(105 days)
No
The summary describes software for pre-operative simulation and planning based on medical imaging, but there is no mention of AI, ML, or related concepts like training data, test data, or performance metrics typically associated with AI/ML models. The functionality described is based on visualizing, generating, and measuring 3D objects from medical image data and providing step-by-step planning assistance, which are standard software functionalities, not indicative of AI/ML.
No
This device is software for pre-operative simulation and planning of surgical treatment options. It does not directly provide therapy or treatment to a patient.
No
Explanation: The device is described as software for pre-operative simulation of surgical treatment options and for planning surgery, not for diagnosing a condition. It assists in planning treatment based on existing imaging information.
Yes
The device is described as "software for pre-operative simulation" and the submission is for a "Traditional 510(k) for the Orthognathic wizard of SurgiCase software application." While the software is used in conjunction with imaging data from hardware (CT/MRI scanners) and can be used to design hardware (guides, implants, splints), the device itself, as described in the submission, is the software application for planning and simulation. There is no indication that the submission includes any hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "pre-operative simulation of orthognathic surgical treatment options, based on imaging information." This is a planning and simulation tool for surgical procedures, not a test performed on a sample from the human body to provide information about a disease or condition.
- Device Description: The description reinforces that it's software for surgical planning and generating patient-specific surgical aids (guides, splints, implants).
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information about a disease or condition
The device is clearly focused on surgical planning and execution based on medical imaging, which falls under the category of medical devices used for treatment planning and surgical guidance, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
SurgiCase is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner.
Product codes
LLZ
Device Description
This submission is a Traditional 510(k) for the Orthognathic wizard of SurgiCase software application.
SurgiCase is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner.
Based on the software planning several options are available to transfer the result of the planning to surgery. Examples:
- The software planning can be used to select appropriate implants or implant sizes for use during surgery.
- . Based on the planning, patient-specific surgical guides and implants can be designed.
- . Patient-specific surgical splints can be generated to transfer the planned dental occlusion to surgery.
The SurgiCase software platform is the basis of all clinical Materialise software designed for surgery planning. The platform allows basic functionality such as visualizing 3D objects, visualizing medical image data, generating 3D objects from medical image data and measuring.
On top of this platform, modules, also called wizards, can be added that each offer additional functionality such as planning a specific surgical routine. This platform is the main general wizard, while additional modules (wizards) are mainly based on the functionality of this general wizard; they assist the surgeon to plan specific surgery types step-by-step by providing each a different user interface, giving the surgeon the opportunity to fine tune parameters specific for that type of surgery. Current premarket notification is only for the Orthognathic wizard of the SurgiCase software. The rest of software wizards have been cleared under K073449 submission for the SurgiCase software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanner or a Magnetic Resonance Imaging (MRI) scanner.
Anatomical Site
Not Found
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)
Non-clinical testing: Software verification and validation testing will be completed by the end of August 2011. Verification and validation reports will be on file at Materialise from that point on and can be sent on request.
Clinical testing: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Submitter information
| Company name | Materialise N.V. |
|---|---|
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Postal code | 3001 |
| Country | Belgium |
| Phone number | +32 16 74 45 37 |
| Fax number | +32 16 39 66 06 |
| Principal contact name | Oliver Clemens |
| Contact title | Quality & Regulatory officer |
| Contact e-mail address | oliver.clemens@materialise.be |
| Additional contact name | Alexandra Razzhivina |
| Contact title | Regulatory officer |
| Contact e-mail address | alexandra.razzhivina@materialise.be |
| Additional contact name | Dieter Vandoren |
| Contact title | Continuous Improvement Manager CMF |
| Contact e-mail address | Dieter.vandoren@materialise.be |
Submission date
The date of the Traditional 510(k) submission is June 10th, 2011
Submission information
| Trade Name | SurgiCase, SurgiCase CMF, ProPlan CMF |
|---|---|
| Common Name | Image processing system and software for |
| simulating/evaluating implant placement and surgical | |
| treatment options | |
| Classification Name | System, Image processing, Radiological |
| Product code | LLZ (21 CFR 892.2050) |
Predicate device
| Trade or proprietary or model name | SurgiCase |
|---|---|
| 510(k) number | K073449 |
| Decision date | 2008/04/16 |
| Product code | LLZ |
| Manufacturer | Materialise N.V. |
1
Device Information
Description of the device
This submission is a Traditional 510(k) for the Orthognathic wizard of SurgiCase software application.
SurgiCase is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner.
Based on the software planning several options are available to transfer the result of the planning to surgery. Examples:
- The software planning can be used to select appropriate implants or implant sizes for use during surgery.
- . Based on the planning, patient-specific surgical guides and implants can be designed.
- . Patient-specific surgical splints can be generated to transfer the planned dental occlusion to surgery.
Functioning of the device
The SurgiCase software platform is the basis of all clinical Materialise software designed for surgery planning. The platform allows basic functionality such as visualizing 3D objects, visualizing medical image data, generating 3D objects from medical image data and measuring.
On top of this platform, modules, also called wizards, can be added that each offer additional functionality such as planning a specific surgical routine. This platform is the main general wizard, while additional modules (wizards) are mainly based on the functionality of this general wizard; they assist the surgeon to plan specific surgery types step-by-step by providing each a different user interface, giving the surgeon the opportunity to fine tune parameters specific for that type of surgery. Current premarket notification is only for the Orthognathic wizard of the SurgiCase software. The rest of software wizards have been cleared under K073449 submission for the SurgiCase software.
Intended use
SurgiCase is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner.
² The surgical splints are Class I, 510k exempt and therefore are not submitted for review in this 510k submission. References to the splints are provided as an example throughout this submission to give a complete overview on the whole process (from planning to surgery).
2
Summary of technological characteristics
Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate device.
Performance data
Non-clinical testing
Software verification and validation testing will be completed by the end of August 2011. Verification and validation reports will be on file at Materialise from that point on and can be sent on request.
Clinical testing
Not applicable.
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are 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. Oliver Clemens Quality and Regulatory Officer Materialise NV Technologielaan 15 3001 Leuven BELGIUM
SEP 26 2011
Re: K111641
Trade/Device Name: SurgiCase Orthognathic software Wizard Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: H Product Code: L.L.Z Dated: September 1, 2011 Received: September 2, 2011
Dear Mr. Clemens:
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
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 Safery 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 Patel
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
510(k) Number (if known):
Device Name: SurgiCase Orthognathic software wizard
Indications for Use:
SurgiCase is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner.
Prescription Use _ X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _1
, "
Mary Stated
(Division Sign-Division f Radiological Devic Office of In Vitro Djagr
K111 641
510K