(149 days)
No
The summary mentions image processing and segmentation but does not contain any keywords or descriptions indicative of AI or ML technology. The testing description focuses on traditional software validation methods.
No
The device is described as pre-planning software for dental implant placement and surgical treatment, it does not directly perform or deliver therapeutic treatment.
No
SimPlant 2011 is described as pre-planning software for dental implant placement and surgical treatment, not for diagnosing medical conditions. It transfers imaging information and segment images.
Yes
The device description explicitly states "SimPlant 2011 is intended for use as a software interface and image segmentation system" and "pre-planning software". The performance studies and testing described focus solely on software validation and testing, with no mention of associated hardware components being part of the device itself.
Based on the provided information, SimPlant 2011 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that SimPlant 2011 is for processing imaging information from medical scanners (CT, MRI) and for pre-planning dental implant placement and surgical treatment. This involves working with medical images of the patient's anatomy, not with samples taken from the patient (like blood, urine, or tissue) which is the hallmark of an IVD.
- Device Description: The device description reiterates the same intended uses, focusing on image processing and surgical planning.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in the body, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. SimPlant 2011's function is centered around image-based planning for surgical procedures.
N/A
Intended Use / Indications for Use
SimPlant 2011 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 pro-planning software for dental implant placement and surgical treatment.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Software for use in pre-operative planning.
Volume Rendering
Direct Volume Rendering
ISO Surface
X-Ray Rendering
Maximum Intensity Projection Rendering
16bit compatibility
Segmentation Wizard
Reorient axial images to occlusal plane
Advanced virtual teeth
Advanced grafts and Volumes
Dual scan registration
Optical scan registration
Optical Scannner support
Optical scan for .sim files
Occlusion tool
Virtual occludator
Advanced Soft tissue simulation
OMS-3D Photomapping
Surgical Guide Wizard
SimPlant 2011 provides a means for transferring patient images from a medical scanner to an output file.
SimPlant 2011 is used to provide a means for advanced pre-operative planning of dental implant placements and orthognatic treatment.
SimPlant 2011 is used to provide a means for image segmentation.
SimPlant 2011 contains a library of dental Implants.
Surgical templates may be designed and fabricated based on the output of the pre- operative planning.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computerized Tomography (CT) scanners, Magnetic Resonance (MR) scanner
Anatomical Site
Dental
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. The tests are intended to establish how the software reacts to usual inputs and to unexpected or invalid inputs (verifying robustness). Software testing includes both static and dynamic analysis of the software. Static evaluation techniques include inspections, walkthroughs, etc. and are intended to find, correct and prevent problems in an early stage of the development process. They are used to focus or augment dynamic analysis, which is concerned with demonstrating the software's run-time behavior in response to selected inputs and conditions.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing and software validation was performed, in accordance with the following Standards:
- ISO 13485:2003 Medical devices Quality Management Systems.
- IEC 62304:2006 Medical device software Software life cycle processes
- EN ISO standard 14971:2007 Medical Device Application of risk management to devices.
The SimPlant software is tested in accordance with a documented test plan. This test plan is derived from the final specifications and ensures that all controls and procedures are functioning properly. It defines what is to be accomplished through the software validation effort. The testing of the software typically consists of Unit testing, Integration testing, IR testing, Smoke testing, different types of Formal testing (General testing, Reference testing, Usage testing), Acceptance testing, Alpha testing and Beta testing.
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.
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).
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JUL - 1 2011
SECTION 10 510(K) PREMARKET NOTIFICATION SUMMARY
SUBMITTER'S NAME AND ADDRESS: MATERIALISE DENTAL NV Technologielaan 15 B-3001 Leuven, Belgium 3006638827 ESTABLISHMENT REGISTRATION NO: Peter Vandeput, Materialise Dental NV CONTACT PERSON: Quality Manager +32 163 960 39 (tel) +32 163 966 22 (fax) peter vandeput@materialise.be November 15, 2010 SUMMARY PREPARATION DATE: Trade Name SimPlant 2011
Common Name:
Image processing system and preoperative software for simulating dental implant placement and surgical treatment options
CLASSIFICATION NAME:
System, Image Processing. This product uses images acquired from Computerized Tomography (CT) scanners.
PREDICATE DEVICE
SimPlant Dr James (K053592)
FUNCTION
The modified SimPlant System is used to transfer images from a medical scanner and to perform a segmentation of the images. It is also used to provide a means for pre-operative planning. Surgical templates may be fabricated based on the output of the pre-operative planning.
INTENDED USE
SimPlant 2011 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 pro-planning software for dental implant placement and surgical treatment.
