(118 days)
Not Found
No
The summary describes a software for visualizing and simulating dental implant placement based on CT data. It focuses on image assessment, simulation features, and validation against a predicate device. There is no mention of AI, ML, or related concepts like training/test sets for algorithmic learning.
No
The device is described as pre-operative software for simulating and evaluating dental implant placement and surgical treatment options, not for providing direct therapy.
No
The device is described as "medical front-end software" for "visualizing gray value images" and "pre-operative software program for simulating /evaluating dental implant placement and surgical treatment options." It explicitly states that "The output file is intended to be used in conjunction with diagnostic tools and expert clinical judgment," indicating it is not a diagnostic tool itself but rather a pre-operative planning and visualization tool.
Yes
The device description and intended use clearly state that the device is a software program for visualizing images and simulating procedures. The performance studies focus on software validation and testing, with no mention of hardware components or their validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "visualizing gray value images" and "pre-operative software program for simulating /evaluating dental implant placement and surgical treatment options." This describes a planning and visualization tool, not a device used to perform tests on biological samples to diagnose a condition.
- Device Description: The description reinforces this by stating it allows assessment of CT images "in a three-dimensional way, to see the anatomical structures without patient contact or surgical insult." It focuses on visualization and simulation, not analysis of biological specimens.
- Lack of Biological Sample Analysis: The core function of an IVD is to perform tests on biological samples (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. This device does not mention any interaction with or analysis of biological samples.
- Input Modality: The input is imaging data (CT, MRI), which is used for visualization and planning, not for in vitro diagnostic testing.
While the software is a medical device used in a clinical setting, its function is related to medical imaging and surgical planning, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Materialise Dental's SimPlant Go software is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is intended for use as a pre-operative software program for simulating /evaluating dental implant placement and surgical treatment options.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
SimPlant Go allows the individual patient's CT image to be assessed in a three-dimensional way, to see the anatomical structures without patient contact or surgical insult. It includes features for dental implant treatment simulation. Additional information about the exact geometry of the tooth surfaces can be visualized together with the CT data and periodontic procedures with dental implants can be simulated. The output file is intended to be used in conjunction with diagnostic tools and expert clinical judgment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT (either conventional multislice or cone beam CT) scanner
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medically trained people
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 to ensure the compatibility of all system components and to support the safety and effectiveness of the device. In particular the following V&V activities were performed:
Testing: The testing of the software consisted of unit testing, peer code reviewing, integration testing, IR testing, smoke testing, formal testing, acceptance testing, alpha testing, beta testing. The results of the complete testing are on file in the Materialise Dental offices and are contained within the Design History File. The results of the testing were: BUGS: differences between software and requirements. The project manager, if necessary after consulting with the application engineer or the acquirer of the project, set the priorities for these bugs; the development manager or team leader assigned a developer to fix the bug. SUGS: suggestions for improvements on the software. Design Review was performed to decide if these suggestions would be implemented.
Validation: Several validation activities were performed: Design validation Beta validation by use of mockups, prototypes and internal validation Clinical Beta validation. For SimPlant GO an extensive design validation was performed by an external usability company i.e. Macadamian. Interviews and usability tests were performed. As part of the Beta validation additional usability tests were performed with in total 28 external users and 5 internal users. Clinical case planning in SimPlant GO was validated. All validation criteria were met. Compared to the predicate device SimPlant 2011, SimPlant Go yielded an identical output when using identical input data.
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.
