(135 days)
No
The document describes standard image processing, measurement, and simulation tools for dental implant planning. There is no mention of AI or ML algorithms being used for any of the described functions.
No.
The "Intended Use / Indications for Use" section clearly states that the device is a "software tool intended for use by dental professionals." It is used for "pre-operative simulation," "planning," and "designing" surgical guides, not for directly treating a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the software is used for "pre-operative simulation of patient anatomy, dental implant placement, surgical instrument positioning, and surgical treatment options." Additionally, the "Device Description" explicitly states, "NemoScan is a comprehensive diagnosis and treatment planning software for dental implantology." These functions are related to identifying or analyzing health conditions or planning treatment.
Yes
The device description explicitly states that NemoScan is a "software tool" and "software" provided in desktop, cloud, and web configurations. While it interacts with imaging data and facilitates the design of physical surgical guides, the device itself is the software application. The manufacturing of the surgical guide is described as a separate process using CAM equipment and materials, which are not part of the NemoScan device itself.
Based on the provided information, NemoScan is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- NemoScan's Intended Use: NemoScan is a software tool used for planning and simulating dental implant procedures based on medical imaging data (CBCT/CT scans and optical scans). It helps dental professionals visualize anatomy, plan implant placement, design surgical guides, and evaluate treatment options.
- Lack of Specimen Examination: NemoScan does not examine any specimens derived from the human body (like blood, tissue, etc.) in a laboratory setting. Its input is imaging data, not biological samples.
- Focus on Planning and Guidance: The primary function of NemoScan is to aid in the planning and execution of surgical procedures, not to diagnose a disease or condition based on the analysis of biological specimens.
While NemoScan uses medical imaging data for diagnostic purposes (e.g., assessing bone density, identifying nerves), its core function is surgical planning and guide design, which falls outside the scope of an IVD device.
N/A
Intended Use / Indications for Use
NemoScan is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in the field of application. The software reads imaging information output from medical scamers such as CBCT or CT scanners.
It is indicated for pre-operative simulation of patient anatomy, dental implant placement, surgical instrument positioning, and surgical treatment options, in edentulous or dentition situations, which may require a surgical guide. It is further indicated for the user to design such guides for, alone or in combination, the guiding of a surgical path along a trajectory or a profile, or to help evaluate a surgical preparation or step.
NemoScan software allows for surgical guide export to a validated manufacturing center or to the point of care.
Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable). A surgical guide may require to be used with accessories.
NemoScan is intended to be used only for Adolescents (12-21 years of age) to adults (>21 years of age) patients.
Product codes (comma separated list FDA assigned to the subject device)
QIH
Device Description
NemoScan is a comprehensive diagnosis and treatment planning software for dental implantology intended to be used by dental professionals who have appropriate knowledge in surgical implantology and dental implants prosthesis. The software works with volume data sets imported from DICOM format produced by third-party CT/CBCT scanners and stored in a filedata repository. Additionally, optical scans of dental impressions can be imported from standard file formats like STL or PLY and registered over the volume to get reliable high definition of the anatomy of teeth and gums of the patients. The software is provided in three configurations: desktop, cloud and web.
Surgical planning is performed through convenient layouts of views, analysis of image data and the placement of virtual dental implants and optionally virtual prosthetic teeth. One patient file may contain multiple surgical plan proposals which allow the user to choose the ideal surgical plan.
Additional functions are available to the user for refinement of the surgical planning, such as:
-
Import, organize, store images from CT or CBCT in DICOM format ● (optionally if the case has these images, called Volume Images).
-
Import digital impressions of the teeth (scanned stone models and intraoral scanner) and/or implant files in STL or PLY format, and align them over the volume image (if exists).
-
Import facial scanner or 3D photos in OBJ or PLY format. ●
-
. Measurements of distances and angles in 2D, for slices, and 3D, for 3D views.
-
Merge the dental digital impressions into the CT/CBCT patient volume. ●
-
Do Orientation of the Volume according to the Natural Head Position of the patient (Reorient the 3D volume).
-
Patient gums, teeth, bones, mandibular nerves and sinus segmentation to help the planner in viewing those anatomical conditions in 3D and their corresponding cross sections in the 2D slices.
-
Possibility of simulation of teeth extractions for immediate implants ● placement.
-
Specific layouts of views with the selected implant centered to ● accurately positioning the virtual implant according to the anatomical volume conditions.
-
Bone densitometry with a density statistic for density measuring in the ● area around a distance outside and inside the limits of the positioned implant.
