(66 days)
No
The summary describes image processing and visualization tools, but does not mention AI, ML, or related terms like deep learning or neural networks. The performance studies focus on registration algorithms and user evaluation, not AI/ML model performance.
No
The device is described as a "tool to aid clinicians with the review of multi-parametric breast magnetic resonance (MR) images" and a "dedicated advanced visualization review and post-processing tool." Its functionalities are centered around image processing, display, and analysis to assist in diagnosis and treatment planning, but it does not directly treat or prevent a disease or condition.
No
Explanation: The "Intended Use" section states that the device provides information that "may aid in diagnosis and treatment planning." It acts as a tool to aid clinicians in reviewing images and performing measurements, but it does not independently provide a diagnosis.
Yes
The device description explicitly states "Software functionalities include" and lists various software-based image processing and visualization tools. There is no mention of any accompanying hardware components being part of the device itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that BreView is a tool for reviewing and processing MR images of the breast. It works with imaging data, not biological samples.
- The device description focuses on image processing and visualization tools. Features like loading datasets, display customization, motion correction, segmentation, and graph views are all related to manipulating and presenting medical images.
- The performance studies described involve bench testing on image databases and end-user evaluation of image manipulation tools. There is no mention of testing with biological specimens or diagnostic assays.
BreView is a medical device, specifically an image processing and visualization software intended to aid clinicians in reviewing breast MR images. It falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
BreView is a medical diagnostic software intended for use by trained healthcare professionals. The clinician remains ultimately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of breast MR images or quantitative data.
BreView is a tool to aid clinicians with the review of multi-parametric breast magnetic resonance (MR) images. The combination of acquired images, reconstructed images, annotations, and measurements performed by the clinician are intended to provide the referring physician with clinically relevant information that may aid in diagnosis and treatment planning.
Product codes
LLZ
Device Description
BreView is a dedicated advanced visualization review and post-processing tool that facilitates optimized post-processing of MR breast data review and assessment workflows for radiologists - including organizing images and composing reports. Adding the techniques of automatic motion correction and subtraction improves the review process. Software functionalities include:
- Ability to load 2D, 3D and 4D MR datasets as well as DICOM Secondary Captures (SCPT) .
- Optimized display of multi-parametric images within a dedicated layout
- Display customization: ability to choose layout, orientation, rendering mode
- Guided workflows for reviewing and processing MR breast exams
- Automated motion correction and/or subtraction of multi-phase datasets
- . Multi-planar reformats and maximum intensity projections (MIPs)
- Semi-automated segmentation and measurement tools
- Graph view for multi-phase datasets
- Save and export capabilities though DICOM Secondary Captures
- Data export in the form of a summary table
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance (MR) images
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench testing was conducted on a database of exams representative of the clinical scenarios where BreView is intended to be used, with consideration of acquisition protocols and clinical indicators.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
BreView Non-Rigid Registration algorithm was tested and found to be successfully implemented. End user evaluation of the brush revealed that its behavior was equivalent or better to that of AutoContour (VV Apps K041521)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
GE Medical Systems SCS Indu Karun Regulatory Affairs Leader 283 rue de la Miniere 78530 Buc Buc, 78530, France
Re: K233714
January 25, 2024
Trade/Device Name: BreView Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: November 20, 2023 Received: November 20, 2023
Dear Indu Karun:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
| Submission Number ( if known ) | |
|---|---|
| --------------------------------------- | -- |
Device Name
BreView
Indications for Use (Describe)
BreView is a tool to aid clinicians with the review of multi-parametric breast magnetic resonance (MR) images. The combination of acquired images, reconstructed images, annotations, and measurements performed by the clinician are intended to provide the referring physician with clinically relevant information that may aid in diagnosis and treatment planning.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image contains the logo for GE HealthCare. The logo consists of a circular emblem with a stylized "GE" monogram in purple, followed by the text "GE HealthCare" in a matching purple font. The text is positioned to the right of the emblem.
