(161 days)
Not Found
No
The summary describes image processing and pre-planning software but does not mention AI, ML, or related terms, nor does it describe characteristics typically associated with AI/ML development like training or test sets.
No
The device is described as a software interface and image segmentation system used for pre-planning dental implant placement and surgical treatment. It assists in visualizing anatomical structures and planning implant positions, but does not directly treat or diagnose a disease or condition. The actual surgical preparation and implant placement are done using separate guides and kits.
No
The device is described as pre-planning software for dental implant placement and surgical treatment, using imaging information for "three-dimensional assessment of the patient" and assisting in the "creation and approval of a pre-surgical plan." While it processes medical images, its primary stated purpose is for surgical planning and guidance, not for diagnosing a disease or condition itself. It's intended to be used "in conjunction with other diagnostic tools and expert clinical judgment."
No
The device description explicitly mentions "SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit" which are used intra-operatively. These are physical components, indicating the system is not solely software.
Based on the provided information, the SimPlant Navigator Personalized Dental Care System 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.
- SimPlant Navigator's Function: The SimPlant Navigator system is described as a software interface and image segmentation system that uses medical imaging data (CT and MRI) to plan dental implant placement and surgical treatment. It works with anatomical structures (the jaw) and aids in pre-operative planning and intra-operative guidance.
- No Sample Analysis: The system does not analyze biological samples from the patient. Its input is medical imaging data, not biological specimens.
Therefore, the SimPlant Navigator Personalized Dental Care System falls under the category of medical devices used for surgical planning and guidance, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
SimPlant Navigator Personalized Dental Care System is intended for use as a softwar interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is als intended as pre-planning software for dental implant placement and surgical treatment.
SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit, which are used intra operatively to prepare the osteotomy for placement of BIOMET 3i implants pre operatively determined in the software.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, NOF, NDP, DZA
Device Description
SimPlant Navigator Personalized Dental Care System provides a method o importing medical imaging information from radiological imaging systems such as Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) to a computer fi that is usable in conjunction with other diagnostic tools and expert clinical judgmen Visual representations of the imaged anatomical structures (e.g. the jaw) are derive allowing for a three-dimensional assessment of the patient without patient contac Dental implant positions including orientations are planned pre-operatively. Compute visualization of the 3D anatomical jaw models, planned implants, planned tooth setu and numerical measurements assist the surgeon in the creation and approval of a pre surgical plan. SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit are use intra-operatively to prepare the osteotomy for placement of BIOMET 3i implants pre operatively determined in the software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computer Tomography (CT), Magnetic Resonance Imaging (MRI)
Anatomical Site
The jaw (for dental implant planning)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified surgeon (pre-operative planning), Dental Setting (intra-operative use of guides and kit)
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)
Software Validation in addition to bench top performance testing was conducted t ensure the compatibility of all system components.
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
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 892.2050.
| Submitter: | Materialise Dental NV
Technologielaan 15
Leuven
Belgium |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Reg. Number: | 3006638827 |
| Contact: | Carl Van Lierde
QA/RA Manager
Materialise Dental NV
Technologielaan 15
Leuven
Belgium
Tel. +32 16 39 67 14
Fax. +32 16 39 66 22
Email: carl.vanlierde@materialise.be |
| Date Prepared: | September 12, 2011 |
| Trade/
Proprietary
Name: | SimPlant Navigator Personalized Dental Care System |
| Common/Usual
Name: | System, Image processing. The product uses images acquired from Computerized
Tomography (CT) scanners |
| Classification
Name/ FDA
Reviewing
Branch: | Radiology branch |
| Device
Classification/
Code: | Class II - 21 CFR §892.2050 LLZ |
1
ge 2 of 7.
K\2679 | K\12679 | K\12679
Special 510(k) Premarket Notification | Rape 2 of 2 of 2 of 2 | 2 of 21 | Plant Care System
T
| Predicate Device
Manufacturer: | SimPlant® 2011; (K110300)
Nobel Biocare Guided Surgery Concept; (K050393) |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Purpose of the
SPECIAL 510(k)
notice: | The reason for this Special 510k submission is to request clearance for a modificatio
to a device that has been cleared under the 510(k) process referred to herein a
SimPlant Navigator Personalized Dental Care System (Image processing system
referenced under 21 CFR §892.2050 and are considered Class II devices. |
| Device
Description: | SimPlant Navigator Personalized Dental Care System provides a method o
importing medical imaging information from radiological imaging systems such as
Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) to a computer fi
that is usable in conjunction with other diagnostic tools and expert clinical judgmen
Visual representations of the imaged anatomical structures (e.g. the jaw) are derive
allowing for a three-dimensional assessment of the patient without patient contac
Dental implant positions including orientations are planned pre-operatively. Compute
visualization of the 3D anatomical jaw models, planned implants, planned tooth setu
and numerical measurements assist the surgeon in the creation and approval of a pre
surgical plan. SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit are use
intra-operatively to prepare the osteotomy for placement of BIOMET 3i implants pre
operatively determined in the software. |
| Indications
for
Use: | SimPlant Navigator Personalized Dental Care System is intended for use as a softwar
interface and image segmentation system for the transfer of imaging information from
a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is als
intended as pre-planning software for dental implant placement and surgical treatment.
SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit, which are used intra
operatively to prepare the osteotomy for placement of BIOMET 3i implants pre
operatively determined in the software. |
| Technological
Characteristics: | The predicate devices, SimPlant® 2011 and Nobel Biocare Guided Surgery Conce
have a number of very similar and equivalent design /technological characteristics:
which are very similar and equivalent with the SimPlant Navigator Personalized Dent
Care System (see Substantial Equivalence comparison table in Section 14). |
| Performance
Data: | Software Validation in addition to bench top performance testing was conducted t
ensure the compatibility of all system components. |
| Clinical Data: | N/A |
2
| Performance
Standards: | a. DICOM NEMA PS3.1-3.18: Digital imaging and communication in medicine:
2009
b. ISO14971: Applications of risk management to medical devices: 2007
c. ISO13485: Medical Devices Quality Management System: 2003
d. ISO9001: Quality Management System: 2008
e. ISO10993: Biological evaluations of medical devices: 1992 | | Intended Use | | | | | | | | | | | | | | | | | | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|---------------------------------------------------------|--|--|
| Substantial
Equivalence: | Materialise Dental NV's SimPlant Navigator Personalized Dental Care System
included in this submission have the same intended use, fundamental scientific
technology, similar indications, and principles of operation as the previously cleare
SimPlant® 2011; (K110300).
Refer to the following substantial equivalence data table: | | The SimPlant Navigator
Navigator Personalized Dental
Care System is intended 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 or a Magnetic
Resonance scanner. It is also
intended as pre-planning
software for dental implant
placement and surgical
treatment.
The SimPlant Navigator
Personalized Dental Care
System can be used with the
following Biomet 3i
instrument kits and their
respective components:
implant mounts, cortical
perforator, tissue punches,
drill positioning handles, twist
drills, countersink drills,
shaping drills, bone taps, bone
profilers, drivers, and ratchets. | Materialise Dental's
SimPlant® 2011 software is
intended 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
or a Magnetic Resonance
scanner. It is also intended
as pre-planning software for
dental implant placement
and surgical treatment. | 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 | | | | | | | | | | | | | | | | |
| | Device for
premarket
notification K110300 K050393 Trade
name SimPlant® Navigator
Personalized Dental Care
System SimPlant® 2011 Nobel Biocare The
Guided Surgery Concept Common
name SimPlant® Software Classification Product Code: LLZ
21 CFR. § 892.2050
Classification Panel: Radiology
Device Class: II Product code: LLZ
21 CFR. § 892.2050
Classification Panel:
Radiology
Device Class: II Product code: DZE
21 CFR. § 872.3640
Classification Panel:
Dental
Device Class: II | | | | | | | | | | | | | | | | | | SurgiGuide® guides are
intended for single use only. | | |
| | | | | | | | | | | | | | | | | | | | | | |
| | Software – magnetic media | Software – Magnetic media | Software – Magnetic
media | | | | | | | | | | | | | | | | | | |
| Material | Hardware –
polyamide guides –
biocompatible
material stainless steel
tubes/sleeves
medical grade | | Hardware
Polyamide
guides
biocompatible
material | | | | | | | | | | | | | | | | | | |
ﻟﻢ
3
Special 510(k) Premarket Notification -The SimPlant® Navigator Personalized Dental Care System
K112679 Page র্য
.
4
K\267-9.
Page 5 of 7
Special S10(k) Premarket Notification – Page 5 – F
Special S10(k) Premarket Notification – The SimPlant® Navigator Personalized Dental Care System
| | | Software for use in pre-
operative planning. | Software for use in pre-
operative planning. | Software for use in pre-
operative planning. |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Design | The SimPlant Navigator
Personalized Dental Care
System includes SimPlant®
software, which provides a
means for the clinician for
image segmentation and
advanced pre-operative
planning. This enables the
clinician to view three-
dimensional CT-scan data as
well as to plan the case in a
virtual three-dimensional
environment. | SimPlant® software provides
a means for image
segmentation and advanced
pre-operative planning.
