(570 days)
No
The summary describes standard image processing, 3D reconstruction, measurement tools, and segmentation, which are common features in medical imaging software and do not inherently indicate the use of AI/ML. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML models.
No.
Explanation: This device is a software tool for planning dental implant surgeries and designing surgical guides. It does not directly provide therapy or treatment to a patient.
No
The device is a software tool for surgical planning and guide design, not for diagnosing medical conditions. It aids in pre-operative simulation and evaluation based on imaging information, but does not provide a diagnosis.
No
While the core device is software, the summary explicitly describes the software's output being used to manufacture physical surgical guides, which are medical devices themselves and require hardware (CAM equipment) and materials for their creation. The summary also details validation and testing related to these physical guides (material properties, biocompatibility, sterilization, manufacturing process), indicating the scope of the submission extends beyond just the software itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Intended Use: The intended use of coDiagnostiX is for pre-operative simulation and evaluation of patient anatomy, dental implant placement, surgical instrument positioning, and surgical treatment options using imaging data (CBCT/CT). It is also used for designing surgical guides.
- Device Description: The device processes imaging data (DICOM format) from medical scanners to create 3D datasets for planning surgical procedures. It does not analyze biological samples from the patient.
- Input: The input is imaging data, not biological samples.
- Output: The output is a surgical plan and potentially a design file for a surgical guide.
The device is a software tool for surgical planning and guide design based on medical imaging, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
coDiagnostiX 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 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.
coDiagnostiX 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.
Product codes (comma separated list FDA assigned to the subject device)
DZJ, LLZ
Device Description
The main uses and capabilities of the coDiagnostiX software are unchanged from the primary predicate version. As in the primary predicate version, it is a software for dental surgical treatment planning. It is designed for the evaluation and analysis of 3-dimensional datasets and the precise image-guided and reproducible preoperative planning of dental surgeries. The first main steps in its workflow include the patient image data being received from CBCT (Cone Beam Computed Tomography) or CT. The data in DICOM format is then read with the coDiagnostiX DICOM transfer module according to the standard, converted into 3-dimensional datasets and stored in a database. The pre-operative planning is performed by the computation of several views (such as a virtual Orthopantomogram or a 3-dimensional reconstruction of the image dataset), by the analysis of the image data, and the placement of surgical items (i.e. sleeves, implants) upon the given views. The pre-operative planning is then followed as decided by the design of a corresponding surgical guide that reflects the assigned placement of the surgical items. Additional functions are available to the user for refinement of the preoperative planning, such as:
- Active measurement tools, length and angle, for the assessment of surgical treatment options;
- Nerve module to assist in distinguishing the nervus mandibularis canal;
- 3D sectional views through the jaw for fine adjustment of surgical treatment options;
- Segmentation module for coloring several areas inside the slice dataset, e.g., jawbone, native teeth, or types of tissue such as bone or skin, and creating a 3D reconstruction for the dataset;
- Parallelizing function for the adjustment of adjacent images; and
- Bone densitometry assessment, with a density statistic in areas of interest.
All working steps are automatically saved to the patient file may contain multiple surgical treatment plan proposals which allows the user to choose the ideal surgical treatment plan. The output file of the surgical guide and/or the guided surgical is then generated from the final surgical treatment plan. coDiagnostiX 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. The changes with respect to the coDiagnostiX predicate device version are to expand on the different surgical planning tools that can be considered as part of the predicate's general implant planning and surgical planning indications for use. The three tools are:
a) Planning of a surgical path along a trajectory this provides for a path to be determined that defines the alignment orientation of a surgical item (e.g., an implant and/or instrument).
b) Planning of a surgical path along a profile this provides for a profile surface to be determined to guide the orientation of a surgical instrument along a profile.
c) Planning of a form suitable to evaluate surgical preparation or other surgical steps this provides for a procedure to be planned with the corresponding design of a form with geometric features to evaluate the results of a surgical procedure or step.
