(15 days)
CubeVue serves as an accessory to Cone Beam CT extremity imaging devices with the intended use to retrieve, display, and distribute 2D and 3D volumetric image displaying component allows users to manipulate the images to aid in diagnosis and treatment planning, including rotating through 3D renderings and 2D MPR slices, adjusting display settings, and making measurements.
It is the User's responsibility to ensure monitor quality and ambient light conditions are consistent with the clinical application.
CubeVue serves as an accessory to Cone Beam CT extremity imaging devices with the intended use to retrieve, display, and distribute 2D and 3D volumetric image data.
CubeVue provides a list of patient scans that have been sent to the its image database through its DICOM interface or imported locally by the user can browse, search, and sort the patient list to select a patient and open his or her image data.
The main screen displays a 3D rendering of the image in addition to axial, sagittal, and coronal slices. In the slices, the user can navigate through the volume by paging and rotating. The user can also adjust the window level, zoom, and pan of the 2D slices. In the 3D volume, the user can rotate the volume, cut through a plane, and change the displayed tissue density threshold and rendering style.
The user can make measurements on the image including distances, angles, and density values.
The user can export patient data to a file or media, with the option to anonymize patient demographic information. It supports DICOM and JPEG for image communication.
The provided text is a 510(k) summary for the CubeVue device, which is a Picture Archiving Communications System (PACS). The submission aims to demonstrate substantial equivalence to the predicate device, Osirix MD.
Here's an analysis of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" in a quantitative manner (e.g., target accuracy percentages or specific error rates) for the CubeVue device itself. Instead, the performance testing focuses on demonstrating that CubeVue's functionalities are equivalent to the predicate device, Osirix MD, for the subset of applications CubeVue supports (extremity Cone Beam CT and extremity X-Ray data).
The "Functionality" table provided in the 510(k) summary lists features and directly states whether both CubeVue and Osirix MD possess them. The "Reported Device Performance" is implied by the "Yes" entries in for CubeVue, indicating it meets the described functionalities.
| Functionality (Acceptance Criteria representing equivalence to predicate) | CurveBeam CubeVue (Reported Device Performance) | Osirix MD (Predicate Performance) |
|---|---|---|
| The device shall have the ability to view DICOM tags | Yes | Yes |
| The device shall have the ability to import/export DICOM data to another AE or export media | Yes | Yes |
| The device shall have the ability to view dose reports | Yes | Yes |
| The device shall have the ability to export images as JPEG | Yes | Yes |
| The device shall have the ability to view 2 series, side by side | Yes | Yes |
| The device shall have the ability to view 3D CT volumes using multi-planar-reformatting (MPR) (axial, sagittal, coronal) | Yes | Yes |
| The device shall have the ability to view 3D CT volumes in MPR using an arbitrary curve | Yes | Yes |
| The device shall have the ability to adjust the rotation (X/Y/Z) of 3D CT volumes. | Yes | Yes |
| The device shall have the ability to cut 3D CT volumes at arbitrary angles | Yes | Yes |
| The device shall have the ability to adjust Window/Level of 3D CT volumes. | Yes | Yes |
| The device shall have the ability to adjust the zoom of 3D CT volumes. | Yes | Yes |
| The device shall have the ability to adjust the center (move, pan) of 3D CT volumes. | Yes | Yes |
| The device shall display orientation markers [right(R), left(L), anterior(A), posterior(P), head(H), and feet(F)] on 3D CT volumes. | Yes | Yes |
| The device shall have the ability to adjust slice thickness on all MPR views. | Yes | Yes |
| The device shall have the ability to render both maximum-intensity-projection (MIP) or radiographic views. | Yes | Yes |
| The device shall have the ability to display Hounsfield Unit (HU) measurements with mean, standard deviation, and area/volume on 3D CT volumes. | Yes | Yes |
| The device shall have the ability to measure and display length and angles on 3D CT volumes. | Yes | Yes |
| The device shall provide surface and volume rendering of the bone, soft tissue and soft tissue with transparency showing the bone | Yes | Yes |
| The device shall have the following 3D volume render view capabilities crop a 3D volume interactively | Yes | Yes |
| The device shall have the following 3D volume render view capabilities create STL (Stereolithography) file format based on desired HU value, with desired name, to be used in third party software. | Yes | Yes |
| The device shall have the following 3D volume render view capabilities segmentation of bones or user-defined regions | Yes | Yes |
| HIPPA compliance, hide patient list, hide patient demographics, anonymize patient information | Yes | Yes |
| The device shall conform to the following consensus standards: DICOM and JPEG. | Yes | Yes |
| For prescription use | Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Verification and Validation testing" and "Testing Results" but does not specify the sample size of image data used for testing. It also does not explicitly state the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not describe the establishment of a "ground truth" for the test set or the involvement of experts for this purpose. The testing primarily involved software validation/verification against system requirements and comparison of functionalities to the predicate device.
