(26 days)
Not Found
Yes
The device description explicitly mentions "machine learning based contouring" as one of the automatic image processing workflows included in the system.
No.
The device is an image processing and data routing tool that generates contours, which can then be used as input for clinical workflows, but it does not directly perform a therapeutic function. It requires human review and further systems (like a treatment planning system) to be used in therapy.
No
The device is described as an "image processing tool" that automatically applies contours to data. It states, "Contours generated by Workflow Box may be used as an input to clinical workflows including, but not limited to, radiation therapy treatment planning." It explicitly states, "Workflow Box is not intended to automatically detect lesions." These characteristics indicate it's a tool for preparing data for further clinical steps, not for making a diagnosis itself.
Yes
The device description explicitly states "Workflow Box is a software application" and details its functions as data routing and image processing workflows. There is no mention of accompanying hardware components included with the device itself. While it interacts with other systems (DICOM nodes, image visualization software), the device being submitted for 510(k) is described solely as software.
Based on the provided information, Workflow Box is NOT an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. Workflow Box operates on medical images (CT, MR, RTSTRUCT) and structures derived from those images. It does not analyze biological specimens.
- The intended use of Workflow Box is focused on image processing and contouring to support clinical workflows like radiation therapy treatment planning. While the generated contours might be used in a diagnostic process, the device itself is not performing the diagnostic test on a biological sample.
- The device description clearly states it's a software application for routing and processing image data.
Therefore, Workflow Box falls under the category of medical image processing software, not an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statements indicating that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
Workflow Box is a software system designed to allow users to route DICOM-compliant data to and from automated processing components. Supported modalities include CT, MR. RTSTRUCT
Workflow Box includes processing components for automatically contouring imaging data using deformable image registration to support atlas based contouring of the same patient and machine learning based contouring.
Workflow Box is a data routing and image processing tool which automatically applies contours to data which is sent to one or more of the included image processing workflows. Contours generated by Workflow Box may be used as an input to clinical workflows including, but not limited to, radiation therapy treatment planning.
Workflow Box must be used in conjunction with appropriate software to review and edit results generated automatically by Workflow Box components, for example image visualization software must be used to facilitate the review and edit of contours generated by Workflow Box component applications.
Workflow Box is intended to be used by trained medical professionals.
Workflow Box is not intended to automatically detect lesions.
Product codes
QKB, LLZ
Device Description
Workflow Box is a software application that enables the routing of image data and structures to automatic image processing workflows, including atlas based contouring, image registration based re-contouring and machine learning based contouring.
Workflow Box data routing and contouring workflows support CT, MR and RTSTRUCT image data and structures. Workflow Box supports the routing of data to and from DICOM nodes within a hospital network.
Once data is routed to the auto contouring workflows there is no user interaction required and no user interface for visualizing image data. The configuration of workflows and data routing rules are managed via an administration interface.
Workflow Box must be used in conjunction with appropriate software to review and edit results generated automatically by Workflow Box components. Image visualization software, such as a treatment planning system, must be used to facilitate the review and edit of contours generated by Workflow Box component applications.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT, MR, RTSTRUCT, Any valid DICOM data for data routing
Anatomical Site
Not Found
Indicated Patient Age Range
Any patient type for whom relevant modality scan data is available.
Intended User / Care Setting
Trained medical professionals. Clinical/Hospital environment
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Workflow Box is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission. The results of performance, functional and algorithmic testing demonstrate that Workflow Box meets the user needs and requirements of the device, which are demonstrated to be substantially equivalent to those of the listed predicate device.
Verification and Validation for Workflow Box has been carried out in compliance with the requirements of CFR 21 Part 820 and in adherence to the DICOM standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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April 22, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name in a rectangular shape.
Mirada Medical Ltd. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K181572
Trade/Device Name: Workflow Box Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QKB
Dear Mr. Job:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated (07.10.2018). Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Sullivan, OHT7: Office of In Vitro Diagnostics and Radiological Health, 240-402-4973, Julie.Sullivan@fda.hhs.gov.
Sincerely.
Michael D. O'Hara
For
Thalia T. Mills Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
July 10th, 2018
Mirada Medical Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K181572
Trade/Device Name: Workflow Box Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 12, 2018 Received: June 14, 2018
Dear Mr. Job:
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. 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.
