← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K171115 # 3D Endo Software (K171115) _Dentsply Sirona · LLZ · Jul 17, 2017 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K171115 ## Device Facts - **Applicant:** Dentsply Sirona - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Jul 17, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## Indications for Use 3D Endo™ Software is intended to aid in the visualization, diagnosis and planning of endodontic treatment and retreatment cases utilizing DICOM images. ## Device Story 3D Endo Software is a standalone desktop application for endodontic pre-operative planning. It imports DICOM images from CBCT scanners; processes multiple 2D images into a virtual 3D volume. Clinicians use a wizard-driven interface to isolate teeth, visualize soft/osseous tissue, examine canal anatomy, and simulate endodontic file placement. Output includes 3D visualizations, measurements (distance, angle, diameter), and simulated X-ray/panoramic views. The software supports treatment planning by allowing practitioners to assess root canal structures and select appropriate files. It does not control CBCT hardware or communicate patient data over the internet; projects are saved locally as encrypted files or PDF reports. The device benefits patients by enabling precise pre-operative assessment and planning for root canal procedures. ## Clinical Evidence No clinical data included. Substantial equivalence supported by non-clinical bench testing, including software unit, integration, functional, and regression testing performed in accordance with IEC 62304. Usability testing conducted per IEC 62366-1 and FDA human factors guidance showed no new or unexpected use errors. ## Technological Characteristics Standalone desktop software; Windows OS; processes DICOM images from CBCT scanners. Features volume rendering, 3D/2D visualization, and measurement tools. Software lifecycle follows IEC 62304. No physical components; no patient-contacting materials. ## Regulatory 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 - SimPlant 2011 ([K110300](/device/K110300.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 17, 2017 Dentsply Sirona % Mr. Karl Nittinger Senior Manager, Corporate Regulatory Affairs 221 West Philadelphia Street. Suite 60W YORK PA 17401 Re: K171115 Trade/Device Name: 3D Endo" Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 26, 2017 Received: June 27, 2017 Dear Mr. Nittinger: 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Michael D. O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K171115 Device Name 3D EndoTM Software Indications for Use (Describe) 3D Endo™ Software is intended to aid in the visualization, diagnosis and planning of endodontic treatment and retreatment cases utilizing DICOM 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." 39 {3}------------------------------------------------ Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 # SECTION 5. 510(k) SUMMARY for 3D Endo™ Software ### Submitter Information: 5.1 DENTSPLY Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 | Contact Person: | Karl Nittinger | |-------------------|----------------| | Telephone Number: | 717 849 4424 | | Fax Number: | 717-849-4343 | | Date Prepared: | April 13, 2017 | #### 5.2 Device Name: 3D Endo™ Software | Proprietary Name: | 3D Endo™ Software | |----------------------|---------------------------------------------| | Classification Name: | Picture archiving and communications system | | CFR Number: | 892.2050 | | Device Class: | II | | Product Code: | LLZ | ### 5.3 Predicate Device: | Table 5.0 Predicate Device Information | | | | |----------------------------------------|---------------|-------------------|--| | Predicate Device Name | 510(k) number | Company Name | | | SimPlant 2011 | K110300 | Dentsply Implants | | ### 5.4 Description of Device: The proposed 3D Endo™ Software is image processing software for simulating 3D images using Digital Imaging and Communication in Medicine (DICOM) images of the respective tooth and the surrounding tissue. The DICOM images used by the proposed 3D Endo™ Software are imported from those generated by Cone Beam Computed Tomography (CBCT) scanners. The proposed 3D Endo™ Software has no direct control or interface with the CBCT Scanner. This imaging is used to provide a means for pre-operative planning for endodontic root canal procedures. The proposed 3D Endo™ Software is stand-alone software, with no physical component. It is downloaded and locally installed on the end user's computer system, and updated automatically as required through an active internet connection. {4}------------------------------------------------ The proposed 3D Endo™ Software allows a user to create a 3D image from DICOM images using a 5 step process. The user can diagnose their case, visually isolate the tooth of interest and surrounding soft and osseous tissue, investigate the canal system, understand the 3D canal anatomy, and create a treatment plan by following the steps laid out in the software's wizard. The proposed 3D Endo™ Software functions by processing 2D images received in DICOM format from a CBCT scanning device, and processing multiple images into a virtual 3D image. The user can measure, assess, and visualize the anatomy of the root canal structure, both with and without simulated instruments, allowing the practitioner to plan the endodontic procedure. While the proposed 3D Endo™ Software is classified as a picture archiving and communication system, the system does not communicate patient data such as DICOM images through the internet. The proposed 3D Endo™ Software functions by accessing DICOM images either stored locally on the system hard drive by the user, or by accessing DICOM images stored on media (e.g. CD/DVD, USB drive) attached to the local system on which proposed 3D Endo™ Software is installed. By default, the proposed 3D Endo™ Software does not export and store any patient data to the local hard drive. Upon explicit action by the user, an encrypted project file may be saved or a PDF report can be generated. The proposed 3D Endo™ Software provides an extra function to anonymize the dataset. - ર : ર Indications for Use: 3D Endo™ Software is intended to aid in the visualization, diagnosis and planning of endodontic treatment and re-treatment cases utilizing DICOM images. - 5.6 Substantial Equivalence {5}------------------------------------------------ | Table 5.1 Comparison between 3D Endo™ Software and SimPlant 2011(K110300) | | | | | |---------------------------------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | No | Feature | Proposed Device
3D Endo™ Software | Predicate Device
SimPlant 2011(K110300) | Similarities/Differences | | 1 | Indications for Use | 3D Endo™ Software is intended to aid in the visualization, diagnosis and planning of endodontic treatment and re-treatment cases utilizing DICOM images. | SimPlant 2011 is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is also intended as pre-planning software for dental implant placement and surgical treatment. | The proposed 3D Endo™ Software utilizes DICOM images from CBCT only.
