Xelis Dental 2.0

K193369 · Infinitt Healthcare Co., Ltd. · LLZ · Apr 14, 2020 · Radiology

Device Facts

• Record ID: K193369
• Device Name: Xelis Dental 2.0
• Applicant: Infinitt Healthcare Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Apr 14, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Xelis Dental 2.0, is a standard PC based software application used for the display and 3D visualization of DICOM medical image files from CT or CBCT. Xelis Dental 2.0, is intended to be used by authorized healthcare professionals such as radiologists, clinicians, refering physicians and other qualified individuals to retrieve, process, review, store, print, distribute images to assist in diagnosis. Xelis Dental 2.0, also provides 3D visualization, 2D analysis and various MPR (Multi-Planar Reconstruction) functions and can be used as a preoperative software application used for the planning and verification of dental implants. There is no population and age restrictions for patients using this software. Xelis Dental 2.0, is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Device Story

Xelis Dental 2.0 is a standalone, Windows-based software application for viewing and manipulating DICOM-compliant CT and CBCT images. Used in dental facilities by clinicians and radiologists, it transforms raw DICOM data into 3D volume renderings (VR), multi-planar reconstructions (MPR), and 2D analyses. Key functions include dental implant planning, mandibular canal drawing, bone density assessment, and report generation. The software assists clinicians in treatment planning and verification by providing visualization tools and quantitative measurements. It does not perform primary diagnostic interpretation of mammography. The device is used in clinical settings to replace traditional film handling, facilitating image review and distribution via network or local storage.

Clinical Evidence

No clinical data. Bench testing only. Validation testing confirmed that the software meets all predetermined acceptance criteria for input/output functions and risk management requirements.

Technological Characteristics

PC-based software; Windows 7/10 compatible. Supports DICOM 3.0 networking, Ethernet connectivity, and lossless/no-compression storage. Features 3D volume rendering, MPR, MIP/MinIP, and dental-specific segmentation. Standards: ISO 14971:2007, NEMA PS 3.1-3.20 (DICOM), IEC 62304:2006. Cybersecurity and software lifecycle processes per FDA guidance.

Indications for Use

Indicated for authorized healthcare professionals (radiologists, clinicians, referring physicians) to retrieve, process, review, store, print, and distribute DICOM CT/CBCT images for diagnostic assistance and preoperative dental implant planning/verification. No patient population or age restrictions.

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

• Xelis Dental (K102684)

Submission Summary (Full Text)

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Infinitt Healthcare Co., Ltd. % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071

April 14, 2020

### Re: K193369

Trade/Device Name: Xelis Dental 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 7, 2020 Received: March 11, 2020

Dear Mr. Alletto:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or post marketing 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

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) K193369

Device Name Xelis Dental 2.0

#### Indications for Use (Describe)

Xelis Dental 2.0, is a standard PC based software application used for the display and 3D visualization of DICOM medical image files from CT or CBCT. Xelis Dental 2.0, is intended to be used by authorized healthcare professionals such as radiologists, clinicians, refering physicians and other qualified individuals to retrieve, process, review, store, print, distribute images to assist in diagnosis. Xelis Dental 2.0, also provides 3D visualization, 2D analysis and various MPR (Multi-Planar Reconstruction) functions and can be used as a preoperative software application used for the planning and verification of dental implants. There is no population and age restrictions for patients using this software. Xelis Dental 2.0, is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|---------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/3/Picture/0 description: The image shows the logo for INFINITT Healthcare. The logo consists of a blue sphere with a white wave design on the left, followed by the word "INFINITT" in large, bold, blue letters. Below the word "INFINITT" is the word "Healthcare" in smaller, gray letters.

K193369

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

### I. SUBMITTER

Mr. Sang Wook Cho Chief Quality Officer, Research and Development Center INFINITT Healthcare Co. Ltd. 12F Daerung Post Tower III, 27 Digital-ro 34-gil, Guro-gu, Seoul, 08378, South Korea Tel: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: November 14, 2019

### II. DEVICE

Name of Device: Xelis Dental 2.0 Common or Usual Name: Picture Archiving Communications System Classification Name: system, image processing, radiological (21 CFR 892.2050) Requlatory Class: II Product Code: LLZ

### III. PREDICATE DEVICES

Primary Predicate Device: Xelis Dental, K102684, by INFINITT Healthcare Co. Ltd., CFR 892.2050, Product Code LLZ.