510K SUMMARY
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | November 20, 2023 |
|---|---|
| Submitter: | GE Medical Systems SCS |
| Establishment Registration Number - 9611343 | |
| 283 rue de la Miniere | |
| 78530 Buc, France | |
| Primary Contact Person: | Indu Karun |
| Regulatory Affairs Leader | |
| GE HealthCare | |
| Tel: 262-232-2055 | |
| Email: Indu.Karun@ge.com | |
| Secondary Contact Person: | Camille Vidal |
| Senior Director Regulatory Affairs | |
| GE HealthCare | |
| Tel: 240-280-5356 | |
| Email: Camille.Vidal@ge.com | |
| Device Trade Name: | BreView |
| Common/Usual Name: | BreView |
| Primary Regulation Number: | Medical image management and processing system (21 CFR 892.2050) |
| Primary Product Code: | LLZ |
| Classification: | Class II |
| Primary Predicate Device | |
| Device name: | READY View |
| Manufacturer: | GE Medical Systems SCS |
| 510(k) number: | K113456 |
| Primary Regulation Number: | 21 CFR 892.2050 Medical image management and processing system |
| Product Code: | LLZ |
| Classification: | Class II |
| Reference Device | |
| Device name: | Integrated Registration |
| Manufacturer: | GE Medical Systems SCS |
| 510(k) number: | K093234 |
| Primary Regulation Number: | 21 CFR 892.2050 Medical image management and processing system |
| Product Code: | LLZ |
| Classification: | Class II |
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Image /page/4/Picture/0 description: The image contains the logo for GE Healthcare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized, circular design, and the text is in a simple, sans-serif font.
Device Description:
BreView is a dedicated advanced visualization review and post-processing tool that facilitates optimized post-processing of MR breast data review and assessment workflows for radiologists - including organizing images and composing reports. Adding the techniques of automatic motion correction and subtraction improves the review process. Software functionalities include:
- Ability to load 2D, 3D and 4D MR datasets as well as DICOM Secondary Captures (SCPT) .
- Optimized display of multi-parametric images within a dedicated layout
- Display customization: ability to choose layout, orientation, rendering mode
- Guided workflows for reviewing and processing MR breast exams
- Automated motion correction and/or subtraction of multi-phase datasets
- . Multi-planar reformats and maximum intensity projections (MIPs)
- Semi-automated segmentation and measurement tools
- Graph view for multi-phase datasets
- Save and export capabilities though DICOM Secondary Captures
- Data export in the form of a summary table
Intended Use:
BreView is a medical diagnostic software intended for use by trained healthcare professionals. The clinician remains ultimately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of breast MR images or quantitative data.
Indication for Use:
BreView is a tool to aid clinicians with the review of multi-parametric breast magnetic resonance (MR) images. The combination of acquired images, reconstructed images, annotations, and measurements performed by the clinician are intended to provide the referring physician with clinically relevant information that may aid in diagnosis and treatment planning.
Technology:
The proposed device BreView employs the same fundamental scientific technology as its predicate device.