The proposed 3D Endo™ Software is intended specifically for endodontic treatment and re-treatment cases (root canal). | | 2 | Intended use | Software for use in endodontic (root canal) pre-operative planning:
• The proposed 3D Endo™ Software Provides a means for transferring DICOM patient images from a CBCT scanner to an output file
• The proposed 3D Endo™ Software is used to provide a means for advanced pre-operative planning of endodontic treatment, including root canal visualization and endodontic files selection support
The proposed 3D Endo™ Software is used to provide a means for DICOM Image Visualization | Software for use in implants pre-operative planning:
• SimPlant 2011 Provides a means for transferring patient images from a medical scanner to an output file
• SimPlant 2011 is used to provide a means for advanced pre-operative planning of dental implant placements and orthognathic treatment
• SimPlant 2011 is used to provide a means for image segmentation
Surgical templates may be designed and fabricated based on the output of the pre-operative planning | The proposed 3D Endo™ Software utilizes DICOM images from CBCT only.
The proposed 3D Endo™ Software is intended specifically for endodontic treatment and re-treatment cases (root canal). | | 3 | Image Modality | CBCT | MRI, CT, CBCT | The proposed 3D Endo™ Software utilizes only CBCT scanning data | | 4 | Input File Type | DICOM | DICOM | No differences | | 5 | Optional output files | PDF report Proprietary project file | Proprietary project file | No differences | | Table 5.1 Comparison between 3D Endo™ Software and SimPlant 2011(K110300) | | | | | | No | Feature | Proposed Device
3D Endo™ Software | Predicate Device
SimPlant 2011(K110300) | Similarities/Differences | | 6 | Used for Pre-
operative
Planning | Yes | Yes | No differences | | 7 | Operating
System | Windows | Windows | No differences | | 8 | Principles of
operation | Desktop software application | Desktop software application | No differences | | 9 | Functions | Volume Rendering with tooth/bone
emphasizing transfer functions
Volume Rendering | Volume Rendering with tooth/bone
emphasizing transfer functions
Segmentation Wizard | No differences
The proposed 3D Endo™ Software utilizes Volume
Rendering, a less complex
methodology suited to the
endodontic requirements of the
software | | | | Reslice the volume data along a predefined
path for view of the tooth axis or a single
root canal midline (Intra-Root view)* | Reorient axial images to occlusal plane | No differences | | | | Open project | Open project | No differences | | | | Save project | Save project | No differences | | | | 3D viewing | 3D viewing | No differences | | | | 2D gray value images | 2D gray value images | No differences | | | | Tooth geometry and anatomy presentation | Geometry presentation | No differences | | | | Measurements (distance, angle, diameter)** | Measurements | No differences | | | | Review the endodontic files | Review implants | No differences | | | | Edit the endodontic files | Edit implants | No differences | | | | Change the endodontic files | Change implant | No differences | | | | Not Applicable | Collision detection | Dissimilar | | | | Simulated panoramic / X-ray view | Simulated panoramic / X-ray view | No differences | | Table 5.1 Comparison between 3D Endo™ Software and SimPlant 2011(K110300) | | | | | | No | Feature | Proposed Device
3D Endo™ Software | Predicate Device
SimPlant 2011(K110300) | Similarities/Differences | | | Semi-Automatic canal midline finding | | Not applicable | Specific to proposed 3D Endo™ Software | | | Endodontic files deformation along the indicated canal midline | | Not applicable | Specific to proposed 3D Endo™ Software | | | Access cavity curve simulation | | Not applicable | Specific to proposed 3D Endo™ Software | | | Endodontic files visualization | | Not applicable | Specific to proposed 3D Endo™ Software | {6}------------------------------------------------ {7}------------------------------------------------ Once the tooth axis is manually defined (cropping) or the canal midline is manually indicated, the resliced views are automatically generated. * ** These are free measurements able to define a number of functing working length, tooth size, and other procedurally important definitions. {8}------------------------------------------------ 5.7 Analysis of differences between Proposed and Predicate Devices: The proposed 3D Endo™ Software is similar to predicate SimPlant 2011 (K110300) in basic technology; since both devices processes the DICOM (Digital Imaging and Communication in Medicine) images received from CBCT (Cone Beam Computed Tomography) scanners to create 3D images of tooth and surrounding tissue anatomy. Both devices utilizes same image format (DICOM image files) from same image source (CBCT scanner). The proposed 3D Endo™ Software and SimPlant 2011 (K110300) are intended to aid in planning for dental Endodontic