EFAI RTSuite CT HN-Segmentation System

K220264 · Ever Fortune.Ai, Co., Ltd. · QKB · Apr 28, 2022 · Radiology

Device Facts

• Record ID: K220264
• Device Name: EFAI RTSuite CT HN-Segmentation System
• Applicant: Ever Fortune.Ai, Co., Ltd.
• Product Code: QKB · Radiology
• Decision Date: Apr 28, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

EFAI HNSeg is a software device intended to assist trained radiation oncology professionals, including, but not limited to, radiation oncologists, medical physicists, and dosimetrists, during their clinical workflows of radiation therapy treatment planning by providing initial contours of organs at risk in the head and neck region on non-contrast CT images. EFAI HNSeg is intended to be used on adult patients only. The contours are generated by deep-learning algorithms and then transferred to radiation therapy treatment planning systems. EFAI HNSeg must be used in conjunction with a DICOM-compliant treatment planning system to review and edit results generated. EFAI HNSeg is not intended to be used for decision making or to detect lesions. EFAI HNSeg is an adjunct tool and is not intended to replace a clinician's judgment and manual contouring of the normal organs on CT. Clinicians must not use the software generated output alone without review as the primary interpretation.

Device Story

EFAI HNSeg is a standalone software device for radiation oncology workflows; receives non-contrast CT images in DICOM format; utilizes deep-learning algorithms to automatically delineate organs-at-risk (OARs) in the head and neck region; outputs contours in DICOM-RTSTRUCT format. Deployed on a specialized server within a local hospital network; requires no user interaction during processing. Clinicians use a separate DICOM-compliant treatment planning system to review, edit, and finalize the software-generated contours. Serves as an adjunct tool to assist clinicians; does not replace manual contouring or clinical judgment; intended to improve efficiency in treatment planning.

Clinical Evidence

Bench testing only. Non-inferiority standalone performance study compared mean Dice coefficients of EFAI HNSeg-generated head and neck OAR contours against the AccuContour predicate. Results confirmed non-inferiority with a margin of 0.1 Dice, deemed clinically acceptable.

Technological Characteristics

Standalone software; deep-learning-based segmentation; runs on Linux Ubuntu 20.04; requires specialized server hardware; DICOM-compliant input/output; no user interface; integrated into local hospital network; software lifecycle compliant with IEC 62304:2006/A1:2016.

Indications for Use

Indicated for trained radiation oncology professionals (radiation oncologists, medical physicists, dosimetrists) to assist in radiation therapy treatment planning by providing initial contours of organs at risk in the head and neck region on non-contrast CT images for adult patients. Not for lesion detection or clinical decision-making.

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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Ever Fortune.AI Co., Ltd. % Ti-Hao Wang, MD Chief Technology Officer Rm. D. 8F. No. 573. Sec. 2 Taiwan Blvd., West Dist. Taichung City, 403020 Taiwan

Re: K220264

Trade/Device Name: EFAI RTSuite CT HN-Segmentation System Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QKB Dated: January 28, 2022 Received: January 31, 2022

Dear Ti-Hao 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 (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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 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,

Julie Sullivan, PhD Assistant 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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Image /page/2/Picture/0 description: The image contains a logo for a company called "EVER FORTUNE.AI". The logo consists of a stylized human figure with a circular head made of interconnected dots, suggesting a network or global connection. The text "EVER FORTUNE.AI" is written in a sans-serif font, with the word "FORTUNE" having a similar circular design element replacing the letter "O".

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

Device Name EFAI HNSeg

Indications for Use (Describe)

EFAI HNSeg is a software device intended to assist trained radiation oncology professionals, including, but not limited to, radiation oncologists, medical physicists, and dosimetrists, during their clinical workflows of radiation therapy treatment planning by providing initial contours of organs at risk in the head and neck region on non-contrast CT images. EFAI HNSeg is intended to be used on adult patients only.

The contours are generated by deep-learning algorithms and then transferred to radiation therapy treatment planning systems. EFAI HNSeg must be used in conjunction with a DICOM-compliant treatment planning system to review and edit results generated. EFAI HNSeg is not intended to be used for decision making or to detect lesions.

