← Product Code [LLZ](/productcode/LLZ) · K180262 # SICAT Endo (K180262) _Sicat GmbH & Co. KG · LLZ · Mar 12, 2018 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K180262 ## Device Facts - **Applicant:** Sicat GmbH & Co. KG - **Product Code:** [LLZ](/productcode/LLZ.md) - **Decision Date:** Mar 12, 2018 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## Indications for Use Aiding diagnosis in the oral-maxillofacial region Aiding comparisons of different treatment options Aiding endodontic treatment planning Aiding treatment planning for endodontic surgical guides ## Device Story SICAT Endo is a software-only device for viewing/analyzing medical 3D volume data (CBCT/CT), intraoral images, and 3D optical surface data (optical impressions). Used by dental professionals in clinics to visualize oral-maxillofacial anatomy; identify/mark root canals; define drill canals; and plan endodontic surgical guides. The software provides tools for 3D volume rendering, orthogonal slices, panoramic views, and curved planar reformation (CPR). It allows registration of optical surface data to volume data using user-specified reference points. Output consists of visualized anatomical data and exported planning data for use in CAD or rapid prototyping systems for surgical guide fabrication. By enabling precise 3D visualization and drill path planning, the device assists clinicians in endodontic treatment planning and surgical guide design, potentially improving treatment predictability and quality. ## Clinical Evidence Bench testing only. Verification and validation activities included design reviews, unit tests, code reviews, usability tests, integration tests, and system verification. Special bench testing verified endodontic planning visualization quality and quantitative accuracy of root canal treatment planning. The device passed all verification and validation activities. ## Technological Characteristics Pure software device; runs on Windows 7/8/10 (64-bit). Inputs: DICOM (CBCT/CT), STL, proprietary SSI/SIXD containers. Visualization: 3D volume/surface rendering, orthogonal slices, panoramic views, CPR. Connectivity: Standalone or integrated as SIDEXIS XG/4 module. Software lifecycle: AAMI/ANSI/IEC 62304 compliant. Accuracy: 100 μm length, 1-degree angular measurement. ## Regulatory 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. ## Special Controls *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). ## Predicate Devices - SICAT Implant ([K103723](/device/K103723.md)) - 3D Endo™ Software ([K171115](/device/K171115.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ March 12, 2018 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. SICAT GmbH & Co. KG % Frederik Kunze Quality Management and Regulatory Affairs Brunnenallee 6 Bonn, NRW 53177 GERMANY Re: K180262 Trade/Device Name: SICAT Endo Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 29, 2018 Received: January 30, 2018 Dear Frederik Kunze: 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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K180262 Device Name SICAT Endo Indications for Use (Describe) - Aiding diagnosis in the oral-maxillofacial region - Aiding comparisons of different treatment options - · Aiding endodontic treatment planning - · Aiding treatment planning for endodontic surgical guides 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) | CONTINUE ON A SEPARATE PAGE IF NEEDED ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### Content and format as required by section 21 CFR 807.92 ( http://www.fda.gov/ MedicalDevices/ DeviceRequlationandGuidance/ 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 Breuer | | Secondary Contact: | Mr. Frederik Kunze | | Date Prepared: | January 29th, 2018 | ### 2. DEVICE NAME AND DEVICE CLASSIFICATION | Proprietary Name: | SICAT Endo | |-------------------------|--------------------------------------------------------------| | Common/Usual Name: | Radiological Visualization Software for Diagnosis and Dental | | | Treatment Planning | | Classification Name: | System, Image Processing, Radiological | | Regulation Description: | Picture archiving and communications system | | Product Code: | LLZ | | Regulation Number: | 21 CFR 892.2050 | | Classification Class: | Class II Product | ### 3. PREDICATE DEVICES - SICAT Implant (K103723) (Primary predicate device) . - 3D Endo™ Software (K171115) . ### 4. DEVICE DESCRIPTION SICAT Endo is a pure software device. SICAT Endo is a software tool intended for viewing and analyzing medical information: {4}------------------------------------------------ - 5 510(k) Summary for SICAT Endo - medical 3D volume data such as volumetric X-ray data from Cone Beam CT (CBCT) and CT scanners, and - . intraoral images, and - . 3D optical surface data like optical impression data from optical scanners, and SICAT Endo provides tools for analyzing the root canal and to mark it visually. It allows to define a drill canal and ordering of a corresponding surgical quide with a drill sleeve. ### 5. Indications for Use Indications for use for SICAT Endo are: - Aiding diagnosis in the oral-maxillofacial region - . Aiding comparisons of different treatment options - . Aiding endodontic treatment planning - Aiding treatment planning for endodontic surgical quides . ### 6. Device Comparison Table The following table shows a summary of the intended use, technological characteristics, design and function of SICAT Endo and the predicate devices. The predicate device SICAT Implant is the primary predicate device. | | SICAT Endo | 3D Endo, Dentsply
Sirona
(marketed in EU /
USA cleared under
510(k) K171115) | SICAT
Implant,
SICAT
(marketed in
EU / USA
cleared under
510(k) number
K103723) | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------------------------------------------------------------------------------------------------|------------| | | Common / Usual Name | | | | | | | | Radiological
Visualization
Software for
Diagnosis and
Endodontic
Treatment Planning | Radiological
Visualization Software
for Diagnosis and
Endodontic Treatment
and Re-treatment
Planning | Radiological
Visualization
Software for
Diagnosis and
Dental Implant
Planning | | | | | Device Description | | | | | | | | General Description | SICAT Endo is a
pure software
device.