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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
Jeff Roggo
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K181572
Device Name Workflow Box
Indications for Use (Describe)
Workflow Box is a software system designed to allow users to route DICOM-compliant data to and from automated processing components. Supported modalities include CT, MR. RTSTRUCT
Workflow Box includes processing components for automatically contouring imaging data using deformable image registration to support atlas based contouring of the same patient and machine learning based contouring.
Workflow Box is a data routing and image processing tool which automatically applies contours to data which is sent to one or more of the included image processing workflows. Contours generated by Workflow Box may be used as an input to clinical workflows including, but not limited to, radiation therapy treatment planning.
Workflow Box must be used in conjunction with appropriate software to review and edit results generated automatically by Workflow Box components, for example image visualization software must be used to facilitate the review and edit of contours generated by Workflow Box component applications.
Workflow Box is intended to be used by trained medical professionals.
Workflow Box is not intended to automatically detect lesions.
| 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/4/Picture/0 description: The image is a logo for Mirada, a company that specializes in imaging software. The logo is composed of the company name in a bold, sans-serif font, with the first letter "M" in a darker blue color and the rest of the letters in a lighter blue color. Below the company name is the tagline "The Imaging Software People" in a smaller, lighter blue font.
510(k) Summary of Safety and Effectiveness
| Date of summary: | 9th July 2018 |
|---|---|
| Submitter's name: | Mirada Medical Ltd |
| Submitter's address: | Oxford Centre for Innovation, New Road, Oxford. |
| Oxfordshire, | |
| OX1 1BY United Kingdom | |
| Submitter's contact: | Gwilym Owen |
| Telephone number: | +44 (0)1865 261410 |
| Device Proprietary Name: | Workflow Box™ (including DLCExpert™, Embrace:CT™, |
| Embrace:MR™, Re:Contour™) | |
| Device Common Name(s): | Workflow Box |
| Classification Name: | Class II: Picture Archiving and Communications System |
| (892.2050) Product Code: LLZ |
Workflow Box is Substantially Equivalent to the following Legally Marketed device:
Predicate Devices
| 510(k) Number | Trade Name | Manufacturer |
|---|---|---|
| K130393 | Mirada RTx | Mirada Medical Ltd. |
Intended Use
Workflow Box is a system designed to allow users to route DICOM-compliant data to and from automated processing components.
Workflow Box includes processing components for automatically contouring imaging data using deformable image registration and machine learning based algorithms.
Workflow Box must be used in conjunction with appropriate software to review and edit results generated automatically by Workflow Box components, for example image visualization software must be used to facilitate the review and edit of contours generated by Workflow Box component applications.
Workflow Box is not intended to automatically detect lesions.
Device Description
Workflow Box is a software application that enables the routing of image data and structures to automatic image processing workflows, including atlas based contouring, image registration based re-contouring and machine learning based contouring.
5
Image /page/5/Picture/0 description: The image shows the logo for Mirada. The logo is in blue and consists of the word "MIRADA" in a sans-serif font. The "M" is a darker blue than the rest of the word. Below the word "MIRADA" is the tagline "The Imaging Software People" in a lighter blue color.
Workflow Box data routing and contouring workflows support CT, MR and RTSTRUCT image data and structures. Workflow Box supports the routing of data to and from DICOM nodes within a hospital network.
Once data is routed to the auto contouring workflows there is no user interaction required and no user interface for visualizing image data. The configuration of workflows and data routing rules are managed via an administration interface.
Workflow Box must be used in conjunction with appropriate software to review and edit results generated automatically by Workflow Box components. Image visualization software, such as a treatment planning system, must be used to facilitate the review and edit of contours generated by Workflow Box component applications.
Indications for Use
Workflow Box is a software system designed to allow users to route DICOM-compliant data to and from automated processing components. Supported modalities include CT, MR, RTSTRUCT
Workflow Box includes processing components for automatically contouring imaging data using deformable image registration to support atlas based contouring of the same patient and machine learning based contouring.
Workflow Box is a data routing and image processing tool which automatically applies contours to data which is sent to one or more of the included image processing workflows. Contours generated by Workflow Box may be used as an input to clinical workflows including, but not limited to, radiation therapy treatment planning.