Comparison:
The table below summarizes the key feature/technological differences and similarities between the predicate devices:
| Specification | Predicate Device | Subject Device: BreView | Comparison |
|---|---|---|---|
| READY View (K113456) | |||
| Indications for | |||
| Use | READY View is an image analysis | ||
| software that allows the user to | |||
| process dynamic or functional | |||
| volumetric data and to generate | BreView is a tool to aid | ||
| clinicians with the review of | |||
| multi-parametric breast | |||
| magnetic resonance (MR) | Equivalent. | ||
| Both the predicate and | |||
| proposed device are | |||
| intended to display and | |||
| Specification | Predicate Device | Subject Device: BreView | Comparison |
| READY View (K113456) | |||
| maps that display changes in | |||
| image intensity over time, echo | |||
| time, b-value (Diffusion imaging) | |||
| and frequency (Spectroscopy). | |||
| The combination of acquired | |||
| images, reconstructed images, | |||
| calculated parametric images, | |||
| tissue segmentation, annotations | |||
| and measurement performed by | |||
| the clinician allows multi- | |||
| parametric analysis and may | |||
| provide clinically relevant | |||
| information for diagnosis. | images. The combination of | ||
| acquired images, | |||
| reconstructed images, | |||
| annotations, and | |||
| measurements performed | |||
| by the clinician are intended | |||
| to provide the referring | |||
| physician with clinically | |||
| relevant information that | |||
| may aid in diagnosis and | |||
| treatment planning. | process multi-parametric | ||
| MR images. While READY | |||
| View is intended for use on | |||
| several anatomies, BreView | |||
| is intended for breast exams | |||
| only, thus BreView has a | |||
| narrower indication for use | |||
| than READY View. | |||
| Computational | AW Server (K081985) platform | AW Server platform | Equivalent. |
| Platform | with Volume Viewer (K041521) | ||
| also known as VVApps framework. | |||
| User accesses the application | leveraging the user interface | ||
| elements and functionalities | |||
| of the Imaging Source | |||
| Viewer and Imaging Fabric. | Both applications are server | ||
| based and accessible | |||
| through connected | |||
| computer. | |||
| through networked computer | |||
| equipped with the compatible | |||
| thick client or through a web | |||
| browser. | User accesses the | ||
| application through a web | |||
| browser on networked | |||
| computers. | The VV Apps framework is | ||
| replaced by modernized | |||
| software elements with | |||
| equivalent user layout and | |||
| image rendering and ROI | |||
| editing tools. | |||
| Compatible | |||
| MR | |||
| series | DICOM format MR series including | ||
| 2D, 3D and 4D (temporal series) | DICOM compliant MR series | ||
| including 2D, 3D and 4D MR | |||
| series. | Identical | ||
| Type of MR exams the | |||
| application takes as input: | |||
| (motion-corrected and/or | |||
| subtracted) T1 - weighted | |||
| DCE sequences, T1 - | |||
| weighted series, T2 - | |||
| weighted series, diffusion | |||
| weighted (DWI) series and | |||
| ADC maps. | |||
| Non-rigid | |||
| registration | |||
| for | |||
| motion correction | |||
| (NRR) | Non-rigid motion correction based | ||
| on ROI groupwise registration. | Non-rigid motion correction | ||
| based on ROI groupwise | |||
| registration. | Identical | ||
| The non-rigid registration | |||
| uses the same method as | |||
| that of Integrated | |||
| Registration (K093234) for | |||
| the registration of MR | |||
| series. | |||
| Specification | Predicate Device | Subject Device: BreView | Comparison |
| READY View (K113456) | |||
| Image | |||
| Subtractions | As part of Breast review protocol, | ||
| the first acquisition of the DCE | |||
| series is used as baseline. | |||
| Subsequent phase acquisitions are | |||
| subtracted from the baseline after | |||
| registration. | Same as READY View with | ||
| the possibility to apply | |||
| subtraction without applying | |||
| non-rigid registration. | Equivalent | ||
| Both proposed and | |||
| predicate devices enable | |||
| image subtraction although | |||
| the proposed device allows | |||
| the user to apply image | |||
| subtraction without NRR | |||
| registration while the | |||
| predicate only allow | |||
| subtraction after | |||
| registration. | |||
| Multi-planar | |||
| reformats | |||
| and | |||
| MIP | READY View is a unified and | ||
| comprehensive advanced | |||
| visualization and analysis solution | |||
| that displays 2D, 3D and 4D | |||
| images of human anatomy, | |||
| creates multi-planar reformatting, | |||
| image subtraction, time intensity | |||
| curves, processes functional | |||
| curves and maps from MR data | |||
| sets and performs tissue | |||
| segmentation from anatomical or | |||
| parametric images. | BreView uses rendering | ||
| methods from Imaging | |||
| Fabric including, amongst | |||
| others Native, MPR (Multi- | |||
| Planar Reformation), MIP | |||