EF AI HNSeg is an adjunct tool and is not intended to replace a clinician's judgment and manual contouring of the normal organs on CT. Clinicians must not use the software generated output alone without review as the primary interpretation.

| Type of Use (Select one or both, as applicable) | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| <table><tr><td><div> <span> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> </div></td><td><div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div></td></tr></table> | <div> <span> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
| <div> <span> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | |

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# Section 5. 510(k) Summary

## 1. General Information

| 510(k) Sponsor | Ever Fortune.AI Co., Ltd. |
|-----------------------|-----------------------------------------------------------------------------------------|
| Address | Rm. D, 8F. No. 573, Sec. 2 Taiwan Blvd.<br>West Dist.<br>Taichung City 403020<br>TAIWAN |
| Applicant | Joseph Chang |
| Contact Information | 886-04-23213838 #216<br>[e-mail] |
| Correspondence Person | Ti-Hao Wang, MD |
| Contact Information | 886-04-23213838 #168<br>[e-mail] |
| Date Prepared | January 29, 2022 |

## 2. Proposed Device

| Proprietary Name | EFAI RTSuite CT HN-Segmentation System v1.0 |
|---------------------|------------------------------------------------|
| Common Name | EFAI HNSeg v1.0 |
| Classification Name | Picture Archiving and Communications System |
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Medical Image Management and Processing System |
| Product Code | QKB |
| Regulatory Class | II |

## 3. Predicate Device

| Proprietary Name | AccuContour |
|------------------------|------------------------------------------------|
| Premarket Notification | K191928 |
| Classification Name | Picture Archiving and Communications System |
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Medical Image Management and Processing System |
| Product Code | QKB |
| Regulatory Class | II |

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Image /page/4/Picture/1 description: The image contains a logo for a company called EVER FORTUNE.AI. The logo consists of a stylized figure of a person with a head made of interconnected dots, and the company name is written in a sans-serif font. The color scheme is primarily teal and light green. The logo appears to be for a technology company, possibly specializing in artificial intelligence.

### 4. Device Description

EFAI RTSuite CT HN-Segmentation System, herein referred to as EFAI HNSeg, is a standalone software that is designed to be used by trained radiation oncology professionals to automatically delineate head-and-neck organs-at-risk (OARs) on CT images. This auto-contouring of OARs is intended to facilitate radiation therapy workflows.

The device receives CT images in DICOM format as input and automatically generates the contours of OARs, which are stored in DICOM format and in RTSTRUCT modality. The device does not offer a user interface and must be used in conjunction with a DICOM-compliant treatment planning system to review and edit results. Once data is routed to EFAI HNSeg, the data will be processed and no user interaction is required, nor provided.

The deployment environment is recommended to be in a local network with an existing hospitalgrade IT system in place. EFAI HNSeg should be installed on a specialized server supporting deep learning processing. The configurations are only being operated by the manufacturer:

- Local network setting of input and output destinations; ●
- Presentation of labels and their color; ●
- Processed image management and output (RTSTRUCT) file management. ●

#### 5. Intended Use

EFAI HNSeg is a software device intended to assist trained radiation oncology professionals, including, but not limited to, radiation oncologists, medical physicists, and dosimetrists, during their clinical workflows of radiation therapy treatment planning by providing initial contours of organs at risk in the head and neck region on non-contrast CT images. EFAI HNSeg is intended to be used on adult patients only.

The contours are generated by deep-learning algorithms and then transferred to radiation therapy treatment planning systems. EFAI HNSeg must be used in conjunction with a DICOM-compliant treatment planning system to review and edit results generated. EFAI HNSeg is not intended to be used for decision making or to detect lesions.

EFAI HNSeg is an adjunct tool and is not intended to replace a clinician's judgment and manual contouring of the normal organs on CT. Clinicians must not use the software generated output alone without review as the primary interpretation.

#### 6. Comparison of Technological Characteristics with Predicate Device

Table below provides a comparison of the intended use and key technological features of EFAI HNSeg with that of the Primary Predicate, AccuContour™ (K191928).

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Image /page/5/Picture/1 description: The image contains a logo for a company called EVER FORTUNE.AI. The logo consists of a stylized human figure in teal, with a green network-like structure forming the head. To the right of the figure, the company name is written in teal, with "EVER" on top and "FORTUNE.AI" below it. The overall design is modern and suggests a focus on technology and human connection.

