(14 days)
Volume Viewer Plus is a medical diagnostic software that allows the processing, review, and communication of 3D reconstructed images and their relationship acquired images from CT, MR, X-Ray Angio and PET Scanning devices. The combination of acquired images, reconstructed images, annotations and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information for diagnosis, surgery and treatment planning.
Volume Viewer Plus is a software package to be used on the GE Advantage Workstation, the GE Centricity PACS Workstation and the GE CT Operator Consoles (LightSpeed and HiSpeed). It allows the 3D processing, review and analysis of DICOM CT, MR, X-Ray Angio and PET images previously acquired, reconstructed and transferred on the corresponding workstation. This software provides Multi-Planar Reformation (MPR) views in any plane (orthogonal, oblique or curved), 3D views in any rendering mode (MIP, MinIP, Average, Volume Rendering, Fly-Through) and their correlation to originally acquired images. Its user interface provides the tools to manipulate, annotate, measure and record these views as well as output an exam report. Additional features allow for segmentation of anatomy as well as display of multi-phase and/or fused hybrid images (PET/CT, PET/MR).
This 510(k) pertains to "Volume Viewer Plus," a software package for 3D processing, review, and analysis of medical images (CT, MR, X-Ray Angio, PET). The submission focuses on demonstrating substantial equivalence to previously cleared devices, rather than a de novo clinical study with specific acceptance criteria and performance data for a novel algorithm.
Therefore, many of the requested sections (acceptance criteria, performance, sample size for test/training, expert adjudication, MRMC study, standalone performance, ground truth details) are not applicable or not provided in this 510(k) summary. The summary focuses on comparing the new device's features and potential risks to its predicates.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission for a software upgrade/enhancement, not a de novo device with novel performance claims requiring specific thresholds. The "acceptance criteria" here is implicitly "performing as well as predicate devices" and "not introducing new safety risks."
- Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are reported for Volume Viewer Plus itself. The claim is that it "performs as well as devices currently on the market" (i.e., the predicate devices).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to predicate devices (K972399, K012313) | "performs as well as devices currently on the market." |
| No new potential safety risks | "does not result in any new potential safety risks." |
| Adherence to specifications, federal regulations, and user requirements | Controlled by "Software Development, Validation and Verification Process." |
| Adherence to industry and international standards | Controlled by "Adherence to industry and international standards." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The submission does not detail a clinical test set for performance validation in the way a novel diagnostic device might.
- Data Provenance: Not specified. Given it's a software for existing imaging modalities, it would utilize DICOM images, but no specific dataset or its origin is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Reason: This information is typically required for studies demonstrating diagnostic accuracy. As this submission focuses on substantial equivalence of image processing/viewing software, such a clinical validation study with expert ground truth is not elaborated upon in the summary.
4. Adjudication method for the test set
- Not specified. (See explanation for point 3).
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
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary.
- Reason: Volume Viewer Plus is described as software for 3D processing, review, and analysis of images, providing tools for clinicians. It is not an AI-assisted diagnostic algorithm intended to improve human reader performance in the typical sense that an AI CADe or CADx device would claim. Its enhancements are in visualization, segmentation, and workflow, which are intended to provide "clinically relevant information" but not explicitly quantified as a human reader performance uplift through an MRMC study in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, a standalone algorithm performance evaluation is not mentioned.
- Reason: This device is a software package for clinicians to use, not an autonomous AI algorithm that performs diagnosis independently. It's an "accessory to Computed Tomography System" and "Magnetic Resonance diagnostic device."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. (See explanation for point 3).
8. The sample size for the training set
- Not applicable/Not specified. This is a software package whose development would typically involve software engineering and validation against specifications, rather than machine learning model training on a "training set" in the context of AI.
9. How the ground truth for the training set was established
- Not applicable/Not specified. (See explanation for point 8).
Summary of Device and Regulatory Context:
The Volume Viewer Plus submission is a 510(k) seeking clearance for a software product that provides enhanced 3D processing, review, and analysis capabilities for various medical imaging modalities. The core of the submission relies on demonstrating substantial equivalence to existing cleared devices (Advantage Windows Volume Rendering Option K972399 and CT Colonography / Navigator2 K012313). The justification for clearance is that the new features are enhancements to existing functionalities and do not introduce new safety risks, while performing as well as the predicates. The documentation focuses on software development and risk management processes rather than a clinical performance study with specific performance metrics and gold standards.
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JUN 2 2 2004
Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The letters and the circle are in black, creating a strong contrast. The logo is simple, recognizable, and represents the General Electric brand.
