AccuContour
Device Facts
| Record ID | K221706 |
|---|---|
| Device Name | AccuContour |
| Applicant | Manteia Technologies Co., Ltd. |
| Product Code | QKB · Radiology |
| Decision Date | Mar 9, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | AI/ML, Software as a Medical Device |
AI Performance
| Output | Algorithm | Acceptance | Observed | Dev DS | Dev Readers | Test DS | Test Readers |
|---|---|---|---|---|---|---|---|
| Deformable image registration | — | — | Non-inferior to reference device (K182624) based on Normalized Mutual Information (NMI) | — | — | — | — |
Indications for Use
It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.
Device Story
AccuContour is standalone software for radiation oncology departments; used by clinicians to process medical images. Inputs: multi-modality images and non-contrast CT data (DICOM compliant). Functions: deep learning-based automatic contouring of organs-at-risk (head, neck, thorax, abdomen, pelvis); automatic rigid and deformable image registration; manual contouring; plan evaluation/comparison; dose analysis. Outputs: segmented images, registered image sets, dose statistics, and DVH data. Clinicians review and edit outputs to support treatment planning and adaptive therapy. Benefits: streamlines contouring and registration workflows, aiding in precise tumor/tissue definition and radiation dose management.
Clinical Evidence
No clinical data included. Substantial equivalence supported by bench testing, including deformable registration accuracy assessment using Normalized Mutual Information (NMI) compared against reference device K182624, and comprehensive software verification and validation.
Technological Characteristics
Standalone software; Windows-based. Features deep learning-based segmentation and intensity-based rigid/deformable image registration. Supports DICOM 3.0 standard. Connectivity: networked image data import/export. Software level of concern: Major.
Indications for Use
Indicated for use by radiation oncology departments to register multi-modality images and segment non-contrast CT images for treatment planning, evaluation, and adaptation.
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
- AccuContour™ (K191928)
Reference Devices
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in a blue square. The full name of the agency, "U.S. Food & Drug Administration," is written in blue letters next to the acronym.
Manteia Technologies Co., Ltd. % Dandan Chen RA 1903, B Tower, Zijin Plaza No. 1811 Huandao East Road Xiamen, 361001 CHINA
Re: K221706
Trade/Device Name: AccuContour Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QKB Dated: Mav 31, 2022 Received: June 13, 2022
Dear Dandan Chen:
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
March 9, 2023
{1}------------------------------------------------
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,
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Lora D. Weidner. The date of the signature is March 9th, 2023. The time of the signature is 19:17:29 -05'00'.
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K221706
Device Name AccuContour
Indications for Use (Describe)
It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.
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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
# 510(k) Summary
# I . SUBMITTER
Manteia Technologies Co., Ltd. 1903, B Tower, Zijin Plaza, No.1811 Huandao East Road, Xiamen
China Establishment Registration Number: 3016686005
Contact Person: Dandan Chen Position: RA Tel: +86 592-6100813 Email: chendandan@manteiatech.com
Date Prepared: March 9, 2023
# II . DEVICE
Name of Device: AccuContour Common or Usual Name: Medical Imaging Software Classification Name: System, Imaging processing, Radiological Regulatory Class: II Product Code: QKB Regulation Number: 21CFR 892.2050 Review Panel: Radiology
### III. PREDICATE DEVICE
| Device | 510(k) Number | Product Name |
|------------------|---------------|-------------------|
| Predicate Device | K191928 | AccuContour™ |
| Reference Device | K182624 | MIM-MRT Dosimetry |
| Reference Device | K173636 | Velocity |
| Reference Device | K181572 | Workflow Box |
### IV. DEVICE DESCRIPTION
The proposed device, AccuContour, is a standalone software which is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.
The product has two image processing functions:
- (1) Deep learning contouring: it can automatically contour organs-at-risk, in head and neck,
{4}------------------------------------------------
thorax, abdomen and pelvis (for both male and female) areas,
- (2) Automatic registration: rigid and deformable registration, and
- (3) Manual contouring.
