PVmed Contouring Software
Device Facts
| Record ID | K210916 |
|---|---|
| Device Name | PVmed Contouring Software |
| Applicant | Perception Vision Medical Technologies Ltd.Co. |
| Product Code | LLZ · Radiology |
| Decision Date | Dec 3, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
AI Performance
| Output | Algorithm | Acceptance | Observed | Dev DS | Dev Readers | Test DS | Test Readers |
|---|---|---|---|---|---|---|---|
| Auto-contouring of Organs at Risk (OARs) | — | — | Dice similarity coefficient | — | — | Retrospective study of CT images from 5 hospitals collected over 3 years. | >1 (radiotherapy doctors) |
Indications for Use
PVmed Contouring Software is a software package. It allows the display, annotation, volume operation, volume rendering, and fusion of medical CT images as an aid during use by radiation therapy planning. it is limited to autocontouring of OARs for head and neck, chest and abdomen, abdomen and pelvis.
Device Story
PVmed Contouring Software is a software package for radiation therapy planning; it processes medical CT images to perform auto-contouring of organs at risk (OARs). Input consists of CT images; the software provides tools for display, annotation, volume rendering, and image fusion. It is intended for use by radiation therapy professionals. The software automates the delineation of anatomical boundaries, which are then reviewed by clinicians to assist in treatment planning. By providing automated contouring, the device aims to improve the efficiency and consistency of the radiation therapy planning workflow. It operates on standard computing platforms (Linux, Windows, Mac OS).
Clinical Evidence
No clinical trials were conducted. Non-clinical bench testing evaluated the accuracy of auto-contouring by comparing software-generated contours against manual contours delineated by radiotherapy doctors with >5 years of experience. Data was sourced from CT images of patients across 5 hospitals. The primary endpoint was the Dice similarity coefficient, which demonstrated that the software meets drawing accuracy requirements.
Technological Characteristics
Software-based medical image management and processing system. Supports DICOM CT image import/export. Features include auto-contouring of OARs, manual contouring tools, image fusion, and 3D volume rendering. Operates on Linux, Windows 10+, and Mac OS 10.14. Software is classified as a 'major' level of concern. Connectivity via standard DICOM protocols.
Indications for Use
Indicated for use as an aid in radiation therapy planning for patients requiring auto-contouring of organs at risk (OARs) in the head and neck, chest, abdomen, and pelvis regions using medical CT images.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
- Velocity (K173636)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Perception Vision Medical Technologies LTD.CO. Chuanji Huang Regulatory Affairs Manager Room 306, First Phase Office Building No. 12, Yuyan Road, Huangpu District Guangzhou, Guangdong 510530 China
Re: K210916
Trade/Device Name: PVmed Contouring Software Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: October 29, 2021 Received: November 3, 2021
Dear Chuanji Huang:
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
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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 devices or postmarketing safety reporting (21 CFR 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Thalia T. Mills, Ph.D. 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
Enclosure
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# Indications for Use
510(k) Number (if known) K210916
Device Name
PVmed Contouring Software
#### Indications for Use (Describe)
PV med Contouring Software is a software package. It allows the display, annotation, volume operation, volume rendering, and fusion of medical CT images as an aid during use by radiation therapy planning. it is limited to autocontouring of OARs for head and neck, chest and abdomen, abdomen and pelvis.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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### Section 5: 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. The assigned 510(k) Number: K210916
### 5.1 Submitter
510(k) owner's name: Perception Vision Medical Technologies LTD.CO. Address: Room 306, First Phase Office Building, No. 12, Yuyan Road, Huangpu District Guangzhou, Guangdong, 510530, P. R. China
Tel: +86-20-34329782 Fax: +86-20-34329782
Contact Person: Chuanji Huang Email: RA@pvmedtech.com Date Prepared: October 28, 2021
#### 5.2 Device
Name of Device: PVmed Contouring Software Common Name: PVmed Contouring Software Model: PVmed Contouring B Classification Name: Medical image management and processing system Regulation No: 21 CFR892.2050 Regulatory Class: Class || Product Code: LLZ
#### 5.3 Predicate Device
PVmed Contouring Software is substantially equivalent to the following legally marketed predicate devices. This predicate device has not been subject to any design related recalls.
