(131 days)
No
The summary describes standard image processing and visualization tools (3D visualization, 2D analysis, MPR, segmentation, implant planning) without mentioning any AI or ML capabilities. There is no mention of AI, DNN, or ML in the provided text, nor is there any description of training or test sets typically associated with ML development.
No
The device is described as software for displaying and visualizing medical images from CT/CBCT scans to assist in diagnosis and for preoperative planning of dental implants. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used "to assist in diagnosis."
Yes
The device description explicitly states "Xelis Dental 2.0, is a software device used for viewing and manipulating DICOM-compliant images". It is described as a "stand-alone, Windows-compatible software" and the testing summary focuses on software validation. There is no mention of accompanying hardware components that are part of the medical device itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: Xelis Dental 2.0 is a software application that processes and visualizes medical images (DICOM files from CT or CBCT). It assists healthcare professionals in reviewing, analyzing, and planning procedures based on these images.
- Lack of Biological Sample Analysis: The device does not interact with or analyze any biological samples from the patient. Its input is image data, not biological material.
Therefore, Xelis Dental 2.0 falls under the category of medical imaging software or a medical device software, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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, 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.
Product codes
LLZ
Device Description
Xelis Dental 2.0, is a software device used for viewing and manipulating DICOM compliant 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM medical image files from CT or CBCT
Anatomical Site
Not Found
Indicated Patient Age Range
There is no population and age restrictions for patients using this software.
Intended User / Care Setting
authorized healthcare professionals such as radiologists, clinicians, refering physicians and other qualified individuals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
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: +82-2-2194-1631 Fax: +82-2-6969-5455 Email: bigmouse@infinitt.com
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
4
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
XELIS DENTAL
2.0 | XELIS DENTAL
K102684
Predicate | If different, Impact on Safety and or
Efficacy |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Computer platform & OS
(minimum requirements) | Microsoft Windows
7/ Windows 10
(32bit & 64 bit)
Professional. IBM
compatible
Memory: 8GB or
more
Disk: 2GB free hard
disk space | Microsoft
Windows XP/Vista
or higher (32bit &
64 bit)
Professional IBM
compatible
Memory: 1GB
Disk: 200MB free
hard disk space | Difference: Computer technology
advancements since 2010 and does not
raise any new potential or increased
safety risks. Therefore, we believe there is
no impact on safety or efficacy of the
subject device. |
| Enterprise distribution of
images and data via Internet or
Intranet | Yes | Yes | No differences |
| Networking Communications
Protocol - DICOM 3.0 | Yes | Yes | No differences |
| Image Compression: | No compression or
Lossless | No compression
or Lossless | No differences |
| Standard Interfaces - Ethernet | Yes | Yes | No differences |
| Image Storage- Server & on-
board hard disk size &
compression dependent. Can
store to Short- or Long-Term
Archives | Yes | Yes | No differences |
| Multi-Planar Reformation
(MPR) - MPR into any classic
planes (axial, sagittal, coronal,
oblique planes) and curved and
free-draw planar reformation.
3D image reformation on VR,
MIP/MinIP | Yes | Yes | No differences |
| Image Layout | Yes | No | Difference: The subject device can be
configured for various user views, e.g. 1
up to 4 up including panoramic views. The
adding of these features befits User |
| Functionality | Subject Device
XELIS DENTAL
2.0 | XELIS DENTAL
K102684
Predicate | If different, Impact on Safety and or
Efficacy |
| | | | viewing and does not modify existing risks
or raise any new potential safety risks.
Therefore, we believe there is no impact
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
area. | Yes | Yes | No differences |
| Print image | Yes | Yes | No differences |
| Common tools for zoom pan,
windowing, rotate invert, VOI
(Volume of Interest), text
overlay reset all | Yes | Yes | No differences |
| Common toolbar edits (tool
show/hide) | Yes | No | Difference: The common toolbar can be
shown or hidden and also be customized
by the User. The features and functions of
the Xelis Dental2.0 are described in
labeling so the user will be aware of the
system functionality. The difference does
not raise any new or additional potential
safety risks and therefore, we believe
there is no impact on safety or efficacy for
the subject device. |
| MIP/MinIP –
maximum/minimum intensity
projection | Yes | Yes | No differences |
| Dental volume reformat
function, such as arch/curve,
drawing nerve-canal, axis and
resliced based on dental arch | Yes | Yes | No differences |
| Implant planning, which
provides simulations of implant
placement, bone-structure
analysis and location of the
mandibular canal | Yes | Yes | No differences |
| Reporting - save, DICOM send,
or print to standard Windows
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
report template and implant report
template, which is populated with
predetermined information as selected by
the User. The 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
XELIS DENTAL
2.0 | XELIS DENTAL
K102684
Predicate | If different, Impact on Safety and or
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
User to check and manage the
information of annotations drawn on the
image shown in the layout. Selecting an
item in the list moves the images to the
location where the annotation is drawn.
The 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. |
| DICOM Report Send | Yes | No | Difference: Reports can be sent as PDF
DICOM format. The 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. |
| Arch List function | Yes | No | Difference: Images can be analyzed by
making a Cross-sectional View setting the
vertical plane along the curve of the arch.
The 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. |
| Bone density color map | Yes | No | Difference: Colors can be assigned to
different bone density and viewed. The
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. |
| Canal Thickness function | Yes | No | Difference: The Nerve Drawing function is
useful when consulting patients. Xelis
Dental offers Canal Draw and Canal
Manager functions. The 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. |
| Auto Project Save function | Yes | No | Difference: Automatically save the
working state. Auto-saved items can be
viewed in the worklist and can be
configured in detail through options. The
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
XELIS DENTAL
2.0 | XELIS DENTAL
K102684
Predicate | If different, Impact on Safety and or
Efficacy |
| | | | 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. |
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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.