(249 days)
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.
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.
The provided text describes the PVmed Contouring Software and its substantial equivalence determination for FDA clearance (K210916). However, the document's detail regarding the acceptance criteria and the specific study that proves the device meets the acceptance criteria is somewhat limited, especially concerning quantitative metrics and the setup of the ground truth for human-only or human-in-the-loop performance improvements.
Based on the available information, here's an attempt to structure the answer according to your request, with limitations noted for absent information.
Acceptance Criteria and Device Performance Study for PVmed Contouring Software
The PVmed Contouring Software underwent non-clinical testing to demonstrate its drawing accuracy for organs at risk (OARs) when compared to manual delineations by radiotherapy doctors.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the PVmed Contouring Software, specifically for drawing accuracy, were evaluated using the Dice Similarity Coefficient (DSC). While the specific numerical acceptance threshold (e.g., DSC > 0.8) is not explicitly stated, the reported performance indicates that the software met these requirements.
| Metric (Type of Criteria) | Acceptance Criteria (Threshold/Target) | Reported Device Performance |
|---|---|---|
| Drawing Accuracy | Dice Similarity Coefficient (DSC) | "The results show that the software can meet the requirements of drawing accuracy." (Specific numerical DSC values are not provided in the document.) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The test set included CT images "of who were admitted to 5 hospitals for radiotherapy in the past 3 years." The exact number of patients or images is not specified.
- Data Provenance: Retrospective, as the data consisted of CT images from patients admitted "in the past 3 years." The country of origin is not explicitly stated, but the submitter's address is in Guangzhou, Guangdong, China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: The ground truth (control group) was established by "radiotherapy doctors." The exact number of doctors involved is not specified.
- Qualifications of Experts: The experts were "radiotherapy doctors with more than 5 years of practice."
4. Adjudication Method for the Test Set
The document states that the test group was delineated by the software, and the control group (ground truth) was delineated by radiotherapy doctors. This implies a comparison between the software's output and the expert's output. The method for resolving discrepancies among multiple experts (e.g., 2+1, 3+1) or if multiple experts were used for each case to establish a consensus ground truth is not specified. It appears to be a direct comparison to expert-drawn contours, implying consensus or a single expert for each contour, but this is not explicitly detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, a formal MRMC comparative effectiveness study to assess how much human readers improve with AI vs. without AI assistance was not described or included in this submission. The study focused on the standalone performance of the auto-contouring feature comparing it to manual contours.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Yes, the "Summary of Non-Clinical Trial" describes a standalone performance evaluation of the auto-contouring software. The software's output ("test group was delineated by software") was directly compared to the manual delineations by radiotherapy doctors ("control group").
7. Type of Ground Truth Used
The ground truth used was expert consensus (or expert delineation, if not a consensus of multiple experts, which is unclear). Specifically, it was the "drawing results manually drawn by radiotherapy doctors."
8. Sample Size for the Training Set
The document does not provide any information regarding the training set's sample size for the AI model. The "Summary of Non-Clinical Trial" only details the test set used for performance validation.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth was established for the training data used to develop the PVmed Contouring Software.
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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) | |
|---|---|
| X 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
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 andprocessing 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 ofdifference |
|---|---|---|---|
| Basic Information | |||
| Device Name | PVmed ContouringSoftware | Velocity | / |
| 510(k) No | / | K173636 | / |
| Regulation No | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Regulation Description | Medical imagemanagement andprocessing system | Picture archiving andcommunications system | Same |
| Classification name | System, ImageProcessing, | System, ImageProcessing, | Same |
| Comparison Elements | Subject Device | Predicate Device | Discussion ofdifference |
| Radiological | Radiological | ||
| Classification | Class II | Class II | Same |
| Product code | LLZ | LLZ | Same |
| Indications for use | PVmed ContouringSoftware is asoftware package. Itallows the display,annotation, volumeoperation, volumerendering, andfusion of medicalCT images as an aidduring use byradiation therapyplanning. it islimited to auto-contouring of OARsfor head and neck,chest and abdomen,abdomen andpelvis. | Velocity is a softwarepackage that providethe physicians ameans forcomparison ofmedical dataincluding imagingdata that is DICOM.It allows the display,annotation, volumeoperation, volumerendering,registration, andfusion of medicalimages as an aidduring use bydiagnostic radiology,oncology, radiationtherapy planning andother medicalspecialties. Velocityis not intended formammography. | Both use foranatomy boundarycontours. |
| General Usage/ Performance Features | |||
| Image Study Importation | YesCT,Query/Retrieve | YesDICOM,PET/SPECT/CT/MRIDose,Query/Retrieveautomation addedin 4.0 | The predicate devicesupport Dose, Thesubject Devicedoesn't supportDICOM,PET/SPECT/MRI. |
