(15 days)
The Advantage Workstation 4.1 is a review station, which allows easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis.
Advantage Workstation 4.1 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as a basis for a diagnosis.
The AW 4.1 is positioned to be the system of choice for all users of CT, MR. Vascular Xray, Cardiac Xray, Digital Xray, PET or even PET/CT systems, MG, NM, US, SR.
The provided text is a 510(k) summary for the GE Advantage Workstation 4.1. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove their fulfillment is not explicitly present in this document.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The document states that the Advantage Workstation 4.1 "provides images comparable to the predicate device." However, it does not provide a table of quantitative acceptance criteria or reported performance metrics against those criteria. The primary "acceptance" criteria for this 510(k) appears to be substantial equivalence to the predicate device, K960613 (Advantage Windows Review Workstation).
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicit) | Reported Device Performance | Comments |
|---|---|---|
| Substantial Equivalence to Predicate Device (Advantage Windows Review Workstation, K960613) | Achieved (as determined by FDA's 510(k) clearance) | The FDA's letter (K020483) states that the device is "substantially equivalent...to legally marketed predicate devices." This is the core "acceptance" for this regulatory filing. |
| Provision of "images comparable to the predicate device." | Stated in Section 7: "Advantage Workstation 4.1 provides images comparable to the predicate device." | No quantitative comparison or study details are provided to support this claim within the document. |
| Integration into Radiology Department Workflow | Stated in Section 7: "Advantage Workstation 4.1 brings additional features in order to integrate seamlessly into the Radiology Department Workflow." | This is a qualitative claim. No specific metrics or studies are provided. |
| Hazard analysis/Risk Management Summary | Completed (mentioned in Section 7) | No details of the summary or specific risk acceptance criteria are provided. |
| Software development and validation process | Completed (mentioned in Section 7) | No details of the process or validation results are provided. |
| Software verification plan | Completed (mentioned in Section 7) | No details of the plan or verification results are provided. |
Study Details
The document does not describe a specific clinical or technical study designed to prove the device meets quantitative performance acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a previously cleared device.
- Sample size used for the test set and the data provenance: Not applicable. The document does not describe a test set or study involving patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is described.
- Adjudication method for the test set: Not applicable.
- 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 document predates widespread AI in medical imaging interpretation and does not describe such a study. The device is a workstation for image review, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a workstation for human review, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. The device is not an AI model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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General Electric Medical Systems
FEB 2 8 2002
Advantage Workstation 4.1 510 (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)
-
- Identification of submitter: Scott R. Evans Regulatory Affairs Specialist Telephone: 847-704-8878 Fax: 847-704-8560 Date Prepared: November 22nd, 2001
2. Identification of Product:
| Device name | Advantage Workstation 4.1 | Advantage Workstation 4.1 |
|---|---|---|
| Classification name | PACS per 21CFR Section 892 2050 | PACS per 21CFR Section 892 205 |
| Manufacturer/Distributor | General Electric Medical Systems283, Rue de la Minière78533 BUC Cedex France | General Electric Medical Systems800E. Business Center DriveMount Prospect, IL 60056USA |
3. Marketed Devices
Advantage Workstation is substantially equivalent to the devices listed below:
| Model: | Advantage Windows Review Workstation |
|---|---|
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K960613 |
Device Description :
Advantage Workstation 4.1 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as a basis for a diagnosis.
The AW 4.1 is positioned to be the system of choice for all users of CT, MR. Vascular Xray, Cardiac Xray, Digital Xray, PET or even PET/CT systems, MG, NM, US, SR.
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The GE Advantage Workstation 4.1 support the following Sun stations:
- . Ultra 60
- Dual processor 2x450MHz .
- . Dual UltraSPARC-II* CPU
- 1 GB RAM (expandable to 2GB) .
- . Two 36 GB internal disc
- 644 MB Internal CD writer (16x write/40x read). .
- . UltraSparc 80
- QUAD Processor 4X450 MHz .
- Ouad UltraSPARC-II* CPU .
- . 2 GB RAM (expandable to 4 GB)
- Two 36 GB internal disc internal disc .
- 644 MB Internal CD writer (12x write/40x read). .
- Monitors specifications .
- SONY* Trinitron Color Monitor .
- SUN Flat Panel Monitor 18.1 LCD .
Advantage Workstation 4.1 supports the following image networking:
- Standard 10/100 Base-T Ethernet .
The GE Advantage Workstation 4.1 is designed and produced by GE Medical Systems and has been previously submitted to PMN (K913770, K942120, K960613).
5. Indications for Use
The Advantage Windows Workstation 4.1 is a review station which allows easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis.
6. Comparison with Predicate Device
The GE Advantage Workstation 4.1 is substantially equivalent to the following workstation:
Advantage Windows Review Workstation
Manufacturer: GE Medical Systems
510(k): K960613
Both of these workstations allow easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.
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7. Conclusions
Advantage Workstation 4.1 brings additional features in order to integrate seamlessly into the Radiology Department Workflow.
The entire potential new hazards has been studied and controlled by a Risk Management Plan:
- A hazard analysis/ Risk Management Summary .
- A software development and validation process .
- A software verification plan .
Advantage Workstation 4.1 provides images comparable to the predicate device.
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Image /page/3/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text around the perimeter is not entirely clear but appears to be the name of an organization or agency. The central symbol consists of three curved lines that resemble a stylized bird or wing design. The overall impression is that of an official emblem or logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2002
General Electric Medical Systems % Mr. Wolfram Gmelin Technical Manager TÜV Rheinland of North America 12 Commerce Road NEWTON CT 06470
Re: K020483
Trade/Device Name: Advantage Workstation 4.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: February 1, 2002 Received: February 13, 2002
Dear Mr. Gmelin:
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 (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); 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.
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
Page 2
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Image /page/5/Picture/0 description: The image shows the words "Attachment 1" written in a handwritten font. The text is oriented diagonally from the bottom left to the top right of the image. The word "Attachment" is written in a larger font size than the number "1".
STATEMENT OF INTENDED USE
510(k) Number (if known): KC20483
Device name: Advantage Workstation 4.1
Indication For Use:
The Advantage Workstation 4.1 is a review station, which allows easy selection, The Advantage Tronicalor - The Change of multi-modality images from a review, processing, himing and systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel G. Ayres
(Division Sim Division in to more to ans in 510kr Numner
Prescription Use _ (Per 21 CFR 801.109) -OR-
Over-The-Counter Use _
§ 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).