(97 days)
Not Found
No
The document describes software for visualizing and planning dental implant placement based on CT/CBCT data. It focuses on user manipulation of objects within the 3D volume and exporting planning data. There is no mention of AI, ML, or any learning-based algorithms for tasks like automated detection, segmentation, or planning suggestions. The description of verification and validation activities also does not suggest the use of AI/ML.
No
The device aids in planning dental implant placement and surgical treatments, but it does not directly treat or diagnose a disease or condition.
No
The device is described as "planning software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments." It visualizes existing imaging information and allows for manipulation of planning objects, but it does not diagnose medical conditions.
Yes
The device description explicitly states "SICAT Implant V2.0 is a pure software device." The intended use and device description focus solely on the software's functionality for planning and visualization based on existing imaging data, with no mention of accompanying hardware components included with 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. They are used to provide information for diagnosis, monitoring, or screening.
- SICAT Implant's Function: SICAT Implant is a software application that processes and visualizes medical imaging data (CT/CBCT scans) of the oral-maxillofacial region. Its purpose is to aid dental professionals in planning surgical procedures, specifically dental implant placement.
- No Sample Analysis: The software does not analyze any biological samples from the patient. It works directly with imaging data.
- Focus on Planning: The primary function is surgical planning based on anatomical visualization, not diagnostic testing of biological markers.
Therefore, SICAT Implant falls under the category of medical device software used for surgical planning and visualization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SICAT Implant is a software application of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. SICAT Implant is intended for use as planning software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data can be exported from SICAT Implanning data includes in particular the positions and types of implants and drill sleeves to be used in the surgical procedures. This data may be used as input to design and manufacture surgical guides for dental implants.
Product codes
LLZ
Device Description
SICAT Implant V2.0 is a pure software device. SICAT Implant V2.0 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 CBCT scanners. SICAT Implant V2.0 is intended for use as planning software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. SICAT Implant V2.0 allows to name, position, move, rotate, resize and visualize dental implants and other planning objects (i.e. nerves) 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 can be exported from SICAT Implant. This planning data includes in particular the positions, orientations and types of implants and drill sleeves to be used in the surgical procedures. This data may be used as input to design and manufacture surgical quides for dental implants. The modifications to SICAT Implant V1.2 (K103723) include the following: Complete reengineering including significant software re-write - -Added planning functionality -Updated user interface
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or CBCT scanners
Anatomical Site
Oral-maxillofacial region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified dental professionals
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
No performance standards applicable to this device have been adopted under Section 514 of the Act. Risk management has been ensured via risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. SICAT GmbH & Co. KG adheres to recognized and established medical industry standards for development including ISO 13485, IEC 62304 and IEC 62366. The device is designed and manufactured in accordance with Quality Systems Regulations as outlined in 21 CFR 820. Verification and validation activities have been successfully performed on the software, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. Among others the following verification and validation activities were performed: Requirements Reviews. Design Validation/Reviews Risk Management ● Software verification and validation including ● O Unit Tests Code Reviews O Usability Tests O Integration Tests O System Verification and Validation Tests O For SICAT Implant V2.0, software verification and validation activities were performed, in accordance with the following quidance and standards: Principles of Software Validation; Final Guidance for Industry and FDA Staff, ● January 2002 ISO 14971:2007-Ed.2 Medical devices Application of risk management to medical ● devices AAMI/ANSI/IEC 62304:2006, Medical device software Software life cycle processes ● IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes. IEC 62366-1 Edition 1.0 2015-02 Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices [Including CORRIGENDUM 1 (2016)] The above-mentioned verification and validation activities concluded that SICAT Implant V2.0 passed all verification and validation activities and that safety and effectiveness of the product has been demonstrated in the context of its intended use.
Key Metrics
*Overall Length Measurement Accuracy: 100 μm
*Overall Angular Measurement Accuracy: 1 degree
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
Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo features a stylized caduceus symbol on the left, followed by a blue square. To the right of the blue square, the text "U.S. Food & Drug ADMINISTRATION" is displayed in a clear, sans-serif font. The text is arranged in three lines, with "U.S." and "Drug" on the top line, "Food" on the second line, and "ADMINISTRATION" on the third line.
December 4, 2019
SICAT GmbH & Co. KG % Manfred Breuer Head of Quality Management and Regulatory Affairs Brunnenallee 6 53177 Bonn. NRW GERMANY
Re: K192348
Trade/Device Name: SICAT Implant V2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 2, 2019 Received: October 7, 2019
Dear Manfred Breuer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K192348
Device Name SICAT Implant V2.0
Indications for Use (Describe)
SICAT Implant is a software application of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. SICAT Implant is intended for use as planning software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data can be exported from SICAT Implanning data includes in particular the positions and types of implants and drill sleeves to be used in the surgical procedures. This data may be used as input to design and manufacture surgical guides for dental implants.
Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
510(k) Summary for Implant V2.0
Content and format as required by section 21 CFR 807.92
( http://www.fda.gov/ MedicalDevices/ DeviceRegulationandGuidance/ HowtoMarket YourDevice/PremarketSubmissions/PremarketNotification510k/ucm142651.htm)
1. SUBMITTER/510(K) HOLDER
SICAT GmbH & Co. KG Brunnenallee 6 53177 Bonn Germany
| Establishment
| Registration Number: | 3006098230 |
|---|---|
| Telephone: | +49 (228) 854697-82 |
| Facsimile: | +49 (228) 854697-99 |
| Primary Contact: | Mr. Dr. Manfred Breue |
| Secondary Contact: | Mr. Markus Gratzfeld |
| Date Prepared: | December 4th, 2019 |
2. DEVICE NAME AND DEVICE CLASSIFICATION
| Proprietary Name: | SICAT Implant V2.0 |
|---|---|
| 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 |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR 892.2050 |
| Device Class: | Class II |
3. PREDICATE DEVICE
| Proprietary Name: | SICAT Implant V1.2 |
|---|---|
| Manufacturer: | SICAT GmbH & Co. KG |
| 510(k) number: | K103723 |
4. DEVICE DESCRIPTION
SICAT Implant V2.0 is a pure software device.
4
SICAT Implant V2.0 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 CBCT scanners.
SICAT Implant V2.0 is intended for use as planning software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments.
SICAT Implant V2.0 allows to name, position, move, rotate, resize and visualize dental implants and other planning objects (i.e. nerves) 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 can be exported from SICAT Implant. This planning data includes in particular the positions, orientations and types of implants and drill sleeves to be used in the surgical procedures. This data may be used as input to design and manufacture surgical quides for dental implants.
The modifications to SICAT Implant V1.2 (K103723) include the following:
- Complete reengineering including significant software re-write -
- -Added planning functionality
- -Updated user interface
5. Indications for Use
Indications for use of SICAT Implant V2.0 are:
SICAT Implant 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 CBCT scanners. SICAT Implant is intended for use as planning software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data can be exported from SICAT Implant. This planning data includes in particular the positions, orientations and types of implants and drill sleeves to be used in the surgical procedures. This data may be used as input to design and manufacture surgical guides for dental implants.
6. Device Comparison Table
The modified device SICAT Implant V2.0 has the same intended use and fundamental scientific technology. A comparison of the proposed device SICAT Implant V2.0 to the currently marketed predicate device SICAT Implant V1.2 including intended use. technological characteristics, design and function is provided in the following table.
| | SICAT Implant V2.0 | SICAT Implant V1.2,
SICAT
(marketed in EU / USA
cleared under 510(k)
number K103723) | |
|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Common/Usual Name | | | |
| | Radiological Visualization
Software for Diagnosis and
Dental Implant Planning | Radiological Visualization
Software for Diagnosis and
Dental Implant Planning | |
| | SICAT Implant V2.0 | SICAT Implant V1.2,
SICAT
(marketed in EU / USA
cleared under 510(k)
number K103723) | |
| | Device Description | | |
| General Description | SICAT Implant V2.0 is a
pure software device.
SICAT Implant V2.0 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 CBCT scanners.
SICAT Implant V2.0 is
intended for use as
planning software to aid
qualified dental
professionals in the
placement of dental
implants and the planning
of surgical treatments.
SICAT Implant V2.0 allows
to name, position, move,
rotate, resize and visualize
dental implants and other
planning objects (i.e.
nerves) 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 can be
exported from SICAT
Implant. This planning data
includes in particular the
positions, orientations and
types of implants and drill
sleeves to be used in the
surgical procedures. This
data may be used as input
to design and manufacture | 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-
maxillo-facial 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. | |
| | SICAT Implant V2.0
surgical guides for dental
implants. | SICAT Implant V1.2,
SICAT
(marketed in EU / USA
cleared under 510(k)
number K103723) | |
| Indications for Use/
Intended use | SICAT Implant 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 CBCT scanners.