SimPlant® 2011; (K110300)
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
K1204333 Page . I of . 6
5 2012 JUL
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
Management Representative QARA
Materialise Dental NV
Technologielaan 15
Leuven
Belgium
Tel. +32 16 39 6620
Fax. +32 16 39 66 22
Email: Carl.VanLierde@materialise.be |
| Date Prepared: | January 31, 2012 |
| Trade/
Proprietary
Name: | SimPlant Go |
| Common/Usual
Name: | Materialise Dental's SimPlant Go software is indicated for use as a medical front-end
software that can be used by medically trained people for the purpose of visualizing
gray value images. It is intended for use as a pre-operative software program for
simulating /evaluating dental implant placement and surgical treatment options. |
| Classification
Name/ FDA
Reviewing
Branch: | Radiology branch |
1
120433 Page 2 of 6
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A The Research Production of the Comments of the Comments of the Course of the Comments of the Comments of the County of the Course of the Comments of the Comments of the Com
10-2017
Vack of D
| Predicate Device
| Manufacturer: | SimPlant® 2011; (K110300) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Purpose of the | ||||||||||||
| 510(k) notice: | The reason for this 510k submission is to request clearance for a device that has been | |||||||||||
| referred to herein as SimPlant Go referenced under 21 CFR §892.2050 and considered | ||||||||||||
| a Class II device. | ||||||||||||
| Device | ||||||||||||
| Description: | SimPlant Go allows the individual patient's CT image to be assessed in a three- | |||||||||||
| dimensional way, to see the anatomical structures without patient contact or surgical | ||||||||||||
| insult. It includes features for dental implant treatment simulation. Additional | ||||||||||||
| information about the exact geometry of the tooth surfaces can be visualized together | ||||||||||||
| with the CT data and periodontic procedures with dental implants can be simulated. | ||||||||||||
| The output file is intended to be used in conjunction with diagnostic tools and expert | ||||||||||||
| clinical judgment. | ||||||||||||
| Indications for | ||||||||||||
| Use: | Materialise Dental's SimPlant Go software is indicated for use as a medical front-end | |||||||||||
| software that can be used by medically trained people for the purpose of visualizing | ||||||||||||
| gray value images. It is intended for use as a pre-operative software program for | ||||||||||||
| simulating /evaluating dental implant placement and surgical treatment options. | ||||||||||||
| Technological | ||||||||||||
| Characteristics: | Materialise Dental NV's SimPlant Go included in this submission has the same | |||||||||||
| technological characteristics as the previously cleared SimPlant® 2011; (K110300). | ||||||||||||
| Both software devices run on the Windows operating system. The main technological | ||||||||||||
| difference between SimPlant Go and the predicate device is the fact that the | ||||||||||||
| programming language used is C# as opposed to C++. | ||||||||||||
| SimPlant Go and the predicate device SimPlant 2011 are manufactured by Materialise | ||||||||||||
| Dental. | ||||||||||||
| Similarities and differences between predicate and subject device in terms of | ||||||||||||
| functions: | ||||||||||||
| Category Features Available (X) or not (0) Predicate Subject File open tools Open and save .Go projects X X |
2
K120733 are 3 of 6
| Planning Tools | Selection, sizing and manipulating implant
representations for planning /simulating their
positions and orientations relative to
anatomical structures of interest | X | X |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|---|
| Communication tools: | Link to an online shop | X | X |
| File open tools | (CB)CT images import;
Image selector | X | 0 |
| Visualization tools | 2D gray value images; Panoramic curve;
Volume rendering | X | 0 |
| Segmentation tools: | SimPlant Go does not have segmentation
tools (e.g. thresholding, region growing,
dynamic region growing, manual editing,
cavity filling, morphological or
Boolean
operations) | X | 0 |
| Measurement tools: | Gray values around implants; Profile line;
Image statistics | X | 0 |
| Preparation tools | Reorient axial images to occlusal plane;
Nerve; Virtual teeth; Optical scan registration;
Dual scan registration; Grafts and volumes | X | 0 |
| Planning Tools | Abutments; Fixation screws; Simulation of
distraction / osteotomy; Occlusion tool | X | 0 |
| Evaluation tools: | Virtual occludator; Soft tissue simulation | X | 0 |
| Communication tools: | Distribute View; E-mail project; Upload for
support; Save or print screenshot; Capture
movie; Export DICOM | X | 0 |
Performance
Software Validation in addition to bench top performance testing was conducted to
3
长120733 Page 4 of 6, 2017
.
:
| Data: | ensure the compatibility of all system components and to support the safety and
effectiveness of the device. In particular the following V&V activities were performed:
Testing:
The testing of the software consisted of unit testing, peer code reviewing, integration
testing, IR testing, smoke testing, formal testing, acceptance testing, alpha testing, beta
testing. The results of the complete testing are on file in the Materialise Dental offices
and are contained within the Design History File.