-
Real time distances and angles to sensible areas like other implants, . nerves, patient teeth, sinus, etc.
-
Possibility of adding prosthetic teeth for designing the immediate loading ● prosthesis or just for helping in orienting the implants according to the prosthetic conditions.
NemoScan works with many manufacturers of implants, abutments, drills, analog, sleeves, hand pieces, etc., libraries to be used for simulation and treatment planning. The software allows importing these libraries and designing different kinds of surgical guides and immediate loading prosthesis to export the designed file in STL format. Finally, these designed files will be used to a validated manufacturing center or to the point of care.
The device has no patient contact nor does it control any life-sustaining devices.
Warning: Anatomical segmented structures cannot be used as sole information for the clinician to make clinical decisions.
3D manufacturing is out of NemoScan software control, depends on many external factors and lies within the sole responsibility of the user.
Warning: The guide must be fabricated based on the FDA cleared or legally marketed 3D printing fabrication method. The STL is to be exported to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CBCT or CT scanners
Anatomical Site
Oral-maxillofacial regions
Indicated Patient Age Range
Adolescents (12-21 years of age) to adults (>21 years of age)
Intended User / Care Setting
Dental professionals / At a validated manufacturing center or to the point of care.
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)
Non Clinical Performance Data:
Process performance qualifications of the manufacturing process are conducted to assure a guide of a certain material can safely and effectively be manufactured. Worst case testing of representative guide designs is utilized. Expected results are met. This process performance qualifications includes centralized manufacturing and point of care procedures. The validated materials and manufacturing processes are safe and effective for their intended use.
Performance Testing:
The subject device NemoScan includes a performance testing report which justify the types of performance testing applicable to software as a medical device.
Risk Assessment:
A risk assessment has been performed based on FDA quidance, "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Aug 2017" with supporting peer-reviewed clinical literature to demonstrate the safety and effectiveness of the subject device for use of the new guides.
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.
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
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.
January 18, 2024
Software Nemotec S.L. % Kevin Walls Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane LITTLETON, CO 80127
Re: K232698
Trade/Device Name: NemoScan Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: September 1, 2023 Received: September 5, 2023
Dear Kevin Walls:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232698
Device Name
NemoScan
Indications for Use (Describe)
NemoScan is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in the field of application. The software reads imaging information output from medical scamers such as CBCT or CT scanners.
It is indicated for pre-operative simulation of patient anatomy, dental implant placement, surgical instrument positioning, and surgical treatment options, in edentulous or dentition situations, which may require a surgical guide. It is further indicated for the user to design such guides for, alone or in combination, the guiding of a surgical path along a trajectory or a profile, or to help evaluate a surgical preparation or step.
NemoScan software allows for surgical guide export to a validated manufacturing center or to the point of care.
Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable). A surgical guide may require to be used with accessories.
NemoScan is intended to be used only for Adolescents (12-21 years of age) to adults (>21 years of age) patients.
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."
3
510(k) Summary
Premarket Notification Number K232698
Date of Summary: 01/16/2024
Substantial equivalence is claimed to the following devices:
Subject Device
Trade Name: NemoScan Common Name: System, Image Processing, Radiological Device Class: Class II Product Code: QIH Regulation Number: 21 CFR 892.2050 Classification Name: Medical image management and processing system
Predicate Device
Trade Name: coDiagnostiX Implant Planning Software (K130724) Common Name: System, Image Processing, Radiological Product Code: LLZ Device Class: Class II Regulation Number: 21 CFR 892.2050 Classification Name: Medical imaqe management and processing system
Reference Device
Trade Name: NemoScan (K192571) Common Name: System, Image Processing, Radiological Device Class: Class II Product Code: LLZ Regulation Number: 21 CFR 892.2050 Classification Name: Medical image management and processing system
Name and Address of the Applicant/Sponsor
Software Nemotec S.L. Av. Juan Caramuel, 1 28919 Leganés, Madrid, Spain
Contact person: Kevin Walls Telephone: 1-720-962-5412 Email: kevin@reginsight.com
Indications for use
NemoScan is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in the field of application. The software reads imaging information output from medical scanners such as CBCT or CT scanners.
It is indicated for pre-operative simulation and evaluation of patient anatomy, dental implant placement, surgical instrument positioning, and surgical
4
treatment options, in edentulous, partial edentulous or dentition situations, which may require a surgical guide. It is further indicated for the user to design such guides for, alone or in combination, the guiding of a surgical path along a trajectory or a profile, or to help evaluate a surgical preparation or step.