Such planning may include the design of drill guides (planning a), cutting guides (planning b) and evaluation guides (planning c). Drill guides are manufactured from acrylate, whereby the drilling area is protected by metal. The same applies for the evaluation guides. Cutting guides are manufactured from commercially pure titanium and - if piezo-surgical instruments are applied acrylate. Note that only cutting guides are subject of this submission. Drill guides and evaluation guides are mentioned for informational purposes only. They are not subject to the premarket clearance in this K193301 submission. Manufacturing takes place at Straumann's validated manufacturing center or at 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 are included or referenced in the surgical item library, as well as items which are required to be known for the surgery planning. These changes were accommodated by changes to the GUI, adding items to the surgical item libraries, and the product's instructions for use to clarify and explain the use of the general surgery planning tool specificities. There are no changes to the base software functionalities or architecture as compared to the predicate device coDiagnostiX software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Medical scanners such as CBCT or CT scanners.
Anatomical Site
Oral-maxillofacial regions
Indicated Patient Age Range
General public
Intended User / Care Setting
Dental professionals who have appropriate knowledge in the field of application.
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)
Software verification and validation is conducted to assure requirements and specifications as well as risk mitigations (design inputs) are correctly and completely implemented and traceable to design outputs. Testing required, including functional and usability testing, shows conformity with expected results. The software documentation provides evidence that the software performs as intended and any potential risks are adequately mitigated as specified.
Software verification and validation includes the evidence that the base accuracy is identical as compared to the predicate device given that the base software (CAD type) capabilities, image sources, and output file functions are unchanged from the predicate device version of coDiagnostiX. This is similar as to the reference device KLS Martin Individual Patient Solution (IPS) Planning System (K182789) and adequate for the respective new tool specificities and related example uses applicable under those predicate and reference devices, given they involve the same base software capabilities (CAD type) and CBCT or CT image sources, as well as the same type of output files.
Guide material types, specific compositions with its properties are similar and provided for the finished material by the material manufacturers. Stability testing is conducted to validate those properties under expected conditions of use. Results demonstrate for all guide materials used, that the properties are not degraded by sterilization or storage, with the shelf-life validated for 10 months. The material compositions are safe for the devices intended use.
Biocompatibility testing is conducted in accordance with ISO 10993-1 for the acrylates, including an assessment of the impact of material reuse. For titanium the evaluations from the reference device (K112280) are leveraged. Biocompatibility testing includes test results provided by material manufacturers, development partners and own testing. The evaluations conducted are within the acceptance criteria defined by the standard. The results demonstrate that there is no evidence that the guides applied as intended are hazardous. It adequately addresses biocompatibility. Similar testing and confirming results are available for the reference devices.
Sterilization validation is performed for steam sterilization for the acrylate guides in accordance with ISO 17665-1 to a sterility assurance level (SAL) of 10-6 using the biological indicator (BI) overkill method. For titanium guides the sterilization from the reference device (K112280), which are identical in formulation, manufacturing process and post-processing procedures, are leveraged. In addition, accuracy and stability testing was conducted after sterilization. The acceptance criteria are met. The results demonstrate that the guides are safe to sterilize for their intended use.
Process performance qualifications of the manufacturing process are conducted to assure a guide of a certain material can safely and effectively be manufactured (with the compatible 3D manufacturing system). Worst case testing of representative guide designs is utilized, including an assessment of the influence of build orientation and build location in the build space as well as of material reuse. 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.
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
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
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June 21, 2021
Dental Wings GmbH % Jennifer Jackson Director of Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K193301
Trade/Device Name: coDiagnostiX Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: May 26, 2021 Received: May 27, 2021
Dear Jennifer Jackson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193301
Device Name coDiagnostiX
Indications for Use (Describe)
coDiagnostiX 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 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.
coDiagnostiX 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 and sterilizable). A surgical guide may require to be used with accessories.
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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3
Image /page/3/Picture/0 description: The image contains the logo for "dental wings". The logo consists of a stylized, rounded shape in shades of gray and blue, resembling a wing or a stylized tooth. To the right of the graphic is the text "dental wings" in a sans-serif font, with the words stacked horizontally.
Section 5: 510(k) Summary - coDiagnostiX 5
Submitter's Contact Information 5.1
| Submitter: | Straumann USA, LLC
60 Minuteman Road
Andover, MA 01810 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Registration No.: | 1222315 Owner/Operator No.: 9005052 |
| On the behalf of: | Dental Wings GmbH
Düsseldorfer Platz 1
09111 Chemnitz
Germany |
| Contact Person: | Jennifer M. Jackson, MS
Director of Regulatory Affairs and Quality
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023 |
| Date of Submission: | June 17, 2021 |
5.2 Name of the Device
| Trade Names: | coDiagnostiX |
|---|---|
| Common Name: | Dental Surgery Planning Software |
| Classification Name: | Bone cutting instrument and accessories |
| Regulation Number: | 21 CFR 872.4120 |
| Device Classification: | II |
| Product Code: | DZJ |
| Secondary Product Code(s): | LLZ |
| Review Panel: | Dental |
Predicate Device(s) 5.3
Primary Predicate:
-
K130724 coDiagnostiX Implant Planning Software -
Reference Devices: -
K182789 KLS Martin Individual Patient Solution (IPS) Planning System -
-
K112280 Straumann® CARES® Screw-retained Bridge Ti, Straumann® CARES® -Dolder® Bar Ti
4
Image /page/4/Picture/0 description: The image contains the logo for "dental wings". The logo consists of a stylized blue and gray graphic on the left, followed by the text "dental wings" in a gray, sans-serif font. The graphic is a rounded shape with a blue lower portion and a gray upper portion, creating a modern and clean design.
5.4 Description
The main uses and capabilities of the coDiagnostiX software are unchanged from the primary predicate version.
As in the primary predicate version, it is a software for dental surgical treatment planning. It is designed for the evaluation and analysis of 3-dimensional datasets and the precise image-guided and reproducible preoperative planning of dental surgeries.
The first main steps in its workflow include the patient image data being received from CBCT (Cone Beam Computed Tomography) or CT. The data in DICOM format is then read with the coDiagnostiX DICOM transfer module according to the standard, converted into 3-dimensional datasets and stored in a database.
The pre-operative planning is performed by the computation of several views (such as a virtual Orthopantomogram or a 3-dimensional reconstruction of the image dataset), by the analysis of the image data, and the placement of surgical items (i.e. sleeves, implants) upon the given views. The pre-operative planning is then followed as decided by the design of a corresponding surgical guide that reflects the assigned placement of the surgical items.
Additional functions are available to the user for refinement of the preoperative planning, such as:
- · Active measurement tools, length and angle, for the assessment of surgical treatment options:
- · Nerve module to assist in distinguishing the nervus mandibularis canal;
- 3D sectional views through the jaw for fine adjustment of surgical treatment options; .
- Segmentation module for coloring several areas inside the slice dataset, e.g., jawbone, . native teeth, or types of tissue such as bone or skin, and creating a 3D reconstruction for the dataset;
- Parallelizing function for the adjustment of adjacent images; and
- · Bone densitometry assessment, with a density statistic in areas of interest.
All working steps are automatically saved to the patient file may contain multiple surgical treatment plan proposals which allows the user to choose the ideal surgical treatment plan. The output file of the surgical guide and/or the guided surgical is then generated from the final surgical treatment plan.
coDiagnostiX 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 quide may require to be used with accessories.
5
Image /page/5/Picture/0 description: The image shows the logo for Dental Wings. The logo consists of a stylized icon on the left and the text "dental wings" on the right. The icon is a rounded shape with two colors: gray on the top and blue on the bottom. The text "dental wings" is in a sans-serif font and is gray in color.
The changes with respect to the coDiagnostiX predicate device version are to expand on the different surgical planning tools that can be considered as part of the predicate's general implant planning and surgical planning indications for use. The three tools are:
- a) Planning of a surgical path along a trajectory this provides for a path to be determined that defines the alignment orientation of a surgical item (e.g., an implant and/or instrument).
- b) Planning of a surgical path along a profile this provides for a profile surface to be determined to quide the orientation of a surgical instrument along a profile.
- c) Planning of a form suitable to evaluate surgical preparation or other surgical steps this provides for a procedure to be planned with the corresponding design of a form with geometric features to evaluate the results of a surqical procedure or step.
Such planning may include the design of drill guides (planning a), cutting guides (planning b) and evaluation guides (planning c). Drill guides are manufactured from acrylate, whereby the drilling area is protected by metal. The same applies for the evaluation guides. Cutting guides are manufactured from commercially pure titanium and - if piezo-surgical instruments are applied acrylate. Note that only cutting guides are subject of this submission. Drill guides and evaluation guides are mentioned for informational purposes only. They are not subject to the premarket clearance in this K193301 submission. Manufacturing takes place at Straumann's validated manufacturing center or at 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 are included or referenced in the surgical item library, as well as items which are required to be known for the surgery planning.
These changes were accommodated by changes to the GUI, adding items to the surgical item libraries, and the product's instructions for use to clarify and explain the use of the general surgery planning tool specificities. There are no changes to the base software functionalities or architecture as compared to the predicate device coDiagnostiX software.
5.5 Indications for Use of the Subject Device:
coDiagnostiX 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 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.
coDiagnostiX 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
6
Image /page/6/Picture/0 description: The image contains the logo for Dental Wings. The logo consists of a stylized graphic to the left of the text "dental wings". The graphic is a rounded shape with a gray upper portion and a blue lower portion. The text "dental wings" is in a sans-serif font and is colored gray.
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.
5.6 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 general planning tools indication has been modified for the subject device coDiagnostiX as compared to its predicate device version (K130724), to also indicate three specific planning tool principles or approaches that are available with the software. The subject device also specifies the indicated patient conditions: for use in edentulous, partial edentulous, and dentition conditions. However, this is already included in the labelling of the primary predicate (K130724). Finally, the alternate workflow involving the printouts and manufacturing method using the manually operated gonyX has been removed.
Similarities and Differences to the Predicate Device
The predicate device coDiagnostiX software version (K130724) is identical or similar to the subject device' technological characteristics with regards to the software, interface requirements, as well as inputs and outputs. The surgical item library has been updated. For manufacturing at the point of care, the acrylate has been replaced by a similar acrylic resin. Central manufacturing of guides made of acrylic resin and commercially pure titanium have been added.
A technological difference is that the subject device proposes the usage of piezo-surgical cutting instruments with acrylic guides. The potential impact on substantial equivalence of this technological difference is addressed by risk analysis and testing. With the non-clinical data obtained this method is considered equivalent to the usage of a state of the art cutting device with a metal guide and does not present any new significant questions of safety or effectiveness.
Reference Devices
KLS Martin Individual Patient Solution (IPS) Planning System (K182789) has been included as reference device to leverage the increased specificity of general tool indication as part of surgery planning and surgical treatment options. KLS Martin Individual Patient Solution (IPS) Planning System is using the same technologies and methods as the subject device and is describing surgical planning tool specificities for maxillofacial treatments, which include the treatments in the oral-maxillofacial region of the subject device.
Straumann® CARES® Screw-retained Bridge Ti, Straumann® CARES® Dolder® Bar Ti (K112280) has been included as reference device to leverage individual customized titanium guides made of commercially pure titanium using subtractive manufacturing method (centralized milling).
The table below summarizes the similarities and differences between the proposed device, the predicate device, and the reference devices with respect to the intended uses and indications for use, and the device features and specifications:
7
K193301 – coDiagnostiX Traditional 510(k)
Image /page/7/Picture/1 description: The image contains the logo for "dental wings". The logo consists of a stylized icon on the left and the text "dental wings" on the right. The icon is a rounded shape with two layers, the top layer is gray and the bottom layer is blue. The text is in a sans-serif font and is also gray.
| Item | coDiagnostiX | coDiagnostiX | IPS | SRBB |
|---|---|---|---|---|
| K193301 | K130724 | K182789 | K112280 | |
| (Subject Device) | (Predicate Device) | (Reference Device) | (Reference Device) | |
| Indications for | ||||
| Use | coDiagnostiX 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 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.
coDiagnostiX 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. | 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. This software reads
imaging information output from
medical scanners such as CT or DVT
scanners. 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
software allows for export of data to
3D manufacturing systems.
Alternatively, coDiagnostiX can
provide printouts of template plans for
the creation of surgical templates
using a manually operated gonyX
table. | The KLS Martin Individual Patient
Solutions (IPS) Planning System is
intended for use as a software system
and image segmentation system for
the transfer of imaging information
from a medical scanner such as a CT
based system. The input data file is
processed by the IPS Planning
System and the result is an output
data file that may then be provided as
digital models or used as input to a
rapid prototyping portion of the system
that produces physical outputs
including anatomical models, guides,
splints, and case reports for use in
maxillofacial surgery. The IPS
Planning System is also intended as a
pre-operative software tool for
simulating / evaluation surgical
treatment options. | Straumann CARES Screw-retained
Bridge Ti and Straumann CARES
Dolder Bar Ti are indicated for use as
bares and bridges that attach to dental
implants (Straumann implant Regular
Neck (RN(Ø4.8mm and Wide Neck
(WN) Ø6.5mm) in the treatment of
partially or totally edentulous jaws for
the purpose of restoring chewing
function.
The Straumann CARES Screw-
retained Bridge Ti can be designed for
specific patient size and spans that
are attached to 2 to 16 implants.
The Straumann CARES Dolder Bar Ti
can be designed for specific patient
sizes and spans that are attached to 2
to 10 implants. |
| Classification | 21 CFR 872.4120, Class II
21 CFR 892.2050, Class II | 21 CFR 892.2050, Class II | 21 CFR 872.4120, Class II
21 CFR 892.2050, Class II | 21 CFR 872.3630, Class II |
| Product Code(s) | DZJ, LLZ | LLZ | DZJ, LLZ | NHA |
| Product Code
Name | Bone Cutting Instruments and Accessories
System, Image Processing, Radiological | System, Image Processing,
Radiological | Bone Cutting Instruments and
Accessories
System, Image Processing,
Radiological | Endosseous Dental Implant Abutment |
| General
Description | Dental Surgery Planning System | Dental Surgery Planning System | Dental Surgery Planning System | Implant Restoration |
| Prescription
Use | Yes | Yes | Yes | Yes |
| Core
Component | Stand-alone software | Stand-alone software | Stand-alone software | Bar, Bridge |
| Target
Population | General public | General public | Pediatric & Adults | N/A |
| Item | coDiagnostiX
K193301
(Subject Device) | coDiagnostiX
K130724
(Predicate Device) | IPS
K182789
(Reference Device) | SRBB
K112280
(Reference Device) |
| Patient
condition | For edentulous, partial edentulous or dentition
situations | For edentulous, partial edentulous or
dentition situations | Non-specific | For edentulous or partial edentulous. |
| Main 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 - Orthognathic modelling | N/A |
| Anatomical site | Oral-maxillofacial regions | Oral-maxillofacial regions | Cranio-maxillofacial regions | N/A |
| Specialty of
application /
Surgical
Planning Tool
Specificities | Surgery treatment planning
Specificities as per surgical planning tool with
treatment examples in the user manual: - Planning of a surgical path along a trajectory
- Planning of a surgical path along a profile
- Planning to help evaluate a surgical preparation or
step
Applicable in: - Restorative Dentistry (including Endodontics and
Implantology) - Oral Surgery
- Maxillofacial Surgery
- Periodontics
- Orthodontics | Surgery treatment planning
Specificities with treatment example
implantation in the user manual.
Applicable in: - Restorative Dentistry (including
Implantology) | Surgery treatment planning
Specificities with treatment example
bone reconstruction, orthognathic
procedures, implant design and model
creation in the user manual.
Applicable in: - Maxillofacial Surgery | N/A |
| Physical output
design per
Planning | Yes | Yes | Yes | N/A |
| Item | coDiagnostiX
K193301
(Subject Device) | coDiagnostiX
K130724
(Predicate Device) | IPS
K182789
(Reference Device) | SRBB
K112280
(Reference Device) |
| 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) | N/A |
| Interface
Requirements | Desktop Application | Desktop Application | Web Application | N/A |
| DICOM
Standard
Compliant | Yes | Yes | Yes | N/A |
| Image Import | - DICOM standard format data from CBCT or CT, - STL standard format from impression and/or
surface scanners | - DICOM standard format data from
CBCT or CT - STL standard format from impression
and/or surface scanners | - DICOM standard format data from
CBCT or CT - STL standard format from impression
and/or surface scanners | N/A |
| Export | STL file format | STL file format | STL file format | N/A |
| Printouts | Report/plan with patient information, screenshots,
plan results | Report/plan with patient information,
screenshots, plan results | Report/plan with patient information,
screenshots, plan results | N/A |
| Guide Material | Acrylate
CP Titanium | Acrylate
Polystyrene | Polyamid, Titanium Alloy (Ti-6AI-4V),
CP Titanium
Methacrylate (splints) | CP Titanium (no guide design, but
bridge and bar on implant) |
| Guide Function | Cutting guide (CP Titanium or Acrylate) | Drill guide, Evaluation Guide | Marking/Cutting Guide (Polyamid,
Titanium Alloy (Ti-6AI-4V), CP
Titanium)
Splints (Methacrylate) | N/A (no guide design) |
| Sterilization | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) | Non-sterile (Steam) |
| Manufacturing
Method | Acrylate: Additive (Digital Light Processing (DLP)) | Acrylate: Additive (Polyjet) | Acrylate: Additive (Stereolithography
(SLA)) | CP Titanium: Subtractive (traditional) |
| | CP Titanium: Subtractive | Polystyrene: gonyX (manually
operated) | Polyamide: Additive (Selective Laser
Sintering (SLS)) | |
| | | | Titanium Alloy: Additive (Selective
Laser Melting (SLM)) | |
| | | | CP Titanium: Subtractive (traditional) | |
| Item | coDiagnostiX
K193301
(Subject Device) | coDiagnostiX
K130724
(Predicate Device) | IPS
K182789
(Reference Device) | SRBB
K112280
(Reference Device) |
| Guide
Specifications | Design Volume:
Min: patient specific
Max: 200 mm x 200 mm x 100 mm | Not provided | Length:
Min: 15 mm
Max: 350 mm;
Width:
Min: 7 mm
Max: 200 mm;
Thickness:
Min: 1 mm
Max: 5 mm;
Degree of curvature (in-plane):
Min: 90°
Max:180°;
Degree of curvature (out of plane):
Min: 60°
Max: 180° | N/A |
| | No. of supporting points:
Min: 3, arranged in a triangle | Not provided | No. of holes:
Min: 2
Max: Depends on length and screw
hole spacing | N/A |
| | Supporting points distance:
Max: 40 mm | Not provided | Screw hole spacing:
$\ge$ 4.5 mm | N/A |
| | Cutting bar dimensions:
Height/Thickness: $\ge$ 3 mm
Width: $\ge$ 4 mm | Not provided | Length:
Min: 15 mm
Max: 350 mm;
Width:
Min: 7 mm
Max: 200 mm;
Thickness:
Min: 1 mm
Max: 5 mm; | N/A |
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Image /page/8/Picture/0 description: The image contains the logo for Dental Wings. The logo consists of a blue and white abstract shape on the left, followed by the text "dental wings" in a gray sans-serif font. The blue shape appears to be a stylized wing or leaf-like design.
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Image /page/9/Picture/0 description: The image contains the logo for "dental wings". The logo consists of a stylized, rounded shape on the left, which is divided into two sections with a gradient of gray and blue. To the right of the shape, the words "dental wings" are written in a simple, sans-serif font, with the text appearing in a light gray color.
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Image /page/10/Picture/0 description: The image contains the logo for "dental wings". The logo consists of a stylized graphic to the left of the text. The graphic is a rounded shape with two layers, the top layer is gray and the bottom layer is blue. The text "dental wings" is in a sans-serif font and is gray.
K193301 – coDiagnostiX Traditional 510(k)
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Image /page/11/Picture/0 description: The image contains the logo for Dental Wings. The logo consists of a stylized icon on the left and the text "dental wings" on the right. The icon is a rounded shape with a gradient of light blue to white. The text "dental wings" is in a sans-serif font and is colored gray.
5.7 Non-Clinical Performance Data
Software verification and validation is conducted to assure requirements and specifications as well as risk mitigations (design inputs) are correctly and completely implemented and traceable to design outputs. Testing required, including functional and usability testing, shows conformity with expected results. The software documentation provides evidence that the software performs as intended and any potential risks are adequately mitigated as specified.
Software verification and validation includes the evidence that the base accuracy is identical as compared to the predicate device given that the base software (CAD type) capabilities, image sources, and output file functions are unchanged from the predicate device version of coDiaqnostiX. This is similar as to the reference device KLS Martin Individual Patient Solution (IPS) Planning System (K182789) and adequate for the respective new tool specificities and related example uses applicable under those predicate and reference devices, given they involve the same base software capabilities (CAD type) and CBCT or CT image sources, as well as the same type of output files.
Guide material types, specific compositions with its properties are similar and provided for the finished material by the material manufacturers. Stability testing is conducted to validate those properties under expected conditions of use. Results demonstrate for all guide materials used, that the properties are not degraded by sterilization or storage, with the shelf-life validated for 10 months. The material compositions are safe for the devices intended use.
Biocompatibility testing is conducted in accordance with ISO 10993-1 for the acrylates, including an assessment of the impact of material reuse. For titanium the evaluations from the reference device (K112280) are leveraged. Biocompatibility testing includes test results provided by material manufacturers, development partners and own testing. The evaluations conducted are within the acceptance criteria defined by the standard. The results demonstrate that there is no evidence that the guides applied as intended are hazardous. It adequately addresses biocompatibility. Similar testing and confirming results are available for the reference devices.
Sterilization validation is performed for steam sterilization for the acrylate quides in accordance with ISO 17665-1 to a sterility assurance level (SAL) of 10-6 using the biological indicator (BI) overkill method. For titanium quides the sterilization from the reference device (K112280), which are identical in formulation, manufacturing process and post-processing procedures, are leveraged. In addition, accuracy and stability testing was conducted after sterilization. The acceptance criteria are met. The results demonstrate that the guides are safe to sterilize for their intended use.
Process performance qualifications of the manufacturing process are conducted to assure a guide of a certain material can safely and effectively be manufactured (with the compatible 3D manufacturing system). Worst case testing of representative guide designs is utilized, including an assessment of the influence of build orientation and build location in the build space as well as of material reuse. Expected results are met. This process performance qualifications includes
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Image /page/12/Picture/0 description: The image contains the logo for Dental Wings. The logo consists of a stylized graphic on the left and the text "dental wings" on the right. The graphic is a rounded shape with a gradient of light blue to white, suggesting a wing-like form. The text "dental wings" is in a sans-serif font and is colored in gray.
centralized manufacturing and point of care procedures. The validated materials and manufacturing processes are safe and effective for their intended use.
Conclusion 6
The coDiagnostiX software has the same intended use and similar technological characteristics as the primary predicate device. The changes to increase the tool indication specificities, together with the minor updates in the software, the labeling, and the expansion of validated material and manufacturing process capabilities do not change the intended use or the applicable fundamental technology, and do not raise any new questions of safety or effectiveness. Additionally, the nonclinical testing supports that the software and its outputs, perform in accordance with the intended us and are safe and effective, and perform as well as the predicate device. The subject device has been shown to be substantially equivalent to the predicate device.