treatment procedure using 3D images. Both devices are desktop software applications running on windows operating system with similar software features such as taking measurements, simulated panoramic/X-ray view, tooth geometry presentation, 2D gray value images, open and save projects. The dissimilar aspects of the proposed 3D Endo™ Software as compared to the SimPlant 2011 (K110300) software are related to the variant uses of the two software packages. The predicate SimPlant 2011 (K110300) software is intended to be used as a pre-planning software for dental implant placement and surgical treatment, and the proposed 3D Endo™ Software is intended for use in the visualization, diagnosis and planning of endodontic treatment and re-treatment cases. The proposed 3D Endo™ Software is used to provide a means for advanced root canal visualization and endodontic files selection support hence functionalities related to the visualization of soft and osseous tissue, virtual occludation, and surgical guidance are not required to fulfill the intended usage of the proposed 3D Endo™ Software as compared to SimPlant 2011 (K110300) functionalities. Because 3D Endo™ Software is used to provide a means for advanced root canal visualization and endodontic files selection, the proposed 3D Endo™ Software utilizes Volume Rendering in its functionality as opposed to the more complex segmentation used by SimPlant 2011 (K110300). These dissimilarities are therefore only related to specific variations of the uses of the imaging software, and do not relate to the fundamental technology or similarities in the intended uses of the two devices. Dentsply believes that segmentation differences do not create any new questions about safety, effectiveness and substantial equivalence as evidence by software verification and validation provided in this submission. # 5.8 Non-Clinical Performance Data: The proposed 3D Endo™ Software is a software device with no physical component. It does not incorporate, nor does it control a patient contacting device or material. Therefore, no biocompatibility, sterilization, shelf life, animal, or clinical testing was included to support substantial equivalence. The performance of proposed 3D Endo™ Software satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence. Software verification and validation was conducted in accordance with the software life cycle processes, as defined in IEC 62304 to ensure the functionality and compatibility of all system components and to support the substantial equivalence of the proposed 3D EndoTM Software. Test data has been provided including: software unit testing, software integration/functional testing, and regression testing in software section. Software testing demonstrated compliance with the requirements of the IEC 62304 standard. In addition to the software validation and verification testing, the following testing was performed on proposed 3D Endo™ Software and was included to support substantial equivalence. {9}------------------------------------------------ | Table 5.2 Performance Test for 3D Endo™ Software | | | | |--------------------------------------------------|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | No | Test | Objective | Results | | 1 | Usability
Test | Usability testing was conducted as per
IEC 62366-1:2015: Medical devices-Part
1: Application of usability engineering to
medical devices and as per FDA guidance
Applying Human Factors and
Usability Engineering to Medical
Devices to determine ease of use, and
potential human usage errors utilizing the
standard System Usability Scale (SUS), as
well as providing evidence that the
software meets user needs and intended
use. | There were no results
demonstrating the
presence of new or
unexpected use errors
which present a serious
residual use-related risk
to the user or patient. | # 5.9 Clinical Performance Data No human clinical data is included in this premarket notification to support substantial equivalence. ## 5.10 Conclusion Regarding Substantial Equivalence: The proposed 3D Endo™ Software is DICOM image visualization software which is intended to aid in the visualization, diagnosis and planning of endodontic treatment and re-treatment cases using DICOM images received from a CBCT Scanner. The proposed 3D Endo™ Software has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicate SimPlant 2011 software cleared under premarket notification K110300. Test data to verify the performance of the proposed 3D Endo™ Software has been provided including: software unit testing, software integration/functional testing, and regression testing. The results of this testing, combined with the design and intended use comparison with the predicate device, support substantial equivalence. --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K171115](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K171115) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com