NemoScan software allows for surgical guide export to a validated manufacturing center or to the point of care.
Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable). A surgical guide may require to be used with accessories.
NemoScan is intended to be used only for Adolescents (12-21 years of age) to adults (>21 years of age) patients.
Device Description
NemoScan is a comprehensive diagnosis and treatment planning software for dental implantology intended to be used by dental professionals who have appropriate knowledge in surgical implantology and dental implants prosthesis. The software works with volume data sets imported from DICOM format produced by third-party CT/CBCT scanners and stored in a filedata repository. Additionally, optical scans of dental impressions can be imported from standard file formats like STL or PLY and registered over the volume to get reliable high definition of the anatomy of teeth and gums of the patients. The software is provided in three configurations: desktop, cloud and web.
Surgical planning is performed through convenient layouts of views, analysis of image data and the placement of virtual dental implants and optionally virtual prosthetic teeth. One patient file may contain multiple surgical plan proposals which allow the user to choose the ideal surgical plan.
Additional functions are available to the user for refinement of the surgical planning, such as:
- Import, organize, store images from CT or CBCT in DICOM format ● (optionally if the case has these images, called Volume Images).
- Import digital impressions of the teeth (scanned stone models and intraoral scanner) and/or implant files in STL or PLY format, and align them over the volume image (if exists).
- Import facial scanner or 3D photos in OBJ or PLY format. ●
- . Measurements of distances and angles in 2D, for slices, and 3D, for 3D views.
- Merge the dental digital impressions into the CT/CBCT patient volume. ●
- Do Orientation of the Volume according to the Natural Head Position of the patient (Reorient the 3D volume).
- Patient gums, teeth, bones, mandibular nerves and sinus segmentation to help the planner in viewing those anatomical conditions in 3D and their corresponding cross sections in the 2D slices.
- Possibility of simulation of teeth extractions for immediate implants ● placement.
- Specific layouts of views with the selected implant centered to ● accurately positioning the virtual implant according to the anatomical volume conditions.
- Bone densitometry with a density statistic for density measuring in the ● area around a distance outside and inside the limits of the positioned
5
implant.
- Real time distances and angles to sensible areas like other implants, . nerves, patient teeth, sinus, etc.
- Possibility of adding prosthetic teeth for designing the immediate loading ● prosthesis or just for helping in orienting the implants according to the prosthetic conditions.
NemoScan works with many manufacturers of implants, abutments, drills, analog, sleeves, hand pieces, etc., libraries to be used for simulation and treatment planning. The software allows importing these libraries and designing different kinds of surgical guides and immediate loading prosthesis to export the designed file in STL format. Finally, these designed files will be used to a validated manufacturing center or to the point of care.
The device has no patient contact nor does it control any life-sustaining devices.
Warning: Anatomical segmented structures cannot be used as sole information for the clinician to make clinical decisions.
3D manufacturing is out of NemoScan software control, depends on many external factors and lies within the sole responsibility of the user.
Warning: The guide must be fabricated based on the FDA cleared or legally marketed 3D printing fabrication method. The STL is to be exported to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable).
Substantial Equivalence Determination
The general intended use is identical for both the subject device and primary predicate device.
As to the indications for use, the subject device specifies the indicated patient conditions: for use in edentulous, partial edentulous, and dentition conditions. However, this is already included in the labeling of the primary predicate (K130724).
The purpose of this submission is also to expand the functionalities from desktop application to web application.
Similarities to Predicate
The subject and predicate devices are intended for supporting the pre-operative digital implant planning and design surgical guide files. They share the same fundamental principles of operation - Software is used to convert individual patient CT scans to digital models for subsequent implant planning.
The subject and predicate devices utilize image data obtained from a CT scan, which is input into validated commercially off-the-shelf (COTS) software applications to transfer patient imaging from DICOM to. STL format and manipulate the images to design a final guide file.
Both systems utilize implants, anatomical models, guides, pins, analog and abutments to design guide files. In addition, the systems design digital models and generate PDF case reports for the doctors to use for planning of implantology surgeries or to use during surgery.
6
The predicate device (K130724) and the subject device NemoScan includes Tooth-supported, Gingiva-supported and Bone-supported surgical guide design possibilities. Also, both systems have options to add a label to identify the surqical quide.
