(84 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image visualization, planning, and export, without mentioning any AI/ML-specific functionalities.
No.
The device is a software interface for image visualization and processing to support diagnostic processes, treatment planning, and design input for dental solutions, but it does not directly apply a therapeutic effect to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software supports "the diagnostic process." The "Device Description" section also notes that it is used to "support the image-based diagnostic process."
Yes
The device description explicitly states it is a "software interface" and details its functions related to image visualization, planning, and export, without mentioning any accompanying hardware components that are part of the medical device itself. The performance studies focus on software verification and validation.
Based on the provided information, NobelClinician® (DTX Studio Implant) is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description of NobelClinician® clearly state that it processes and visualizes image data from equipment like CT scanners, photographic images, X-ray images, and surface scans. These are imaging modalities and data sources, not biological specimens.
- The purpose of NobelClinician® is to support diagnostic processes, treatment planning, and follow-up based on imaging. While it supports the diagnostic process, it does so by providing tools for visualizing and analyzing medical images, not by performing tests on biological samples to diagnose a condition.
Therefore, NobelClinician® falls under the category of medical imaging software or treatment planning software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
NobelClinician® (DTX Studio Implant) is a software interface for the transfer and visualization of 2D and 3D image information from equipment such as a CT scanner for the purposes of supporting the diagnostic process, treatment planning and follow-up in the dental and cranio-maxillofacial regions.
NobelClinician® (DTX Studio Implant) can be used to support guided implant surgery and to provide design input for and review of dental restorative solutions. The results can be exported to be manufactured.
Product codes
LLZ
Device Description
NobelClinician® is a software interface used to support the image-based diagnostic process and treatment planning of dental, cranio-maxillofacial, and related treatments. The product will also be marketed as DTX Studio implant.
The software offers a visualization technique for (CB)CT images of the patient for the diagnostic and treatment planning process. In addition, 2D image data such as photographic images and X-ray images or surface scans of the intra-oral situation may be visualized to bring diagnostic image data together. Prosthetic information can be added and visualized to support prosthetic implant planning. The surgical plan, including the implant positions and the prosthetic information, can be exported for the design of dental restorations in NobelDesign® (DTX Studio design).
Surgical planning may be previewed using the software and the related surgical template may be ordered.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D and 3D image information from equipment such as a CT scanner; DICOM data from (CB)CT scanner; Digital data of the intraoral situation (open file format such as STL); NXA format (proprietary format)
Anatomical Site
dental and cranio-maxillofacial regions; Maxilla; Mandible; Cranio-maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Studies
- Software verification and validation per EN IEC 62304:2006
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K152078, K130724, K110300, K112251, K123519
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2017
Nobel Biocare AB % Chalemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway YORBA LINDA CA 92887
Re: K163122
Trade/Device Name: NobelClinician®, DTX Studio Implant Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 7, 2016 Received: November 8, 2016
Dear Chalemagne 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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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/Resourcesfor You/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.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K163122 |
|---|---|
| Device Name | NobelClinician(R) |
| DTX Studio Implant |
Indications for Use (Describe)
NobelClinician® (DTX Studio Implant) is a software interface for the transfer and visualization of 2D and 3D image
information from equipment such as a CT scanner for the purposes of supporting the diagnostic process, treatment
planning and follow-up in the dental and cranio-maxillofacial regions.
NobelClinician® (DTX Studio Implant) can be used to support guided implant surgery and to provide design input for and
review of dental restorative solutions. The results can be exported to be manufactured.
| 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) |
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|---|---|
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3
1.0 510(k) Summary
Submitter I.
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 Goteburg, SE-411 17 Sweden
Date Prepared: January 11, 2017
II. Device
Device Proprietary Name(s):
| Trade Name No. 1: | NobelClinician® |
|---|---|
| Trade Name No. 2: | DTX Studio Implant |
| Common or Usual Name: | Picture Archiving and Communications System |
| Classification Name: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Device Classification | 2 |
III. Predicate Device
Substantial equivalence is claimed to the following device:
- . NobelClinician®, K123976, Nobel Biocare AB
4
The following reference devices are cited within the submission:
- Implant Studio 2015, K152078, 3Shape Medical A/S ●
- coDiagnostix Implant Planning Software, K130724, Straumann USA
- Simplant 2011, K110300, Materialise Dental NV
- Swissmeda Dental Planning System, K112251, Swissmeda AG ●
- InVivo Dental, K123519, Anatomage, Inc. ●
IV. Device Description
NobelClinician® is a software interface used to support the image-based diagnostic process and treatment planning of dental, cranio-maxillofacial, and related treatments. The product will also be marketed as DTX Studio implant.
The software offers a visualization technique for (CB)CT images of the patient for the diagnostic and treatment planning process. In addition, 2D image data such as photographic images and X-ray images or surface scans of the intra-oral situation may be visualized to bring diagnostic image data together. Prosthetic information can be added and visualized to support prosthetic implant planning. The surgical plan, including the implant positions and the prosthetic information, can be exported for the design of dental restorations in NobelDesign® (DTX Studio design).
Surgical planning may be previewed using the software and the related surgical template may be ordered.
V. Indications for Use
NobelClinician® (DTX Studio Implant) is a software interface for the transfer and visualization of 2D and 3D image information from equipment such as a CT scanner for the purposes of supporting the diagnostic process, treatment planning and follow-up in the dental and cranio-maxillofacial regions.
