NOBELCLINICIAN
Device Facts
| Record ID | K123976 |
|---|---|
| Device Name | NOBELCLINICIAN |
| Applicant | Nobel Biocare AB |
| Product Code | LLZ · Radiology |
| Decision Date | Mar 26, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
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 in the dental and craniomaxillofacial regions. The NobelClinician software can be used to design a surgical template for the purposes of aiding placement of dental implants.
Device Story
NobelClinician is a software interface for transferring and visualizing 3D (CT/MRI) and 2D (photographic/X-ray) imaging data. Used by clinicians for dental and cranio-maxillofacial diagnostics and treatment planning; enables prosthetic-driven implant planning using digitized patient data and scanned radiographic guides. Features include 2D/3D viewer management, nerve structure editing, implant/abutment placement simulation, surgical template visualization, and order generation. Software supports clinical decision-making by allowing preview of surgical plans and creation of templates to aid implant placement, potentially improving surgical accuracy and patient outcomes.
Clinical Evidence
Bench testing only. Performance verified and validated following FDA guidance for the content of premarket submissions for software in medical devices.
Technological Characteristics
PC-based software (Windows/MAC). Functions as an image processing and visualization interface. Supports DICOM data import. Features include 3D model creation, nerve structure editing, implant/abutment planning, and surgical template design. No direct patient contact. Standalone software application.
Indications for Use
Indicated for dental and cranio-maxillofacial diagnosis and treatment planning, including surgical template design for dental implant placement. Intended for use by qualified dental professionals.
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
Submission Summary (Full Text)
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K123976
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### 510(k) Summary of Safety and Effectiveness 1.4
26 2013
| Submitted by: | Phuong Nguyen<br>Manager Regulatory Affairs | DATE | Clinician | PREDICATE<br>The Guided Surgery Concept<br>(K050393) | PREDICATE<br>Swissmeda Dental Planning<br>System<br>(K112251) | PREDICATE<br>Maxilim<br>(K052424) |
|----------------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 | | atient | DICOM<br>- Help assistant<br>- Create a new patient record<br>- Create and manage planning scenarios and treatments<br>- Create and edit 3D Models<br>- Create a snapshot of a viewer | DICOM<br>- Create a new patient record<br>- Create and edit 3D Models | DICOM<br>- Help assistant<br>- Create a new patient record<br>- Add images to a patient<br>- Create and manage planning scenarios and treatments<br>- Create and edit 3D Models<br>- Create a snapshot of a viewer |
| Telephone: | (714) 282-4800 x7830 | | a patient<br>nage<br>rios and | - Display and manipulate reslices | - Display and manipulate reslices | - Display and manipulate reslices |
| Facsimile: | (714) 998-9348 | | 3D Models<br>hot of a | - Define the dental curve shape | - Define the dental curve shape<br>- Define a new visualization for the volume model | - Annotate structures |
| Date of Submission: | December 21, 2012 | | anipulate | - Adding prosthetics information | - Adding prosthetics information | - Diagnostic 3D visualisation for diagnostics of maxillofacial anatomy |
| Classification Name: | System, Image Processing System, Radiology (21 CFR 892.2050) | | cal curve | - Alignment of radiographic guide and patient model | - Alignment of radiographic guide and patient model<br>- Indicate and edit nerve structures | - Measure the distance between 2 points |
| Trade or Proprietary<br>or Model Name: | NobelClinician | | isualization<br>model | - Annotate structures | - Adding an implant to a planning and edit | - Warning system |
| Legally Marketed Device(s): | Swissmeda Dental Planning System (K112251)<br>The Guided Surgery Concept (K050393)<br>Maxilim (K052424) | | tics<br>diographic<br>ent model | - Measure the distance between 2 points | - Adding an abutment to an implant | |
| | ures<br>visualisation<br>of<br>atomy<br>stance<br>ts | - Measure the plane angle between 2 points<br>- Indicate and edit nerve structures<br>- Adding an implant to a planning and edit | - Manage objects in a 2D and 3D viewer<br>- Surgical template visualization<br>- Approve function<br>- Create and send an order | | | |
### Device Description:
NobelClinician is a software interface for the transfer and visualization of imaging information: 3D imaging like medical or Cone Beam CT data, 2D imaging like photographic images and X-ray images. NobelClinician is used to support diagnostics and treatment planning for dental and cranio-maxillofacial treatment through the use of prosthetic-driven implant planning based on the digitized patient data and the scanned radiographic guide representing the ideal diagnostic tooth setup. The planning can be previewed using the software and a surgical template realizing the planning can be ordered.
### Indications for Use:
The NobelClinician 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 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.
### Summary of testing to demonstrate safety and effectiveness:
The performance of the NobelClinician software was verified and validated following the guidance provided in Guidance for the Content of Premarket Submissions for Software in Medical Devices.
### Conclusions:
The information provided in this submission demonstrates that NobelClinician is substantially equivalent to the predicate device.
