(14 days)
Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images.
AW 4.3 is a multi-modality review workstation. It includes one or two color flat panel monitors for image review. The workstation allows for easy review, post processing and filming of DICOM images from a variety of imaging systems. AW 4.3 combines AW 4.1 features with the 2D image display features of the Volume Viewer Plus software option.
The provided submission describes a medical device, the Advantage Workstation 4.3 (AW 4.3), which is a multi-modality review workstation. The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a detailed study with specific acceptance criteria and performance metrics for the AW 4.3 itself.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, as detailed in points 1 through 9 of your request, cannot be found in the provided text.
Explanation:
The document is a 510(k) summary for the AW 4.3. The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically means showing that the new device has the same intended use and the same technological characteristics as the predicate, or if there are different technological characteristics, that these do not raise new questions of safety and effectiveness.
In this context:
- Acceptance Criteria and Reported Device Performance (Point 1): The document doesn't provide specific numerical acceptance criteria for performance metrics (e.g., accuracy, speed, image quality benchmarks) for the AW 4.3, nor does it report the device's performance against such criteria. It states that the device "performs as well as devices currently on the market" and is "equivalent to those of Advantage Workstation 4.1 and Volume Viewer Plus," which implies equivalence to established performance without quantifying it.
- Study Details (Points 2-9): Since the submission focuses on substantial equivalence through comparison, it does not describe an independent study designed to establish performance metrics for the AW 4.3 with details on sample size, data provenance, ground truth establishment, expert adjudication, or MRMC studies. The "study" here is more of a comparative analysis against predicate devices. The "Adverse Effects on Health" section mentions "Software Development, Validation and Verification Process to ensure performance to specifications," but these are general processes, not a specific performance study with quantifiable results.
The current document is a regulatory submission for premarket clearance based on substantial equivalence, not a clinical trial report or a detailed performance validation study report.
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Image /page/0/Picture/1 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 border. There are small, decorative flourishes or swirls around the outer edge of the circle. The logo is black and white.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
- Larry A. Kroger, Ph.D. Submitter Senior Regulatory Programs Manager Tel: (262) 544-3894 Fax: (262) 544-4768 GE Healthcare W-400 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: July 25, 2005.
PRODUCT IDENTIFICATION
| Name: | Advantage Workstation 4.3 |
|---|---|
| Classification Name: | PACS per 21 CFR 892-2050 |
| Manufacturer : | General Electric Medical Systems283, rue de la Minière78533 Buc Cedex, FRANCE |
| Distributor: | GE Healthcare, P.O. Box 414, Milwaukee, WI 53210 |
| Marketed Devices below: | The Advantage Workstation is substantially equivalent to the devices listed |
| • Model: | Advantage Workstation 4.1, 510(k) # K020483 |
| • Manufacturer: | General Electric Medical Systems, Buc, France |
| • Model: | Volume Viewer Plus, 510(k) #K041521 |
- General Electric Medical Systems, Buc, France Manufacturer: .
Device Description:
AW 4.3 is a multi-modality review workstation. It includes one or two color flat panel monitors for image review. The workstation allows for easy review, post processing and filming of DICOM images from a variety of imaging systems. AW 4.3 combines AW 4.1 features with the 2D image display features of the Volume Viewer Plus software option.
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The hardware configuration supported by AW 4.3 includes:
- HP Linux based workstation (xw4000, xw8000 or xw8200) ●
- One or two 19" LCD monitors .
- 1 US QWERTY Keyboard
- l three button mouse .
Indications for Use:
Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images.
Comparison with Predicate:
A W4.3 is substantially equivalent to the predicate devices listed above :
| Device Name | FDA Clearance Number |
|---|---|
| Advantage Workstation 4.1 | K020483 |
| Volume Viewer Plus | K041521 |
Adverse Effects on Health:
The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:
- · Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
- · Adherence to industry and international standards.
Conclusions:
Advantage Workstation 4.3 does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the Advantage Workstation 4.3 to be equivalent to those of Advantage Workstation 4.1 and Volume Viewer Plus.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with its wings spread, rendered in a thick, black line. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol.
NOV - 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Healthcare % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Service NA., Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
K052995 Re.:
Trade/Device Name: Advantage Workstation 4.3 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and Communication system Regulatory Class: II Product Code: LLZ Dated: October 27, 2005 Received: October 28, 2005
Dear Mr. Lehtonen:
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 registrations, 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 advices 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 he Act or any Federal statues 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.
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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at 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 premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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Indications for Use
510(k) Number (if known): حكومك مك Device Name: Advantage Workstation 4.3 Indications for Use:
Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images.
Prescription Use _ Over-The-Counter Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number
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§ 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).