DTX Studio diagnose

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January 11, 2018 Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Sasvi Ranch Parkway Yorba Linda, California 92887 Re: K172224 Trade/Device Name: DTX Studio diagnose Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: December 13, 2017 Received: December 14, 2017 Dear Charlemagne Chua: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 D. O'Hara For Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | PSC Publishing, Services (101) 415-5740<br>на | FORM FDA 3881 (1144<br>Page 1 of 1 | |---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | of a concello a products of painted in nosted is nosued is not of your your of a concertion of<br>information and and and a currently valid OMB mumber. | | | Office of Chief Information Officer<br>Department of Health and Human Services<br>PRODITION@gddd.hths.good<br>Paperwork Reduction Act (PRA) State<br>Food and Drug Administration | | | ə bir və bərən mənisi və mərkəzi və məsən qalını sənələr şərək çalışını və və mili<br>a market the many of the prible sing prises and more more more more more of worker pre<br>əd bulbulanı ,əsnoqsə nəq sunod 87 əgərəvs ot bətəninə sinfi olan sinfi növələrinin əmir rəbrud ədə<br>this in is in buisning suggestion in including in ibuloni, to: | | | of the seat and and and and of the series and on the sense tow on<br>SEEL To ISA noticular and to sincementupes of the sellage noilleas sing | | | armangis) (HAQC) MIlleeH lesipoloibeR bus secived 10 reineC to esnermano2 | | | FOR FDA USE ONLY | | | A WORD FOR A FRANCE A NO FUNITHO CONSTITUTION CONSTITUTION OR ASSESS FOR | | Suppart C) | Pressure User Use (FBR 21 CFR 80 Suppers D<br>__ Over-The-Counter Use (21 CFR 801 | | | Type of Use (Select one or both, as applicable | | | | | | but sever I sessed in entress from various sources to support the disguns and stores and<br>STO<br>Indications for Use (Describe)<br>onumunicates these intent the system or across computers systems a distributed locations | | | DTX Studio diagnose<br>D<br>evice Name | | | sub(k) Number (if known)<br>みてててくる! | | ese PRA Statement below | ndications for Use | | orm Approved: OMB No. 0910-0120<br>xiquition Date: January 31, 2017 | A PARTMENT OF HEALTH AND HUMAN SEVICES<br>Food and Drug Administration | | | | ອຂອບເງຣເນີ {3}------------------------------------------------ A.4. # I. SUBMITTER Nobel Biocare AB Västra Hamngatan 1 Goteborg, SE-411 17 Sweden Submitted by Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887 Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348 Date Prepared: December 12, 2017 II. DEVICE Name of Device: DTX Studio diagnose Common or Usual Name: System, Image Processing, Radiology Classification Name: Picture Archiving and Communications System (21 CFR 892.2050) Requlatory Class: II Product Code: LLZ # III. PREDICATE DEVICE Primary predicate: Palodex Group Oy - Cliniview (K162799) Reference predicate: Sirona Dental Systems - Sidexis 4 (K132773) # IV. DEVICE DESCRIPTION DTX Studio diagnose is a software solution used to support the image-based diagnostic process of dental and cranio-maxillofacial cases. DTX Studio diagnose has specific functionalities to visualize imaging information for facilitating diagnosis, e.g. 2D and 3D X-ray information, and to perform specific measurements on the data to support users with the diagnostic process. The types of digital image data which are supported by the DTX Studio diagnose include, for example, 3D (CB)CT images, orthopantomograph(OPG)/panorex images, intraoral images, cephalograms and clinical pictures. {4}------------------------------------------------ DTX Studio diagnose allows the user to view and inspect the patient images, and to add findings and measurements. Indicated findings can be saved within the patient profile in DTX Studio. For the purposes of diagnosis, different workspaces are available within the diagnostic module. The DTX Studio diagnose software is compatible with both Windows and Mac OS X operating systems. Two different software versions/installers are available based on the user's operating system. ## V. INDICATIONS FOR USE DTX Studio diagnose is a software program for the transfer and visualization of dental and craniomaxillofacial image information. It displays and enhances digital images from various sources to support the diagnostic process It stores and communicates these images within the system or across computer systems at distributed locations. {5}------------------------------------------------ # VI. Comparison of Technological Characteristics | | SUBJECT | Primary Predicate | Reference Predicate | Comments | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | Technological<br>characteristics | DTX Studio diagnose | Cliniview<br>(K162799) | Sidexis 4<br>(K132773) | Except