Differences to Predicate
The subject device differs from the predicate mainly in that the subject device is able to add prosthetic design data using the prosthesis wizard of the reference device. coDiagnostiX is able to connect to DWOS to access the wizard prosthesis.
coDiagnostiX uses DWOS Synergy interface to communicate with Dental Wings DWOS. It makes prosthetic design data available in coDiagnostiX and, in turn, sends planning. Also, DWOS Synergy interface would be used for mesh transformation.
The alternate workflow involving the printouts and manufacturing method using the manually operated gonyX is not included in the subject device.
Finally, the target population of the subject device is adolescents (12-21 years of age) to adults (>21 years of age), which is a subgroup of the general public of the predicate device.
Reference Devices
NemoScan (K192571) has been included as a reference device because it included all the immediate loading prosthesis features, mesh transformation, photo mapping and import 3D photograph.
Align 3D with Photos is the same functionality presented on the last NemoScan K192571 submission with the name Photo Mapping. Import 3D Photos (OBJ) is the same functionality presented on the last NemoScan K192571 submission with the name Import 3D Photograph. These functionalities have no medical purpose; they are used only for visualization.
Performance Testing
Although NemoScan (K192571) did not include exhaustive performance testing, the points Sterilization and Shelf Life, Biocompatibility, EMC and Electrical Safety are not applicable.
NemoScan (K192571) included Labeling and verification and validation testing Report.
The subject device NemoScan includes a performance testing report which justify the types of performance testing applicable to software as a medical device.
A risk assessment has been performed based on FDA quidance, "Use of RealWorld Evidence to Support Regulatory Decision-Making for Medical Devices, Aug 2017" with supporting peer-reviewed clinical literature to demonstrate the safety and effectiveness of the subject device for use of the new guides.
7
Non Clinical Performance Data
Process performance qualifications of the manufacturing process are conducted to assure a guide of a certain material can safely and effectively be manufactured. Worst case testing of representative guide designs is utilized. Expected results are met. This process performance qualifications includes centralized manufacturing and point of care procedures. The validated materials and manufacturing processes are safe and effective for their intended use.
Comparison of Technological Characteristics
The subject and predicate device are software based planning tools which allow for transfer of medical images, and design of 3D guides.
A comparison of the subject, reference device and predicate devices are provided in the table below.
8
A device comparison table of the subject, predicate, and reference devices is provided below:
| Feature | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE | |
|---|---|---|---|---|
| Indications for | ||||
| Use Statement | NemoScan | coDiagnostiX, | ||
| Implant Planning Software (K130724) | NemoScan, Software Nemotec | |||
| S.L, (K192571) | ||||
| NemoScan is an implant planning | ||||
| and surgery planning software tool | ||||
| intended for use by dental | ||||
| professionals who have appropriate | ||||
| knowledge in the field of application. | CoDiagnostiX is an implant planning and | |||
| surgery planning software tool intended | ||||
| for use by dental professionals who have | ||||
| appropriate knowledge in dental | ||||
| implantology and surgical dentistry. | NemoScan is a software indicated | |||
| for supporting the diagnostic and | ||||
| treatment planning of dental | ||||
| implants. NemoScan is software | ||||
| that is also used as an image | ||||
| segmentation system and for the | ||||
| transfer of imaging information | ||||
| from a scanner such as a CT | ||||
| scanner. | ||||
| The software reads imaging | ||||
| information output from medical | ||||
| scanners such as CBCT or CT | ||||
| scanners. | This software reads imaging information | |||
| output from medical scanners such as CT | ||||
| or DVT scanners. | ||||
| It is indicated for pre-operative | ||||
| simulation and evaluation of patient | ||||
| anatomy, dental implant placement, | ||||
| surgical instrument positioning, and | ||||
| surgical treatment options, in | ||||
| edentulous, partial edentulous or | ||||
| dentition situations, which may | ||||
| require a surgical guide. | It allows pre-operative simulation and | |||
| evaluation of patient anatomy and dental | ||||
| implant placement. |
For automated manufacturing of drill
guides in the dental laboratory
environment, the coDiagnostiX can
provide printouts of template plans for the
creation of surgical templates using a
manually operated gonyX table. | | |
| | It is further indicated for the user to
design such guides for, alone or in
combination, the guiding of a
surgical path along a trajectory or a
profile, or to help evaluate a surgical
preparation or step | | | |
| | NemoScan software allows for
surgical guide export to a validated
manufacturing center or to the point
of care.
Manufacturing at the point of care
requires a validated process using
CAM equipment (additive
manufacturing system, including
software and associated tooling) and
compatible material (biocompatible
and sterilizable).