4. Adjudication Method for the Test Set:
No adjudication method is described as the testing was focused on software functionality rather than diagnostic performance against a ground truth assessed by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement:
No MRMC comparative effectiveness study is mentioned. This type of study is typically performed for AI/CADe devices that directly assist in diagnostic tasks, which is not the primary claim of this PACS system (CubeVue's role is display and manipulation of images for diagnosis and planning, not direct AI-based interpretation).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The testing appears to be "standalone" in the sense that it evaluates the software's functionality independently. However, CubeVue is a PACS accessory to Cone Beam CT devices, and its intended use is to aid users (humans) in diagnosis and treatment planning. The software itself is not making diagnostic decisions without human oversight. The testing described is functional testing of the software.
7. The Type of Ground Truth Used:
As noted above, no specific "ground truth" (like expert consensus, pathology, or outcomes data) is mentioned as being used for performance evaluation in the context of diagnostic accuracy. The ground truth for the functional testing would be the expected behavior of the software based on its design specifications and standard requirements (DICOM, JPEG).
8. The Sample Size for the Training Set:
This device is not an AI/ML algorithm that requires a training set in the conventional sense for learning patterns from data. It is a PACS system for displaying and manipulating images. Therefore, the concept of a "training set" is not applicable here.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health and Human Services logo. The logo on the right is the Food and Drug Administration logo. The FDA logo is in blue and contains the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
CurveBeam, LLC % Mr. Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd. WARREN NJ 07059
August 7, 2018
Re: K181962
Trade/Device Name: CubeVue Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 20, 2018 Received: July 23, 2018
Dear Mr. Yungvirt:
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. 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 located 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.
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) for
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devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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 Bager
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
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Indications for Use
510(k) Number (if known)
K181962
Device Name CubeVue
Indications for Use (Describe)
CubeVue serves as an accessory to Cone Beam CT extremity imaging devices with the intended use to retrieve, display, and distribute 2D and 3D volumetric image displaying component allows users to manipulate the images to aid in diagnosis and treatment planning, including rotating through 3D renderings and 2D MPR slices, adjusting display settings, and making measurements.
It is the User's responsibility to ensure monitor quality and ambient light conditions are consistent with the clinical application.
| 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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Section 5 510(k) Summary
| 510 (k) Submitter/Owner | CurveBeam, LLC175 Titus Ave, Suite 300Warrington, PA 18976Phone: 267-483-8081Fax: 267-483-8086 |
|---|---|
| Contact Person | Senior Project Engineer267-483-8081Email: Stuti.singh@curvebeam.com |
| Date Prepared | August 3, 2018 |
| Trade Name | CubeVue |
| Model Number | SWCV10 |
| Common Name | Picture Archiving Communications System |
| Classification Name | Picture Archiving Communications System |
| Product Code | LLZ |
| 510(k) Type | Traditional |
| Regulation Number | 892.2050 |
| Device Classification | Class II |
Predicate Device:
| Company | Devicename | Product Code | 510(k) | Regulation Number | DeviceClassification |
|---|---|---|---|---|---|
| Pixmeo Sarl | Osirix MD | LLZ | K101342 | 892.2050 | Class II |
This is the first 510(k) submission for this software as a standalone device. Previously, this software had been approved as a component of CurveBeams's pedCAT (510(k) number K113548) and In Reach (510(k) number K170789) Cone Beam Computed Tomography Imaging systems. Upon approval of this application, CurveBeam intends to sell this software independently, instead of packaged with its imaging devices.