NobelClinician® (DTX Studio Implant) can be used to support guided implant surgery and to provide design input for and review of dental restorative solutions. The results can be exported to be manufactured.
5
VI. Comparison of Technological Characteristics
NobelClinician® and the predicate device share the following characteristics:
- Treatment of same anatomic areas (maxilla, mandible, and cranio-maxillofacial)
- . Patient data management features
- 3D planning environment ●
- Creation of surgical templates (through a radiographic guide workflow) ●
- Communication module (data sharing capability) using NobelConnect and ● NobelClinician® Viewer
- . Order module
- . Support of the NobelGuide1 clinical concept for oral rehabilitation based on dental implants.
NobelClinician® is technologically different from the predicate device as follows:
- . Acceptance of surface data from the intraoral situation. This surface information is aligned to DICOM data to support the prosthetic implant planning and guided surgery protocols.
- For partially edentulous patients, the shape of missing teeth is automatically designed
- Creation of surgical template based on intraoral surface data
- Export of the surgical template design to be manufactured ●
- . Export of the treatment plan for dental restoration design in NobelDesign® (DTX Studio design)
- Option to design surgical templates for fully guided implant insertion or pilot drill ●
- . Volume based matching of data such as voxel base matching of (CB)CT (e.g. for postop evaluation), and surface alignment of 3D data
A comparison of the subject and predicate devices is provided in the table below.
| Parameter | NobelClinician® | NobelClinician®
(K123976) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use Statement | NobelClinician® (DTX Studio
Impant) is a software interface
for the transfer and visualization
of 2D and 3D image information
from equipment such as a CT
scanner for the purposes of
supporting the diagnostic process, | The NobelClinician® software is a
software interface for the transfer
and visualization of imaging
information from equipment such
as a CT scanner or a magnetic
resonance scanner for the
purposes of diagnosis and |
| | treatment planning and follow-up
in the dental and cranio-
maxillofacial regions.
NobelClinician® (DTX Studio
Implant) can be used to support
guided implant surgery and to
provide design input for and
review of dental restorative
solutions. The results can be
exported to be manufactured. | treatment planning in the dental
and cranio-maxillofacial regions.
The NobelClinician® software can
be used to design a surgical
template for the purposes of
aiding placement of dental
implants. |
| Anatomic Areas | Maxilla
Mandible
Cranio-maxillofacial | Maxilla
Mandible
Cranio-maxillofacial |
| Input | DICOM data from (CB)CT
scanner
Digital data of the intraoral
situation (open file format such
as STL)
NXA format (proprietary format) | DICOM data from (CB)CT
scanner
N/A
N/A |
| Software
Features | Create and manage planning
scenarios and treatments
Create and edit 3D Models
Alignment of radiographic guide
and patient model
Adding an implant, abutments
and anchor pins to a planning
Surgical template creation from
radiographic guide
Alignment of intraoral surface
data (proprietary or open format)
with (CB)CT data
Automatic tooth setup design
Surgical template calculation
from intraoral surface data
Pilot drill sleeves
Volume based matching of data
(such as voxel base matching of | Create and manage planning
scenarios and treatments
Create and edit 3D Models
Alignment of radiographic guide
and patient model
Adding an implant, abutments and
anchor pins to a planning
Surgical template creation from
radiographic guide
N/A
N/A
N/A
N/A
N/A |
| | (CB)CT data, surface alignment
of 3D data) | |
| Data Sharing | NobelConnect
NobelClinician® Viewer
NobelDesign® (DTX Studio design) | NobelConnect
NobelClinician® Viewer |
| Output | Export surgical template design
for centralized production in
Nobel Biocare facilities | Export surgical template design
for centralized production in
Nobel Biocare facilities |
| | Export surgical template design
(proprietary or open format) to be
manufactured | N/A |
| | Export treatment plan for dental
restoration design in
NobelDesign® (DTX Studio design) | N/A |
| | | |
| Design Options | Diagnostics
Prosthetic driven surgical
planning for dental implants
Creation of surgical templates
from a radiographic guide or
intraoral surface data
Treatment plan exchange with
NobelDesign® (DTX Studio
design) for dental restoration
design
Post-op evaluation – compare pre
and post op (CB)CT scans using
volume base matching | Diagnostics
Prosthetic driven surgical
planning for dental implants
Creation of surgical templates
from a radiographic guide
N/A
N/A |
| | | |
| | | |
| | | |
| | | |
| Computer
Format | PC – Windows based
MAC - OS | PC – Windows based
MAC - OS |
1See Section 9.3
6
7
Discussion
As seen above, the subject and predicate devices have similar indications for use statements. Slight differences in wording allow for clarity and align with the added functionality within the subject device. These changes in the indications for use statement do not alter the intended use of the product.
8
Added software features within the subject device provide users with more flexibility and options to support the diagnostic process and treatment planning. These technological differences are addressed by the performance data identified below and do not raise different questions of safety or effectiveness.
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Studies
- Software verification and validation per EN IEC 62304:2006 ●
VIII. Conclusion
Although minor differences in design and technology exist between the subject and predicate device, the testing cited above supports these differences. Therefore, it is concluded that the NobelClinician® is substantially equivalent to the predicate devices.
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