one of the following numbers, based on the regulation number 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 premaiket notification" (21 CFR Also, please note the regulation entitled, "Risonanians of your responsibilities under the Act from the 807.97). You may obtain other general international its toll-free number (800)
Division of Small Manufacturers, International and Consumers assistance and Division of Small Manufacturers, International and Collection Internet and results of the main. http://www.fdsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Medical Image Management Device 510(k) Premarket Notification Medical Image Management and Reporting System April 12, 2005
Attachment E
Indications for Use
K050943 510(k) Number (if known):
Device Name: GE ViewPoint
Indications For Use: The GE ViewPoint is intended to accept, transfer, display, The OE viow ons medical images and data, including the store and probose mountal in annotate and prepare and ability to measure, called creports primarily for diagnostic ultrasound.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Gountor-Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniela Layman
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number .
§ 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).