(90 days)
Not Found
No
The summary describes a software for image visualization and treatment planning, but does not mention any AI or ML capabilities.
No
The device is described as a software interface for diagnosis and treatment planning, and it aids in designing surgical templates, but it does not directly treat or restore health.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software is for "the purposes of diagnosis and treatment planning." The "Device Description" also mentions that NobelClinician is "used to support diagnostics and treatment planning."
Yes
The device description explicitly states "NobelClinician is a software interface" and describes its function as processing and visualizing imaging data for diagnosis and treatment planning. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, the NobelClinician software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- NobelClinician's Function: The NobelClinician software processes and visualizes medical imaging data (CT, MRI, X-ray, photographic images) taken from the patient's body. It does not perform tests on samples taken from the body.
- Intended Use: The intended use is for diagnosis and treatment planning in the dental and cranio-maxillofacial regions, specifically for implant placement. This is based on analyzing existing imaging data, not on analyzing biological samples.
- Device Description: The description focuses on software processing and visualization of imaging data, not on laboratory testing or analysis of biological specimens.
- Regulation: The listed regulation (21 CFR 892.2050) is for Radiology devices, specifically Image Processing Systems. This further supports its classification as a radiology device, not an IVD.
In summary, NobelClinician is a medical device that processes and visualizes imaging data for diagnostic and treatment planning purposes, which falls under the category of radiology devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
System, Image Processing System, Radiology
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanner or a magnetic resonance scanner, medical or Cone Beam CT data, 2D imaging like photographic images and X-ray images.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K123976
page 1 of 5
510(k) Summary of Safety and Effectiveness 1.4
26 2013
| Submitted by: | Phuong Nguyen
Manager Regulatory Affairs | DATE | Clinician | PREDICATE
The Guided Surgery Concept
(K050393) | PREDICATE
Swissmeda Dental Planning
System
(K112251) | PREDICATE
Maxilim
(K052424) |
|----------------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC
22715 Savi Ranch Parkway
Yorba Linda, CA 92887 | | atient | DICOM
- Help assistant
- Create a new patient record
- Create and manage planning scenarios and treatments
- Create and edit 3D Models
- Create a snapshot of a viewer | DICOM
- Create a new patient record
- Create and edit 3D Models | DICOM
- Help assistant
- Create a new patient record
- Add images to a patient
- Create and manage planning scenarios and treatments
- Create and edit 3D Models
- Create a snapshot of a viewer |
| Telephone: | (714) 282-4800 x7830 | | a patient
nage
rios and | - Display and manipulate reslices | - Display and manipulate reslices | - Display and manipulate reslices |
| Facsimile: | (714) 998-9348 | | 3D Models
hot of a | - Define the dental curve shape | - Define the dental curve shape - 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 - Indicate and edit nerve structures | - Measure the distance between 2 points |
| Trade or Proprietary
or Model Name: | NobelClinician | | isualization
model | - Annotate structures | - Adding an implant to a planning and edit | - Warning system |
| Legally Marketed Device(s): | Swissmeda Dental Planning System (K112251)
The Guided Surgery Concept (K050393)
Maxilim (K052424) | | tics
diographic
ent model | - Measure the distance between 2 points | - Adding an abutment to an implant | |
| | ures
visualisation
of
atomy
stance
ts | - Measure the plane angle between 2 points - Indicate and edit nerve structures
- Adding an implant to a planning and edit | - Manage objects in a 2D and 3D viewer
- Surgical template visualization
- Approve function
- 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
1
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
Page 2 of 5
2
| CHARACTERISTIC | CANDIDATE | PREDICATE | PREDICATE | PREDICATE |
|---|---|---|---|---|
| NobelClinician | The Guided Surgery Concept (K050393) | Swissmeda Dental Planning System (K112251) | Maxilim (K052424) | |
| - Adding an abutment to an implant |
- Manage objects in a 2D and 3D viewer
- Warning system
- Surgical template visualization
- Approve function
- Create and send an order | | |
| Intended use | - Measure the plane angle between 2 points - Indicate and edit nerve structures
- Adding an implant to a planning and edit
- Adding an abutment to an implant
- Manage objects in a 2D and 3D viewer
- Warning system
- Surgical template visualization
- Approve function
- Create and send an order
- Diagnostics
- Surgical planning for dental implants
- Creation of surgical template | - Diagnostics
- Surgical planning for dental implants
- Creation of surgical template | - Diagnostics
- Surgical planning for dental implants
- Creation of surgical template | - Diagnostics
- Surgical planning for dental implants
- Creation of surgical template |
| Computer format | PC - Windows based
MAC - OS | PC - Windows based | PC - Windows based | PC - Windows based |
| Anatomic areas | Maxilla
Mandible
Cranio-maxillofacial | Maxilla
Mandible | Maxilla
Mandible | Maxilla
Mandible
Cranio-maxillofacial |
| CHARACTERISTIC | CANDIDATE | PREDICATE | PREDICATE | PREDICATE |
| Indications for Use | NobelClinician
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 cranio-maxillofacial
regions. The NobelClinician
software can be used to design
a surgical template for the
purposes of aiding placement
of dental implants. | The Guided Surgery Concept
(K050393)
The Guided Surgery Concept
and Teeth-in-an-Hour are
indicated for the treatment of
single, partially and totally
edentulous jaws for placement
of implant fixtures with
immediate function to restore
patient esthetics and chewing
function. The following
prerequisites must be fulfilled: - Adequate amount of jaw
bone - The quality of jaw bone must
be judged as adequate | Swissmeda Dental Planning
System
(K112251)
Swissmeda Dental Planning
System is intended for use by
qualified dental professionals
for Windows based diagnostics
and implant planning.
The software is an interface for
imaging data that originates
from medical scanners such as
CT or DVT scanners and it is
also a pre-operative software
for simulation and evaluation of
dental implant placement in the
patient's mandible/maxilla and
for surgical treatment options.
Swissmeda Implant Planning
System is not intended to be
used in direct contact with the
patient nor is it intended to be
used with life sustaining
devices. | Maxilim
(K052424)
Maxilim is indicated for use as a
software interface and image
segmentation system for the
transfer of imaging information
from a medical scanner such as
a CT scanner. It is also
indicated for use as a planning
an simulation software for
surgical treatment, specifically
maxillofacial treatment. |
| | | | The planning data may be
exported from Swissmeda
Dental Planning System and
used as input data for a special
drilling device from company
Georg Schick for manufacturing | |
| CHARACTERISTIC | CANDIDATE | PREDICATE | PREDICATE | PREDICATE |
| | NobelClinician | The Guided Surgery Concept
(K050393) | Swissmeda Dental Planning
System
(K112251) | Maxilim
(K052424) |
| | | | drilling
templates in a laboratory
environment. The drilling
template is then used in direct
contact with the patient to
realize the implant planning. | |
Nobel Biocare Traditional 510(k) Notification
NobelClinician
December 2012
K123976
Page 3 of 5
Substantial Equivalence Comparison to Predicate Devices
510(k) Summary of Safety and Effectiveness
1.4
3
510(k) Summary of Safety and Effectiveness 1.4
Substantial Equivalence Comparison to Predicate Devices
Nobel Biocare Traditional 510(k) Notification
NobelClinician
December 2012