| Image Structure Import,Save & Export | Yes | Yes | Same |
| Volume rendering | YesImage 3D rendering | Yes4D Cine Volumesupport in 4.0.0 | Both supportvolume rendering. |
| Advanced Visualization | Yes | Yes | Same |
| Comparison Elementsand NavigationFeatures | Subject Device | Predicate Device | Discussion of difference |
| Volume Operations | No | Yes | The subject Devicedoesn't support. |
| Diagnostic Imageregistration | Yes | Yes | Same |
| Image Fusion | Yes | Yes | Same |
| Contouring | Yes | Yes | The subject deviceonly allows for autocontouring OARs. |
| Manual ContouringTools | Yes | Yes | Same |
| Image Analysis | No | Yes | The subject Devicedoesn't support. |
| Plan Review of importedplans orcreated dose composites | No | Yes | The subject Devicedoesn't support. |
| Oncology workflowautomation | No | Yes | The subject Devicedoesn't support. |
| Image/ROI Export toDICOM RT | Yes | Yes | Same |
| Secure login and datastorage | Yes | Yes | Same |
| Operating SystemPlatform | Supports Linux,Windows 10 andabove and Mac OS10.14 | Microsoft Windows 7& 10 (64 bitonly)/ WindowsServer 2008R2(Citrix), 2012R2,2016MAC OS 10.12Sierra, macOS 10.13High Sierra | Both supportWindows and MacOS. The Windowsand Mac OS areupdating.The risk of theSubject Device wasverified(Section21-3 System Test) |
| Multimodality DICOM Import | |||
| Import and displayDICOM CT, MR, DS,PET, RTS, RTP | Supports DICOMCT | Yes | The subject Devicedoesn't supportMR,PET DS andRTP |
| Advanced Visualization & Navigation | |||
| General image viewerwith view layoutselection and toolbars | Yes | Yes | Same |
| Volume Operations | |||
| User scaling of imagevolumes | No | Yes | The subject Devicedoesn't support. |
| Biological EffectiveDose (BED) Scaling | No | Yes | The subject Devicedoesn't support. |
| Y-90 MicrosphereDosimetry -conversionof SPECT to DS | No | Yes | The subject Devicedoesn't support. |
| Automated Image-based Registration | |||
| Comparison Elements | Subject Device | Predicate Device | Discussion ofdifference |
| Manual registrationediting | Yes | Yes | Same |
| Auto Rigid Registration | Yes | Yes | Same |
| Deformable Registration | Yes | Yes | Same |
| Inverse deformableregistration | Yes | Yes | Same |
| Inverse deformableregistration | No | Yes | The subject Devicedoesn't support. |
| Structure Guideddeformable | No | Yes | The subject Devicedoesn't support. |
| Segmentation | |||
| Manual Contouring tools | Yes | Yes | Same |
| Image analysis with volumetric graphs | |||
| Histograms and VoxelAssessmentgraphs | No | Yes | The subject Devicedoesn't support. |
| DVH statistics display | No | Yes | The subject Devicedoesn't support. |
| Plan Review | |||
| Storage and display ofDICOM RT Plans | No | Yes | The subject Devicedoesn't support. |
| Lesion volume trackingby associatingstructure with name tag | No | Yes | The subject Devicedoesn't support. |
| Navigator Semi-Automated Workflows | |||
| Semi-automaticworkflows to assistwith common clinicalimageregistration & analysistasks | No | Yes | The subject Devicedoesn't support. |
| Adaptive Navigators toassist in offlinedose review: includesworkflows tocreate adaptive CT basedon CBCTregistration, copy plan toadaptive CT,and compare dose. | No | Yes | The subject Devicedoesn't support. |
| Security | |||
| Logging of databaseactivity | Yes | Yes | Same |
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Premarket Notification Traditional 510(k) Submission PVmed Contouring Software
Section 5: 510(k) Summary Ref No.: TF-FDA- Contouring -005
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Premarket Notification Traditional 510(k) Submission PVmed Contouring Software
Section 5: 510(k) Summary Ref No.: TF-FDA- Contouring -005
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The features table lists the features of PVmed Contouring Software, as compared to the predicate device.
Compared with the predicate devices, Velocity (K173636), the Indications for Use,
Performance Features are substantial equivalence.
PVmed Contouring Software is substantially equivalent to the cited predicate device. Differences in the design and performance from the predicate devices do not affect either the safety or the effectiveness of PV med Contouring Software for its intended use.
5.7 Performance Date
The following performance data were provided in support the substantial equivalence determination.
Software Verification and Validation Testing
Software verification and validation testing were 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.
Summary of Non-Clinical Trial
In order to verify the drawing accuracy of the software, the drawing results of organs at risk using the software were compared and evaluated with the drawing results manually drawn by radiotherapy doctors. The test selected CT images of who were admitted to 5 hospitals for radiotherapy in the past 3 years. The test group was delineated by software, and the radiotherapy doctors with more than 5 years of practice were delineated as the control group. The effectiveness evaluation indexes of the trial were delineated dice similarity coefficient. The results show that the software can meet the requirements of drawing accuracy.
Summary of Clinical Trial
No clinical tests have been included in this pre-market submission.
5.8 Conclusions
PV med Contouring Software has the same indications for use, intended use and technological characteristics as the predicate device. All technological characteristics of the PV med Contouring Software are substantially equivalent to the predicate device. Where operational and performance differences exist between the proposed device and the predicate device, performance testing demonstrated that these differences do not adversely affect the device's safety and effectiveness.
Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements.
PVmed therefore considers PV med Contouring Software software to be substantially equivalent and to perform at least as well as 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).