OnyxCeph

{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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. January 4, 2023 Image Instruments GmbH % Greg Holland Sr. Partner Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, California 92606 Re: K213263 Trade/Device Name: OnyxCeph3TM Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ, PNN Dated: November 30, 2022 Received: December 5, 2022 Dear Greg Holland: 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, # Bobak Shirmohammadi -S For 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) K213263 Device Name OnyxCeph3TM #### Indications for Use (Describe) OnyxCeph*™ software is intended to be used for the medical purpose of managing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only. The use of OnyxCeph7™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software. The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> <span> <b> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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}------------------------------------------------ ### 5. 510(k) Summary - K213263 | 510(k) Owner | Image Instruments GmbH<br>Niederwaldstr. 3<br>09123 Chemnitz<br>Germany<br>Phone: +49 371 9093140<br>Facsimile: +49 371 9093149 | | OnyxCeph3 TM<br>K213263<br>Subject Device | VISTADENTTM AT<br>COMPLETE K053010<br>Predicate Device | | OnyxCeph3™<br>K213263<br>Subject Device | VISTADENT™ AT<br>COMPLETE K053010<br>Predicate Device | |------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-------------------------------------------|--------------------------------------------------------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person | Greg Holland<br>Regulatory Specialists, Inc.<br>3722 Ave. Sausalito<br>Irvine, CA 92606<br>Phone: 949.262.0411<br>Fax: 949.552.2821<br>Email: greg@regulatoryspecialists.com | Intended Use | Orthodontic Software | Orthodontic Software | Indications for<br>Use | OnyxCeph3™ software<br>is intended to be used<br>for the medical<br>purpose of managing<br>and evaluating two-<br>dimensional and three-<br>dimensional images in<br>the framework of<br>digital orthodontics by<br>qualified staff only.<br>The use of<br>OnyxCeph3™ requires<br>the user to have the<br>necessary training and<br>domain knowledge in<br>the practice of<br>orthodontics, as well<br>as to have received a<br>dedicated training in<br>the use of the<br>software.<br>The software can be<br>used to digitally perform<br>certain image- based<br>orthodontic workflows,<br>such as metric and<br>angular evaluation of<br>image data. | VISTADENT™ AT<br>COMPLETE software is<br>a digital database for<br>storing, retrieving and<br>printing images that also<br>has the ability to perform<br>image manipulation and<br>cephalometric analysis. | | Submission Date | January 3, 2023 | Product Code | LLZ | LLZ | | | | | Common Name<br>Trade Name<br>Classification Name<br>Regulation<br>Class<br>Panel<br>Primary Product Code<br>Secondary Product Code | Orthodontic Software<br>OnyxCeph3TM<br>Radiological Image Processing System<br>892.2050<br>Class II<br>Dental<br>LLZ<br>PNN | 2 Dimensional<br>Image Import | Yes | Yes | | | | | Primary Predicate Device | K053010<br>VISTADENTTM AT<br>COMPLETE<br>From: Dentsply INTL.,<br>Inc. | 2 Dimensional<br>Image Adjust | Yes | Yes | | | | | Reference Device | K171634<br>Ortho SystemTM<br>From: 3Shape A/S<br>K192475<br>NemoFAB<br>From: Software<br>Nemotec S.L. | | | | | | | ## Description OnyxCeph3™ dental aligner software device is designed for the simulation and planning of orthodontic and maxillofacial surgical combination treatments, based on virtual models and CT / DVT volume data. OnyxCeph3™ is a software device that includes both 3D and 2D versions both suitable for dental facilities to use for orthodontic treatments. {4}------------------------------------------------ #### Intended Use OnyxCeph3™ is a software only device and is intended to be used for the medical purpose of manaqing and evaluating two-dimensional and threedimensional images in the framework of digital orthodontics by qualified staff only who have received dedicated training for use of the software. Diagnostic and therapeutic decisions cannot be motivated exclusively or even mainly on evaluation results provided by the software. ### Indications for Use OnyxCeph3™ software is intended to be used for the medical purpose of manaqing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only. The use of OnyxCeph3™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software. The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data. ## Technological Characteristics The predicates and the Image Instruments GmbH OnyxCeph3™ were compared in the following areas and found to have similar technological characteristics and to be equivalent. Both predicates are shown as a comparison in separate tables. {5}------------------------------------------------ {6}------------------------------------------------ | | OnyxCeph3™<br>K213263<br>Subject Device | VISTADENT™ AT<br>COMPLETE K053010<br>Predicate Device | |----------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | 2 Dimensional<br>Cephalometric<br>Evaluation | Yes | Yes | | 2 Dimensional<br>Image<br>Combination | Yes | Yes | | 2 Dimensional<br>Image<br>Comparison | Yes | Yes | | 2 Dimensional<br>Mirroring | Yes | Yes | | CO/CR-<br>Conversion | Yes | Yes | | Ricketts VTO | Yes | Yes | | 2 Dimensional<br>Treatment<br>Simulation | Yes | Yes | | Windows Based | Yes | Yes | | Activation by<br>Key | Yes | Yes | | Client<br>Requirements | Hardware Type, CPU,<br>RAM, Disk, Network,<br>Graphic