A surgical guide may require to be
used with accessories. | | | |
| Classification | 21 CFR 892.2050, Class II | 21 CFR 892.2050, Class II | 21 CFR 892.2050, Class II | |
| Product Code | QIH | LLZ | LLZ | |
| Product Code
Name | System, Image Processing, Radiological | System, Image Processing, Radiological | System, Image Processing, Radiological | |
| General
Description | Dental Surgery Planning System | Dental Surgery Planning System | Dental Surgery Planning System | |
| Prescription Use | Yes | Yes | Yes | |
| Core
Component | Stand-alone software | Stand-alone software | Stand-alone software | |
| Target
population | Adolescents (12-21 years of age) to
adults (>21 years of age) | General public | Adults | |
| Patient
condition | For edentulous, partial edentulous or
dentition situations | For edentulous, partial edentulous or
dentition situations | non-specific | |
| Input Source | CT / CBCT scanner | CT / CBCT, DVT scanners | CT / CBCT scanner | |
| Input Data
formats | DICOM, .stl, .ply, .obj files | DICOM, .stl files | DICOM, .stl, .obj files | |
| Export | .stl file format | .stl file format | .stl file format | |
| Printouts | Make reports of the implant treatment plan. | Make reports of the implant treatment plan. | Make reports of the implant treatment plan. | |
| Anatomical site | Oral-maxillofacial regions | Oral-maxillofacial regions | Oral-maxillofacial regions | |
| Physical output design per Planning | Yes | Yes | Yes | |
| Minimum system requirements | PC with specified requirements on hardware, operating system and security (in user manual) | PC with specified requirements on hardware, operating system and security (in user manual) | PC with specified requirements on hardware, operating system and security (in user manual) | |
| Image registration (alignment) | The scanned surface data acquired by the optical/intraoral scanner can be aligned to the CT/CBCT reconstruction through a point-based registration technique | The scanned surface data acquired by the optical/intraoral scanner can be aligned to the CT/CBCT reconstruction through a point-based registration technique | The scanned surface data acquired by the optical/intraoral scanner can be aligned to the CT/CBCT reconstruction through a point-based registration technique | |
| Interface requirements | Desktop Application
Web Application | Desktop Application | Desktop Application | |
| DICOM Standard Compliant | Yes | Yes | Yes | |
| Projects management | Project exporting/importing | Project exporting/importing | Project exporting/importing | |
| Mean Features/ Tools | CAD tools to manipulate/modify/ render/import/export/sectioning patient models (teeth, upper/lower jaws), surgical item models, areas of interest. Includes:
- Panoramic curve
- Nerve detection
- Virtual structures
- Orient images to occlusal plane-
Surgical item libraries - Bone density analyses, geometric measurements | CAD tools to manipulate/modify/ render/import/export/sectioning patient models (teeth, upper/lower jaws), surgical item models, areas of interest. Includes:
- Panoramic curve
- Nerve detection
- Virtual structures
- Orient images to occlusal plane-
Surgical item libraries - Bone density analyses, geometric measurements | CAD tools to manipulate/modify/ render/import/export/sectioning patient models (teeth, upper/lower jaws), surgical item models, areas of interest. Includes:
- Panoramic curve
- Nerve detection
- Virtual structures
- Orient images to occlusal plane-
Surgical item libraries - Bone density analyses, geometric measurements | |
| Case
visualization | 2D gray value images
3D model rendering
Panoramic mode
MPR mode
Individual editing of imaging artifacts
3D Photo in .Obj format
Align 3D with Photos
Image treatment | 2D gray value images
3D model rendering
Panoramic mode
MPR mode
Individual editing of imaging artifacts | 2D gray value images
3D model rendering
Panoramic mode
MPR mode
3D Photo in .Obj format
Align 3D with Photos | |
| Measurement
tool | Distance/Angle
Bone density measurement | Distance/Angle
Bone density measurement | Distance/Angle
Bone density measurement | |
| Virtual Wax-up | Possible | Possible | Possible | |
| Nerve tracing | Possible | Possible | Possible | |
| Implant
Preparation
tools | Teeth segmentation and coordinate
system:
DICOM to STL conversion;
Mesh transformation;
Sinus segmentation;
Reorient the 3D volume;
Root and teeth segmentation;
Teeth extractions;
Panoramic curve; | Teeth segmentation and coordinate
system:
DICOM to STL conversion;
Sinus segmentation;
Reorient the 3D volume;
Root and teeth segmentation;
Teeth extractions;
Panoramic curve; | Teeth segmentation and
coordinate system;
DICOM to STL conversion;
Mesh transformation;
Sinus segmentation;
Reorient the 3D volume;