It also has the following general functions:
- > Receive, add/edit/delete, transmit, input/export, medical images and DICOM data;
- > Patient management;
- > Review of processed images;
- ► Extension tool;
- > Plan evaluation and plan comparison;
- ► Dose analysis.
# V . INDICATIONS FOR USE
It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.
{5}------------------------------------------------
# VI. SUBSTANTIALLY EQUIVALENT (SE) COMPARISION
Table 1 Comparison of Technology Characteristics
| ITEM | Proposed Device | Predicate Device<br>K191928 | Reference Device<br>K182624 | Reference Device<br>K173636 | Reference Device<br>K181572 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Information | | | | | |
| Regulation No. | 21CFR 892.2050 | 21CFR 892.2050 | 21CFR 892.2050 | 21CFR 892.2050 | 21CFR 892.2050 |
| Product Code | QKB | QKB | LLZ | LLZ | LLZ |
| Indication for Use | It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation. | It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT information for treatment planning, treatment evaluation and treatment adaptation. | MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM assists in the following indications:<br>Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.Create, display and print reports from medical images. | Velocity is a software package that provides the physicians a means for comparison of medical data including imaging data that is DICOM compliant.<br>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. | Workflow Box is a software system designed to allow users to route DICOM-compliant data to and from automated processing components.<br>Supported modalities include CT, MR, RTSTRUCT.<br>Workflow Box includes processing components for automatically contouring imaging data using deformable image registration to support atlas based contouring, re-contouring of the same patient and machine learning based contouring.<br>Workflow Box is a data routing and image processing tool which automatically applies contours to |
{6}------------------------------------------------
| | | Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning. Evaluation of cardiac left ventricular function and perfusion, including left ventricular enddiastolic volume, end-systolic volume, and ejection fraction. Localization and definition of objects such as tumors and normal tissues in medical images. Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy transferring contours to | data which is sent to one or more of the included image processing workflows. Contours generated by Workflow Box may be used as an input to clinical workflows including, but not limited to radiation therapy treatment planning. Workflow Box must be used in conjunction with appropriate software to review and edit results generated automatically by Workflow Box components, for example image visualization software must be used to facilitate the review and edit of contours generated by Workflow Box component applications. Workflow Box is intended to be used by trained medical professionals. Workflow Box is not intended to automatically detect lesions. |
|--|---|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | radiation<br>therapy | |
| | | transferring contours to | |
| | | radiation therapy treatment | |
| | | planning systems,<br>and | |
| | | archiving contours for | |
| | | patient<br>follow-up<br>and | |
| | | management. | |
| | ● | Quantitative and statistical | |
| | | analysis of PET/SPECT | |
| | | brain scans by comparing | |
| | | to other<br> | |
| | | PET/SPECT brain scans. | |
| | | Planning and evaluation of | |
| | | permanent<br>implant | |
| | | brachytherapy<br>procedures | |
| | | (not including radioactive | |
| | | microspheres). | |
| | ● | Calculating<br>absorbed | |
| | | radiation dose as a result of | |
| | | administering<br>a | |
| | | radionuclide. When using | |
| | | device clinically, the user | |
| | | should only use FDA | |
| | | approved | |
| | | radiopharmaceuticals. If | |
| | | using with unapproved | |
{7}------------------------------------------------
{8}------------------------------------------------
| Label/labeling | Conform with 21CFR<br>Part 801 | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 |
|-----------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|
