(66 days)
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.
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
The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study that proves the device meets acceptance criteria. The document is primarily a 510(k) premarket notification, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with specific acceptance metrics.
However, based on the type of information typically expected for such a submission and the limited details provided, I can infer some aspects and highlight what is missing.
Here's an analysis based on the provided text, structured to address your questions as much as possible, while also noting where information is explicitly not present:
Context: The device, "BreView," is a medical diagnostic software intended to aid clinicians in reviewing multi-parametric breast MR images. Its core functionalities include image organization, display customization, automated motion correction and/or subtraction, multi-planar reformats, semi-automated segmentation and measurement tools, graph view, and data export. It is marketed as a Class II device.
1. Table of Acceptance Criteria and Reported Device Performance
Critique: The document does not provide a specific table of acceptance criteria with corresponding performance metrics. It mentions "Performance testing (Verification, Validation)" and "Bench testing" but lacks quantifiable results against predefined acceptance thresholds.
However, we can infer some criteria from the "Comparison" table against the predicate device, although these are qualitative comparisons rather than quantitative performance data.
| Feature/Functionality | Acceptance Criteria (Inferred/Generic) | Reported Device Performance (as described in the document) |
|---|---|---|
| Indications for Use | Equivalent or narrower than predicate. | "Equivalent. Both the predicate and proposed device are intended to display and process multi-parametric MR images... BreView is intended for breast exams only, thus BreView has a narrower indication for use than READY View." |
| Computational Platform | Equivalent to predicate (AW Server). | "Equivalent. Both applications are server based and accessible through connected computer." |
| Compatible MR Series | DICOM compliant, supporting 2D, 3D, 4D. | "Identical. DICOM compliant MR series including 2D, 3D and 4D MR series." Explicitly lists types of MR exams (T1 DCE, T1, T2, DWI, ADC maps). |
| Non-rigid registration (NRR) | Identical to predicate's method for motion correction. | "Identical. The non-rigid registration uses the same method as that of Integrated Registration (K093234) for the registration of MR series." "Non-Rigid Registration algorithm was tested and found to be successfully implemented." |
| Image Subtraction | Equivalent functionality to predicate, with added flexibility. | "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 allows subtraction after registration." |
| Multi-planar reformats & MIP | Equivalent rendering methods to predicate. | "Equivalent. Imaging Fabric rendering methods are used in cleared applications like CardIQ Suite (K213725)." |
| Smart Brush Tool (Segmentation) | Equivalent or better semi-automated segmentation. | "Equivalent, both the predicate and proposed device include semi-automated contouring tools... End user evaluation of the brush revealed that its behavior was equivalent or better to that of AutoContour (VV Apps K041521)." |
| Graph View | Equivalent capability for temporal variation display. | "Equivalent. Both applications have the capability to display in a graphical form the temporal variation of pixel values in a temporal series." |
| Data Export | Equivalent DICOM Secondary Capture export. | "Equivalent. Both the predicate and proposed device have capabilities to export the information displayed in the application." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "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." However, no numerical sample size (e.g., number of cases, number of images) is provided for this test set.
- Data Provenance: Not specified. There is no mention of the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document mentions "End user evaluation of the brush," implying radiologists or similar clinical professionals, but their specific qualifications or number are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: None stated. The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) used for establishing ground truth or evaluating performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Conducted: No. The document does not describe a formal MRMC study where human readers' performance with and without AI assistance was evaluated. The evaluation appears to be primarily focused on the device's technological equivalence rather than its impact on human reader effectiveness.
- Effect Size of Improvement: Not applicable, as no MRMC study was described.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
- Standalone Performance Evaluation: Implied, but not explicitly quantified with metrics. The statement, "BreView Non-Rigid Registration algorithm was tested and found to be successfully implemented," suggests a standalone evaluation of this specific algorithm. However, no quantitative performance metrics (e.g., accuracy, precision, dice score for segmentation, registration error) are provided for any standalone algorithm. The "equivalence or better" statement for the Smart Brush tool is a comparative qualitative assessment based on "End user evaluation," not a formal standalone study result.
7. Type of Ground Truth Used
- Type of Ground Truth: The document does not explicitly define how ground truth was established for "bench testing." For functionalities like non-rigid registration and image subtraction, the "ground truth" might be implied by successful implementation against a known good algorithm (the predicate's method). For the "Smart Brush tool," the ground truth seems to be based on expert (end-user) evaluation comparing its behavior to the predicate's tool. There's no mention of pathology, clinical outcomes data, or a formal consensus process.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not specified. The document only mentions "Bench testing was conducted on a database of exams representative of the clinical scenarios," which refers to a test set, not a training set. Given that this is a 510(k) submission and the device is presented as applying "the same fundamental scientific technology as its predicate device," it is possible that new training data (in the context of deep learning) was not a primary focus of this submission, if the core algorithms are established or rule-based.
9. How Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable / Not specified. Since no training set or related machine learning components requiring explicit ground truth labeling were discussed in detail, this information is not provided.
