(60 days)
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No
The document describes image processing and simulation software but does not mention AI, ML, or related terms, nor does it describe features or processes typically associated with these technologies (like training or testing on large datasets for learning).
No
The device is described as medical front-end software for visualizing gray value images, image segmentation, and simulating/evaluating orthodontic treatment. It is a diagnostic and simulation tool that aids in treatment planning rather than directly providing a therapeutic effect.
No
The "Intended Use" states it is "a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images" and is "intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner". It also mentions it is "used as a software system for simulating/evaluating orthodontic treatment". The "Device Description" clarifies that "The output file is intended to be used in conjunction with diagnostic tools and expert clinical judgment." This indicates it is a pre-diagnostic tool for visualization and simulation, rather than a diagnostic device itself.
Yes
The device description explicitly states "SimPlant Ortho; Vistadent 3D is software for simulating/evaluating orthodontic treatment... programmed in C++ language and running on the Windows operating system." It focuses on image processing, visualization, and simulation, with no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device 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.
- Device Function: The description clearly states that this software is used for visualizing and analyzing medical images (CT and MRI scans) and simulating orthodontic treatments. It does not involve testing biological samples from the patient.
- Intended Use: The intended use is focused on image processing, visualization, and treatment simulation, not on performing diagnostic tests on biological specimens.
Therefore, while it is a medical device used for diagnostic and treatment planning purposes, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Materialise Dental's SimPlant Ortho; Vistadent 3D 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 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 used as a software system for simulating/evaluating orthodontic treatment i.e. dental bite options.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Simplant Ortho provides a method of segmenting CT images. This file 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 cephalometric analysis of the patient and orthodontic treatment simulation. Additional information about the exact geometry of the tooth surfaces can be visualized together with the CT data and orthodontic procedures with TADs (temporary anchorage devices) can be simulated.
Osteotomies and distractions can be visualized to simulate the desired relation of both jaws and the result on the soft tissue profile of the patient can be visualized.
The output file is intended to be used in conjunction with diagnostic tools and expert clinical judgment.
SimPlant Ortho; Vistadent 3D is software for simulating/evaluating orthodontic treatment (i.e. dental bite options) programmed in C++ language and running on the Windows operating system.
Mentions image processing
Common Name: Image processing system and software for simulating /evaluating dental orthodontic treatment i.e. dental bite options
Classification Name: System, Image Processing (C.F.R. Section 892.2050, Product code: LLZ)
Mentions AI, DNN, or ML
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Input Imaging Modality
CT scanner or a Magnetic Resonance scanner
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
medically trained people
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The software is thoroughly tested in accordance with a documented test plan. This test plan is derived from the specifications and ensures that all controls and features are functioning properly. The software is validated together with end-users.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
KoriYoz
| SUBMITTER'S NAME AND ADDRESS: | MATERIALISE DENTAL N.V.
Technologielaan 15
B-3001 Leuven, Belgium |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT REGISTRATION NO: | 3006638827 |
| CONTACT PERSON: | Carl Van Lierde, Materialise Dental N.V.
Quality Manager
+32 163 967 14 (tel)
+32 163 966 22 (fax)
carl.vanlierde@materialise.be |
| SUMMARY PREPARATION DATE: | April 21, 2008 |
| TRADE NAME: | SimPlant Ortho; Vistadent 3D |
| COMMON NAME: | Image processing system and software for simulating
/evaluating dental orthodontic treatment i.e. dental bite
options |
| CLASSIFICATION NAME: | System, Image Processing (C.F.R. Section 892.2050,
Product code: LLZ) |
PREDICATE DEVICE
SimPlant System; SimPlant Dr. James (K053592)
FUNCTION
Simplant Ortho provides a method of segmenting CT images. This file 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 cephalometric analysis of the patient and orthodontic treatment simulation. Additional information about the exact geometry of the tooth surfaces can be visualized together with the CT data and orthodontic procedures with TADs (temporary anchorage devices) can be simulated.
Osteotomies and distractions can be visualized to simulate the desired relation of both jaws and the result on the soft tissue profile of the patient can be visualized.
The output file is intended to be used in conjunction with diagnostic tools and expert clinical judgment.
INTENDED USE
Materialise Dental's SimPlant Ortho; Vistadent 3D 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 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 used as a software system for simulating/evaluating orthodontic treatment i.e. dental bite options.
TESTING & VALIDATION
The software is thoroughly tested in accordance with a documented test plan. This test plan is derived from the specifications and ensures that all controls and features are functioning properly. The software is validated together with end-users.
1
TECHNOLOGICAL CHARACTERISITICS
.
:
and the same of the same of the states of the states
and the comments of the country
SimPlant Ortho; Vistadent 3D is software for simulating/evaluating orthodontic treatment (i.e. dental bite options) programmed in C++ language and running on the Windows operating system.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2008
Mr. Carl Van Lierde Quality Manager Materialise Dental NV Technologielaan 15, 3001 Leuven BELGIUM
Re: K081402
Trade/Device Name: SimPlant Ortho; Vistadent 3D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 21, 2008 Received: May 19, 2008
Dear Mr. 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. Iisting 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 such 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.
3
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 not 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the seconomic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 10(L) marketed predicate device results in a classification for your device of your device to re device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Houlth's (CDRH's) Office of Comptiment on the of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRF s Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/1276-3474. For questions regarding the reporting of device adverse events (Medical Device Reportion (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. Boveon reportain other general information on your responsibilities under the Act from the Division of Mary of Manufacturers, International and Consumer Assistance at its toll-free number (800) 63-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html .
Sincerely vours.
Nancy C brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K081402
Device Name: SimPlant Ortho; Vistadent 3D
Indications for Use:
Materialise Dental's SimPlant Ortho; Vistadent 3D 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 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 used as a software system for simulating/evaluating orthodontic treatment i.e. dental bite options.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Argin McWhan
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _