NobelDesign Software

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and appear to be emerging from a single form. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 2, 2016 Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare, USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887 Re: K153036 Trade/Device Name: NobelDesign Software Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 21, 2016 Received: April 22, 2016 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 {1}------------------------------------------------ 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### CEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) #### K153036 Device Name NobelDesign Software #### Indications for Use (Describe) The NobelDesign Software uses patients data from scanners and defines the shapes of dental prosthetic devices such as dental abutinents, copings and bridges through the use of a CAD tool. The software also serves as a means of creating, ordering and managing cases 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. 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OMS No. 0913-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ #### A.4 510(k) Summary | Submitter: | Nobel Biocare AB | |--------------------------------|------------------------------------------------------------------------------------| | Address: | Vastra Hamngatan 1<br>Goteborg, SWEDEN 411 17 | | Establishment Registration No. | 9611992 | | Submitted By: | Nobel Biocare, USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA. 92887 | | Establishment Registration No. | 2027971 | | Contact Person: | Charlemagne Chua<br>Senior Regulatory Affairs Manager<br>Telephone: (714) 282-4800 | | Date Prepared: | June 2, 2016 | | Classification and Device Name | | | Classification Name: | Endosseous Dental Implant Abutment | | Regulation Number: | NHA (21 CFR 872.3630) | | Trade/Propriety Name: | Nobel Design Software | ## 1. Predicate Device(s): | 510(K) Number | Product Name | Manufacturer | Clearance Date | |---------------|------------------|---------------|----------------| | K053602 | Procera Software | Nobel Biocare | Feb 10, 2006 | | | | | | ## 2. Reason for Submission: New Device ## 3. Device Description: NobelDesign software is an integrated CAD Software in a cockpit application that enables the user to scan, design and order the designed products (prosthetics). The software is a solution that allows the use of the NobelProcera 2G scanner and integrates a third party software which is used to perform the actual design (CAD design) for the previously cleared Nobel Biocare patient specific dental implant abutments and implant bridges. Using this system it is possible for the user to create and track cases, scan models and order NobelProcera prosthetics from the global production resources of Nobel Biocare. NobelDesign v1.0 includes to the following modules: {4}------------------------------------------------ - . Design Setup. Module to allow users to define restoration type and design on which tooth position - Scan Center. Module to assist in acquiring all required scans for the design . setup. - Case Management. Module with tools to help manage designs. ● - Basic Application. Basic functionality (About, Help framework) are in place. ● - Order Manager. Module for ordering designed components and order tracking. ● - CAD Design. Module to allows designing of different types of restorations . virtually with easy to use tools. Each physical product (prosthetic) which is designed in the software has been previously FDA cleared with its own specifications and requirements. # 4. Indications for Use: The NobelDesign Software uses patient-specific data from scanners and defines the shapes of dental prosthetic devices such as dental abutments, copings and bridges through the use of a CAD tool. The software also serves as a means of creating, ordering and managing cases. | Criteria | NobelDesign Software<br>(Subject Device) | Procera Software<br>(K053602)<br>Predicate Device | Notes | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications<br>for Use | The NobelDesign Software<br>uses patient-specific data<br>from scanners and defines<br>the shapes of dental<br>prosthetic devices such as<br>dental abutments, copings,<br>crowns and bridges through<br>the use of a CAD tool. The<br>software also serves as a<br>means of creating, ordering<br>and managing cases. | Nobel Biocare's Procera<br>Software imports patient<br>specific data from<br>scanners and defines the<br>shapes of dental prosthetic<br>devices such as dental<br>abutments, copings,<br>laminates and bridges<br>through the use of a 3D-<br>CAD tool. The software<br>also serves as means of<br>ordering and managing<br>orders of Procera products | Slight difference<br>with the addition<br>of crowns and<br>removal of<br>laminate. The<br>addition of<br>crowns to bridge<br>design does not<br>change the<br>intended use of<br>the device | | Intended<br>use | The software is intended to<br>be used at a dental clinic or<br>a dental laboratory. The<br>software uses patient-<br>specific data, e.g., a<br>scanned geometry, and | The Procera Software is<br>intended to be used at the<br>lab/clinic to import patient<br>specific data (eg a scanned<br>geometry of a tooth) and<br>design a patient specific | Same | | Criteria | NobelDesign Software<br>(Subject Device) | Procera Software<br>(K053602)<br>Predicate Device | Notes | | facilitates the CAD of an<br>individual restorative<br>solution based on these<br>data, e.g., a supporting<br>dental framework. The<br>design data of the<br>individualized design and<br>any associated<br>standardized components<br>are transmitted via a<br>network to a production<br>facility where the<br>individualized prosthetic<br>device is manufactured. | restorative solution based<br>on these data (eg a dental<br>prosthetic framework or a<br>coping). The CAD designed<br>solution is sent via internet<br>to the Procera Production<br>facility. | | | | Anatomic<br>areas | Maxilla<br>Mandible | Maxilla<br>Mandible | Same | | Design<br>options | Dental abutments, copings,<br>crowns and bridges. Allows<br>for selection of specific<br>Nobel Abutment design<br>including material<br>composition | Dental abutments, copings,<br>laminates and bridges | The design<br>options allows for<br>inclusion of more<br>information in the<br>design output in<br>addition to just<br>dimensions. | | Computer<br>format | PC - Windows based | PC - Windows based | Same | | CAD<br>component | Integrated | Separate | The CAD module<br>contains similar<br>functions as the<br>predicate but is<br>not integrated<br>into a single<br>system with scan<br>and ordering<br>modules | | Input | STL file from a scanner | STL file from a scanner | Same<br>(The compatible<br>scanner has<br>been updated<br>from the<br>predicate). | | Output | Encrypted proprietary format<br>(.NDO file) sent to Nobel<br>Biocare manufacturing | Proprietary format (.bcf<br>.c3b file) sent to Nobel<br>Biocare manufacturing | The NobelDesign<br>file format (.NDO)<br>is the only | | Criteria | NobelDesign Software<br>(Subject Device) | Procera Software<br>(K053602)<br>Predicate Device | Notes | | | facility | facility. | encrypted file.<br>However, both file<br>formats are<br>proprietary and<br>contain<br>information for<br>the Nobel Biocare<br>manufacturing<br>facility. | # 5. Comparison of Technological Characteristics {5}------------------------------------------------ {6}------------------------------------------------ ## Discussion: The identified differences between the submission device and the identified predicate do not affect the substantial equivalence of the device as the changes only allow for the amount and type of information provided by the dental laboratory to Nobel Biocare. The final abutment design and all other screw retained restorations (e.g., abutments, crowns and bridges) will continue to be sent to a Nobel Biocare facility for validation of the design for appropriate dimensions and manufacturing. ## 6. Testina The device is designed and manufactured under the Quality System Requlation as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of IEC 62304 (2006) standards. Design Control Activities including risk management following the ISO 14971 verification/validation testing, was conducted and are included in this submission. The performance of the NobelDesign software was verified and validated following the guidance provided in FDA Guidance General Principles of Software Validation including an entire end-to-end validation (scan, design, and order) for multiple worst-case scenario scan and design requirements 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 document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission. ## 7. Substantial Equivalence Based on the substantial equivalence discussion and software verification //alidation activities described above. NobelDesign Software is substantially equivalent to the identified previously cleared predicate device referenced in this submission.