(83 days)
Not Found
No
The document describes image processing and registration techniques, including deformable registration and atlas-based segmentation, but does not explicitly mention or describe the use of AI or ML algorithms. The predicate device K081076 includes "AI" in its name, but the description of the proposed device does not elaborate on any AI functionalities.
No
The device is a software package for medical image comparison, display, and analysis, primarily used as an aid for diagnostic radiology and radiation therapy planning. It does not directly treat or diagnose diseases but provides tools for medical professionals.
Yes
The 'Intended Use / Indications for Use' states that Velocity is an "aid during use by diagnostic radiology, radiation therapy planning and other medical specialties." It allows for the "display, annotation, volume rendering, registration, and fusion of medical images," which directly supports diagnostic processes. Additionally, the 'Device Description' mentions that it facilitates "comparison of medical imaging data from different modalities, points in time, and / or scanning protocols," and allows users to "draw Regions of Interest (ROI), calculate and report relative differences in pixel intensities, Standardized Uptake Value (SUV) or other values within those regions," all of which are diagnostic functions.
Yes
The device description explicitly states "Velocity is a software application" and "Velocity is a Picture Archiving and Communication System (medical imaging software)". It is used as a "stand-alone application on recommended Off-The-Shelf (OTS) computers". There is no mention of proprietary hardware components included with the device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that Velocity is a software package for the comparison, display, annotation, rendering, registration, and fusion of medical imaging data. It is used as an aid during use by diagnostic radiology, radiation therapy planning, and other medical specialties. This focuses on the processing and analysis of in vivo imaging data, not in vitro samples.
- Device Description: The description reinforces this by detailing its function as a Picture Archiving and Communication System (PACS) and its use in processing medical images from various modalities (PET, SPECT, CT, RT Dose, MR). It describes tools for image analysis, ROI drawing, and data export, all related to interpreting images of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing information about a patient's health status based on in vitro testing.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Velocity's function is entirely focused on the manipulation and analysis of medical images acquired from the body.
N/A
Intended Use / Indications for Use
Velocity is a software package that provides the physicians a means for comparison of medical data including imaging data that is DICOM compliant. It allows the display, annotation, volume rendering, registration, and fusion of medical images as an aid during use by diagnostic radiology, radiation therapy planning and other medical specialties. Velocity is not intended for mammography.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Velocity is a software application providing relevant tools for Radiotherapy professionals to use while creating treatment plans. The Velocity device is a Picture Archiving and Communication System (medical imaging software). Velocity provides medical image processing designed to facilitate the oncology or other clinical specialty work flow by allowing the comparison of medical imaging data from different modalities, points in time, and / or scanning protocols. The product provides users with the means to display, co-register and analyze medical images from multiple modalities including PET, SPECT, CT, RT Dose and MR; draw Regions of Interest (ROI), calculate and report relative differences in pixel intensities, Standardized Uptake Value (SUV) or other values within those regions; and import / export results to/from commercially available radiation treatment planning systems and PACS devices. Co-registration includes deformable registration technology that can be applied to DICOM data including diagnostic and planning image volumes, structures, dose, and automatic anatomical atlas-based segmentation tools. Velocity is used as a stand-alone application on recommended Off-The-Shelf (OTS) computers supplied by the company or by the end-user.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM, PET, SPECT, CT, RT Dose, MR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians, diagnostic radiology, oncology, radiation therapy planning and other medical specialties.
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)
Software verification and validation demonstrate that the Velocity device performs as intended. Clinical Tests No clinical tests have been included in this pre-market submission. Varian therefore considers Velocity 4.0 to be safe and effective and to perform at least as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
February 15, 2018
Image /page/0/Picture/1 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K173636
Trade/Device Name: Velocity Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 22, 2017 Received: November 24, 2017
Dear Mr. Coronado:
We have reviewed vour 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 mediation-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,
Michael D. O'Hara 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
2
Indications for Use
510(k) Number (if known)
K173636
Device Name Velocity
Indications for Use (Describe)
Velocity is a software package that provides the physicians a means for comparison of medical data including imaging data that is DICOM compliant. It allows the display, annotation, volume rendering, registration, and fusion of medical images as an aid during use by diagnostic radiology, radiation therapy planning and other medical specialties. Velocity is not intended for mammography.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Premarket Notification [510(k)] Summary
Velocity 4.0
The following information is provided following the format of 21 CFR 807.92(c).