Surgical templates may be
fabricated based on the
output of the pre-operative
planning. | The Guided Surgery
Concept includes a 3D-
Planning Software that
enables the clinician to
view three-dimensional
CT-scan data as well as
to plan the case in a
virtual three-
dimensional
environment. |
| | | The case planning can be
used to produce a Surgical
Template, thus transferring
the virtual case planning into
physical tools enabling the
surgical installation according
to the virtual case planning. | | This case planning can
be used to produce a
Surgical Template, thus
transferring the virtual
case planning into
physical tools enabling
the surgical installation
according to the virtual
case planning. |
| | | The SimPlant Navigator
Personalized Dental Care
System is based upon
knowledge of the location
and orientation of the
implant(s) prior to the
surgery. This knowledge
enables the production of a
SurgiGuide. | | The Guided Surgery
Concept is based upon
knowledge of the
location and orientation
of the implant(s) prior
to the surgery. This
knowledge enables the
production of a Surgical
Template. |
| | | Aided by the SurgiGuide, the
sites can be prepared and the
implants placed in the
predetermined locations
enabling the immediate
attachment of the
prefabricated temporary or
final prosthesis. | | Aided by the Surgical
Template, the sites can
be prepared and the
implants placed in the
predetermined locations
enabling the immediate
attachment of the
prefabricated temporary
or final prosthesis. |
| | | | | |
| | The SimPlant® software
component is used to
incorporate the images from
either an MRI or CT scan of
the affected joint into the
specialized planning
software. | SimPlant® software is used to
incorporate the images from
either an MRI or CT scan of
the affected joint into the
specialized planning software. | | |
| | The SimPlant® software is
used by a qualified surgeon
to plan, inspect, fine-tune
and approve the pre-surgical
plan. The software is used
pre-operatively. | The SimPlant® software is
used by a qualified surgeon to
plan, inspect, fine-tune and
approve the pre-surgical plan.
The software is used pre-
operatively. | | |
| Function | SimPlant® software contains
a library of dental implants,
and additional instruments
for the placement of
implants. | SimPlant® software contains
a library of dental implants,
and additional instruments for
the placement of implants. | | |
| | A SurgiGuide® guide may be
designed and fabricated
based on the output of the
pre-operative planning. | A SurgiGuide® guide may be
designed and fabricated
based on the output of the
pre-operative planning. | | |
| | SurgiGuide® guides are
patient specific templates
that are intended to transfer
the pre-operatively
determined positioning of
the dental implants to the
patient intra-operatively,
assisting the surgeon in
placing dental implants by
guiding and marking drill
locations. | | | |
| Programming
language | C++ | C++ | | |
| Operating
system | Windows | Windows | | |
| | | | | |
5
Special 510(k) Premarket Notification --The SimPlant® Navigator Personalized Dental Care System
Page
X112679
87
6
| Testing | Hardware testing:
• Biocompatibility
testing of patient
contacting
components
• Sterilization testing
• Sterilization
dimensional
stability test | |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Software testing:
• Unit testing
• Integration testing
• IR testing
• Smoke testing
• Formal testing
• Acceptance testing
• Alpha testing
• Beta testing | Software testing:
• Unit testing
• Integration testing
• IR testing
• Smoke testing
• Formal testing
• Acceptance testing
• Alpha testing
• Beta testing |
| Conclusion: | SimPlant Navigator Personalized Dental Care System and its predicate device:
SimPlant® 2011 (K110300) and the Nobel Biocare Guided Surgery Concep
(K050393), have the same intended use, indications for use, similar technologica
characteristics, and principles of operation.
SurgiGuide® guides and the BIOMET 3i Navigator® Surgical Kit, which are used intra
operatively to prepare the osteotomy for placement of BIOMET 3i implants pre
operatively determined in the software.
By modifying the SimPlant® 2011 to include the SurgiGuide® and Navigation Surgica
Kit does not raise any new questions of safety or effectiveness. | |
| | The differences noted above do not present new issues of safety or effectiveness for th
SimPlant® Navigator Personalized Dental Care System. | |
K112679
, 7 of 7
7
Image /page/7/Picture/0 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" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Carl Van Lierde QA/RA Manager Materialise Dental NV Technologielaan 15 3001 LEUVEN BELGIUM
FEB 2 2 2012
Re: K112679
Trade/Device Name: SimPlant® Personalized Dental Care System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, NOF, NDP, and DZA Dated: January 10, 2012 Received: February 16, 2012
Dear Mr. Van Lierde:
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 r ou may, merelove, manel 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 class II (Special Controls), it may be subject to such 11 your device is elassified to regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 r reads of ac now has a determination that your device complies with other requirements of the Act that I Dr has intact a and regulations administered by other Federal agencies. You must or uny 1 eather the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
8
medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical do rece forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as set form in the quarty, adevice as described in your Section 510(k) premarket win anow you to begin marial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 You don't openite and the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Tou may 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
9
Special 510(k) Premarket Notification --The SimPlant® Navigator Personalized Dental Care System
Indications for Use
510(k) Number (if known): K // Ze 79
Device Name: SimPlant® Personalized Dental Care System
Indications for Use:
SimPlant Navigator Personalized Dental Care System is intended for use as a software Simirralit Navigator Tersonation system for the transfer of imaging information from a medical meriate and mage segmentation by Magnetic Resonance scanner. It is also intended as prebearing software for dental implant placement and surgical treatment.
SurgiGuide® guides and the BIOMET 3i Navigator Surgical Kit, which are used intra-Surgioure guides and the Droming of BIOMET 31 implants pre-operatively determined in the software.
Prescription Use
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
AND/OR
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510K. | K112679 |
|---|---|
| ------- | --------- |