Workflow Box must be used in conjunction with appropriate software to review and edit results generated automatically by Workflow Box components, for example image visualization software must be used to facilitate the review and edit of contours generated by Workflow Box component applications.
Workflow Box is intended to be used by trained medical professionals.
Workflow Box is not intended to automatically detect lesions.
Comparison of Indications for Use with Predicate Device
Both the proposed device and the predicate device are software devices designed to be used by trained medical professionals within a hospital environment and are indicated for the creation of contours for use in clinical workflows including radiation therapy treatment planning.
The proposed device and the predicate device both utilize deformable image registration to support one or more of the workflows they perform and facilitate the transformation of region of interest structures/Contours.
The proposed and predicate device both allow the clinician to load existing contour sets and associated planning volumes and transform them to a new planning volume using rigid and non-rigid registration as part of a re-planning/re-contouring workflow.
The proposed and predicate device both utilize an atlas based technique for the automated delineation of structures on CT.
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Image /page/6/Picture/0 description: The image shows the logo for Mirada, a company that specializes in imaging software. The logo consists of the word "MIRADA" in a bold, sans-serif font, with the "M" in a lighter shade of blue than the rest of the letters. Below the company name is the tagline "The Imaging Software People" in a smaller, lighter blue font.
The proposed and predicate device are both designed to interoperate via DICOM objects and networking with other DICOM capable devices such as PACS and Radiation Treatment Planning Systems.
The predicate device is intended to display and visualize image data and enables a comparison of image data by the user, whereas the proposed device does not facilitate the display or visualization of data by the user.
The review and editing of contouring results can be performed within the predicate device where a different image visualization system is needed to perform the review and edit of contours generated by the proposed device, however both the predicate and proposed device require users to confirm and review output in a different system. The proposed device is intended for a sub-set of the intended use of the predicate device where the image visualization and comparison purpose of the predicate device is not applicable to the proposed device.
Therefore, the intended use of the proposed device is substantially equivalent to the predicate device, excepting the image visualization features in the predicate device which are not applicable to the proposed device.
| Characteristic | Workflow Box | predicate |
|---|---|---|
| Target Population | Any patient type for whom relevant | |
| modality scan data is available. | Any patient type for whom relevant modality | |
| scan data is available. | ||
| Where Used | Clinical/Hospital environment | Clinical/Hospital environment |
| Energy Used and/or | ||
| Delivered | None - software only application. The | |
| software application does not deliver | ||
| or depend on energy delivered to or | ||
| from patients | None - software only application. The software | |
| application(s) do not deliver or depend on energy | ||
| delivered to or from patients | ||
| Human Factors | Designed to be used by trained | |
| clinicians | Designed to be used by trained clinicians | |
| Design: Data | ||
| Visualisation/Graphic | ||
| al User Interface | None – the proposed device has no data | |
| visualization functionality. All data | ||
| processing is automated and does not | ||
| require user interaction. A control | ||
| interface is provided for system | ||
| administration and configuration only. | Yes | |
| Design: View | ||
| manipulation and | ||
| Volume rendering | None - Not applicable | Window and level, pan, zoom, cross-hairs, slice |
| navigation. | ||
| Maximum or minimum intensity projection (MIP), | ||
| volume rendering, color rendering, surface rendering, | ||
| multi-planar reconstruction (MPR), fused views, | ||
| gallery views. | ||
| Design: Image | ||
| registration | Registration for the purposes of re- | |
| planning/re-contouring and atlas based | ||
| contouring. The algorithms used for image | Manual and Landmark Rigid. Automatic multi-modal | |
| rigid. Mono-modal and multi-modal deformable | ||
| registration are the same for both | ||
| predicate and proposed devices. | registration. Motion correction in hybrid scans and | |
| gated scans. | ||
| Registration for the purposes of re-planning/re- | ||
| contouring and atlas based contouring. | ||
| Regions and Volumes | ||
| of interest (ROI) | Atlas Based contouring, registration based | |
| re-contouring, machine learning based | ||
| contouring | 2D and 3D ROIs, semi-automatic ROI definition, iso- | |
