QOCA® image Smart RT Contouring System

K231855 · Quanta Computer, Inc. · QKB · Feb 13, 2024 · Radiology

Device Facts

• Record ID: K231855
• Device Name: QOCA® image Smart RT Contouring System
• Applicant: Quanta Computer, Inc.
• Product Code: QKB · Radiology
• Decision Date: Feb 13, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

QOCA® image Smart RT Contouring System is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms. Contours that are generated by QOCA® image Smart RT Contouring System may be used as input for clinical workflows including external beam radiation therapy treatment planning. QOCA® image Smart RT Contouring System must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by QOCA® image Smart RT Contouring System. The output of QOCA® image Smart RT Contouring System in the format of RTSTRUCT objects are intended to be used by radiation oncology department. QOCA® image Smart RT Contouring System does not provide a user interface for data visualization. System settings, user settings, progress status, and other functionalities are managed via a web-based interface. The software is not intended to automatically detect or contour lesions. Only DICOM images of adult patients are considered to be valid input.

Device Story

Post-processing software; automates contouring of organs at risk (OAR) on DICOM CT images for radiation therapy planning. Uses deep-learning algorithms to generate RTSTRUCT objects. Operated by radiation oncology staff; requires integration with external Treatment Planning Systems (TPS) or interactive contouring software for review, editing, and final acceptance. Web-based interface manages system settings and status. Does not visualize data or detect lesions. Benefits include standardized, automated anatomical segmentation to support efficient, precise radiation therapy treatment planning.

Clinical Evidence

No clinical data. Bench-only retrospective performance study using 220 independent CT cases (110 head/neck, 110 pelvis) from Taiwan and US (TCIA). Ground truth established via consensus guidelines. Primary endpoint: Dice Similarity Coefficient (DSC) and Hausdorff Distance (HD95). Results showed median DSC > 0.80 across validated OARs, confirming performance consistency across contrast and non-contrast CT images.

Technological Characteristics

Software-only device; deep-learning-based segmentation algorithm. Compatible with DICOM CT images (contrast/non-contrast). Outputs RTSTRUCT objects. Web-based management interface. Operates on Windows. Complies with IEC 62304:2006/A1:2016 for software lifecycle and cybersecurity standards.

Indications for Use

Indicated for adult patients undergoing radiation therapy requiring identification of organs at risk (OAR) in head, neck, and pelvis regions using DICOM CT imaging data.

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)

Submission Summary (Full Text)

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February 13, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Quanta Computer Inc. % Joe Wang, Research Specialist No. 188, Wenhua 2nd Rd Guishan Dist. Taoyuan City, 33383 TAIWAN

## Re: K231855

Trade/Device Name: QOCA® image Smart RT Contouring System Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QKB Dated: January 8, 2024 Received: January 8, 2024

Dear Joe Wang:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming

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product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Lora Weidner

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 Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K231855

#### Device Name

QOCA® image Smart RT Contouring System

#### Indications for Use (Describe)

QOCA® image Smart RT Contouring System is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms.

Contours that are generated by QOCA® image Smart RT Contouring System may be used as input for clinical workflows including external beam radiation therapy treatment planning. QOCA® image Smart RT Contouring System must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by OOCA® image Smart RT Contouring System. The output of QOCA® image Smart RT Contouring System in the format of RTSTRUCT objects are intended to be used

by radiation oncology department.

QOCA® image Smart RT Contouring System does not provide a user interface for data visualization. System settings, user settings, progress status, and other functionalities are managed via a web-based interface.