| Submitter's Name: | Varian |
|---|---|
| 3100 Hansen Way E-110 | |
| Palo Alto, CA 94304 | |
| Contact Name: Peter J. Coronado | |
| Phone: 650.424.6320 | |
| Fax: 650.646.9200 | |
| Date: February 6, 2018 | |
| Proprietary Name: | Velocity |
| Classification Name: | Image Processing System, Radiology |
| 21 CFR 892.2050, Class II | |
| Product Code: LLZ | |
| Common/Usual Name: | Picture Archiving and Communication System (Medical Imaging Software) |
| Predicate Devices: | Primary predicate: Velocity AI – K081076 |
| Secondary predicate: MIM Y90 Dosimetry - K172218 | |
| Device Description: | Velocity is a software application providing relevant tools for Radiotherapy |
| professionals to use while creating treatment plans. | |
| The Velocity device is a Picture Archiving and Communication System (medical imaging | |
| software). Velocity provides medical image processing designed to facilitate the | |
| oncology or other clinical specialty work flow by allowing the comparison of medical | |
| imaging data from different modalities, points in time, and / or scanning protocols. The | |
| product provides users with the means to display, co-register and analyze medical | |
| images from multiple modalities including PET, SPECT, CT, RT Dose and MR; draw | |
| Regions of Interest (ROI), calculate and report relative differences in pixel intensities, | |
| Standardized Uptake Value (SUV) or other values within those regions; and import / | |
| export results to/from commercially available radiation treatment planning systems | |
| and PACS devices. Co-registration includes deformable registration technology that can | |
| be applied to DICOM data including diagnostic and planning image volumes, | |
| structures, dose, and automatic anatomical atlas-based segmentation tools. | |
| Velocity is used as a stand-alone application on recommended Off-The-Shelf (OTS) | |
| computers supplied by the company or by the end-user. | |
| Intended Use Statement | Velocity is a software package that provides the physicians a means for comparison of |
| medical data including imaging data that is DICOM compliant. | |
| It allows the display, annotation, volume operation, volume rendering, registration, | |
| and fusion of medical images as an aid during use by diagnostic radiology, oncology, | |
| radiation therapy planning and other medical specialties. Velocity is not intended for | |
| mammography. | |
| Indications for Use | Velocity is a software package that provides the physicians a means for comparison of |
| Statement | medical data including imaging data that is DICOM compliant. |
| It allows the display, annotation, volume operation, volume rendering, registration, | |
| and fusion of medical images as an aid during use by diagnostic radiology, oncology, | |
| radiation therapy planning and other medical specialties. Velocity is not intended for | |
| mammography. |
4
Technological Characteristics:
| VELOCITY 4.0 - DEVICE COMPARISON TABLE | ||
|---|---|---|
| FEATURE AND/OR SPECIFICATION OF | ||
| NEW/MODIFIED DEVICE | VELOCITYAIS v2.0 | |
| K081076 | VELOCITY 4.0 | |
| Indications for Use/Intended Use | VelocityAIS (VelocityAl) is a stand- | |
| alone software product that | ||
| provides the physician a means | ||
| for comparison of medical imaging | ||
| data from multiple DICOM | ||
| conformant imaging modality | ||
| sources. It allows the display, | ||
| annotating, volume rendering, | ||
| registration and fusing of medical | ||
| images as an aid during use by | ||
| diagnostic radiology, oncology, | ||
| radiation therapy planning and | ||
| other medical specialties. | ||
| VelocityAIS (VelocityAI) is not | ||
| intended for mammography | ||
| diagnosis. | Velocity is a software package that | |
| provides the physicians a means | ||
| for comparison of medical data | ||
| including imaging data that is | ||
| DICOM compliant. | ||
| It allows the display, annotation, | ||
| volume operation, volume | ||