| contour ROIs using threshold and percentage of | ||
| maximum, one-click seed-pointing contouring, manual | ||
| ROI manipulation, ROI transformation, Atlas-based | ||
| contouring. | ||
| Design: | ||
| Region/volume of | ||
| interest | ||
| measurements and | ||
| size measurements | None - not applicable | Intensity, Hounsfield units, activity and SUV |
| measurements including min, max, mean, peak, | ||
| standard deviation, total glycolytic activity, median, | ||
| histogram, max and mean ratio to reference region. | ||
| Gray for RT Dose. | ||
| Size measurements include 2D and 3D measurements | ||
| including rulers and volume, line profile. | ||
| Design: | ||
| Region/Volume | ||
| Quantification | None - not applicable | Regions table with charting supports analysis of |
| measurement over multiple studies using standard | ||
| protocols such as RECIST, PERCIST and WHO | ||
| Design: Supported | ||
| modalities | CT, MR, DICOM RTSTRUCT for image | |
| processing | Static and gated CT and PET, and static MR, SPECT, | |
| NM, DICOM RT | ||
| Any valid DICOM data for data routing | ||
| Design: Reporting | ||
| and data routing | Supports routing and distribution of | |
| images to other DICOM nodes including to | Yes- Distribution of DICOM compliant Images into | |
| other DICOM compliant systems. | ||
| custom executables determined by the | ||
| user. | Built-in basic reporting | |
| Compatibility with | ||
| the environment and | ||
| other devices | Compatible with data from any DICOM | |
| compliant scanners for the applicable | ||
| modalities. | Compatible with data from any DICOM compliant | |
| scanners for the applicable modalities. | ||
| Compatible with Microsoft Windows | Compatible with Microsoft Windows | |
| Integration with Mirada DBx application launcher and | ||
| Integration with Mirada DBx application | ||
| launcher and data browser | data browser | |
| Communications/ | ||
| Networking | TCP/IP and SCP | TCP/IP and SCP |
| Computer platform & | ||
| operating system | Server based application supporting | |
| Microsoft Windows 10 (64-bit) and | ||
| Microsoft Windows Server 2016. | Workstation and Server based application supporting | |
| Windows Server 2008 R2, SP1 and Windows 7 (64-bit) |
Comparison of Technological Characteristics with Predicate Device
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Image /page/7/Picture/0 description: The image shows the logo for Mirada. The logo is in blue and features the company name in a bold, sans-serif font. The letter "I" in Mirada is a lighter shade of blue than the rest of the letters. Below the company name is the tagline "The Imaging Software People" in a smaller font.
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Image /page/8/Picture/0 description: The image shows the logo for Mirada, a company that specializes in imaging software. The logo is composed of the word "MIRADA" in a bold, sans-serif font, with the "I" in a lighter shade of blue. Below the company name is the tagline "The Imaging Software People" in a smaller, lighter font. The logo is simple and modern, and it conveys the company's focus on imaging software.
The predicate device and Workflow Box are both standalone software applications for medical image processing. Both devices process DICOM image data and include design features to enable automatic delineation of contours on input image data.
Both the proposed device and the predicate device utilize algorithms to automatically generate region of interest structures/contours. Both devices utilize image registration for the purposes of atlas based contouring and re-contouring.
The automatic image processing tools are the same in both devices where image registration is used to apply contours to image data.
In addition to automatic image processing, the predicate device offers manual image manipulation, processing and quantification tools which are not applicable to Workflow Box.
Both devices are compatible with the same use environments and utilize the same networking technology and operate on similar operating systems.
Workflow Box offers a sub-set of the automated image processing technical features presented by the predicate device. These features are substantially equivalent to the predicate device and do not present any addition or new risks when compared to the predicate device.
Testing
Workflow Box is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission. The results of performance, functional and algorithmic testing demonstrate that Workflow Box meets the user needs and requirements of the device, which are demonstrated to be substantially equivalent to those of the listed predicate device.
Verification and Validation for Workflow Box has been carried out in compliance with the requirements of CFR 21 Part 820 and in adherence to the DICOM standard.
Conclusion
In conclusion, performance testing demonstrates that Workflow Box is substantially equivalent to, and performs at least as safely and effectively as the listed predicate device. Workflow Box meets requirements for safety and effectiveness and does not introduce any new potential safety risks.