(94 days)
Not Found
No
The description focuses on standard image processing techniques to create 3D visualizations from 2D DICOM images and does not mention any AI or ML algorithms.
No
The device is described as image processing software intended to aid in visualization, diagnosis, and planning of endodontic treatment, but it does not directly treat or diagnose a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software is "intended to aid in the visualization, diagnosis and planning of endodontic treatment." The "Device Description" also mentions that "The user can diagnose their case."
Yes
The device description explicitly states it is "stand-alone software, with no physical component" and is "downloaded and locally installed on the end user's computer system."
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: The 3D Endo™ Software processes medical images (DICOM from CBCT) to aid in the visualization, diagnosis, and planning of endodontic treatment. It does not analyze biological samples from the patient's body.
- Intended Use: The intended use clearly states it's for "visualization, diagnosis and planning of endodontic treatment and retreatment cases utilizing DICOM images." This aligns with medical imaging software, not IVD.
- Device Description: The description focuses on image processing, creating 3D models from 2D images, and providing tools for visualization and planning. There is no mention of analyzing biological samples.
Therefore, the 3D Endo™ Software falls under the category of medical imaging software used for diagnosis and treatment planning, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
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.
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.
Mentions image processing
Yes, "The proposed 3D Endo™ Software is image processing software"
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CBCT
Anatomical Site
Tooth and surrounding tissue (specifically for endodontic treatment/root canal)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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.
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.
Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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)
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)
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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.
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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
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| 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 |
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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.
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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.
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| 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.