| Item | Predicate Device |
|-------------------------|---------------------------------------------------|
| 510(k) Submitter/Holder | Varian Medical Systems, Inc. |
| 510(k) Number | K173636 |
| Device Name | Velocity |
| Regulation Name | Medical image management and<br>processing system |
| Product Code | LLZ |
| Regulation Class | Class II |
| Regulation Number | 21 CFR892.2050 |
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### 5.4 Device Description
The device, PVmed Contouring Software is a software package. It allows the display, annotation, volume operation, volume rendering, and fusion of medical CT images as an aid during use by radiation therapy planning. it is limited to auto-contouring of OARs for head and neck, chest and abdomen, abdomen and pelvis.
The product mainly has the following image processing functions:
Support contour drawing of organs at risk in head and neck, chest and abdomen, abdomen and pelvis.
It also has the following general functions:
- Receive, add/edit/delete, transmit, input/export, medical images and DICOM data;
- Data set management, patient data management;
- Review of processed images;
- Image fusion;
- Open and Save of files.
#### 5.5 Indications for Use Statement
PVmed Contouring Software is a software package. It allows the display, annotation, volume operation, volume rendering, and fusion of medical CT images as an aid during use by radiation therapy planning. it is limited to auto-contouring of OARs for head and neck, chest and abdomen, abdomen and pelvis.
#### 5.6 Substantial Equivalence Discussion
Table 5.1 Summary Comparison Table
| Comparison Elements | Subject Device | Predicate Device | Discussion of<br>difference |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basic Information | | | |
| Device Name | PVmed Contouring<br>Software | Velocity | / |
| 510(k) No | / | K173636 | / |
| Regulation No | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Regulation Description | Medical image<br>management and<br>processing system | Picture archiving and<br>communications system | Same |
| Classification name | System, Image<br>Processing, | System, Image<br>Processing, | Same |
| Comparison Elements | Subject Device | Predicate Device | Discussion of<br>difference |
| | Radiological | Radiological | |
| Classification | Class II | Class II | Same |
| Product code | LLZ | LLZ | Same |
| Indications for use | PVmed Contouring<br>Software is a<br>software package. It<br>allows the display,<br>annotation, volume<br>operation, volume<br>rendering, and<br>fusion of medical<br>CT images as an aid<br>during use by<br>radiation therapy<br>planning. it is<br>limited to auto-<br>contouring of OARs<br>for head and neck,<br>chest and abdomen,<br>abdomen and<br>pelvis. | Velocity is a software<br>package that provide<br>the physicians a<br>means for<br>comparison of<br>medical data<br>including imaging<br>data that is DICOM.<br>It allows the display,<br>annotation, volume<br>operation, volume<br>rendering,<br>registration, and<br>fusion of medical<br>images as an aid<br>during use by<br>diagnostic radiology,<br>oncology, radiation<br>therapy planning and<br>other medical<br>specialties. Velocity<br>is not intended for<br>mammography. | Both use for<br>anatomy boundary<br>contours. |
| | General Usage/ Performance Features | | |
| Image Study Importation | Yes<br>CT,<br>Query/Retrieve | Yes<br>DICOM,<br>PET/SPECT/CT/MRI<br>Dose,<br>Query/Retrieve<br>automation added<br>in 4.0 | The predicate device<br>support Dose, The<br>subject Device<br>doesn't support<br>DICOM,PET/SPEC<br>T/MRI. |
| Image Structure Import,<br>Save & Export | Yes | Yes | Same |