### IV. DEVICE DESCRIPTION

Xelis Dental 2.0, is a software device used for viewing and manipulating DICOMcompliant images from CBCT (Cone beam computed tomography). Xelis Dental 2.0 is an advanced, easy-to-use dental software providing various tools to dental facilities. Xelis Dental 2.0. provides a practical tool for 3D (three dimensional) and 2D (two dimensional) viewing to optimize dental treatment planning and placement. This stand-alone, Windows-compatible software provides 3D volume rendering (VR), multi-planar reconstruction (MPR) and image segmentation. Xelis Dental 2.0, offers dental implant planning, canal draw, bone density assessment, segmentation and report functionalities. The subject device (Xelis Dental 2.0) is based upon the predicate device, Xelis Dental, (K102684). Xelis Dental 2.0 has updated the software from the predicate to reflect current computer technology and also has a number of new/improved functions. Both the subject device and the predicate are from INFINITT Healthcare Co. Ltd.

### V. INDICATIONS FOR USE

Xelis Dental 2.0, is a standard PC based software application used for the display and 3D visualization of DICOM medical image files from CT or CBCT. Xelis Dental 2.0, is intended to be used by authorized healthcare professionals such as radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, review, store, print, distribute images to assist in diagnosis. Xelis Dental 2.0, also provides 3D visualization, 2D analysis and various MPR (Multi-Planar Reconstruction) functions and can be used as a

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Image /page/4/Picture/0 description: The image shows the logo for INFINITT Healthcare. The logo features a blue globe-like icon on the left, followed by the word "INFINITT" in bold, blue letters. Below "INFINITT" is the word "Healthcare" in a smaller, lighter font.

preoperative software application used for the planning and verification of dental implants. There is no population and age restrictions for patients using this software.

Xelis Dental 2.0, is not intended for use with or for the primary diagnostic interpretation of Mammography images.

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The subject device and primary predicate are both PACS, which are indicated for dental medical image management, review, and data distribution. Both systems have been developed to replace traditional film handling in radiology. The subject device and the predicate device are substantially equivalent in the areas of general function, application, and intended use. Any differences between the predicate and the new device has no impact on safety or efficacy of the new device and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices.