| rendering, registration, and fusion | ||
| of medical images as an aid during | ||
| use by diagnostic radiology, | ||
| oncology, radiation therapy | ||
| planning and other medical | ||
| specialties. | ||
| Velocity is not intended for | ||
| mammography diagnosis. | ||
| General Usage/ Performance Features | ||
| Image Study Importation | Yes | |
| DICOM, PET/SPECT/CT/MRI | ||
| Dose | Yes | |
| DICOM, PET/SPECT/CT/MRI | ||
| Dose | ||
| Query/Retrieve automation added | ||
| in 4.0 | ||
| Image Structure Import, Save & Export | ||
| to Treatment Planning Systems | Yes | Yes |
| Volume rendering | Yes | Yes |
| 4D Cine Volume support in 4.0.0 | ||
| Advanced Visualization and Navigation | ||
| Features | Yes | Yes |
| multi-volume view support in 4.0 | ||
| Volume Operations | No | Yes |
| Diagnostic Image registration | Yes | Yes |
| Image Fusion | Yes | Yes |
| Anatomical and Functional Images | Anatomical and Functional Images | |
| ROI & Contouring | Yes | Yes |
| Manual Contouring Tools | Yes | Yes |
| Image Analysis | Yes | Yes |
| Plan Review of imported plans or | ||
| created dose composites | No | Yes |
| Oncology workflow automation | No | Yes |
| Image/ROI Export to DICOM RT | Yes | Yes |
| Secure login and data storage | Yes | Yes |
| Operating System Platform | Microsoft Windows XP 32 bit | |
| only/Windows 7, Vista | Microsoft Windows 7 & 10 (64 bit | |
| only)/ Windows Server 2008R2 | ||
| (Citrix), 2012R2, 2016 | ||
| MAC OSX 10.6 | MAC OS 10.12 Sierra, macOS 10.13 | |
| High Sierra | ||
| Multimodality DICOM Import | ||
| Import and display DICOM CT, MR, DS, | ||
| PET, RTS, RTP | Yes | Yes |
| Advanced Visualization & Navigation | ||
| General image viewer with view layout | ||
| selection and toolbars | Yes | Yes |
| Volume Operations | ||
| User scaling of image volumes | No | Yes |
| Biological Effective Dose (BED) Scaling | No | Yes |
| Y-90 Microsphere Dosimetry - | No | Yes |
| conversion of SPECT to DS | ||
| Automated Image-based Registration | ||
| Manual registration editing | Yes | Yes |
| Auto Rigid Registration | Yes | Yes |
| Deformable Registration | Yes | Yes |
| Inverse deformable registration | No | Yes |
| Structure Guided deformable | No | Yes |
| Segmentation (Manual Contouring Tools and Atlas Segmentation) | ||
| Manual Contouring tools | Yes | Yes |
| Atlas Auto-Segmentation | Yes | Yes |
| Image analysis with volumetric graphs | ||
| Histograms and Voxel Assessment | ||
| graphs | Yes | Yes |
| DVH statistics display | Yes | Yes |
| Plan Review | ||
| Storage and display of DICOM RT Plans | No | Yes |
| Lesion volume tracking by associating | ||
| structure with name tag | No | Yes |
| Navigator Semi-Automated Workflows | ||
| Semi-automatic workflows to assist | ||
| with common clinical image | ||
| registration & analysis tasks | No | Yes |
| Adaptive Navigators to assist in offline | ||
| dose review: includes workflows to | ||
| create adaptive CT based on CBCT | ||
| registration, copy plan to adaptive CT, | ||
| and compare dose. | No | Yes |
| Security | ||
| Logging of database activity | No | Yes |
5
6
7
MIM Y90 Dosimetry (K172218) was determined to be a predicate for the RapidSphere SPECT Microsphere Dosimetry feature. Both features:
- are intended for post-treatment absorbed dose calculation and evaluation
- are compatible with Y90 PET and SPECT image types
- and use the Local deposition model for dose calculation.
Performance Data:
Software Verification and Validation Testing
Software verification and validation was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.
Clinical Tests No clinical tests have been included in this pre-market submission.
Conclusions
The non-clinical data support the safety of the device and the software verification and validation demonstrate that the Velocity device performs as intended. Varian therefore considers Velocity 4.0 to be safe and effective and to perform at least as well as the predicate device.