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TECHNOLOGICAL COMPARISON OF DEVICES
| Feature | SimPlant 2011 | SimPlant System |
|---|---|---|
| Material | Software - magnetic media | Software - magnetic media |
| Design | Software for use in pre-operative planning. | |
| Volume Rendering Direct Volume Rendering ISO Surface X-Ray Rendering Maximum Intensity Projection Rendering 16bit compatibility Segmentation Wizard Reorient axial images to occlusal plane Advanced virtual teeth Advanced grafts and Volumes Dual scan registration Optical scan registration Optical Scannner support Optical scan for .sim files Occlusion tool Virtual occludator Advanced Soft tissue simulation OMS-3D Photomapping Surgical Guide Wizard | Software for use in pre-operative planning. | |
| Volume Rendering Direct Volume Rendering No ISO Surface No X-Ray Rendering No Maximum Intensity Projection Rendering 16bit compatibility No Segmentation Wizard No Reorient axial images to occlusal plane Virtual teeth Grafts and Volumes No dual scan registration No optical scan registration No Optical Scannner support No Optical scan for .sim files No occlusion tool No virtual occludator Soft tissue simulation No OMS-3D Photomapping Surgical Guide Wizard | ||
| Function | SimPlant 2011 provides a means for | |
| transferring patient images from a medical | ||
| scanner to an output file. | ||
| SimPlant 2011 is used to provide a | ||
| means for advanced pre-operative | ||
| planning of dental implant placements and | ||
| orthognatic treatment. | ||
| SimPlant 2011 is used to provide a | ||
| means for image segmentation. | ||
| SimPlant 2011 contains a library of dental | ||
| Implants. | ||
| Surgical templates may be designed and | ||
| fabricated based on the output of the pre- operative planning. | SimPlant System provides a means for | |
| transferring patient images from a medical | ||
| scanner to an output file. | ||
| SimPlant System is used to provide a | ||
| means for pre-operative planning of dental | ||
| implant placements and orthognatic | ||
| treatment. | ||
| SimPlant System is used to provide a | ||
| means for image segmentation. | ||
| SimPlant contains a library of dental | ||
| implants. | ||
| Surgical templates may be designed and | ||
| fabricated based on the output of the pre- operative planning. |
SimPlant System Special 510(k) -- Premarket Notification
SimPlant System Special 510(k) -- Premarket Notification
NV
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Non-clinical testing and software validation
The SimPlant 2011 software originates from the same medical software platform as the SimPlant system marketed by Materialise Dental and cleared under K033849.
Thorough testing has been performed. This software product does not contact the patient and does not deliver medication or therapeutic treatment.
For the SimPlant software, non-clinical testing was performed, in accordance with the following Standards:
- ISO 13485:2003 Medical devices Quality Management Systems.
- IEC 62304:2006 Medical device software Software life cycle processes
- EN ISO standard 14971:2007 Medical Device Application of risk management to devices.
The SimPlant software is tested in accordance with a documented test plan. This test plan is derived from the final specifications and ensures that all controls and procedures are functioning properly. It defines what is to be accomplished through the software validation effort. The testing of the software typically consists of Unit testing, Integration testing, IR testing, Smoke testing, different types of Formal testing (General testing, Reference testing, Usage testing), Acceptance testing, Alpha testing and Beta testing,
The tests are intended to establish how the software reacts to usual inputs and to unexpected or invalid inputs (verifying robustness). Software testing includes both static and dynamic analysis of the software. Static evaluation techniques include inspections, walkthroughs, etc. and are intended to find, correct and prevent problems in an early stage of the development process. They are used to focus or augment dynamic analysis, which is concerned with demonstrating the software's run-time behavior in response to selected inputs and conditions.
The results of the complete testing are on file in the offices of Materialise Dental and are contained within the Design History File.
CONCLUSION
The modified SimPlant 2011 is considered to be substantially equivalent in design, material and function to the unmodified SimPlant (Dr. James). It is believed to perform as well as the predicate device for pre-operative planning and for image segmentation. Accordingly, we respectfully request the Agency to expeditiously find this special 510(k) premarket notification to be Substantially Equivalent.
Plant System Special 510(k) -- Premarket Notification
Materialise Dental NV
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
JUL - 1 2011
Mr. Peter Vandeput Quality Manager. Regulatory Affairs Representative Materialise Dental NV Technologietaan 15, 3001 Leuven BELGIUM
Re: K110300
Trade/Device Name: SimPlant 2011 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 21, 2011 Received: June 23, 2011
Dear Mr. Vanderput:
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 vour 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
4
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,
Mary S. Patil
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known): K110300
Device Name: SimPlant 2011
Indications for Use:
SimPlant 2011 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.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Michael D O'Hern
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 110300
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