Board, Desktop<br>Resolution | Hardware Type CPU, RAM,<br>Disk, Network, Graphic<br>Board,<br>Desktop Resolution | | Client<br>Requirements | Not Required | Internet Access,<br>Internet Speed | | Server<br>Requirements | Hardware Type, CPU,<br>RAM, Disk, Network,<br>Port Sharing | Hardware Type, CPU,<br>RAM, Disk, Network,<br>Port Sharing | {7}------------------------------------------------ | | OnyxCeph3™<br>K213263<br>Subject Device | Ortho System<br>3Shape A/S<br>K171634<br>Reference<br>Device | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use<br>Indications | Orthodontic Software<br>OnyxCeph3™ software is<br>intended to be used for the<br>medical purpose of<br>managing and evaluating<br>two-dimensional and<br>three-dimensional images<br>in the framework of digital<br>orthodontics by qualified<br>staff only. The use of<br>OnyxCeph3™ requires the<br>user to have the necessary<br>training and domain<br>knowledge in the practice<br>of orthodontics, as well as<br>to have received a<br>dedicated training in the<br>use of the software.<br>The software can be used<br>to digitally perform certain<br>image- based orthodontic<br>workflows, such as metric<br>and angular evaluation of<br>image data. | Orthodontic Software<br>The 3Shape Ortho<br>System™ is intended for<br>use as a medical front-<br>end device providing<br>tools for management of<br>orthodontic models,<br>systematic inspection,<br>detailed analysis,<br>treatment simulation and<br>virtual appliance design<br>options (Custom Metal<br>Bands, Export of<br>Models, Indirect<br>Bonding Transfer<br>Media) based on 3D<br>models of the patient's<br>dentition before the start<br>of an orthodontic<br>treatment. It can also be<br>applied during the<br>treatment to inspect and<br>analyze the progress of<br>the treatment. It can be<br>used at the end of the<br>treatment to evaluate if<br>the outcome is<br>consistent with the<br>planned/desired<br>treatment objectives.<br>The use of the Ortho<br>System™ requires the<br>user to have the<br>necessary training and<br>domain knowledge in<br>the practice of<br>orthodontics, as well as<br>to have received a<br>dedicated training in the<br>use of the software. | | Product Code | LLZ | PNN | | | OnyxCeph3TM<br>K213263<br>Subject Device | Ortho System<br>3Shape A/S<br>K171634<br>Reference<br>Device | | 2 Dimensional<br>Evaluation | Yes | Yes | | 2 Dimensional<br>Cephalometric<br>Evaluation | Yes | No | | 3 Dimensional<br>Evaluation | Yes | Yes | | Supported<br>anatomical areas | Maxilla and Mandible | Maxilla and Mandible | | Determine arch<br>shape | Yes | Yes | | Determine wire<br>length | Yes | Yes | | Determine tooth<br>width | Yes | Yes | | Determine Bolton | Yes | Yes | | Determine space<br>analysis | Yes | Yes | | Determine overbite | Yes | Yes | | Determine<br>occlusion | Yes | Yes | | Extract/Segment<br>Volume Scans | Yes | Yes | | Combine Bony and<br>Dental Scan Data | Yes | Yes | | Windows Based | Yes | Yes | | Data Storage | Local | Local / Cloud | | Activation by<br>Dongle | No | Yes | | | OnyxCeph3™<br>K213263<br>Subject Device | Ortho System<br>3Shape A/S<br>K171634<br>Reference<br>Device | | Activation by Key | Yes | No | | Client<br>Requirements | Hardware Type, CPU,<br>RAM, Disk, Network,<br>Graphic Board, Desktop<br>Resolution | Hardware Type, CPU,<br>RAM, Disk, Network,<br>Graphic Board,<br>Desktop Resolution | | Client<br>Requirements | Not required | Internet Access,<br>Internet Speed | | Server<br>Requirements | Hardware Type, CPU,<br>RAM, Disk, Network,<br>Port Sharing | Hardware Type, CPU,<br>RAM, Disk, Network,<br>Port Sharing | {8}------------------------------------------------ {9}------------------------------------------------ Although the Indications for Use Statement for the subject device is different from the predicate device, K053010, the intended use of the software is the same, to allow for two-dimensional and three-dimensional evaluation of images. The predicate device includes Internet Access which is not required for the subject device. The subject device includes 3-dimensional evaluation capabilities; whereas the predicate device does not. However, the reference devices support this function. The reference device, K171634, was included to support the 3-dimensional evaluation capabilities of the subject device. This reference device does not include 2-Dimensional Cephalometric function, and activation by Key. However, the 2-Dimensional Cephalometric function is supported by the predicate device. The reference device offers activation by Dongle. In addition, the reference device supports the use of Data Storage via the Cloud and requires Internet Access whereas the subject device does not. Additional reference device, K192475 was included to support the devices intended use for supporting the treatment planning process of orthognathic procedures. In summary, the similarities between the subject device, OnyxCeph3™, and the predicate devices are functionally very similar. The differences identified do not raise different questions of safety and effectiveness as discussed in the table above. Nonclinical Testing Software Validation conducted per FDA Guidance for Software Contained in Medical Devices IEC 62304 - Software Life Cycle Processes #### Clinical Testing Clinical testing has not been included and is not required to demonstrate substantial equivalence. #### Conclusion Based on the similarities between the intended use, indications, principle of operation, features and technical data, the subject device, OnyxCeph3™, is found to be substantially equivalent to the predicate device.