(195 days)
The software is intended to be used at a dental laboratory. The software uses patient-specific data from scanners, e.g. a scanned geometry, and facilitates the CAD of individual restorative solutions based on these data, such as a supporting dental framework, dental abutments, copings, crowns, and bridges. The software also serves as a means of creating and managing of cases, and the ordering of products.
NobelDesign (also marketed as DTX Studio design) is an integrated CAD Software in a cockpit application that enables the user to design dental restorations. The software receives and reads scan data containing topographical characteristics of real teeth and dental impressions from extra and intra-oral scanners. The NobelDesign/DTX Studio design software uses the data and it integrates a third-party software used to perform the CAD design of the dental restorations. Using this software, the user can create and track cases, scan models and design prosthetics restorations (excluded implant/abutment interface). The output of the device is a computer file which contains the dental restoration design in a digital form. The dental restoration is manufactured in Nobel Biocare registered facilities using the digital format. Prosthetic restorations (excluding prosthetic restorations with implant/abutment interface or as part of a multi-piece or Ti-base abutment under 872.3630, NHA) can also be designed with the software but can be manufactured in the dental lab, using 510k cleared material for this purpose (872.3770, EBG).
This document does not contain the detailed information necessary to complete all sections of your request. It is a 510(k) summary for a medical device (NobelDesign/DTX Studio Design software) and focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed performance study with acceptance criteria and results.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document states that "Design Control Activities including risk management following the ISO 14971:2012 verification/validation testing, was conducted... This documentation includes testing which demonstrates that the requirements for the features have been met." However, it does not specify what those requirements (acceptance criteria) were or the quantitative results of the performance testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not explicitly provided for a specific test set. The document mentions "an entire end-to-end validation (scan, design, and order) for multiple worst-case scenario scan and design requirements," but details about the sample size (number of scans, designs, or orders), the nature of the data, or its provenance are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in this document. This software is a CAD design tool, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the software as enabling "the user to design dental restorations" and facilitating "the CAD of individual restorative solutions." This implies human-in-the-loop operation, as it's a design tool. Therefore, a purely standalone algorithm evaluation would likely not be applicable or relevant to this device's function. The document does not describe a standalone performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions "an entire end-to-end validation (scan, design, and order)." For CAD design software, "ground truth" would likely relate to the accuracy and precision of the digital designs compared to predefined specifications or validated physical models, and the fidelity of the manufacturing output to the digital design. However, the specific type of "ground truth" or how it was established is not detailed. It's implied that designs are evaluated against "design requirements" and "manufacturing specifications."
8. The sample size for the training set
This information is not applicable in the context of this document. The software described is a CAD design tool, not a machine learning model that undergoes "training." Its functionality is based on predefined algorithms for geometric design and integration, not on learning from a large dataset.
9. How the ground truth for the training set was established
This information is not applicable as the document does not describe a training set for machine learning.
Summary of what is available from the document:
- Device Name: NobelDesign / DTX Studio Design
- Device Type: CAD Software for dental restorations (abutments, copings, crowns, bridges)
- Purpose of Study (as described): Software verification and validation activities conducted under Design Control Activities, following ISO 14971:2012 and FDA Guidance General Principles of Software Validation. This demonstrated that "requirements for the features have been met."
- Validation Scope: "An entire end-to-end validation (scan, design, and order) for multiple worst-case scenario scan and design requirements."
- Regulatory Compliance: Conformance with IEC 62304:2006 standards. FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" (May 2005) guidance was also followed for documentation.
For a detailed answer to your request, the original 510(k) submission document, particularly the verification and validation reports, would need to be reviewed, as the summary provided here does not contain that level of detail.
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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 seal on the left and the FDA acronym followed by the words "U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the text.
