coDiagnostiX

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". 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) | 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}------------------------------------------------ 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<br>60 Minuteman Road<br>Andover, MA 01810 | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------| | Registration No.: | 1222315 Owner/Operator No.: 9005052 | | On the behalf of: | Dental Wings GmbH<br>Düsseldorfer Platz 1<br>09111 Chemnitz<br>Germany | | Contact Person: | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs and Quality<br>Phone Number: +1-978-747-2509<br>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<br>Use | coDiagnostiX is an implant planning and surgery<br>planning software tool intended for use by dental<br>professionals who have appropriate knowledge in the<br>field of application. The software reads imaging<br>information output from medical scanners such as<br>CBCT or CT scanners.<br><br>It is indicated for pre-operative simulation and<br>evaluation of patient anatomy, dental implant<br>placement, surgical instrument positioning, and<br>surgical treatment options, in edentulous, partial<br>edentulous or dentition situations, which may require<br>a surgical guide. It is further indicated for the user to<br>design such guides for, alone or in combination, the<br>guiding of a surgical path along a trajectory or a<br>profile, or to help evaluate a surgical preparation or<br>step.<br><br>coDiagnostiX software allows for surgical guide<br>export to a validated manufacturing center or to the<br>point of care. Manufacturing at the point of care<br>requires a validated process using CAM equipment<br>(additive manufacturing system, including software<br>and associated tooling) and compatible material<br>(biocompatible and sterilizable). A surgical guide may<br>require to be used with accessories. | coDiagnostiX is an implant planning<br>and surgery planning software tool<br>intended for use by dental<br>professionals who have appropriate<br>knowledge in dental implantology and<br>surgical dentistry. This software reads<br>imaging information output from<br>medical scanners such as CT or DVT<br>scanners. It allows pre-operative<br>simulation and evaluation of patient<br>anatomy, and dental implant<br>placement.<br><br>For automated manufacturing of drill<br>guides in the dental laboratory<br>environment, the coDiagnostiX<br>software allows for export of data to<br>3D manufacturing systems.<br>Alternatively, coDiagnostiX can<br>provide printouts of template plans for<br>the creation of surgical templates<br>using a manually operated gonyX<br>table. | The KLS Martin Individual Patient<br>Solutions (IPS) Planning System is<br>intended for use as a software system<br>and image segmentation system for<br>the transfer of imaging information<br>from a medical scanner such as a CT<br>based system. The input data file is<br>processed by the IPS Planning<br>System and the result is an output<br>data file that may then be provided as<br>digital models or used as input to a<br>rapid prototyping portion of the system<br>that produces physical outputs<br>including anatomical models, guides,<br>splints, and case reports for use in<br>maxillofacial surgery. The IPS<br>Planning System is also intended as a<br>pre-operative software tool for<br>simulating / evaluation surgical<br>treatment options. | Straumann CARES Screw-retained<br>Bridge Ti and Straumann CARES<br>Dolder Bar Ti are indicated for use as<br>bares and bridges that attach to dental<br>implants (Straumann implant Regular<br>Neck (RN(Ø4.8mm and Wide Neck<br>(WN) Ø6.5mm) in the treatment of<br>partially or totally edentulous jaws for<br>the purpose of restoring chewing<br>function.<br><br>The Straumann CARES Screw-<br>retained Bridge Ti can be designed for<br>specific patient size and spans that<br>are attached to 2 to 16 implants.<br><br>The Straumann CARES Dolder Bar Ti<br>can be designed for specific patient<br>sizes and spans that are attached to 2<br>to 10 implants. | | Classification | 21 CFR 872.4120, Class II<br>21 CFR 892.2050, Class II | 21 CFR 892.2050, Class II | 21 CFR 872.4120, Class II<br>21 CFR 892.2050, Class II | 21 CFR 872.3630, Class II | | Product Code(s) | DZJ, LLZ | LLZ | DZJ, LLZ | NHA | | Product Code<br>Name | Bone Cutting Instruments and Accessories<br>System, Image Processing, Radiological | System, Image Processing,<br>Radiological | Bone Cutting Instruments and<br>Accessories<br>System, Image Processing,<br>Radiological | Endosseous Dental Implant Abutment | | General<br>Description | Dental Surgery Planning System | Dental Surgery Planning System | Dental Surgery Planning System | Implant Restoration | | Prescription<br>Use | Yes | Yes | Yes | Yes | | Core<br>Component | Stand-alone software | Stand-alone software | Stand-alone software | Bar, Bridge | | Target<br>Population | General public | General public | Pediatric & Adults | N/A | | Item | coDiagnostiX<br>K193301<br>(Subject Device) | coDiagnostiX<br>K130724<br>(Predicate Device) | IPS<br>K182789<br>(Reference Device) | SRBB<br>K112280<br>(Reference Device) | | Patient<br>condition | For edentulous, partial edentulous or dentition<br>situations | For edentulous, partial edentulous or<br>dentition situations | Non-specific | For edentulous or partial edentulous. | | Main Features/<br>Tools | CAD tools to manipulate/modify/<br>render/import/export/sectioning patient models (teeth,<br>upper/lower jaws), surgical item models, areas of<br>interest.<br>Includes:<br>- Panoramic curve<br>- Nerve detection<br>- Virtual structures<br>- Orient images to occlusal plane<br>- Surgical item libraries<br>- Bone density analyses, geometric<br>measurements | CAD tools to manipulate/modify/<br>render/import/export/sectioning patient<br>models (teeth, upper/lower jaws),<br>surgical item models, areas of interest.<br>Includes:<br>- Panoramic curve<br>- Nerve detection<br>- Virtual structures<br>- Orient images to occlusal plane<br>- Surgical item libraries<br>- Bone density analyses,<br>geometric measurements | CAD tools to manipulate/modify/<br>render/import/export/sectioning patient<br>models (teeth, upper/lower jaws),<br>surgical item models, areas of interest.<br>Includes:<br>- Panoramic curve<br>- Nerve detection<br>- Virtual structures<br>- Orient images to occlusal plane<br>- Surgical item libraries<br>- Bone density analyses,<br>geometric measurements<br>- Orthognathic modelling | N/A | | Anatomical site | Oral-maxillofacial regions | Oral-maxillofacial regions | Cranio-maxillofacial regions | N/A | | Specialty of<br>application /<br>Surgical<br>Planning Tool<br>Specificities | Surgery treatment planning<br>Specificities as per surgical planning tool with<br>treatment examples in the user manual:<br>- Planning of a surgical path along a trajectory<br>- Planning of a surgical path along a profile<br>- Planning to help evaluate a surgical preparation or<br>step<br>Applicable in:<br>- Restorative Dentistry (including Endodontics and<br>Implantology)<br>- Oral Surgery<br>- Maxillofacial Surgery<br>- Periodontics<br>- Orthodontics | Surgery treatment planning<br>Specificities with treatment example<br>implantation in the user manual.<br>Applicable in:<br>- Restorative Dentistry (including<br>Implantology) | Surgery treatment planning<br>Specificities with treatment example<br>bone reconstruction, orthognathic<br>procedures, implant design and model<br>creation in the user manual.<br>Applicable in:<br>- Maxillofacial Surgery | N/A | | Physical output<br>design per<br>Planning | Yes…