Nobel Biocare Traditional 510(k) Notification NobelClinician December 2012
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Substantial Equivalence Comparison to Predicate Devices
510(k) Summary of Safety and Effectivenes
1.4
Nobel Biocare Traditional 510(k) Notification
NobelClinician
December 2012
K123976
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| CHARACTERISTIC | CANDIDATE | PREDICATE | PREDICATE | PREDICATE |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NobelClinician | The Guided Surgery Concept (K050393) | Swissmeda Dental Planning System (K112251) | Maxilim (K052424) |
| | | - Adding an abutment to an implant<br>- Manage objects in a 2D and 3D viewer<br>- Warning system<br>- Surgical template visualization<br>- Approve function<br>- Create and send an order | | |
| Intended use | - Measure the plane angle between 2 points<br>- Indicate and edit nerve structures<br>- Adding an implant to a planning and edit<br>- Adding an abutment to an implant<br>- Manage objects in a 2D and 3D viewer<br>- Warning system<br>- Surgical template visualization<br>- Approve function<br>- Create and send an order<br>- Diagnostics<br>- Surgical planning for dental implants<br>- Creation of surgical template | - Diagnostics<br>- Surgical planning for dental implants<br>- Creation of surgical template | - Diagnostics<br>- Surgical planning for dental implants<br>- Creation of surgical template | - Diagnostics<br>- Surgical planning for dental implants<br>- Creation of surgical template |
| Computer format | PC - Windows based<br>MAC - OS | PC - Windows based | PC - Windows based | PC - Windows based |
| Anatomic areas | Maxilla<br>Mandible<br>Cranio-maxillofacial | Maxilla<br>Mandible | Maxilla<br>Mandible | Maxilla<br>Mandible<br>Cranio-maxillofacial |
| CHARACTERISTIC | CANDIDATE | PREDICATE | PREDICATE | PREDICATE |
| Indications for Use | NobelClinician<br>The NobelClinician software is<br>a software interface for the<br>transfer and visualization of<br>imaging information from<br>equipment such as a CT<br>scanner or a magnetic<br>resonance scanner for the<br>purposes of diagnosis and<br>treatment planning in the dental<br>and cranio-maxillofacial<br>regions. The NobelClinician<br>software can be used to design<br>a surgical template for the<br>purposes of aiding placement<br>of dental implants. | The Guided Surgery Concept<br>(K050393)<br>The Guided Surgery Concept<br>and Teeth-in-an-Hour are<br>indicated for the treatment of<br>single, partially and totally<br>edentulous jaws for placement<br>of implant fixtures with<br>immediate function to restore<br>patient esthetics and chewing<br>function. The following<br>prerequisites must be fulfilled:<br>- Adequate amount of jaw<br>bone<br>- The quality of jaw bone must<br>be judged as adequate | Swissmeda Dental Planning<br>System<br>(K112251)<br>Swissmeda Dental Planning<br>System is intended for use by<br>qualified dental professionals<br>for Windows based diagnostics<br>and implant planning.<br>The software is an interface for<br>imaging data that originates<br>from medical scanners such as<br>CT or DVT scanners and it is<br>also a pre-operative software<br>for simulation and evaluation of<br>dental implant placement in the<br>patient's mandible/maxilla and<br>for surgical treatment options.<br>Swissmeda Implant Planning<br>System is not intended to be<br>used in direct contact with the<br>patient nor is it intended to be<br>used with life sustaining<br>devices. | Maxilim<br>(K052424)<br>Maxilim is indicated for use as a<br>software interface and image<br>segmentation system for the<br>transfer of imaging information<br>from a medical scanner such as<br>a CT scanner. It is also<br>indicated for use as a planning<br>an simulation software for<br>surgical treatment, specifically<br>maxillofacial treatment. |
| | | | The planning data may be<br>exported from Swissmeda<br>Dental Planning System and<br>used as input data for a special<br>drilling device from company<br>Georg Schick for manufacturing | |
| CHARACTERISTIC | CANDIDATE | PREDICATE | PREDICATE | PREDICATE |
| | NobelClinician | The Guided Surgery Concept<br>(K050393) | Swissmeda Dental Planning<br>System<br>(K112251) | Maxilim<br>(K052424) |
| | | | drilling<br>templates in a laboratory<br>environment. The drilling<br>template is then used in direct<br>contact with the patient to<br>realize the implant planning. | |
Nobel Biocare Traditional 510(k) Notification
NobelClinician
December 2012
K123976
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Substantial Equivalence Comparison to Predicate Devices
510(k) Summary of Safety and Effectiveness
1.4
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# 510(k) Summary of Safety and Effectiveness 1.4
Substantial Equivalence Comparison to Predicate Devices
Nobel Biocare Traditional 510(k) Notification
NobelClinician
December 2012
<123976
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510(k) Summary of Safety and Effectiveness 1.4
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Substantial Equivalence Comparison to Predicate Devices
Nobel Biocare Traditional 510(k) Notification
NobelClinician
December 2012
:
K123976
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a person with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 26, 2013
Nobel Biocare USA, LLC % Mr. Phuong Nguyen Manager Regulatory Affairs 22715 Savi Ranch Parkway YORBA LINDA CA 92887
Re: K123976
Trade/Device Name: NobelClinician Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 21, 2012 Received: December 26, 2012
Dear Mr. Nguyen:
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.
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.
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## Page 2 - Mr. Phuong Nguyen
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Smh.7)
for
Janine Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number K123976
Device Name: NobelClinician
Indications For Use:
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 in the dental and craniomaxillofacial regions. The NobelClinician software can be used to design a surgical template for the purposes of aiding placement of dental implants.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Smh.P.)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) 123976
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