November 29, 2017
Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Sasvi Ranch Parkway Yorba Linda, California 92887
Re: K171466
Trade/Device Name: NobelDesign, DTX Studio Design Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, NOF Dated: November 2, 2017 Received: November 3, 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);
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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,
Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171466
Device Name NobelDesign /DTX Studio Design
Indications for Use (Describe)
The software is intended to be used at a dental laboratory. The software uses patient-specific data from scanners, e.g. a scanned geometry, and facilitates the CAD of individual restorative solutions based on these data, such as a supporting dental framework, dental abutments, copings, crowns, and bridges. The software also serves as a means of creating and managing of cases, and the ordering of products."
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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1.0 510(k) Summary
I. Submitter
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 x7830 Fax: (714) 998-9348
Submitted for:
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Date prepared: November 28, 2017
II. Device
Device Proprietary Names:
| Trade name No. 1: | NobelDesign |
|---|---|
| Trade name No. 2: | DTX Studio design |
| Primary Classification Name: | Endosseous Dental Implant Abutment |
| Primary Regulation Number: | 21 CFR 872.3630 |
| Primary Product Code: | NHA |
| Device Classification | 2 |
| Secondary Product Code: | NOF |
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Predicate Device III.
Substantial equivalence is claimed to the following predicate devices:
- Primary Predicate: ●
- o NobelDesign Software, K153036, Nobel Biocare
- Reference Predicates
Device Description IV.
NobelDesign (also marketed as DTX Studio design) is an integrated CAD Software in a cockpit application that enables the user to design dental restorations.
The software receives and reads scan data containing topographical characteristics of real teeth and dental impressions from extra and intra-oral scanners. The NobelDesign/DTX Studio design software uses the data and it integrates a third-party software used to perform the CAD design of the dental restorations.
Using this software, the user can create and track cases, scan models and design prosthetics restorations (excluded implant/abutment interface). The output of the device is a computer file which contains the dental restoration design in a digital form. The dental restoration is manufactured in Nobel Biocare registered facilities using the digital format. Prosthetic restorations (excluding prosthetic restorations with implant/abutment interface or as part of a multi-piece or Ti-base abutment under 872.3630, NHA) can also be designed with the software but can be manufactured in the dental lab, using 510k cleared material for this purpose (872.3770, EBG).
NobelDesign/DTX Studio design includes the following features:
- Case Manager: enter and edit the general information of the case, the patients details . as well as information related to the restorations to be designed;
- Scan Center: allows for scanning the needed objects for designing all types of supported restorations;
- CAD Design: allows for virtual design of different types of restorations; ●
- Integrated workflow with NobelClinician (K163122)
- Order Manager: allows for ordering designed components and order tracking
- Export of digital design (.STL) for prosthetic restorations (e.g., TempShell or other ● prosthetic restorations that exclude devices with implant/abutment interface or as part
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of a multi-piece or Ti-base abutment under 872.3630, NHA), per 872.3661, NOF
Each Nobel Biocare abutment designed in the software has been previously FDA cleared with its own specifications and requirements.
V. Indications for Use
The software is intended to be used at a dental clinic or a dental laboratory. The software uses patient-specific data from scanners, e.g. a scanned geometry, and facilitates the CAD of individual restorative solutions based on these data, such as a supporting dental framework, dental abutments, copings, crowns, and bridges. The software also serves as a means of creating and managing of cases, and the ordering of products.
VI. Comparison of Technological Characteristics
NobelDesign/DTX Studio design and the previous cleared NobelDesign version share the following characteristics:
- Intended for design of dental restorative solutions for the maxilla and mandible .
- Integrated CAD software ●
- Supports use of imaging data imported from extra-oral scanners. ●
- Allows for ordering designed restorations from Nobel Biocare manufacturing facilities.