as noted<br>comparison is made to<br>the primary predicate | | Trade name | DTX Studio diagnose | Cliniview | Sidexis 4 | | | FDA product<br>code | LLZ | LLZ | LLZ | Same | | Classification | Class II | Class II | Class II | Same | | Indications for<br>use / Intended<br>Use | DTX Studio diagnose is a<br>software program for the<br>transfer and visualization of<br>dental and craniomaxillofacial<br>image information. It displays<br>and enhances digital images<br>from various sources to<br>support the diagnostic process<br>It stores and communicates<br>these images within the<br>system or across computer<br>systems at distributed<br>locations. | Cliniview software program is<br>indicated for general dental and<br>maxillofacial diagnostic imaging.<br>It controls capture, display,<br>enhancement, and saving of<br>digital images from various<br>digital imaging systems. It<br>stores and communicates these<br>images within the system or<br>across computer systems at<br>distributed locations. | SIDEXIS 4 is software that offers<br>functions for the acquisition,<br>administration, analysis,<br>diagnosis, presentation and<br>transfer of digital or digitized<br>image data, e.g. X-ray images or<br>video recordings, for medical<br>use, predominantly in dentistry. | Different - See<br>discussion below | | Input data/<br>Image<br>acquisition | 2D and 3D images such as<br>(CB)CT scans and 2D images<br>such as OPG/ panorex<br>images, cephalometric images<br>intra-oral images and clinical<br>pictures | 2D (CB)CT scans and 2D<br>images such as OPG/ panorex<br>images, cephalometric images<br>intra-oral images and clinical<br>pictures | 2D and 3D images such as<br>(CB)CT scans and 2D images<br>such as OPG/ panorex images,<br>cephalometric images intra-oral<br>images and clinical pictures | Same as reference<br>predicate | | Image<br>processing<br>functionality | Enhancement, annotation,<br>measurement, import/export | Enhancement, annotation,<br>measurement, import/export<br>and printing | Enhancement and presentation,<br>import/export | Same | | Technological<br>characteristics | SUBJECT | Primary Predicate | Reference Predicate | Comments | | DTX Studio diagnose | Cliniview<br>(K162799) | Sidexis 4<br>(K132773) | Except as noted<br>comparison is made to<br>the primary predicate | | | Output data | Data is stored locally or in<br>remotely accessible database<br>in the network (DTX core) | Images and related data are<br>stored in the Cliniview database<br>or remotely accessible<br>database in the network.<br>Image export | 2D Views/images export to<br>specified location or via e-mail<br>DICOM exam/report/volume<br>export<br>Facescan OBJ export<br>Image and workspace printing | Same | | Software<br>features | The software provides several<br>workspaces to review the<br>images. It provides specific<br>workspaces to review (a<br>selection of) the imported<br>images like e.g. full mouth<br>series template for intraoral<br>images, and it provides<br>workspaces to review a<br>specific set of images to<br>support diagnosis of a selected<br>area combining several image<br>types. | A workspace is available to<br>work with imported images. It is<br>also possible to load and view<br>3D images or multilayer pan<br>images by using 3rd party<br>software. | The software provides several<br>layouts to review the images. It<br>provides specific layout to review<br>(a selection of) the imported<br>images like e.g. full mouth series<br>template for intraoral images. | Same as reference<br>predicate | | | Access images from DTX core<br>database or allow manual<br>import | Access images from database<br>or allow manual import | Acquire images from x-ray<br>devices or allow manual import | Same | | | Scan requests creation for<br>image acquisition | Image acquisition from<br>connected devices | X-ray exposure creation to<br>request image acquisition | Different - See<br>discussion below | | | 2D and 3D data visualization | 2D data visualization<br>Cliniview is able to send 2D and<br>3D images to 3rd party viewers<br>and is also able to receive<br>patient information from 3rd<br>party patient management<br>software | 2D and 3D data visualization | Same as reference<br>predicate | | | SUBJECT | Primary Predicate | Reference Predicate | Comments | | Technological<br>characteristics | DTX Studio diagnose | Cliniview<br>(K162799) | Sidexis 4<br>(K132773) | Except as noted<br>comparison is made to<br>the primary predicate | | | Adjust patient positioning in<br>the software and optimize<br>cross-sections and projected<br>images | Not available | Adjust data with the panorama<br>curves editor | Same as reference<br>predicate | | | Apply image filters, make<br>annotations | Apply image filters, make<br>annotations | Apply image filters, make<br>annotations | Same | | | Length and angles<br>measurement | Length, angle and free angle<br>measurements | Length and angles measurement | Same | | System<br>Requirements | Workstation:<br>Operating System: Windows®<br>7, 8.1, 10 (64 bit), Mac OS® X<br>(Yosemite, El Capitan); Mac<br>OS® Sierra<br>HDD ≥ 5 GB of free disk space<br>RAM ≥ 8 GB<br>CPU ≥ 2.8 GHz QuadCore<br>Graphic Card ≥ 2 GB<br>Screen Full HD (1920 x 1080)<br>or higher | Workstation PC:<br>Operating system:<br>Windows 7<br>Professional/Ultimate/Enterprise<br>SP1 (32 or 64-bit)<br>Windows 8/8.1<br>Professional/Enterprise (32 or<br>64-bit)<br>Windows 10<br>HDD ≥ 8 GB<br>RAM ≥ 4GB<br>CPU Intel Core i3 or better | Workstation PC:<br>Operating System:<br>Windows 7 Pro SP1 (32 o. 64<br>bit)<br>Windows 8.1 Pro (64 bit)<br>Windows 10 Pro (64 bit)<br>HDD ≥ 5 GB<br>RAM ≥ 4 GB<br>CPU ≥ 2 GHz DualCore<br>Graphic Card ≥ 512 MB<br>Screen 1280 x 1024 Pixel | Different - See<br>discussion below | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ Analysis of Differences Between Subject Device and Predicates The subject device DTX Studio diagnose and primary predicate Cliniview (K162799) have the same intended use and share most software features. Other software features are shared with the reference predicate Sidexis 4 (K132773). Differences in indications for use and software features are discussed below. #### Indications for Use/ Intended Use The Indications for Use statement between the subject and the primary predicate devices (K162799) are primarily the same. Minor differences in wording do not alter the intended therapeutic use of the subject device. Both DTX Studio diagnose and the primary predicate Cliniview (K162799) allow display and enhancement of medical images from various sources, i.e. from various digital imaging systems. In addition, they also allow for retrieving and storage of image within the system (locally) or across computer systems at distributed locations. DTX Studio diagnose allows transfer of images and patient data (store and retrieval) to and from the DTX core database, thus making the data available at different locations. The primary predicate Cliniview (K162799) allows to store and retrieve patient data and related image data in a local or central database called Data Warehouse. Both the subject and primary predicate are software solutions indicated for the display and processing of medical image information and are intended to support the diagnostic process predominately within dentistry. Oral and maxillofacial surgeons offer treatments which can cover the complete cranio-maxillofacial area (including the dental area). For this reason, the subject device allows the user to visualize and evaluate data for the entire cranio-maxillofacial area, as a support for the diagnostic process. ## Software features Scan request - The subject DTX Studio diagnose allows to request scans through DTX core by selecting the scanner device, e.g. 3D scan or OPG / panorex. Cliniview (K162799) controls image capturing of imaging devices for image acquisition and image exposure. Both devices allow for the placing of scan requests and retrieval of scan data. The difference between the subject and the primary predicate is that the predicate software controls the acquisition of scan data including the exposure settings. The subject device allows placing of a scan request where the exposure is set or confirmed and the scanning started by the operator directly on the scanner. The change in scanner operation does not affect the scan output or the use of the scan data in the software. System requirements - The subject device DTX Studio diagnose is available for both Windows and Mac OS X operating systems. The primary predicate Cliniview (K162799) is only available for the Windows operating system. This change is supported by verification and validation testing conducted on both operating systems. ## VII. PERFORMANCE DATA #### Summary of Non-Clinical Testing: The performance of the subject device was verified and validated following the guidance provided in FDA Guidance General Principles of Software Validation", issued on January 11, 2002. This documentation includes testing which demonstrates that the requirements for the features have been met. Software Documentation for a Moderate Level of Concern, per the FDA guidance {9}------------------------------------------------ document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, is also included as part of this submission. No clinical data was used to support the decision of substantial equivalence. ## VIII. CONCLUSIONS The DTX Studio diagnose was evaluated for substantial equivalence using standard testing. Based on technological characteristics and non-clinical test data included in this submission, the DTX Studio diagnose was shown to be substantially equivalent to the Cliniview software (K162799).