GE Medical Systems
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).
| Submitter | Larry A. Kroger, Ph.D.Senior Regulatory Programs ManagerTel: (262) 544-3894Fax: (262) 544-4768GE Medical Systems W-4003000 North Grandview Blvd.Waukesha, WI 53188 USADate Prepared: March 10, 2004. |
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PRODUCT IDENTIFICATION
| Name: | Volume Viewer Plus |
|---|---|
| Classification Name: | Accessory to Computed Tomography SystemAccessory to Magnetic Resonance diagnostic device |
| Manufacturer : | General Electric Medical Systems283, rue de la Minière78533 Buc Cedex, FRANCE |
| Distributor: | General Electric Medical Systems, Buc, France. |
| Marketed Devices | The Volume Viewer Plus is substantially equivalent to the devices listed below: |
| Model: Manufacturer: 510(k) #: | Advantage Windows Volume Rendering OptionGeneral Electric Medical Systems, Buc, FranceK972399 |
- CT Colonography / Navigator2 Model: .
- General Electric Medical Systems, Buc, France Manufacturer: ● K012313 510(k) #:
Device Description:
Volume Viewer Plus is a software package to be used on the GE Advantage Workstation, the GE Centricity PACS Workstation and the GE CT Operator Consoles (LightSpeed and HiSpeed). It allows
NOMFICHIFR
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the 3D processing, review and analysis of DICOM CT, MR, X-Ray Angio and PET images previously acquired, reconstructed and transferred on the corresponding workstation.
This software provides Multi-Planar Reformation (MPR) views in any plane (orthogonal, oblique or curved), 3D views in any rendering mode (MIP, MinIP, Average, Volume Rendering, Fly-Through) and their correlation to originally acquired images. Its user interface provides the tools to manipulate, annotate, measure and record these views as well as output an exam report. Additional features allow for segmentation of anatomy as well as display of multi-phase and/or fused hybrid images (PET/CT, PET/MR).
Indications for Use:
Volume Viewer Plus is a medical diagnostic software that allows the processing, review, and communication of 3D reconstructed images and their relationship acquired images from CT, MR, X-Ray Angio and PET Scanning devices. The combination of acquired images, reconstructed images, annotations and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information for diagnosis, surgery and treatment planning.
Comparison with Predicate:
Volume Viewer Plus is substantially equivalent to the predicate devices listed above and provides additional processing capabilities with standard review protocols per anatomy and acquisition technique (One Touch, Layout Presets, Compare Mode), enhanced segmentation tools (AutoSelect, Multi-Object Volume Rendering), enhanced visualization tools (Fused Display, Dynamic Volume Review, ROI Tool) and finally real-time interactive exporting tools (Batch Reformat/Filming, Movie Builder).
| Device Name | FDA Clearance Number |
|---|---|
| Advantage Windows Volume RenderingOption | K972399 |
| CT Colonography / Navigator2 | K012313 |
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:
The Volume Viewer Plus does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the Volume Viewer Plus to be equivalent to those of Advantage Windows Volume Rendering Option (K972399) and CT Colonography / Navigator2 (K012313).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'JUN 2 2 2004
General Electric Medical Systems % Mr. Tamas Borsai Program Manager TUV Rheinland of North America 1279 Quarry Lane, Suite A PLEASANTON CA 94566
Re: K041521
Trade/Device Name: Volume Viewer Plus Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 JAK and LNH Dated: June 7, 2004 Received: June 8, 2004
Dear Mr. Borsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boctor. Doctor is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enatebally) it the enactment date of the Medical Device Amendments, or to commerce pror to they 20, 2014 11:47 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 I ou may, merciore, mains of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is olassinod (social controls. Existing major regulations affecting your device can may be subject to back access as 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 i hat FDA has made a determination that your device complies with other requirements of the Act that FDA has made a doternmantin that Juni 1978 - 1999 - 1991 - 1991 - 1999 - 1999 - 1999 - 19 or any I odolar statuted and not including, but not limited to: registration and listing (21 CFR Part with an the Ace 3 requirements, measure manufacturing practice requirements as set forth in the 607); laooning (21 CFR Part 820); and if applicable, the electronic product quality systems (QB) regular(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) This letter will anow you to ogen marketing of substantial equivalence of your device to a legally premarket notification. The PDF maining of easification 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 If you desire specific advice for your an of the following numbers, based on the regulation number at the top of the 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 Additionally, for questions on the promote the regulation entitled, "Misbranding Other of Compliance at (2017 97) 97 100 100 100 100 100 100 100 100 100 100 100 by relected to premarket neumoution (er the Act may be obtained from the Division of Small mornlation on your responsional 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. Brydon
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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K04 1521
Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is in black and white.
General Electric Medical Systems
STATEMENT OF INDICATION FOR USE
Device name: Volume Viewer Plus
Indication for Use:
510(k) Number _
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
21 CFR 801.109)
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Division of Reproductive, Abdominal,
and Radiological Devices
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11
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.