NobelDesign/DTX Studio design is different from the previous cleared NobelDesign version as follows:
- . Allows for exchange of treatment plan data with NobelClinician (K163122)
- Supports use of imaging data imported from intra-oral scanners (e.g. STL import). ●
- Design of prosthetic restorations (e.g., TempShell or other prosthetic restorations that ● exclude devices with implant/abutment interface or as part of a multi-piece or Ti-base abutment under 872.3630, NHA), per 872.3661, NOF
- New User Interface layout and tools to facilitate the execution of common tasks. ●
- Increased number of supported products compared to NobelDesign v1.0 ●
List of restorations available in the software:
| Product name | 510k reference |
|---|---|
| Procera Implant Bridge Zirconia | K974150 |
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| Nobelactive Wide Platform (WP) | K133731 |
|---|---|
| Esthetic Zirconia Abutment | K031719 |
| NobelActive Zirconia Abutment | K072129 |
| NobelProcera Angulated Screw Channel Abutment Conical Connection | K132746 |
| NobelProcera Ti Abutment | K091756 |
| NobelProcera Ti Abutment Camlog Platforms | K122602 |
| NobelProcera Zi Abutment | K091904 |
| Procera Implant Bridge Zirconia | K053091 |
| NobelProcera Implant Bridge Zirconia | K091907 |
| Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | K041236 |
| Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | K043042 |
| NobelProcera Implant Bridge | K091848 |
| NobelProcera HT ML Full Contour Zirconia Crown | K153534 |
| Procera Copings and Pontic | K032562 |
| Procera Bridge Zirconia | K041283 |
| Procera Bridge Zirconia | K053125 |
| Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 To 30-4013 | K071182 |
| Coping CoCr | Exempt* |
| Bridge CoCr | Exempt* |
| TempShell | K171466 |
*Note: Exempt devices per 872.3710 (EJH).
A short comparison of the subject and all predicate devices is provided in the table below.
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NobelDesign/DTX Studio design Traditional 510(k)
| Criteria | NobelDesign/DTXStudio design(Subject Device) | NobelDesign SoftwareK153036(Primary Predicate) | 3M Lava SoftwareK062493(Reference Predicate) | Zfx Dental CAD SystemK121709(Reference Predicate) | Notes |
|---|---|---|---|---|---|
| Indications forUse Statement | The software is intendedto be used at a dentalclinic or a dentallaboratory. The softwareuses patient-specific datafrom scanners, e.g. ascanned geometry, andfacilitates the CAD ofindividual restorativesolutions based on thesedata, such as asupporting dentalframework, dentalabutments, copings,crowns, and bridges. Thesoftware also serves as ameans of creating andmanaging of cases, andthe ordering of products. | The NobelDesignSoftware uses patient-specific data fromscanners and defines theshapes of dentalprosthetic devices suchas dental abutments,copings, crowns andbridges through the useof a CAD tool. Thesoftware also serves as ameans of creating,ordering and managingcases. | The Lava software isused with 3M ESPE'sLava system, an all-ceramic system for theCAD/CAM fabricationof dental restorationssuch as inlays, onlays,veneers, crowns andbridges.The software controls themeasuring process,processing of themeasurement data (3D-CAD tool), and export ofthe data to the millingmachine. In addition,various patient and caseinformation elements canbe entered. Otherfunctions are availablefor verification andservice of the measuringsystem.The Lava software alsofacilitates the transfer of3D data from a scannerto a remote millingmachine via internet. | The Zfx Dental CADSystem is intended to allowthe user to acquire patientspecific data via a scan ordigital file and define theshapes of dental prostheticdevices such as dentalabutments, crowns, bridges,copings, in-lays, on-lays,and veneers through the useof a 3D-CAD tool. ZfxDental CAD System createsan output file of therestorations designed by theuser that can bemanufactured using a CAMsystem. | Change: inclusion ofindication ofprofessional use,difference in verbiage(to ensure moreclarity to theindications) |
| Classificationcode | NHA, NOF | NHA | NHA, EIH | NHA, NOF | Change: addtionl ofNOF product code |
| Criteria | NobelDesign/DTXStudio design(Subject Device) | NobelDesign SoftwareK153036(Primary Predicate) | 3M Lava SoftwareK062493(Reference Predicate) | Zfx Dental CAD SystemK121709(Reference Predicate) | Notes |
| Anatomic areas | MaxillaMandible | MaxillaMandible | MaxillaMandible | MaxillaMandible | Same |