SICAT Implant is intended
for use as planning
software to aid qualified
dental professionals in the
placement of dental
implants and the planning
of surgical treatments. The
dental professionals'
planning data can be
exported from SICAT
Implant. This planning data
includes in particular the
positions, orientations and
types of implants and drill
sleeves to be used in the
surgical procedures. This
data may be used as input
to design and manufacture
surgical guides for dental
implants. | SICAT Implant 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 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 and used as input
data for CAD or Rapid
Prototyping Systems. | |
| Contraindications | None | None | |
| Medical data viewing | | | |
| Data types
visualized | 3D volume data, 3D surface
data (optical impressions,
restorations, implant
objects) | 3D volume data, 3D surface
data (optical impressions,
implant objects) | |
| Imaging data
visualization region | Oral-maxillofacial region | Oral-maxillofacial region | |
| Viewing modes | | | |
| *Orthogonal slices | Axial, coronal, sagittal | Axial, coronal, sagittal | |
| | SICAT Implant V2.0 | SICAT Implant V1.2,
SICAT
(marketed in EU / USA
cleared under 510(k)
number K103723) | |
| *Panoramic view | Panoramic view (ray sum)
based on a panoramic
curve.
Panoramic curve can be
manually adjusted. | Panoramic view (ray sum)
based on a panoramic
curve.
Panoramic curve can be
manually adjusted. | |
| *Panoramic slice | Movable small or not
movable maximized
"Panoramic Slicing Window"
embedded in panoramic
view | Movable "Panoramic Slicing
Window" embedded in
panoramic view | |
| *TSA and LSA | Transversal slice (TSA) and
longitudinal slice (LSA),
both with respect to
panoramic curve panoramic
view | Transversal slice (TSA) and
longitudinal slice (LSA),
both with respect to
panoramic curve | |
| * 3D volume
rendering | Yes | Yes | |
| * 3D surface
rendering of volume
data | Yes | Yes | |
| | Volume Data Navigation and Manipulation | | |
| *View manipulating
tools | Zoom, Pan, Change of
orientation | Zoom, Pan, Change of
orientation | |
| *Color manipulating
tools | Brightness, Contrast | Brightness, Contrast | |
| *Scrolling through
slices | Yes | Yes | |
| Volume orientation | Yes | Yes | |
| | Measurements | | |
| *Length
measurement | Yes | Yes | |
| *Angle
measurement | Yes | Yes | |
| *Overall Length
Measurement
Accuracy | 100 μm | 100 μm | |
| *Overall Angular
Measurement
Accuracy | 1 degree | 1 degree | |
| | SICAT Implant V2.0 | SICAT Implant V1.2, SICAT
(marketed in EU / USA cleared under 510(k) number K103723) | |
| | Optical surface data visualization | | |
| *Optical impression
(maxilla, mandible,
or a part thereof) | Polygonal mesh in 3D view and panorama view, cut through polygonal mesh (contour) in some slice views | Polygonal mesh in 3D view and panorama view, cut through polygonal mesh (contour) in some slice views | |
| Optical impression
identification | Names of loaded optical impression in object browser. | A list view in a dedicated toolbar contains the names of all loaded optical impressions. | |
| * Restoration model | Polygonal mesh in 3D view and panorama view, cut through polygonal mesh (contour) in slice views. | Polygonal mesh in 3D view and panorama view, cut through polygonal mesh (contour) in slice views. | |
| Restoration model
identification | Names of loaded restoration model in object browser, hierarchically sorted according to the corresponding optical impressions. | A list view in a dedicated toolbar contains the names of all loaded restorations, hierarchically sorted according to the corresponding optical impressions. | |
| *Show/Hide a
surface object | Yes
Visibility applies to all views simultaneously. | Yes
Visibility applies to all views simultaneously. | |
| *Rendering of
optical surface data | Yes, 3D | Yes, 3D | |
| | Optical surface data manipulation | | |
| *Registration of
surface data (optical
impressions) to
volume data | Semi-automatic, using user specified reference points. | Semi-automatic, using user specified reference points. | |
| *Fine tuning the
accuracy of the
registration | Restart of the registration with a different set of reference points. | Restart of the registration with a different set of reference points. | |
| Delete | Yes, each loaded optical surface dataset separately. Restorations are deleted together with their associated optical impression. | Yes, each loaded optical impression separately. Restorations are deleted together with their associated optical impression. | |
| | Input/Output (I/O) | | |
| *Volume data
import | DICOM | DICOM | |
| | SICAT Implant V2.0 | SICAT Implant V1.2,
SICAT
(marketed in EU / USA
cleared under 510(k)
number K103723) | |
| *Optical surface
data / optical
impression import | Standard STL format and
proprietary SSI or SIXD
container format. | Standard STL format and
proprietary SSI. | |
| Data Import/Export | A "study" consisting of
planning data, volume data
and optical surface data
may be exported and
imported in a SICAT
proprietary format. | Proprietary: Planning,
volume and surface data. | |
| *Data Compression | Lossless ZIP compression | Lossless ZIP compression | |
| * Export of data for
realization of
planned therapy | For Surgical guide design
and production by the
SICAT dental laboratory or
a third party manufacturer. | For Surgical guide design
and production by the
SICAT dental laboratory | |
| Export of planning
report | PDF | PNG | |