The results of the testing were:
BUGS: differences between software and requirements. The project manager, if
necessary after consulting with the application engineer or the acquirer of the
project, set the priorities for these bugs; the development manager or team
leader assigned a developer to fix the bug. SUGS: suggestions for improvements on the software. Design Review was
performed to decide if these suggestions would be implemented. Validation:
Several validation activities were performed:
Design validation Beta validation by use of mockups, prototypes and internal validation Clinical Beta validation For SimPlant GO an extensive design validation was performed by an external
usability company i.e. Macadamian. Interviews and usability tests were performed.
As part of the Beta validation additional usability tests were performed with in total 28
external users and 5 internal users.
Clinical case planning in SimPlant GO was validated. All validation criteria were met.
Compared to the predicate device SimPlant 2011, SimPlant Go yielded an identical
output when using identical input data. |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Data: | N/A |
| Performance
Standards: | DICOM NEMA PS 3.1-3.18: Digital imaging and communication in medicine: 2009
ISO14971: Applications of risk management to medical devices: 2007
ISO 13485: Medical devices Quality Management System: 2003
ISO 9001: Quality Management System: 2008 |
. . . . .
4
Substantial Equivalence:
Materialise Dental NV's SimPlant Go included in this submission uses similar (K110300).
| Device comparison table | ||
|---|---|---|
| Device for premarket notification | K110300 | |
| Trade name | SimPlant® Go | SimPlant® 2011 |
| Common.name | SimPlant® Basic Software | SimPlant® Software |
| Classification | Product Code: LLZ | |
| 21 CFR. § 892.2050 | Product code: LLZ | |
| 21 CFR. § 892.2050 | ||
| Classification Panel: Radiology | ||
| Device Class: II | Classification Panel: Radiology | |
| Device Class: II | ||
| Intended Use | Materialise Dental's SimPlant Go | |
| software is indicated for use as a medical | ||
| front-end software that can be used by | ||
| medically trained people for the purpose | ||
| of visualizing gray value images. It is | ||
| intended for use as a pre-operative | ||
| software program for simulating | ||
| /evaluating dental implant placement | ||
| and surgical treatment options. | Materialise Dental's SimPlant® | |
| 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. | ||
| Material | Software - Magnetic media | Software - Magnetic media |
| Design | Software for use in pre-operative | |
| planning. | Software for use in pre-operative | |
| planning. | ||
| Materialise Dental's SimPlant Go | ||
| software is intended for use as a | ||
| software interface for the transfer of | ||
| imaging information from a medical | ||
| scanner such as a CT (either conventional | ||
| multislice or cone beam CT) scanner to a | ||
| computer file usable in conjunction with | ||
| other diagnostic tools and expert clinical | ||
| judgment. The software is intended to be | ||
| used for simulating / evaluating dental | ||
| implant placement and surgical | ||
| treatment options, supporting a wide | SimPlant® software provides | |
| means for image segmentation and | ||
| advanced pre-operative planning. | ||
| Surgical templates may be fabricated | ||
| based on the output of the pre- | ||
| operative planning. |
5
| Function | 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.
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.
SimPlant® software contains a library of
dental implants, and additional
instruments for the placement of
implants. | 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.
SimPlant® software contains a
library of dental implants, and
additional instruments for the
placement of implants. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Programming
language | C# | C++ |
| Operating
system | Windows | Windows |
| Hardware
Testing | N/A | N/A |
| Software
testing | Unit testing Integration testing IR testing Smoke testing Formal testing Acceptance testing Alpha testing Beta testing | Unit testing Integration testing IR testing Smoke testing Formal testing Acceptance testing Alpha testing Beta testing |
:
K120783
Page 6, 0846
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6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
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 Management Representative QARA Materialise Dental NV Technologielaan 15 LEUVEN 3001 BELGIUM
5 2012 JUL
Re: K120733
Trade/Device Name: SimPlant® GO Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 25, 2012 Received: June 1, 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 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 class II (Special Controls), it may be subject to such additional controls. Existing major 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 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 Parts 801 and 809); medical device reporting (reporting of
7
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial 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 809), please contact 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 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/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
8
K120733
510(k) Premarket Notification -SimPlant® Go
Indications for Use
510(k) Number (if known): K 12 o + 3 3
Device Name: SimPlant® GO
Indications for Use:
Materialise Dental's SimPlant Go software is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is intended for use as a pre-operative software program for simulating dental implant placement and surgical treatment options.
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)
Aranald D. O'Hern
Division Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
S10K 120733