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Indications for Use:
CubeVue serves as an accessory to Cone Beam CT extremity imaging devices with the intended use to retrieve, display, and distribute 2D and 3D volumetric image displaying component allows users to manipulate the images to aid in diagnosis and treatment planning, including rotating and navigating through 3D renderings and 2D MPR slices, adjusting display settings, and making measurements.
It is the User's responsibility to ensure monitor quality and ambient light conditions are consistent with the clinical application.
Device Description:
CubeVue serves as an accessory to Cone Beam CT extremity imaging devices with the intended use to retrieve, display, and distribute 2D and 3D volumetric image data.
CubeVue provides a list of patient scans that have been sent to the its image database through its DICOM interface or imported locally by the user can browse, search, and sort the patient list to select a patient and open his or her image data.
The main screen displays a 3D rendering of the image in addition to axial, sagittal, and coronal slices. In the slices, the user can navigate through the volume by paging and rotating. The user can also adjust the window level, zoom, and pan of the 2D slices. In the 3D volume, the user can rotate the volume, cut through a plane, and change the displayed tissue density threshold and rendering style.
The user can make measurements on the image including distances, angles, and density values.
The user can export patient data to a file or media, with the option to anonymize patient demographic information. It supports DICOM and JPEG for image communication.
Substantial Equivalence Summary:
The indications for use for CubeVue are a subset of those for Osirix MD. While Osirix MD is intended to be used for viewing CT, MR, CR, DR, US, and other DICOM compliant data, CubeVue is only intended for viewing extremity Cone Beam CT and extremity X-Ray data. Osirix MD can also be used to review Mammographic images while CubeVue cannot. Although CubeVue's indications for use are a subset of those of Osirix MD's, its capabilities for this subset are substantially equivalent as outlined in the table below. CubeVue's labeling indicates the type of datasets it is intended for viewing and states that it not does not use lossless compression. Therefore, when used as intended, CubeVue functions safely and effectively for its intended purpose.
Performance testing included software validation, verification and testing. CubeVue functioned as intended and the observed results demonstrated substantial equivalence with the predicate device.
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| Functionality | CurveBeam CubeVue | Osirix MD |
|---|---|---|
| CubeVue serves as an accessory to Cone BeamCT extremity imaging devices with theintended use to retrieve, display, and distribute2D and 3D volumetric image data. The imagedisplaying component allows users tomanipulate the images to aid in diagnosis andtreatment planning, including rotating andnavigating through 3D renderings and 2D MPRslices, adjusting display settings, and makingmeasurements. | OsiriX MD" M is a software deviceintended for viewing of images acquiredfrom CT, MR, CR, DR, US and other DICOMcompliant medical imaging systems wheninstalled on suitable commercial standardhardware.Images and data can be captured, stored,communicated, processed, and displayedwithin the system and or across computernetworks at distributed locations. | |
| Indications for Use | It is the User's responsibility to ensure monitorquality and ambient light conditions areconsistent with the clinical application. | Lossy compressed mammographic imagesand digitized film screen images must notbe reviewed for primary diagnosis orimage interpretation. For primarydiagnosis, post process DICOM "forpresentation" images must be used.Mammographic images should only beviewed with a monitor approved by FDAfor viewing mammographic images.It is the User's responsibility to ensuremonitor quality, ambient light conditions,and image compression ratios areconsistent with the clinical application. |
| The device shall have the abilityto view DICOM tags | Yes | Yes |
| The device shall have the abilityto import/export DICOM data toanother AE or export media | Yes | Yes |