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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 forUse | READY View is an image analysissoftware that allows the user toprocess dynamic or functionalvolumetric data and to generate | BreView is a tool to aidclinicians with the review ofmulti-parametric breastmagnetic resonance (MR) | Equivalent.Both the predicate andproposed device areintended to display and |
| Specification | Predicate Device | Subject Device: BreView | Comparison |
| READY View (K113456) | |||
| maps that display changes inimage intensity over time, echotime, b-value (Diffusion imaging)and frequency (Spectroscopy).The combination of acquiredimages, reconstructed images,calculated parametric images,tissue segmentation, annotationsand measurement performed bythe clinician allows multi-parametric analysis and mayprovide clinically relevantinformation for diagnosis. | images. The combination ofacquired images,reconstructed images,annotations, andmeasurements performedby the clinician are intendedto provide the referringphysician with clinicallyrelevant information thatmay aid in diagnosis andtreatment planning. | process multi-parametricMR images. While READYView is intended for use onseveral anatomies, BreViewis intended for breast examsonly, thus BreView has anarrower indication for usethan 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 interfaceelements and functionalitiesof the Imaging SourceViewer and Imaging Fabric. | Both applications are serverbased and accessiblethrough connectedcomputer. |
| through networked computerequipped with the compatiblethick client or through a webbrowser. | User accesses theapplication through a webbrowser on networkedcomputers. | The VV Apps framework isreplaced by modernizedsoftware elements withequivalent user layout andimage rendering and ROIediting tools. | |
| CompatibleMRseries | DICOM format MR series including2D, 3D and 4D (temporal series) | DICOM compliant MR seriesincluding 2D, 3D and 4D MRseries. | Identical |
| Type of MR exams theapplication takes as input:(motion-corrected and/orsubtracted) T1 - weightedDCE sequences, T1 -weighted series, T2 -weighted series, diffusionweighted (DWI) series andADC maps. | |||
| Non-rigidregistrationformotion correction(NRR) | Non-rigid motion correction basedon ROI groupwise registration. | Non-rigid motion correctionbased on ROI groupwiseregistration. | IdenticalThe non-rigid registrationuses the same method asthat of IntegratedRegistration (K093234) forthe registration of MRseries. |
| Specification | Predicate Device | Subject Device: BreView | Comparison |
| READY View (K113456) | |||
| ImageSubtractions | As part of Breast review protocol,the first acquisition of the DCEseries is used as baseline.Subsequent phase acquisitions aresubtracted from the baseline afterregistration. | Same as READY View withthe possibility to applysubtraction without applyingnon-rigid registration. | EquivalentBoth proposed andpredicate devices enableimage subtraction althoughthe proposed device allowsthe user to apply imagesubtraction without NRRregistration while thepredicate only allowsubtraction afterregistration. |
| Multi-planarreformatsandMIP | READY View is a unified andcomprehensive advancedvisualization and analysis solutionthat displays 2D, 3D and 4Dimages of human anatomy,creates multi-planar reformatting,image subtraction, time intensitycurves, processes functionalcurves and maps from MR datasets and performs tissuesegmentation from anatomical orparametric images. | BreView uses renderingmethods from ImagingFabric including, amongstothers Native, MPR (Multi-Planar Reformation), MIP(Maximum IntensityProjection), VR (VolumeRendering). | EquivalentImaging Fabric renderingmethods are used in clearedapplications like CardIQSuite (K213725) |
| Smart brush toolforenhancedsegmentationvolumetricassessment | Auto contour is a semi-automatedsegmentation tool for delineationof regions of interest.This is a functionality of VolumeViewer (K041521)It creates a semi-automatedcontour with a defined pixelthreshold based on a user clickwithin the region of interest. | Brush tools are semi-automatic segmentationalgorithms.Two brush types areavailable in BreView thatenable the segmentation ofa region of interest based ona user click: Smart Brush andThreshold Brush. | Equivalent, both thepredicate and proposeddevice include semi-automated contouring toolsto allow the user to selectregion of interest in theimage.In both applications the usercan adjust the sensitivity ofthe brush to intensitydistribution in the image. |
| Graph View | Graphical representation of pixelvalues in the temporal series, for acursor position, or for the pixelvalues within one or more regionsof interest (ROI) defined on theviews by the user. | Graph Viewport displays aline plot representingstatistics computed on atemporal series representingsignal intensity evolution ofdefined regions of interest atdifferent phases. | EquivalentBoth applications have thecapability to display in agraphical form the temporalvariation of pixel values in atemporal series. |
| Data Export | DICOM Secondary Capture export | DICOM Secondary Captureexport | EquivalentBoth the predicate andproposed device havecapabilities to export the |
| Specification | Predicate DeviceREADY View (K113456) | Subject Device: BreView | Comparison |
| Copy viewports content andfindings to Clipboard forfurther pasting. | information displayed in theapplication. |
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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.
§ 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).