Roots segmentation and complete
teeth fusion;
Teeth extractions;
Panoramic curve; | |
| Implant Planning
tools | Implant, sleeve, drill, abutment,
analog, and pin positioning;
Custom Implant, Sleeve, Drill,
Abutment, and Pin creation;
Implant-to-implant, Implant-to-nerve
canal, Sleeve-to-Sleeve, and
Sleeve-to- STL surface
distance/collision warning;
Prosthesis wizards; | Implant, sleeve, drill, abutment, analog,
and pin positioning;
Custom Implant, Sleeve, Drill, Abutment,
and Pin creation;
Implant-to-implant, Implant-to-nerve
canal, Sleeve-to-Sleeve surface
distance/collision warning; | Implant, sleeve, drill, abutment,
and pin positioning;
Custom Implant, Sleeve, Drill,
Abutment, and Pin creation;
Implant-to-implant, Implant-to-nerve
canal, Sleeve-to-Sleeve, and Sleeve-to-
STL surface distance/collision
warning | |
| | Implant validations: | | Prosthesis wizards;
Implant validations; | |
| Surgical guide design | Design the surgery guide based on the implant treatment plan, such as:
Tooth-supported surgical guide design possible; Gingiva-supported surgical guide design possible; Bone-supported surgical guide design possible; Export of surgical guide design data set possible; Gingivectomy guide; Offset, thickness and connector setting possible; Add label text in surgical guide; | Design the surgery guide based on the implant treatment plan, such as:
Tooth-supported surgical guide design possible; Gingiva-supported surgical guide design possible; Bone-supported surgical guide design possible; Gingivectomy guide; Export of surgical guide design data set possible; Offset, wall thickness and connector thickness setting possible. Add label text in surgical guide; | Design the surgery guide based on the implant treatment plan, such as:
Tooth-supported surgical guide design possible; Gingiva-supported surgical guide design possible; Bone-supported surgical guide design possible; Offset, wall thickness and connector thickness setting possible; Export of surgical guide design data set possible; | |
| Surgical protocol design and creation tool | Details protocol: available per implant providing detailed implant, sleeve and surgical protocol information together with images of the planning views;
Surgical protocol: The sequence of surgical instruments to be used as specified by the selected guided surgery system (selected manufacturers only) | Details protocol: available per implant providing detailed implant, sleeve and surgical protocol information together with images of the planning views;
Surgical protocol: The sequence of surgical instruments to be used as specified by the selected guided surgery system (selected manufacturers only) | Details protocol: available per implant providing detailed implant, sleeve and surgical protocol information together with images of the planning views;
Surgical protocol: The sequence of surgical instruments to be used as specified by the selected guided surgery system (selected manufacturers only) | |
| Other tools | Analog model, Virtual pour up and model builder. | N/A | N/A | |
| Minimum system | OS - Windows 10 64-bit;
16 GB RAM Memory minimum | OS - Windows 7, 64-bit;
8GB RAM Memory minimum | Windows 7/8/8.1/10
4 GB RAM Memory minimum | |
| hardware and
software
requirements | (CPU) - Intel Core i7 at 2.8GHz
Network cards wired, minimum
speed 1 Gb./sec;
NVidia graphics card. Minimum 2
GB. VRAM
HDD – 15 GB of free space | (CPU) - Intel® Core™ 2 Duo processor
P8600
Graphics Card and Network cards- Not
specified
HDD – 128 GB of free space | 16 GB RAM Memory
recommended
Intel Core i7 at 2.8GHz
5 GB free disc space or more
Internet connection requirement | |
| | Payment model | Pay per use
License Fee
Annual Fee | License Fee
Annual Fee | Pay per use
License Fee
Annual Fee |
9
10
11
12
13
Conclusion from nonclinical and clinical tests
Image treatment includes functionalities such as: crop image, edit image and calibrate image. These functionalities are added to modify the input image or photo and it is not used for patients directly, these functionalities do not affect the security or effectiveness of the subject device.
Other tools from table before include: Analog model builder, which are functionalities used to export models to inspect them physically in 3D, but they are not used in the patient. These functionalities do not affect the security and effectiveness of the device.
The Indications for Use statement between the subject and predicate devices are equivalent;
minor differences in wording do not alter the intended use of the subject device. In addition, there are in the software functions or technical requirements; none of the safety and effectiveness of the subject device relative to the predicate, both can be considered equivalent.