| (Maximum Intensity | |||
| Projection), VR (Volume | |||
| Rendering). | Equivalent | ||
| Imaging Fabric rendering | |||
| methods are used in cleared | |||
| applications like CardIQ | |||
| Suite (K213725) | |||
| Smart brush tool | |||
| for | |||
| enhanced | |||
| segmentation | |||
| volumetric | |||
| assessment | Auto contour is a semi-automated | ||
| segmentation tool for delineation | |||
| of regions of interest. | |||
| This is a functionality of Volume | |||
| Viewer (K041521) | |||
| It creates a semi-automated | |||
| contour with a defined pixel | |||
| threshold based on a user click | |||
| within the region of interest. | Brush tools are semi- | ||
| automatic segmentation | |||
| algorithms. | |||
| Two brush types are | |||
| available in BreView that | |||
| enable the segmentation of | |||
| a region of interest based on | |||
| a user click: Smart Brush and | |||
| Threshold Brush. | Equivalent, both the | ||
| predicate and proposed | |||
| device include semi- | |||
| automated contouring tools | |||
| to allow the user to select | |||
| region of interest in the | |||
| image. | |||
| In both applications the user | |||
| can adjust the sensitivity of | |||
| the brush to intensity | |||
| distribution in the image. | |||
| Graph View | Graphical representation of pixel | ||
| values in the temporal series, for a | |||
| cursor position, or for the pixel | |||
| values within one or more regions | |||
| of interest (ROI) defined on the | |||
| views by the user. | Graph Viewport displays a | ||
| line plot representing | |||
| statistics computed on a | |||
| temporal series representing | |||
| signal intensity evolution of | |||
| defined regions of interest at | |||
| different phases. | Equivalent | ||
| Both applications have the | |||
| capability to display in a | |||
| graphical form the temporal | |||
| variation of pixel values in a | |||
| temporal series. | |||
| Data Export | DICOM Secondary Capture export | DICOM Secondary Capture | |
| export | Equivalent | ||
| Both the predicate and | |||
| proposed device have | |||
| capabilities to export the | |||
| Specification | Predicate Device | ||
| READY View (K113456) | Subject Device: BreView | Comparison | |
| Copy viewports content and | |||
| findings to Clipboard for | |||
| further pasting. | information displayed in the | ||
| application. |
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Image /page/5/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the text "GE HealthCare" is written in purple, with "GE" slightly larger than "HealthCare".
GE HealthCare 510(k) Premarket Notification Submission-BreView K233714
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Image /page/6/Picture/0 description: The image contains the GE HealthCare logo. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is purple and features a stylized design. The text is also purple.
GE HealthCare 510(k) Premarket Notification Submission-BreView K233714
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Image /page/7/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem with the letters "GE" intertwined inside. To the right of the emblem, the words "GE HealthCare" are written in a simple, sans-serif font.
GE HealthCare 510(k) Premarket Notification Submission-BreView K233714
Determination of Substantial Equivalence:
Summary of Non-Clinical, Design Control Testing
BreView has successfully completed the design control testing per GE HealthCare's quality system. It was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. The proposed device complies with NEMA PS 3.1 - 3.20 (2022) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard.
The following quality assurance measures were applied to the development of the device:
- Requirements Definition
- Risk Analysis
- Technical Design Reviews
- Formal Design Reviews
- Software Development Lifecycle
- Performance testing (Verification, Validation)
- . Safety Testing (Verification)
The proposed BreView application has been successfully verified and validated on the AW Server. The documentation level was determined to be Basic Documentation Level.
Bench testing was conducted on a database of exams representative of the clinical scenarios where BreView is intended to be used, with consideration of acquisition protocols and clinical indicators. BreView Non-Rigid Registration algorithm was tested and found to be successfully implemented. End user evaluation of the brush revealed that its behavior was equivalent or better to that of AutoContour (VV Apps K041521)
Conclusion:
BreView has substantial equivalent technological characteristics as its predicate device.
Based on development under GE HealthCare's quality system, successful design verification and validation, software documentation for Basic Level of Documentation, along with the engineering bench testing GE HealthCare believes that the proposed BreView is substantially equivalent to, and hence as safe and as effective for its Intended Use as the legally marketed predicate device.