| Implant visualization | | | |
| * Body | Polygonal mesh (conical
frustum) in 3D view and cut
through polygonal mesh in
planar slice views. | Polygonal mesh (conical
frustum) in 3D view and cut
through polygonal mesh in
planar slice views | |
| * Axis | Line in 3D view and
projected line in planar slice
views | Line in 3D view and
projected line in planar slice
views | |
| Identification | Name (tooth number) of
implants in object browser | Name (tooth number) of
active implant in toolbar | |
| Dimensions
(occlusal diameter,
apical diameter,
length)/Models | Dimensions/Models of
implants in object browser
and of active implant in
properties area. | Dimensions of (active)
implant in toolbar. | |
| Implant database | | | |
| Implant database | Realistic geometric data of
manufacturer implants,
abutments and sleeves | Realistic geometric data of
manufacturer implants | |
| | Implant manipulation and planning | | |
| * Plan/insert
realistic
manufacturer and
generic implants | Via workflow toolbar
1-click in all planar slice
views and in the panoramic
view. | 1-click in all planar slice
views and in the panoramic
view. | |
| * Plan/insert
realistic | Via workflow toolbar
1-click with a rough implant
pre-positioning based on | 1-click with a rough implant
pre-positioning at the site
of the restoration | |
| | SICAT Implant V2.0 | SICAT Implant V1.2,
SICAT
(marketed in EU / USA
cleared under 510(k)
number K103723) | |
| manufacturer and
generic implants
based on a
restoration included
in the optical
surface data | the position and orientation
of the restoration. | | |
| Delete implants | All implants or active
implant via object browser | Active implant via toolbar
or context menu | |
| * Move implants | Active implant in all planar
slice views and in the
panoramic view | Active implant in all planar
slice views | |
| * Rotate implants | Active implant about both
end points in all planar slice
views | Active implant about both
end points in all planar slice
views | |
| Change implant
dimensions/models | Via object browser and
properties area. | Via toolbar or context menu | |
| Change
identification | Tooth number of (active)
implant via tooth chart | Tooth number via tooth
chart | |
| Safety margin
visualization | For all implants in all views | For active implant in all
views | |
| * Nerve | Polygonal mesh (tube) in
3D view and panoramic
view and cut through
polygonal mesh in planar
slice views | Polygonal mesh (tube) in
3D view and panoramic
view and cut through
polygonal mesh in planar
slice views | |
| Insert | Manual definition of a
sequence of spline control
points in all planar slice
views | Manual definition of a
sequence of spline control
points in all planar slice
views | |
| Delete | Via object browser. | Via toolbar | |
| Insert control point | In all planar slice views. | In all planar slice views | |
| Delete control point | Via properties area. | Via toolbar | |
| Move control point | In all planar slice views. | In all planar slice views | |
| Change diameter | Via properties area. | Via toolbar | |
| | Abutment visualization | | |
| Body | Polygonal mesh in 3D view
and cut through polygonal
mesh in planar slice views | No | |
| | SICAT Implant V2.0 | SICAT Implant V1.2,
SICAT
(marketed in EU / USA
cleared under 510(k)
number K103723) | |
| Identification | Tooth number of
corresponding implant in
object browser | No | |
| Dimensions/Models | Dimensions/Models of
abutments in object
browser and of active
abutment in properties
area. | No | |
| Abutment manipulation and planning | | | |
| Add compatible
realistic
manufacturer
abutments | Via workflow toolbar for
compatible planned
implants. | No | |
| Add generic
abutments for
planned implants | Via workflow toolbar for
planned implants. | No | |
| Delete abutments | Active abutment via object
browser | No | |
| Change abutment
dimensions/models | Via object browser and
properties area. | No | |
| Change
identification | N/A, Identification via
corresponding implant | No | |
| | Sleeve visualization | | |
| Body | Polygonal mesh in 3D view
and cut through polygonal
mesh in planar slice views. | No | |
| Identification | Tooth number of
corresponding implant in
object browser | No | |
| Dimensions/Models | Dimensions/models of
sleeve in object browser
and for active sleeve in
properties area. | No | |
| Sleeve manipulation | | | |
| Add realistic
manufacturer
sleeves | Via workflow toolbar or
plan area for compatible
planned implants | No | |
| Delete sleeves | All sleeves via object
browser and plan area | No | |
| Change sleeve
dimensions/models | Via object browser,
properties area and plan
area. | No | |
| | SICAT Implant V2.0 | SICAT Implant V1.2,
SICAT
(marketed in EU / USA
cleared under 510(k)
number K103723) | |
| Change sleeve
position | Via planar slice views,
object browser and
properties area | No | |
| Change
identification | N/A, Identification via
corresponding implant | No | |
| Generation of
planning report for
documentation | Yes | Yes | |
| Programming
Language | C# and C++ | C# and C++ | |
| PC Hardware &
Software
requirements
(minimum) | Operating System:
Windows 7 64-bit SP1+
"Platform Update"
KB2670838, Windows 8.1
64-bit (Desktop), Windows
10 64-bit (Desktop)
CPU: Quad Core 2.3 GHz
RAM: 8 GB
HDD: 20 GB free space
Video card: 2 GB RAM
(dedicated), must support
DirectX 11 or higher, feat
driver WDDM 1.0 or higher,
e.g. NVidia GTX 960 (2GB
RAM)
Screen:
Resolution min. 1980x1080
(Full HD), Scaling 100 % -
125 %,
Resolution max.
