(150 days)
Not Found
No
The summary describes standard visualization and planning software for dental implants, with no mention of AI, ML, or related concepts.
No
The device is described as planning and simulation software; it does not directly treat or diagnose a disease.
No
The device is described as "planning and simulation software" to aid in the placement of dental implants and planning surgical treatments. It does not perform diagnosis or provide a diagnostic output.
Yes
The device description explicitly states "SICAT Implant V1.2 is a pure software device."
Based on the provided information, the SICAT Implant V 1.2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue, etc.
- SICAT Implant V 1.2 Function: The SICAT Implant V 1.2 is a software application that processes and visualizes medical imaging data (CT/DVT scans) of the oral-maxillofacial region. Its purpose is to aid dental professionals in planning and simulating dental implant placement and surgical treatments. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments." This is a planning and visualization tool, not a diagnostic test performed on a specimen.
Therefore, the SICAT Implant V 1.2 falls under the category of medical imaging software or surgical planning software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SICAT Implant V 1.2 is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or DVT scanners. The SICAT Implant V 1.2 is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data may be exported from SICAT Implant V 1.2 and used as input data for CAD or Rapid Prototyping Systems.
Product codes
LLZ
Device Description
SICAT Implant V1.2 is a pure software device. SICAT Implant V1.2 is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or DVT scanners. SICAT Implant V1.2 is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments.
SICAT Implant V1.2 allows to name, position, move, rotate, resize and visualize dental implants and other planning objects (i.e. nerve canals) within the visualized 3D volume. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of implants to be placed in the patient's mandible/maxilla together with the related surgical procedures.
The dental professionals' planning data may be exported from SICAT Implant V1.2 and used as input data for CAD or Rapid Prototyping Systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or DVT scanners
Anatomical Site
oral-maxillofacial region, mandible/maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified dental professionals / 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)
Performance testing to validate the safety and effectiveness of the SICAT Implant V1.2 system included validation testing and bench tests of the software functions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K090119, K033849, K053592, K081402
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).
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MAY 2 0 2011
510(k) Summary for the SICAT GmbH & Co. KG SICAT Implant V 1.2
(per 21 CFR 807.92 and http://www.fdagov/MedicalDevices/DeviceRegulationandGuidance/default.htm)
1. SUBMITTER/510(K) HOLDER
SICAT GmbH & Co. KG Brunnenallee 6 D-53177 Bonn Germany
+49-228/854 697 82 Telephone: +49-228/854 697 99 Facsimile:
Primary Contact: Mr. Dr. Manfred Breuer Secondary Contact: Mr. Markus Pfister
Date Prepared: December 16, 2010
2. DEVICE NAME AND DEVICE CLASSIFICATION
| Proprietary Name: | SICAT Implant V 1.2 |
|---|---|
| Common/Usual Name: | Radiological Visualization Software for Diagnosis and |
| Dental Implant Planning | |
| Classification Name: | System, Image Processing, Radiological |
| Regulation Description: | Picture archiving and communications system |
| Product Code: | LLZ |
| Regulation Number: | 892.2050 |
| Classification Class: | Class II Product |
3. PREDICATE DEVICES
- · SICAT Implant (V 1.0 incl. SP1), K090119
- · Materialise SimPlant V 12.0 with OMS Module, K033849, K053592, K081402
4. DEVICE DESCRIPTION
SICAT Implant V1.2 is a pure software device. SICAT Implant V1.2 is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or DVT
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scanners. SICAT Implant V1.2 is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments.
SICAT Implant V1.2 allows to name, position, move, rotate, resize and visualize dental implants and other planning objects (i.e. nerve canals) within the visualized 3D volume. Thus, dental professionals like implantologists are enabled to precisely plan the positions, orientations, types and sizes of implants to be placed in the patient's mandible/maxilla together with the related surgical procedures.
The dental professionals' planning data may be exported from SICAT Implant V1.2 and used as input data for CAD or Rapid Prototyping Systems.
5 INTENDED USE
SICAT Implant V1.2 is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or DVT scanners. SICAT Implant V1.2 is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data may be exported from SICAT Implant V1.2 and used as input data for CAD or Rapid Prototyping Systems.
6 SUBSTANTIAL EQUIVALENCE
The SICAT Implant V1.2 system is substantially equivalent to the SimPlant System (K033849. K053592. K081402) and the SICAT Implant (V1.0 incl. SP1) System (K090119) based on the equivalence of the intended use, similar features and technical characteristics.
Performance testing to validate the safety and effectiveness of the SICAT Implant V1.2 system included validation testing and bench tests of the software functions.
7 CONCLUSION
SICAT Implant V1.2 is considered to be substantially equivalent to the SimPlant System and the SICAT Implant (V1.0 incl. SP1) System.
Based on the information and supporting documentation provided in the premarket notification, the SICAT Implant V1.2 is substantially equivalent to the predicate devices in design, material and function. Testing demonstrates that the SICAT Implant V 1.2 fulfills prospectively defined design and performance specifications.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Contro! Room - WO66-G609 Silver Spring, MD 20993-0002
SICAT GMBH & Co. KG % Mr. Mark Sheehan Regulatory Associate Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760
MAY 2 0 2011
Re: K103723 Trade/Device Name: SICAT Implant V 1.2 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 16, 2010 Received: December 21, 2010
Dear Mr. Sheehan:
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
3
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 Pastel
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
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Indications for Use
510(k) Number (if known): K103 723
Device Name: SICAT Implant V 1.2
Indications for Use:
The SICAT Implant V 1.2 is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or DVT scanners. The SICAT Implant V 1.2 is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data may be exported from SICAT Implant V 1.2 and used as input data for CAD or Rapid Prototyping Systems.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mum Slastel
(Division Sign-Off)
510K K163723
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