(225 days)
DTX Studio design software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. DTX Studio design software is intended to be used by dental laboratory staff or a dental practitioner for designing patient specific component of a two-piece, one-piece or hybrid dental implant abutment. The single or multiple patient specific abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
DTX Studio design is a stand-alone software platform that integrates CAD software to render a design of a dental abutment. The software receives surface scan data containing topographical characteristics of real teeth, position and orientation of implants and uses also an integrated third-party software to perform the CAD design of the dental abutment. Additional functions include creating and tracking cases. The output of the device is a computer file containing the dental abutment in a digital form.
I am sorry, but the provided text from the FDA 510(k) K181932 submission for "DTX Studio design" does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets those criteria.
The document primarily focuses on:
- The FDA's letter confirming substantial equivalence.
- The Indications for Use.
- A comparison table between the subject device (DTX Studio design), a primary predicate device (3Shape Abutment Designer Software), and a reference predicate device (previous DTX Studio design K171466).
- A brief discussion of the comparison.
- A general statement about performance data, noting that the device was designed under Quality System Regulations (21 CFR § 820, ISO 13485:2016), conforms to EN IEC 62304:2006, and underwent design control activities including risk management (ISO 14971:2012) and verification/validation testing per FDA guidance.
It explicitly states: "This documentation includes testing which demonstrates that the requirements for the features have been met." However, it does not provide the specifics of:
- A table of acceptance criteria and the reported device performance: This is not present in the document.
- Sample size, data provenance, number of experts, qualifications, and adjudication methods for the test set: These details are not mentioned.
- Whether MRMC comparative effectiveness studies were done, or specific effect sizes: Not discussed. The device is CAD software, not an AI for diagnostic imaging interpretation in the traditional sense that would typically involve MRMC studies for reader performance improvement.
- Whether standalone (algorithm only) performance was done: While it's software, the performance data section is very general and doesn't specify standalone performance metrics.
- Type of ground truth used: Not specified.
- Sample size for the training set: Not mentioned.
- How ground truth for the training set was established: Not mentioned.
The information provided is typical for a 510(k) summary, which generally aims to demonstrate substantial equivalence to a predicate device rather than providing the granular detail of a comprehensive clinical study report or a detailed V&V report for software. For such detailed performance data, one would typically need access to the full 510(k) submission and supporting documentation, which is not usually made public in this summarized format.
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March 1, 2019
Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887
Re: K181932
Trade/Device Name: DTX Studio design Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: PNP, NHA Dated: January 24, 2019 Received: January 28, 2019
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. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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
Tina Kiang, Ph.D. for 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) K181932
Device Name DTX Studio design
Indications for Use (Describe)
DTX Studio design software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. DTX Studio design software is intended to be used by dental laboratory staff or a dental practitioner for designing patient specific component of a two-piece or hybrid dental implant abutment. The single or multiple patient specific abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
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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K181932 510(k) Summary
l. Submitter
Submitted by:
Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Contact Person: Charlemagne Chua Phone: (714) 282-4800 x7830 Fax: (714) 998-9348
Submitted for:
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Date prepared: 03/01/2019
II. Device
Device Proprietary Name:
| Trade name: | DTX Studio design |
|---|---|
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Primary Product Code: | PNP (Dental Abutment Design Software for Dental Laboratory) |
| Secondary Product Code : | NHA (Endosseous Dental Implant Abutment) |
| Device Classification | 2 |
III. Predicate/Reference Devices
Substantial equivalence is claimed to the following predicate devices:
- Primary Predicate:
- o 3Shape Abutment Designer Software K151455
- Reference Predicate
- o DTX Studio design K171466
IV. Device Description
DTX Studio design* is a stand-alone software platform that integrates CAD software to render a design of a dental abutment. The software receives surface scan data containing topographical characteristics of real teeth, position and orientation of implants and uses also an integrated third-party software to
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perform the CAD design of the dental abutment. Additional functions include creating and tracking cases. The output of the device is a computer file containing the dental abutment in a digital form. *Note: DTX Studio design will transition to a new name and will also be known as DTX Studio Lab.
In accordance with the classification of the dental abutment and the related 510k clearance, the output file can be sent to an FDA registered facility or can be used by 3″ party providers to manufacture the physical dental abutment based on their 510(k) product clearance.
