(249 days)
Not Found
Unknown
The document mentions "auto-contouring" and image processing, which are tasks often performed by AI/ML algorithms, but it does not explicitly state that AI or ML is used. The lack of mention of AI/ML terms, training sets, or specific algorithm types makes it impossible to definitively confirm the presence of AI/ML.
No
The device is described as a software package used as an aid during radiation therapy planning for tasks such as display, annotation, volume operation, volume rendering, and fusion of medical CT images, with a focus on auto-contouring of organs at risk. It does not exert therapeutic action itself.
No
The device is described as an aid for radiation therapy planning, specifically for auto-contouring organs at risk. It does not provide a diagnosis itself, but rather helps prepare for treatment.
Yes
The device description explicitly states it is a "software package" and lists only software-based functions related to image processing and data management. There is no mention of accompanying hardware components or hardware-specific validation.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of the PVmed Contouring Software clearly states its function is to process and analyze medical CT images, which are generated from the patient's body, not from a specimen taken from the body (like blood, urine, tissue samples, etc.).
- The intended use is for radiation therapy planning. This is a clinical application involving image analysis for treatment planning, not for diagnosing a disease or condition based on laboratory analysis of a specimen.
- The device description focuses on image processing functions. The listed functions are related to manipulating and analyzing medical images, not performing tests on biological samples.
Therefore, the PVmed Contouring Software falls under the category of medical imaging software used for treatment planning, not an IVD.
N/A
Intended Use / 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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
head and neck, chest and abdomen, abdomen and pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiation therapy planning
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Clinical Trial: No clinical tests have been included in this pre-market submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
dice similarity coefficient.
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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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 and |
| 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
difference |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basic Information | | | |
| Device Name | PVmed Contouring
Software | Velocity | / |
| 510(k) No | / | K173636 | / |
| Regulation No | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Regulation Description | Medical image
management and
processing system | Picture archiving and
communications system | Same |
| Classification name | System, Image
Processing, | System, Image
Processing, | Same |
| Comparison Elements | Subject Device | Predicate Device | Discussion of
difference |
| | Radiological | Radiological | |
| Classification | Class II | Class II | Same |
| Product code | LLZ | LLZ | Same |
| 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 auto-
contouring of OARs
for head and neck,
chest and abdomen,
abdomen and
pelvis. | Velocity is a software
package that provide
the physicians a
means for
comparison of
medical data
including imaging
data that is DICOM.
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. | Both use for
anatomy boundary
contours. |
| | General Usage/ Performance Features | | |
| Image Study Importation | Yes
CT,
Query/Retrieve | Yes
DICOM,
PET/SPECT/CT/MRI
Dose,
Query/Retrieve
automation added
in 4.0 | The predicate device
support Dose, The
subject Device
doesn't support
DICOM,PET/SPEC
T/MRI. |
| Image Structure Import,
Save & Export | Yes | Yes | Same |
| Volume rendering | Yes
Image 3D rendering | Yes
4D Cine Volume
support in 4.0.0 | Both support
volume rendering. |
| Advanced Visualization | Yes | Yes | Same |
| Comparison Elements
and Navigation
Features | Subject Device | Predicate Device | Discussion of difference |
| Volume Operations | No | Yes | The subject Device
doesn't support. |
| Diagnostic Image
registration | Yes | Yes | Same |
| Image Fusion | Yes | Yes | Same |
| Contouring | Yes | Yes | The subject device
only allows for auto
contouring OARs. |
| Manual Contouring
Tools | Yes | Yes | Same |
| Image Analysis | No | Yes | The subject Device
doesn't support. |
| Plan Review of imported
plans or
created dose composites | No | Yes | The subject Device
doesn't support. |
| Oncology workflow
automation | No | Yes | The subject Device
doesn't support. |
| Image/ROI Export to
DICOM RT | Yes | Yes | Same |
| Secure login and data
storage | Yes | Yes | Same |
| Operating System
Platform | Supports Linux,
Windows 10 and
above and Mac OS
10.14 | Microsoft Windows 7
& 10 (64 bit
only)/ Windows
Server 2008R2
(Citrix), 2012R2,
2016
MAC OS 10.12
Sierra, macOS 10.13
High Sierra | Both support
Windows and Mac
OS. The Windows
and Mac OS are
updating.
The risk of the
Subject Device was
verified(Section
21-3 System Test) |
| Multimodality DICOM Import | | | |
| Import and display
DICOM CT, MR, DS,
PET, RTS, RTP | Supports DICOM
CT | Yes | The subject Device
doesn't support
MR,PET DS and
RTP |
| Advanced Visualization & Navigation | | | |
| General image viewer
with view layout
selection and toolbars | Yes | Yes | Same |
| Volume Operations | | | |
| User scaling of image
volumes | No | Yes | The subject Device
doesn't support. |
| Biological Effective
Dose (BED) Scaling | No | Yes | The subject Device
doesn't support. |
| Y-90 Microsphere
Dosimetry -conversion
of SPECT to DS | No | Yes | The subject Device
doesn't support. |
| Automated Image-based Registration | | | |
| Comparison Elements | Subject Device | Predicate Device | Discussion of
difference |
| Manual registration
editing | Yes | Yes | Same |
| Auto Rigid Registration | Yes | Yes | Same |
| Deformable Registration | Yes | Yes | Same |
| Inverse deformable
registration | Yes | Yes | Same |
| Inverse deformable
registration | No | Yes | The subject Device
doesn't support. |
| Structure Guided
deformable | No | Yes | The subject Device
doesn't support. |
| Segmentation | | | |
| Manual Contouring tools | Yes | Yes | Same |
| Image analysis with volumetric graphs | | | |
| Histograms and Voxel
Assessment
graphs | No | Yes | The subject Device
doesn't support. |
| DVH statistics display | No | Yes | The subject Device
doesn't support. |
| Plan Review | | | |
| Storage and display of
DICOM RT Plans | No | Yes | The subject Device
doesn't support. |
| Lesion volume tracking
by associating
structure with name tag | No | Yes | The subject Device
doesn't support. |
| Navigator Semi-Automated Workflows | | | |
| Semi-automatic
workflows to assist
with common clinical
image
registration & analysis
tasks | No | Yes | The subject Device
doesn't support. |
| 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 | The subject Device
doesn't support. |
| Security | | | |
| Logging of database
activity | 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
6
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.