The software is not intended to automatically detect or contour lesions. Only DICOM images of adult patients are considered to be valid input.

| 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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# 510(k) Summary

| <b>5.1. Type of Submission:</b> | Traditional |
|---------------------------------|------------------------------------------------------------------------------|
| <b>5.2. Date of Summary:</b> | 01/08/2024 |
| <b>5.3. Submitter:</b> | Quanta Computer Inc. |
| <b>Address:</b> | No. 188, Wenhua 2nd Rd., Guishan Dist. Taoyuan<br>City 33383, Taiwan (R.O.C) |
| <b>Phone:</b> | [phone] |
| <b>Contact:</b> | Joe Wang<br>[e-mail] |

## 5.4. Identification of the Device:

| Proprietary/Trade Name: | QOCA® image Smart RT Contouring System |
|-------------------------|------------------------------------------------|
| Model Number: | ZSWR901 |
| Review Panel: | Radiology |
| Regulation Name: | Medical Image Management and Processing System |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | QKB |
| Device Class: | II |

# 5.5. Identification of the Predicate Device:

| Predicate Device Name: | AccuContour™ |
|------------------------|--------------------------------|
| Model Number: | -- |
| 510(k) Number: | K191928 |
| Manufacturer: | Xiamen Manteia Technology LTD. |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | QKB |
| Device Class: | II |

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### 5.6. Intended Use/Indications for Use of the Device

QOCA® image Smart RT Contouring System is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms.

Contours that are generated by QOCA® image Smart RT Contouring System may be used as input for clinical workflows including external beam radiation therapy treatment planning. QOCA® image Smart RT Contouring System must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by QOCA® image Smart RT Contouring System.

The output of QOCA® image Smart RT Contouring System in the format of RTSTRUCT objects are intended to be used by radiation oncology department.

QOCA® image Smart RT Contouring System does not provide a user interface for data visualization. System settings, user settings, progress status, and other functionalities are managed via a web-based interface.

The software is not intended to automatically detect or contour lesions. Only DICOM images of adult patients are considered to be valid input.

## 5.7. Device Description

QOCA® image Smart RT Contouring System is a post-processing software used to automatically contour DICOM CT imaging data using deep-learning-based algorithms. OOCA® image Smart RT Contouring System contouring workflow supports CT inout data and produces RTSTRUCT outputs. Contours that are generated by QOCA® image Smart RT Contouring System may be used as input for clinical workflows including external beam radiation therapy treatment planning.

The output of QOCA® image Smart RT Contouring System, in the form of RTSTRUCT objects, are intended to be used by radiation oncology department. The output of QOCA® image Smart RT Contouring System must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by QOCA® image Smart RT Contouring System.

QOCA® image Smart RT Contouring System includes the following functionality:

- Automated contouring of organs at risk (OAR) workflow ●
- Input - DICOM CT
- Output - DICOM CT (Original), DICOM RTSTRUCT

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- Web-based interface of system settings, user settings, and checking progress status
QOCA® image Smart RT Contouring System is intended to be used on adults undergoing treatment that requires the identification of anatomical structures in the body considered to be OAR. QOCA® image Smart RT Contouring System is intended to be used in the head, neck, and pelvis regions.

## 5.8. Comparison of Technological Characteristics with the Predicate Device

QOCA® image Smart RT Contouring System submitted in this 510(k) file is substantially equivalent in intended use, safety and performance to the cleared AccuContour™ (K191928). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