| Functionality | Subject Device<br>XELIS DENTAL<br>2.0 | XELIS DENTAL<br>K102684<br>Predicate | If different, Impact on Safety and or<br>Efficacy |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Computer platform & OS<br>(minimum requirements) | Microsoft Windows<br>7/ Windows 10<br>(32bit & 64 bit)<br>Professional. IBM<br>compatible<br>Memory: 8GB or<br>more<br>Disk: 2GB free hard<br>disk space | Microsoft<br>Windows XP/Vista<br>or higher (32bit &<br>64 bit)<br>Professional IBM<br>compatible<br>Memory: 1GB<br>Disk: 200MB free<br>hard disk space | Difference: Computer technology<br>advancements since 2010 and does not<br>raise any new potential or increased<br>safety risks. Therefore, we believe there is<br>no impact on safety or efficacy of the<br>subject device. |
| Enterprise distribution of<br>images and data via Internet or<br>Intranet | Yes | Yes | No differences |
| Networking Communications<br>Protocol - DICOM 3.0 | Yes | Yes | No differences |
| Image Compression: | No compression or<br>Lossless | No compression<br>or Lossless | No differences |
| Standard Interfaces - Ethernet | Yes | Yes | No differences |
| Image Storage- Server & on-<br>board hard disk size &<br>compression dependent. Can<br>store to Short- or Long-Term<br>Archives | Yes | Yes | No differences |
| Multi-Planar Reformation<br>(MPR) - MPR into any classic<br>planes (axial, sagittal, coronal,<br>oblique planes) and curved and<br>free-draw planar reformation.<br>3D image reformation on VR,<br>MIP/MinIP | Yes | Yes | No differences |
| Image Layout | Yes | No | Difference: The subject device can be<br>configured for various user views, e.g. 1<br>up to 4 up including panoramic views. The<br>adding of these features befits User |
| Functionality | Subject Device<br>XELIS DENTAL<br>2.0 | XELIS DENTAL<br>K102684<br>Predicate | If different, Impact on Safety and or<br>Efficacy |
| | | | viewing and does not modify existing risks<br>or raise any new potential safety risks.<br>Therefore, we believe there is no impact<br>on safety or efficacy of the subject device. |
| Draw lines or arrows | Yes | Yes | No differences |
| Write text | Yes | Yes | No differences |
| Measure distance, angle and<br>area. | Yes | Yes | No differences |
| Print image | Yes | Yes | No differences |
| Common tools for zoom pan,<br>windowing, rotate invert, VOI<br>(Volume of Interest), text<br>overlay reset all | Yes | Yes | No differences |
| Common toolbar edits (tool<br>show/hide) | Yes | No | Difference: The common toolbar can be<br>shown or hidden and also be customized<br>by the User. The features and functions of<br>the Xelis Dental2.0 are described in<br>labeling so the user will be aware of the<br>system functionality. The difference does<br>not raise any new or additional potential<br>safety risks and therefore, we believe<br>there is no impact on safety or efficacy for<br>the subject device. |
| MIP/MinIP –<br>maximum/minimum intensity<br>projection | Yes | Yes | No differences |
| Dental volume reformat<br>function, such as arch/curve,<br>drawing nerve-canal, axis and<br>resliced based on dental arch | Yes | Yes | No differences |
| Implant planning, which<br>provides simulations of implant<br>placement, bone-structure<br>analysis and location of the<br>mandibular canal | Yes | Yes | No differences |
| Reporting - save, DICOM send,<br>or print to standard Windows<br>printers | Yes | Yes | No differences |
| Real size printing | Yes | Yes | No differences |
| Report PDF export | Yes | Yes | No differences |
| Template based report | Yes | Yes | No differences |
| Implant report | Yes | No | Difference: The User can define a default<br>report template and implant report<br>template, which is populated with<br>predetermined information as selected by<br>the User. The feature is described in<br>labeling so the user will be aware of the<br>system functionality. The difference does<br>not raise any new or potential safety risks<br>and therefore, we believe there is no<br>impact on safety or efficacy for the subject<br>device. |
| Functionality | Subject Device<br>XELIS DENTAL<br>2.0 | XELIS DENTAL<br>K102684<br>Predicate | If different, Impact on Safety and or<br>Efficacy |
| CD/DVD/USB-burning | Yes | Yes | No differences |
| Project save | Yes | Yes | No differences |
| Annotation List function | Yes | No | Difference: This feature will enable the<br>User to check and manage the<br>information of annotations drawn on the<br>image shown in the layout. Selecting an<br>item in the list moves the images to the<br>location where the annotation is drawn.<br>The feature is described in labeling so the<br>user will be aware of the system<br>functionality. The difference does not<br>raise any new or potential safety risks and<br>therefore, we believe there is no impact<br>on safety or efficacy for the subject<br>device. |
| DICOM Report Send | Yes | No | Difference: Reports can be sent as PDF<br>DICOM format. The feature is described<br>in labeling so the user will be aware of the<br>system functionality. The difference does<br>not raise any new or potential safety risks and<br>therefore, we believe there is no<br>impact on safety or efficacy for the subject<br>device. |
| Arch List function | Yes | No | Difference: Images can be analyzed by<br>making a Cross-sectional View setting the<br>vertical plane along the curve of the arch.<br>The feature is described in labeling so the<br>user will be aware of the system<br>functionality. The difference does not<br>raise any new or potential safety risks and<br>therefore, we believe there is no impact<br>on safety or efficacy for the subject<br>device. |
| Bone density color map | Yes | No | Difference: Colors can be assigned to<br>different bone density and viewed. The<br>feature is described in labeling so the user<br>will be aware of the system functionality.<br>The difference does not raise any new or<br>potential safety risks and therefore, we<br>believe there is no impact on safety or<br>efficacy for the subject device. |
| Canal Thickness function | Yes | No | Difference: The Nerve Drawing function is<br>useful when consulting patients. Xelis<br>Dental offers Canal Draw and Canal<br>Manager functions. The feature is<br>described in labeling so the user will be<br>aware of the system functionality. The<br>difference does not raise any new or<br>potential safety risks and therefore, we<br>believe there is no impact on safety or<br>efficacy for the subject device. |
| Auto Project Save function | Yes | No | Difference: Automatically save the<br>working state. Auto-saved items can be<br>viewed in the worklist and can be<br>configured in detail through options. The<br>feature is described in labeling so the user will be aware of the system functionality. The difference does not raise any new or potential safety risks and therefore, we believe there is no impact on safety or efficacy for the subject device. |
| Functionality | Subject Device<br>XELIS DENTAL<br>2.0 | XELIS DENTAL<br>K102684<br>Predicate | If different, Impact on Safety and or<br>Efficacy |
| | | | will be aware of the system functionality.<br>The difference does not raise any new or<br>potential safety risks and therefore, we<br>believe there is no impact on safety or<br>efficacy for the subject device. |