The following functionality was added compared with the previously cleared DTX Studio design (K171466) software:
- Allow the user to design and order a NobelProcera Bar;
- Extension of the function to import STL files from different scan sources; ●
- Dental abutments may be produced from scan data from 30d party scanners for centralized production;
- Dental abutment design requests including intraoral scan be received in DTX Studio design from a clinician;
- . Implementation of verified and validated prosthetic libraries provided by 3″ parties to allow design and export for localized production.
These libraries contain a number of design parameters and product constraints, such as connection geometry, minimum thickness, titanium base, implant lab analog, screw channel angle, maximum angulation for abutments/2-piece abutment/ hybrid crown, abutment post height above implant collar;
- . Export of digital design file (.STL) for dental implant abutment (per 872.3630, NHA) for local production of patient-specific abutment components.
DTX Studio design is programmed in C++ and can be run on standard consumer PC running Windows 64bit.
V. Indications for Use
DTX Studio design software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. DTX Studio design software is intended to be used by dental laboratory staff or a dental practitioner for designing patient specific component of a two-piece, onepiece or hybrid dental implant abutment. The single or multiple patient
specific abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
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Nobel Biocare AB Traditional 510(k)
VI. Comparison of Technological Characteristics
| Subject DeviceDTX Studio design | Primary Predicate3Shape Abutment DesignerSoftware K151455 | Reference PredicateDTX Studio designK171466 | Notes | |
|---|---|---|---|---|
| Indications For Use | DTX Studio design software isintended as an aid to the restorationof chewing function in partially orfully edentulous mandibles andmaxillae. DTX Studio design softwareis intended to be used by dentallaboratory staff or a dentalpractitioner for designing patientspecific component of a two-piece,one-piece or hybrid dental implantabutment. The single or multiplepatient specific abutment design isintended to be used by themanufacturer of an endosseousdental implant abutment to createthe final device. | The 3Shape Abutment DesignerSoftware is intended as an aid to therestoration of chewing function inpartially or fully edentulousmandibles and maxillae. The 3ShapeAbutment Designer Software isintended for use by a dentalpractitioner or dental laboratorystaff for designing the patientspecific component of a two-piece,one-piece or hybrid dental implantabutment. The single or multi-unitabutment design is intended to beused by the manufacturer of anendosseous dental implantabutment to create the final device. | The software is intended to be usedat a dental clinic or a dentallaboratory. The software usespatient-specific data from scanners,e.g. a scanned geometry, andfacilitates the CAD of individualrestorative solutions based on thesedata, such as a supporting dentalframework, dental abutments,copings, crowns, and bridges. Thesoftware also serves as a means ofcreating and managing of cases, andthe ordering of products. | Equivalent toprimary predicate.Patient specific isadded since thesoftware is used todesign customizeddental abutments,based on thepatient anatomy. |
| Regulation Number | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Same |
| Regulation Name: | Endosseous Dental ImplantAbutment | Endosseous Dental ImplantAbutment | Endosseous Dental ImplantAbutment | Same |
| Regulatory Class | 2 | 2 | 2 | Same |
| Products Code* | PNP, NHA | PNP | NHA, NOF | See note below. |
| Intended user | Dental practitioner or dentallaboratory staff | Dental practitioner or dentallaboratory staff | Dental practitioner or dentallaboratory staff | Same |
| Features | ||||
| Case management | Yes | Yes | Yes | Same |
| Scan module | Yes | Yes | Yes | Same |
| CAD Design module | Yes | Yes | Yes | Same |
| Order module | Yes | Yes | Yes | Same |
| User interface | Workspace with 3D model | Workspace with 3D model | Workspace with 3D model | Same |
| Subject DeviceDTX Studio design | Primary Predicate3Shape Abutment DesignerSoftware K151455 | Reference PredicateDTX Studio designK171466 | Notes | |
| Wizards | Yes | Yes | Yes | Same |
| Visualization tools | Yes | Yes | Yes | Same |
| Safety limitations | Yes (warning and/or hard block) | Yes (warning and/or hard block) | Yes (warning and/or hard block) | Same |
| Configuration and settings | Controlled availability of products,based on the country of the userand the regulatory status. | Locked libraries for US | Controlled availability of products,based on the country of the userand the regulatory status. | Same as referencepredicate |
| User able to modifylibraries | No | No | No | Same |
| Input | Desktop and intraoral scanners | Desktop and intraoral scanners | Desktop and intraoral scanners | Same |
| Output | Computer file containing CAD model | Computer file containing CAD model | Computer file containing CAD model | Same |
| Device includes premanufactured prosthetics(per 872.3630) | No | No | No | Same |
| Milling location | Abutment Manufacturer or Dentallaboratory per the 510k clearance ofthe dental abutment | Abutment Manufacturer or Dentallaboratory per the 510k clearance ofthe dental abutment | Nobel Biocare | Same as primarypredicate |
| CAD Indications | ||||
| Customized abutment | Yes | Yes | Yes | Same |
| Anatomical abutment | Yes | Yes | Yes | Same |
| Screw retained abutment | Yes | Yes | Yes | Same |
| Wax up abutment** | Yes | Yes | Yes | Same |
| Implant bridge design | Yes | Yes | Yes | Same |
| Consumables | ||||
| Nobel Biocare prostheticlibraries | Yes | Yes | Yes | Same |
| 3rd party prostheticlibraries | Yes | Yes | No | Same as primarypredicate |
| CAD tools | ||||
| Measurement tool | Yes | Yes | Yes | Same |
| Align meshes | Yes | Yes | Yes | Same |
| Annotations | Yes | Yes | Yes | Same |
| Subject DeviceDTX Studio design | Primary Predicate3Shape Abutment DesignerSoftware K151455 | Reference PredicateDTX Studio designK171466 | Notes | |
| Virtual articulator | ત્વની દિવેલા તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉપયોગ તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખે | ત્વની દિવેલા તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉપયોગ તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખે | Yes | Same |
| Screenshot tool | Yes | Yes | Yes | Same |
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Nobel Biocare AB Traditional 510(k)
DTX Studio design K181932
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Nobel Biocare AB Traditional 510(k)
DTX Studio design K181932
Notes:
- Changes to subject software include both local and centralized milling of dental abutments, therefore PNP and NHA are included
**The design of a wax up abutment starts from an intial shape based on a scan of a wax up technique). The abutment design is then further optimized within DTX Studio design using CAD tools.
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VII. Discussion
The Indications for Use between the subject and the primary predicate devices are equivalent and the minor differences are to provide more clarity to the user, but do not alter the intended clinical use of the subject device.
DTX Studio design and the predicate 3Shape Abutment Designer Software are both standalone software used for the CAD design of dental abutments. Both software utilize a graphic user interface with a large 3D based main window, several visualization tools and implement a system of wizards that guide the user through all steps of the workflows.
DTX Studio design and the predicate include similar tools for the management of patient cases and for tracking the orders, can import of surface scan data and use proprietary file formats (for supporting specific desktop scanners), and can import an open file format.
DTX studio design provides similar CAD tools to design the same types of dental abutments available in the predicate 3Shape Abutment Designer. If the dental abutment design exceeds the safety limits, the user can experience a warning and a "hard stop", meaning that the user cannot continue designing, in the subject and predicate devices do not allow end-users changing the implant settings or safety limits in the libraries.
Both devices are capable of exporting the digital design to be used for manufacturing of the physical device, either by means of a proprietary format or an open format, such as the STL format.
VIII. Performance Data
DTX Studio design is designed and manufactured under the Quality System Regulations as outline in 21 CFR § 820 and ISO 13485:2016 Standards. This device is in conformance with the applicable parts of EN IEC 62304:2006 standards. Design Control Activities, including risk management following the ISO 14971:2012, verification/validation testing, were 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. This documentation includes testing which demonstrates that the requirements for the features have been met. Software documentation for Moderate Level of Concern and description of respective V&V activities, per the FDA guidance 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.
IX. Conclusion
Based on the comparison of the intended use, the features and workflows, the user interface, the technical characteristics, and based on the software verification activities described in this submission, DTX Studio design is found to be substantially equivalent to the identified Predicate Device.
§ 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.)