| Operating<br>System | Windows | Windows | Windows and MAC system | Windows and MAC system | Windows |
| Segmentation Features<br>Algorithm | Deep Learning | Deep Learning | Atlas-based | Atlas-based | Atlas Based contouring |
| | | | ones, this device should<br>only be used for research<br>purposes.<br>Lossy compressed<br>mammographic images and<br>digitized film screen images<br>must not be reviewed for<br>primary image interpretations.<br>Images that are printed to film<br>must be printed using an<br>FDA-approved printer for the<br>diagnosis of digital<br>mammography images.<br>Mammographic images must be<br>viewed on a display system that<br>has been cleared by the FDA for<br>the diagnosis of digital<br>mammography images. The<br>software is not to be used for<br>mammography CAD. | | |
| | | | | | registration based |
| | | | | | re-contouring, machine learning<br>based contouring |
| Compatible<br>Modality | Non-Contrast CT | Non-Contrast CT | Non-Contrast CT | Non-Contrast CT | CT、MR |
| Compatible<br>Scanner Models | No Limitation on scanner model,<br>DICOM 3.0 compliance required. | No Limitation on scanner model,<br>DICOM 3.0 compliance required. | No Limitation on scanner model,<br>DICOM 3.0 compliance required. | No Limitation on scanner model,<br>DICOM 3.0 compliance required. | No Limitation on scanner model,<br>DICOM 3.0 compliance required. |
| Compatible<br>Treatment<br>Planning<br>System | No Limitation on TPS model, DICOM<br>3.0 compliance required. | No Limitation on TPS model, DICOM<br>3.0 compliance required. | No Limitation on TPS model, DICOM<br>3.0 compliance required. | No Limitation on TPS model, DICOM<br>3.0 compliance required. | No Limitation on TPS model, DICOM<br>3.0 compliance required. |
| Unattended<br>workstation | Yes | No | Not stated | No | Yes |
| Registration Features | | | | | |
| Algorithm | Intensity Based. | Intensity Based. | Intensity Based. | Intensity Based. | Intensity Based. |
| Image<br>registration | Auto rigid registration and auto deformable registration. | Auto rigid registration | Auto rigid registration and deformable registration. | Auto rigid registration and deformable registration. | Auto rigid registration and deformable registration. |
| Compatible<br>Modality | Auto rigid registration:<br>CT, MRI, PET<br>Auto deformable<br>registration: CT, MRI, CBCT | CT, MRI, PET | CT, MRI, CR, DX, MG, US, SPECT, PET and XA | PET/SPECT/CT/MRI | CT, MRI |
| | Compatible<br>Scanner Models | | | | |
| Compatible<br>Scanner Models | No Limitation on scanner model,<br>DICOM 3.0 compliance required. | No Limitation on scanner model,<br>DICOM 3.0 compliance required. | No Limitation on scanner model,<br>DICOM 3.0 compliance required. | No Limitation on scanner model,<br>DICOM 3.0 compliance required. | No Limitation on scanner model,<br>DICOM 3.0 compliance required. |
| Compatible<br>Treatment<br>Planning<br>System | No Limitation on scanner model,<br>DICOM 3.0 compliance required. | No Limitation on scanner model,<br>DICOM 3.0 compliance required. | No Limitation on scanner model,<br>DICOM 3.0 compliance required. | No Limitation on scanner model,<br>DICOM 3.0 compliance required. | No Limitation on scanner model,<br>DICOM 3.0 compliance required. |
| Plan Evaluation Feature | | | | | |
| Display of<br>DICOM RT<br>Plans | Yes | No | Not stated | Yes | No |
| Isodose Line<br>Display | Yes | No | Not stated | Yes | No |
| DVH statistics<br>display | Yes | No | Not stated | Yes | No |
| RT Plans<br>comparison | Yes | No | Not stated | Yes | No |
| Dose Analysis Feature | | | | | |
| Display of<br>DICOM RT<br>Doses | Yes | No | Not stated | Yes | No |
| Dose<br>accumulation | Yes | No | Not stated | Yes | No |
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
## VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
### 1. Non-Clinical Test Conclusion
### Deformable registration performance test
The registration performance test was performed on proposed device and reference device (K182624) to evaluate the deformable registration accuracy. All fixed images and moving images are generated in healthcare institutions in U.S. The scanner models covered products from five major vendors. The image registration feature is tested on multi-modality image sets from different patients. The Normalized Mutual Information (NMI) was used for evaluation. NMI values were calculated on two sets of images for b…