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Image /page/5/Picture/0 description: The image is a logo for INFINITT Healthcare. The logo consists of a blue circular graphic on the left and the word "INFINITT" in large, bold, blue letters on the right. Below the word "INFINITT" is the word "Healthcare" in smaller, gray letters. The circular graphic appears to be a stylized representation of a globe or sphere with a curved line running through it.

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Image /page/6/Picture/0 description: The image shows the logo for INFINITT Healthcare. The logo consists of a blue sphere with a wave-like design on the left, followed by the word "INFINITT" in large, bold, blue letters. Below "INFINITT" is the word "Healthcare" in smaller, lighter blue letters.

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Image /page/7/Picture/0 description: The image shows the logo for INFINITT Healthcare. The logo consists of a blue circular graphic on the left, followed by the word "INFINITT" in large, bold, blue letters. Below the word "INFINITT" is the word "Healthcare" in smaller, lighter blue letters. The logo is simple and professional, and the blue color scheme gives it a sense of trust and reliability.

### VII. PERFORMANCE DATA

### Nonclinical Testing:

The Xelis Dental 2.0. PACS has been assessed and tested at the factory and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate input functions, output functions, and actions performed by Xelis Dental 2.0, and followed the process documented in the Validation Test Plan.

Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.

### Summary:

Based on the performance as documented in the Validation Testing. Xelis Dental 2.0, was found to have a safe and effectiveness profile that is similar to the predicate device.

The following Standards were used to develop Xelis Dental 2.0, and the device has met all the requirements listed in the Standards except for inapplicable requirements:

- . ISO14971:2007/(R)2010 (Corrected 4 October 2007), Medical devices -Applications of risk management to medical devices, FDA FR Recognition # 5-40.
- . NEMA PS 3.1 - 3.20 (2016, Digital Imaging and Communications in Medicine (DICOM) Set, FDA FR Recognition # 12-300.
- IEC 62304:2006, Medical device software - Software life cycle processes, FDA FR Recognition # 13-32.
- . FDA Guidance on Cyber Security: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Document Issued on: October 2, 2014
- . FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005

### VIII. CONCLUSIONS

The 510(k) Pre-Market Notification for Xelis Dental 2.0, contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The new device and predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise

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Image /page/8/Picture/0 description: The image shows the logo for INFINITT Healthcare. The logo consists of a blue circular graphic on the left, followed by the word "INFINITT" in large, bold, blue letters. Below "INFINITT" is the word "Healthcare" in a smaller font, also in blue. The logo is clean and professional, suggesting a company in the healthcare industry.

any new potential safety risks and is equivalent in performance to existing legally marketed devices.

Nonclinical tests demonstrate that the device is as safe, as effective, and performs comparably to the predicate devices.