| Design options | Prosthetic restorationssuch as dental abutments,copings, crowns andbridges. Allows forselection of specificNobel Abutment designsincluding materialcomposition | Dental restorations suchas dental abutments,copings, crowns andbridges. Allows forselection of specificNobel Abutment designsincluding materialcomposition | Dental restorations suchas inlays, onlays,veneers, crowns andbridges | Dental prosthetic devices:dental abutments, crowns,bridges, copings, in-lays,on-lays, and veneers | Same |
| Computerformat | PC – Windows based | PC - Windows based | PC – Windows based | PC – Windows based | Same |
| CADcomponent | Integrated | Integrated | Information not available | Integrated | Same |
| Input | Digital surface scan dataimage/impression of thepatient's oralenvironment from intra-or extra-oral scanners.Allows for exchange oftreatment plan data withNobelClinician. | Digital data fromdesktop scanner | Open digital file from ascanner (STL) | STL file from a scanner | Change: Addedsupport of intra-oral scanners andinterface withtreatment planningsoftware |
| Output | Encrypted proprietaryformat (NDO file) sent toNobel Biocaremanufacturing facility.Encrypted and non-encrypted CAD design ofa prosthetic restoration | Encrypted proprietaryformat (NDO file) sent toNobel Biocaremanufacturing facility | 3D data (plain scan dataor fully modelled data).Project file to be sent formillingSTL file 3D data (plainscan data or fullymodelled data). Projectfile to be sent for milling | STL file to a Zimmer Dentalmilling center | Change: Added optionto export a non-encrypted STL file ofprosthetic restorationssuch as the TempShellor other prostheticrestorations, excludingdevices withimplant/abutment |
| Criteria | NobelDesign/DTXStudio design(Subject Device) | NobelDesign SoftwareK153036(Primary Predicate) | 3M Lava SoftwareK062493(Reference Predicate) | Zfx Dental CAD SystemK121709(Reference Predicate) | Notes |
| such as the TempShell(STL file) | interface or as part ofa multi-piece or ti-base abutment under872.3630, NHA |
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Discussion:
NobelDesign/DTX Studio design allows the design of prosthetics restorations. Compared to previous NobelDesign 1.0, the new software version 1.4 supports more Nobel Biocare products, it allows the exchange of treatment plan with NobelClinician (K163221), it now supports use of imaging data from an intra-oral scanner (e.g. STL import); it allows the design and exporting of prosthetic restorations (excluding prosthetic restorations with implant/abutment interface or as part of a multi-piece or Ti-base abutment under 872.3630, NHA), per 872.3661, NOF. The prosthetic restorations (excluding prosthetic restorations with implant/abutment interface or as part of a multi-piece or Ti-base abutment under 872.3630, NHA) can then be manufactured in the dental lab, using a 510k cleared material for this purpose.
The functionality of design prosthetic restorations under 872.3661, NOF code was cleared within the Zfx Dental CAD System, K121709, while the functionality of exporting digital design data for manufacturing on a local milling machine was cleared within the 3M Lava Software (K062493). Compared with the NobelDesign 1.0, a similar capability will now be available for NobelDesign/DTX Studio design for prosthetic restorations (excluding prosthetic restorations with implant/abutment interface or as part of a multi-piece or Tibase abutment under 872.3630, NHA), per 872.3661, NOF.
Prosthetic restorations with implant/abutment interface or as part of a multi-piece or Ti-base abutment under 872.3630. NHA will be sent to a Nobel Biocare FDA registered facility for validation of the design for appropriate dimensions and manufacturing.
VII. Performance Data
The device is designed and manufactured under the Quality System Regulations as outline 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 14971:2012 verification/validation testing, was conducted and are included in this submission. The performance of the subject device 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
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Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.
VIII. Conclusion
Based on the substantial equivalence evaluation and the software verification/validation activities described above, NobelDesign/DTX Studio design is substantially equivalent to the identified previously predicate devices referenced in this submission.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)