| The device shall have the abilityto view dose reports | Yes | Yes |
| The device shall have the abilityto export images as JPEG | Yes | Yes |
| The device shall have the abilityto view 2 series, side by side | Yes | Yes |
| The device shall have the abilityto view 3D CT volumes usingmulti-planar-reformatting (MPR)(axial, sagittal, coronal) | Yes | Yes |
| The device shall have the abilityto view 3D CT volumes in MPRusing an arbitrary curve | Yes | Yes |
| The device shall have the abilityto adjust the rotation (X/Y/Z) of3D CT volumes. | Yes | Yes |
| The device shall have the abilityto cut 3D CT volumes at arbitraryangles | Yes | Yes |
| The device shall have the abilityto adjust Window/Level of 3D CTvolumes. | Yes | Yes |
| The device shall have the abilityto adjust the zoom of 3D CTvolumes. | Yes | Yes |
| The device shall have the abilityto adjust to adjust the center(move, pan) of 3D CT volumes. | Yes | Yes |
| The device shall displayorientation markers [right(R),left(L), anterior(A), posterior(P),head(H), and feet(F)] on 3D CTvolumes. | Yes | Yes |
| The device shall have the abilityto adjust slice thickness on allMPR views. | Yes | Yes |
| The device shall have the abilityto render both maximum-intensity-projection (MIP) orradiographic views. | Yes | Yes |
| The device shall have the abilityto display Hounsfield Unit (HU)measurements with mean,standard deviation, and | Yes | Yes |
| area/volume on 3D CT volumes. | ||
| The device shall have the abilityto measure and display lengthand angles on 3D CT volumes. | Yes | Yes |
| The device shall provide surfaceand volume rendering of thebone, soft tissue and soft tissuewith transparency showing thebone | Yes | Yes |
| The device shall have thefollowing 3D volume render viewcapabilities crop a 3D volumeinteractively | Yes | Yes |
| The device shall have thefollowing 3D volume render viewcapabilities create STL (Stereolithography) file format based ondesired HU value, with desiredname, to be used in third partysoftware. | Yes | Yes |
| The device shall have thefollowing 3D volume render viewcapabilities segmentation ofbones or user-defined regions | Yes | Yes |
| HIPPA compliance, hide patientlist, hide patient demographics,anonymize patient information | Yes | Yes |
| The device shall conform to thefollowing consensus standards:DICOM and JPEG. | Yes | Yes |
| For prescription use | Yes | Yes |
CurveBeam, LLC CubeVue 510(k) Application
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CurveBeam, LLC CubeVue 510(k) Application
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Safety and Effectiveness Information:
The CubeVue software is a Class II medical device.
CurveBeam, LLC CubeVue 510(k) Application
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Conformity
The CubeVue device has been tested to the following standards to ensure safety, effectiveness, and compliance with industry norms:
[NEMA] [PS 3.1 – 3.20] [Digital Imaging and Communications in Medicine (DICOM) Set] [2016]
[ISO/IEC] [10918-1] [Information Technology - Digital Compression And Coding Of Continuous-Tone Still Images: Requirements And Guidelines] [02/15/1994]
Testing Results
The software passed all applicable sections of the consensus standards. These results indicate the software will be functional in utilizing JPEG compression, processing DICOM data, and interacting with DICOM entities.
Verification and Validation testing confirmed that the software performed to the system requirements. The results from these test reports indicate that the functionalities equivalent to the predicate device work as intended, verifying that CubeVue is indeed substantially equivalent to Osirix MD.
FDA Guidance
The following FDA Guidance Documents were regarded to the extent they were applicable in the preparation of this 510(k) Submission
- Guidance for the Submission of Premarket Notifications for Medical Image Management Devices
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices ●
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
Conclusion:
CurveBeam, LLC has demonstrated through its comparison of characteristics with the predicate device and comparison of performance testing with the predicate device that the CubeVue device is substantially equivalent to the 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).