| Item | Subject Device | Predicate Device | Substantial<br>Equivalence<br>Determination | |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K231855 | K191928 | -- | |
| Proprietary<br>Name | QOCA® image Smart<br>RT Contouring<br>System | AccuContour™ | -- | |
| Manufacturer | Quanta Computer Inc. | Xiamen Manteia<br>Technology LTD. | -- | |
| Regulation<br>Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same | |
| Product Code | QKB | QKB | Same | |
| Classification | Class II | Class II | Same | |
| Intended<br>Use/Indication<br>for Use | QOCA® image Smart<br>RT Contouring<br>System is a post-<br>processing software<br>intended to<br>automatically contour<br>DICOM CT imaging<br>data using deep-<br>learning-based<br>algorithms. | It is used by<br>radiation oncology<br>department to<br>register<br>multimodality<br>images and<br>segment (non-<br>contrast) CT<br>images, to generate<br>needed information | Similar<br>Both devices utilize<br>artificial<br>intelligence<br>algorithms to<br>automatically<br>contour organs at<br>risk, including the<br>head and neck, as<br>well as the pelvis. | |
| Contours that are | for treatment | for radiation | | |
| generated by QOCA® | planning, treatment | treatment planning. | | |
| image Smart RT | evaluation and | | | |
| Contouring System | treatment | | | |
| may be used as input | adaptation. | | | |
| for clinical workflows | | | | |
| including external | | | | |
| beam radiation | | | | |
| therapy treatment | | | | |
| planning. QOCA® | | | | |
| image Smart RT | | | | |
| Contouring System | | | | |
| must be used in | | | | |
| conjunction with | | | | |
| appropriate software | | | | |
| such as Treatment | | | | |
| Planning Systems and | | | | |
| Interactive Contouring | | | | |
| applications, to | | | | |
| review, edit, and | | | | |
| accept contours | | | | |
| generated by QOCA® | | | | |
| image Smart RT | | | | |
| Contouring System. | | | | |
| The output of QOCA® | | | | |
| image Smart RT | | | | |
| Contouring System in | | | | |
| the format of | | | | |
| RTSTRUCT objects | | | | |
| are intended to be | | | | |
| used by radiation | | | | |
| oncology department. | | | | |
| QOCA® image Smart | | | | |
| RT Contouring | | | | |
| System does not | | | | |
| | provide a user<br>interface for data<br>visualization. System<br>settings, user settings,<br>progress status, and<br>other functionalities<br>are managed via a<br>web-based interface.<br>The software is not<br>intended to<br>automatically detect or<br>contour lesions. Only<br>DICOM images of<br>adult patients are<br>considered to be valid<br>input. | | | |
| Operating System | Windows | Windows | Same | |
| Algorithm | Deep Learning | Deep Learning | Same | |
| Segmentation of<br>Organ at Risk in<br>the Anatomic<br>Regions | Brain stem,<br>Esophagus, Mandible,<br>Pharyngeal,<br>Constrictor Muscle<br>(PCM), Spinal cord,<br>Thyroid, Right eye,<br>Light eye, Right lens,<br>Left lens, Right optic<br>nerve, Left optic<br>nerve, Right parotid,<br>Left parotid,<br>Anorectum, Bladder,<br>Bowel bag, Lumbar<br>spine L5, Bilateral<br>seminal vesicles,<br>Right iliac, Left iliac. | Head and Neck,<br>Thorax, Abdomen,<br>and Pelvis | <i>Similar</i><br>The subject device<br>contains head and<br>neck, and pelvis. | |
| Left proximal femur | | | | |
| Compatible<br>Modality | CT Images | Non-Contrast CT<br>Images | Similar<br>The subject device<br>and the predicate<br>device are both<br>compatible only<br>with CT images for<br>the segmentation<br>feature. The<br>predicate device<br>claims to handle<br>only non-contrast<br>CT images, while<br>the subject device<br>can be used with<br>both contrast and<br>non-contrast CT<br>images. | |
| Compatible<br>Scanner Models | No specific<br>requirement for the<br>scanner model, it is<br>recommended to use<br>multi-detector CT<br>(MDCT) equipment<br>with more than 16<br>slices for Radiation<br>Therapy Simulation<br>CT, and DICOM<br>compliance required. | No Limitation on<br>scanner model,<br>DICOM 3.0<br>compliance<br>required. | Similar<br>The Subject Device<br>and Predicate<br>Device are<br>substantially<br>equivalent in their<br>requirements for<br>DICOM<br>compliance,<br>ensuring<br>interoperability and<br>standardization in<br>medical imaging<br>data. The Subject<br>Device<br>recommends a | |
| | | | scanner with more | |
| | | | than 16 slices | |
| | | | specifically for | |
| | | | Radiation Therapy | |
| | | | Simulation CT to | |
| |…