NobelClinician, DTX Studio implant

K163122 · Nobel Biocare AB · LLZ · Jan 31, 2017 · Radiology

Device Facts

• Record ID: K163122
• Device Name: NobelClinician, DTX Studio implant
• Applicant: Nobel Biocare AB
• Product Code: LLZ · Radiology
• Decision Date: Jan 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

Software interface for dental/cranio-maxillofacial diagnostic and treatment planning. Inputs: DICOM data from (CB)CT scanners, intraoral surface scans (STL), and proprietary NXA files. Transforms inputs via visualization, alignment of surface data to DICOM, and automated tooth setup design. Outputs: surgical plans, implant positions, and surgical template designs for manufacturing; treatment plans for dental restoration design. Used in clinical settings by dental professionals. Facilitates prosthetic-driven implant planning, guided surgery, and post-operative evaluation via volume-based matching. Benefits: improved surgical precision, streamlined restorative workflows, and enhanced diagnostic visualization.

Clinical Evidence

Bench testing only. Software verification and validation performed per EN IEC 62304:2006.

Technological Characteristics

Software-based image processing and planning system. Operates on PC (Windows) and MAC (OS). Supports DICOM, STL, and proprietary NXA formats. Features include 3D model editing, surface-to-DICOM alignment, automated tooth setup, and volume-based matching. Connectivity via NobelConnect and NobelClinician® Viewer.

Indications for Use

Indicated for dental and cranio-maxillofacial diagnostic support, treatment planning, follow-up, guided implant surgery, and dental restorative design input/review.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• NobelClinician® (K123976)

Reference Devices

• Implant Studio 2015 (K152078)
• coDiagnostix Implant Planning Software (K130724)
• Simplant 2011 (K110300)
• Swissmeda Dental Planning System (K112251)
• InVivo Dental (K123519)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

| FORM FDA 3881 (8/14) | Page 1 of 1 |
|----------------------|-------------|
|----------------------|-------------|

PSC Publishing Services [phone] EF

(อิโบร วัสติ ยา) 10-องเข้าวหารของแม่ :SSFESSFA
(อิโซรี อัลบี 61) 10-องค้าวิธาราชวันที่ :SSF รอมพิ

{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: [phone] x7830 Fax: [phone]

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®<br>(K123976) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use Statement | NobelClinician® (DTX Studio<br>Impant) is a software interface<br>for the transfer and visualization<br>of 2D and 3D image information<br>from equipment such as a CT<br>scanner for the purposes of<br>supporting the diagnostic process, | The NobelClinician® software is a<br>software interface for the transfer<br>and visualization of imaging<br>information from equipment such<br>as a CT scanner or a magnetic<br>resonance scanner for the<br>purposes of diagnosis and |
| | treatment planning and follow-up<br>in the dental and cranio-<br>maxillofacial regions.<br><br>NobelClinician® (DTX Studio<br>Implant) can be used to support<br>guided implant surgery and to<br>provide design input for and<br>review of dental restorative<br>solutions. The results can be<br>exported to be manufactured. | treatment planning in the dental<br>and cranio-maxillofacial regions.<br><br>The NobelClinician® software can<br>be used to design a surgical<br>template for the purposes of<br>aiding placement of dental<br>implants. |
| Anatomic Areas | Maxilla<br>Mandible<br>Cranio-maxillofacial | Maxilla<br>Mandible<br>Cranio-maxillofacial |
| Input | DICOM data from (CB)CT<br>scanner<br>Digital data of the intraoral<br>situation (open file format such<br>as STL)<br>NXA format (proprietary format) | DICOM data from (CB)CT<br>scanner<br>N/A<br>N/A |
| Software<br>Features | Create and manage planning<br>scenarios and treatments<br>Create and edit 3D Models<br>Alignment of radiographic guide<br>and patient model<br>Adding an implant, abutments<br>and anchor pins to a planning<br>Surgical template creation from<br>radiographic guide<br>Alignment of intraoral surface<br>data (proprietary or open format)<br>with (CB)CT data<br>Automatic tooth setup design<br>Surgical template calculation<br>from intraoral surface data<br>Pilot drill sleeves<br>Volume based matching of data<br>(such as voxel base matching of | Create and manage planning<br>scenarios and treatments<br>Create and edit 3D Models<br>Alignment of radiographic guide<br>and patient model<br>Adding an implant, abutments and<br>anchor pins to a planning<br>Surgical template creation from<br>radiographic guide<br>N/A<br>N/A<br>N/A<br>N/A<br>N/A |
| | (CB)CT data, surface alignment<br>of 3D data) | |
| Data Sharing | NobelConnect<br>NobelClinician® Viewer<br>NobelDesign® (DTX Studio design) | NobelConnect<br>NobelClinician® Viewer |
| Output | Export surgical template design<br>for centralized production in<br>Nobel Biocare facilities | Export surgical template design<br>for centralized production in<br>Nobel Biocare facilities |
| | Export surgical template design<br>(proprietary or open format) to be<br>manufactured | N/A |
| | Export treatment plan for dental<br>restoration design in<br>NobelDesign® (DTX Studio design) | N/A |
| | | |
| Design Options | Diagnostics<br>Prosthetic driven surgical<br>planning for dental implants<br>Creation of surgical templates<br>from a radiographic guide or<br>intraoral surface data<br>Treatment plan exchange with<br>NobelDesign® (DTX Studio<br>design) for dental restoration<br>design<br>Post-op evaluation – compare pre<br>and post op (CB)CT scans using<br>volume base matching | Diagnostics<br>Prosthetic driven surgical<br>planning for dental implants<br>Creation of surgical templates<br>from a radiographic guide<br>N/A<br>N/A |
| | | |
| | | |
| | | |
| | | |
| Computer<br>Format | PC – Windows based<br>MAC - OS | PC – Windows based<br>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.

---------------------------This space intentionally left blank----------------------------------------------------------------------------------------------------------------