| Volume rendering | Yes<br>Image 3D rendering | Yes<br>4D Cine Volume<br>support in 4.0.0 | Both support<br>volume rendering. |
| Advanced Visualization | Yes | Yes | Same |
| Comparison Elements<br>and Navigation<br>Features | Subject Device | Predicate Device | Discussion of difference |
| Volume Operations | No | Yes | The subject Device<br>doesn't support. |
| Diagnostic Image<br>registration | Yes | Yes | Same |
| Image Fusion | Yes | Yes | Same |
| Contouring | Yes | Yes | The subject device<br>only allows for auto<br>contouring OARs. |
| Manual Contouring<br>Tools | Yes | Yes | Same |
| Image Analysis | No | Yes | The subject Device<br>doesn't support. |
| Plan Review of imported<br>plans or<br>created dose composites | No | Yes | The subject Device<br>doesn't support. |
| Oncology workflow<br>automation | No | Yes | The subject Device<br>doesn't support. |
| Image/ROI Export to<br>DICOM RT | Yes | Yes | Same |
| Secure login and data<br>storage | Yes | Yes | Same |
| Operating System<br>Platform | Supports Linux,<br>Windows 10 and<br>above and Mac OS<br>10.14 | Microsoft Windows 7<br>& 10 (64 bit<br>only)/ Windows<br>Server 2008R2<br>(Citrix), 2012R2,<br>2016<br>MAC OS 10.12<br>Sierra, macOS 10.13<br>High Sierra | Both support<br>Windows and Mac<br>OS. The Windows<br>and Mac OS are<br>updating.<br>The risk of the<br>Subject Device was<br>verified(Section<br>21-3 System Test) |
| Multimodality DICOM Import | | | |
| Import and display<br>DICOM CT, MR, DS,<br>PET, RTS, RTP | Supports DICOM<br>CT | Yes | The subject Device<br>doesn't support<br>MR,PET DS and<br>RTP |
| Advanced Visualization & Navigation | | | |
| General image viewer<br>with view layout<br>selection and toolbars | Yes | Yes | Same |
| Volume Operations | | | |
| User scaling of image<br>volumes | No | Yes | The subject Device<br>doesn't support. |
| Biological Effective<br>Dose (BED) Scaling | No | Yes | The subject Device<br>doesn't support. |
| Y-90 Microsphere<br>Dosimetry -conversion<br>of SPECT to DS | No | Yes | The subject Device<br>doesn't support. |
| Automated Image-based Registration | | | |
| Comparison Elements | Subject Device | Predicate Device | Discussion of<br>difference |
| Manual registration<br>editing | Yes | Yes | Same |
| Auto Rigid Registration | Yes | Yes | Same |
| Deformable Registration | Yes | Yes | Same |
| Inverse deformable<br>registration | Yes | Yes | Same |
| Inverse deformable<br>registration | No | Yes | The subject Device<br>doesn't support. |
| Structure Guided<br>deformable | No | Yes | The subject Device<br>doesn't support. |
| Segmentation | | | |
| Manual Contouring tools | Yes | Yes | Same |
| Image analysis with volumetric graphs | | | |
| Histograms and Voxel<br>Assessment<br>graphs | No | Yes | The subject Device<br>doesn't support. |
| DVH statistics display | No | Yes | The subject Device<br>doesn't support. |
| Plan Review | | | |
| Storage and display of<br>DICOM RT Plans | No | Yes | The subject Device<br>doesn't support. |
| Lesion volume tracking<br>by associating<br>structure with name tag | No | Yes | The subject Device<br>doesn't support. |
| Navigator Semi-Automated Workflows | | | |
| Semi-automatic<br>workflows to assist<br>with common clinical<br>image<br>registration & analysis<br>tasks | No | Yes | The subject Device<br>doesn't support. |
| Adaptive Navigators to<br>assist in offline<br>dose review: includes<br>workflows to<br>create adaptive CT based<br>on CBCT<br>registration, copy plan to<br>adaptive CT,<br>and compare dose. | No | Yes | The subject Device<br>doesn't support. |
| Security | | | |
| Logging of database<br>activity | Yes | Yes…