| Company | Ever Fortune.AI Co., Ltd. (EFAI) | Xiamen Manteia Technology LTD. |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | EFAI HNSeg | AccuContourTM |
| 510k Number | Pending | K191928 |
| Regulation No. | 21CFR 892.2050 | 21CFR 892.2050 |
| Classification | II | II |
| Product Code | QKB | QKB |
| Intended Use/Indication<br>for Use | EFAI HNSeg is a software device<br>intended to assist trained radiation<br>oncology professionals, including,<br>but not limited to, radiation<br>oncologists, medical physicists,<br>and dosimetrists, during their<br>clinical workflows of radiation<br>therapy treatment planning by<br>providing initial contours of organs<br>at risk in the head and neck region<br>on non-contrast CT images. EFAI<br>HNSeg is intended to be used on<br>adult patients only.<br><br>The contours are generated by<br>deep-learning algorithms and then<br>transferred to radiation therapy<br>treatment planning systems. EFAI<br>HNSeg must be used in conjunction<br>with a DICOM-compliant<br>treatment planning system to<br>review and edit results generated.<br>EFAI HNSeg is not intended to be<br>used for decision making or to<br>detect lesions.<br><br>EFAI HNSeg is an adjunct tool and<br>is not intended to replace a<br>clinician's judgment and manual<br>contouring of the normal organs on<br>CT. Clinicians must not use the<br>software generated output alone<br>without review as the primary<br>interpretation. | It is used by radiation oncology<br>department to register<br>multimodality images and segment<br>(non-contrast) CT images, to<br>generate needed information for<br>treatment planning, treatment<br>evaluation and treatment adaptation.<br><br>The product has two image process<br>functions:<br>(1) Deep learning contouring: it can<br>automatically contour the organ-at-<br>risk, including head and neck,<br>thorax, abdomen and pelvis (for<br>both male and female),<br>(2) Automatic Registration, and<br>(3) Manual Contour.<br><br>It also has the following general<br>functions:<br>(1) Receive, add/edit/delete,<br>transmit, input/export, medical<br>images and DICOM data;<br>(2) Patient management;<br>(3) Review of processed images;<br>(4) Open and save of files. |
| Segmentation<br>(Contouring)<br>Technology | Deep learning<br> | Deep learning |
| Operating System | Linux Ubuntu 20.04 | Microsoft Windows |
| | | |
| User Population | Trained medical professionals<br>including, but not limited to,<br>radiation oncologists, medical<br>physicists, and dosimetrists. | It is used by radiation oncology<br>department. |
| Supported Modalities | Non-contrast CT | Segmentation Features: Non-<br>Contrast CT<br>Registration Features: CT, MRI,<br>PET |
| Image Input | Complies with DICOM standard | Complies with DICOM standard |
| Compatible Scanner<br>Models | No Limitation on scanner model<br>DICOM 3.0 compliance required. | No Limitation on scanner model<br>DICOM 3.0 compliance<br>required. |
| Localization and<br>Definition of Objects<br>(ROI) | Organ-at risk of head and neck<br>region | Organ-at-risk, including head and<br>neck, thorax, abdomen and pelvis<br>(for both male and female) |
| Compatible<br>Treatment Planning<br>System | No Limitation on TPS model,<br>DICOM compliance required. | No Limitation on TPS model,<br>DICOM 3.0 compliance required. |
| Automated<br>Workflow | EFAI HNSeg automatically<br>processes input image data and<br>sends the results as DICOM-RT<br>Structure Sets to a user-<br>configurable<br>target node. | AccuContour automatically<br>processes input image data |
| User Interface | No | Yes |

## Table - Comparison with the Predicate Device.

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Image /page/6/Picture/1 description: The image shows the logo for Ever Fortune AI. The logo consists of a stylized teal-colored figure with a circular head made of interconnected dots, resembling a network. To the right of the figure, the words "EVER" and "FORTUNE.AI" are written in a teal sans-serif font, with the word "FORTUNE.AI" appearing below "EVER" and slightly offset to the right. The logo has a clean and modern design.

The proposed device, EFAI HNSeg, is substantially equivalent to the claimed predicate, AccuContour™ (K191928).

## 7. Performance Data

Performance of the EFAI HNSeg v1.0 has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/A1:2016 - Medical device software – Software life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"(2005) and the recently published "Content of Premarket submissions for Devices Software Functions (11-04-2021), and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices. "

To establish the contour performance of EFAI HNSeg, a non-inferiority standalone performance test was performed. This non-inferiority test compared the mean Dice coefficient of the automatically generated head and neck OAR contours for EFAI HNSeg against that of the predicate device, AccuContour™. The results demonstrate that the EFAI HNSeg device was noninferior to the predicate by at least a non-inferiority limit of 0.1 Dice, which was the largest

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K220264

Image /page/7/Picture/1 description: The image shows the logo for EVER FORTUNE.AI. The logo consists of a stylized human figure in teal with a green globe on top of its head. To the right of the figure is the text "EVER" in teal, with "FORTUNE.AI" below it, also in teal. The globe on the figure's head is made up of interconnected dots, suggesting a network or global connection.

difference that is clinically acceptable based on previous studies, and thus we conclude that equivalence has been demonstrated.

## 8. Conclusion

Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics, and performance testing, the EFAI HNSeg v1.0 raises no new questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, effectiveness, and performance.