3840x2160, Scaling 100 %
- 200 % must pass test
with SMPTE Test pattern
Additional requirements
when running as SIDEXIS 4
Module: SIDEXIS 4.3.1 or
higher, Sirona Planning API | Operating System:
Windows XP with SP2 and
.NET 2.0 Runtime Libraries
or Windows Vista
CPU: Dual Core 1.6 GHz
RAM: 2 GB
Free space on HDD: 5 GB
Video card: 128 MB
external video card, 24-bit
color, Shader Model 3 (for
advanced 3D rendering)
Screen resolution:
1280x1024 pixels
CD-Writer, network
interface card (100 MBit/s,
1 GBit/s
recommended), keyboard,
mouse | |
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- for functions and algorithms used in SICAT Implant V2.0 and SICAT Implant V2.0 having the same principle;
The software algorithms used in SICAT Implant V2.0 are equal or similar to algorithms used in the predicate device SICAT Implant V2.0.
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The added abutment planning functionality is for visualization purposes and the dentist determines if the abutment offers a reasonable starting point for possible future prosthetics. Within SICAT Implant, the user is not able to design any abutments or parts thereof. Furthermore, within SICAT Implant the user is not able to design a dental restauration such as a crown. There is no kind of output at all for the design of the abutment or a dental restauration such as a crown.
The modifications to the predicate device SICAT Implant V1.2 do not affect safety and effectiveness of the proposed device SICAT Implant V2.0.
Based on this information, SICAT GmbH & Co. KG believes that SICAT Implant V2.0 described in this submission is substantially equivalent to the predicate device SICAT Implant V1.2.
7. Non-Clinical Performance Testing and Verification and Validation Activities
No performance standards applicable to this device have been adopted under Section 514 of the Act.
Risk management has been ensured via risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. SICAT GmbH & Co. KG adheres to recognized and established medical industry standards for development including ISO 13485, IEC 62304 and IEC 62366. The device is designed and manufactured in accordance with Quality Systems Regulations as outlined in 21 CFR 820.
Verification and validation activities have been successfully performed on the software, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented.
Among others the following verification and validation activities were performed:
- Requirements Reviews
- . Design Validation/Reviews
- Risk Management ●
- Software verification and validation including ●
- O Unit Tests
- Code Reviews O
- Usability Tests O
- Integration Tests O
- System Verification and Validation Tests O
For SICAT Implant V2.0, software verification and validation activities were performed, in accordance with the following quidance and standards:
- Principles of Software Validation; Final Guidance for Industry and FDA Staff, ● January 2002
- ISO 14971:2007-Ed.2 Medical devices Application of risk management to medical ● devices
- AAMI/ANSI/IEC 62304:2006, Medical device software Software life cycle processes ●
- IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes
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- . IEC 62366-1 Edition 1.0 2015-02 Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices [Including CORRIGENDUM 1 (2016)]
The above-mentioned verification and validation activities concluded that SICAT Implant V2.0 passed all verification and validation activities and that safety and effectiveness of the product has been demonstrated in the context of its intended use.
8. Conclusion
Based on the information and supporting documentation provided in the premarket notification, SICAT Implant V2.0 is considered to be comparable in design, material and function to the predicate device SICAT Implant V1.2. It is believed to perform as well as the predicate device for the visualization of imaging information of the oral-maxillofacial region toqether with optical impression data, the diagnostic purpose and the planning functionality to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. Any minor differences between SICAT Implant V2.0 and the predicate device do not affect safety and effectiveness.