SICAT Endo is a
software application
for visualization of
imaging information
of the oral-
maxillofacial region.
The imaging data | 3D Endo™ is a CBCT
based software device
designed to improve
endodontic treatment
planning for more
predictability.
It is designed to
improve treatment
quality: to isolate the
tooth of interest, to | SICAT Implant
V1.2 is a pure
software device.
SICAT Implant
V1.2 is a
software
application for
the visualization
of imaging
information of | | | | | SICAT Endo | 3D Endo, Dentsply
Sirona
(marketed in EU /
USA cleared under
510(k) K171115) | SICAT
Implant,
SICAT
(marketed in
EU / USA
cleared under
510(k) number
K103723) | | | | | | originates from
medical scanners
such as CT or CBCT
scanners. It is also
used as a software
system to aid
medical
professionals with
the planning, the
evaluation and the
comparison of
treatment options
and the planning of
endodontic accesses
for an endodontic
treatment. The
medical
professionals'
planning data may
be exported from
SICAT Endo and
used for the
realization of the
planned therapy. | clearly visualize the
tooth anatomy in 3D,
to identify all canals
and to anticipate
areas.
The use of 3D Endo
provides:
- Diagnosis and
pathology
- 3D tooth anatomy
- Canal system
- 3D canal anatomy
- Treatment plan
The Wizard allows to:
· Diagnose the case;
• Isolate the tooth of
interest;
· Investigate the
canal system;
• Understand the 3D
Canal anatomy;
· Create a Treatment
plan.
The use of 3D Endo
allows to:
· evaluate 3D working
length and cavity
access depth
• locate canal orifices
without opening the
tooth
• plan for an optimal
cavity access and your
final instrument
· investigate canals'
irregularities following
their curvatures
In addition, the
simulated Intra-Root
Camera View Visualize | 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 | | | | | | | SICAT Endo | 3D Endo, Dentsply
Sirona
(marketed in EU /
USA cleared under
510(k) K171115) | SICAT
Implant,
SICAT
(marketed in
EU / USA
cleared under
510(k) number
K103723) | | | | | | | throughout the canal
the theoretical cutting
envelope of the
Dentsply Sirona
Endodontics
instruments. | 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. | | | | | Indications for Use | | | | | | | | Indications for
Use | Aiding diagnosis in
the oral-maxillofacial
region
Aiding comparisons
of different
treatment options
Aiding endodontic
treatment planning
Aiding treatment
planning for
endodontic surgical
guides | 3D Endo™ Software is
intended to aid in the
visualization,
diagnosis and
planning of
endodontic treatment
and re-treatment
cases utilizing DICOM
images. | 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 | | | | | | SICAT Endo | 3D Endo, Dentsply
Sirona
(marketed in EU /
USA cleared under
510(k) K171115) | SICAT
Implant,
SICAT
(marketed in
EU / USA
cleared under
510(k) number
K103723) | | | | | | | | planning data
may be exported
from SICAT
Implant and
used as input
data for CAD or
Rapid
Prototyping
Systems. | | | | | Contraindications | None | Do not use 3D Endo™
Software for implants
or any other dental
procedure outside
endodontics.
There are no known
serious adverse
reactions or potential
safety hazards. | None | | | | | | Medical Data Viewing | | | | | | | Data types
visualized | 3D volume data, 3D
surface data (optical
impressions), 2D
radiographs | 2D and 3D visualized
CBCT data | 3D volume data,
3D surface data
(optical
impressions,
implant objects) | | | | | Imaging data
visualization
region | Oral-maxillofacial
region | Oral-maxillofacial
region | Oral-maxillofacial
region | | | | | | Viewing Modes typically used for dental procedures | | | | | | | *Orthogonal
slices | Axial, coronal,
sagittal within the
Endoline wizard | Axial | Axial, coronal,
sagittal | | | | | *Panoramic view | Panoramic view (ray
sum) based on a
panoramic curve.
Panoramic curve can
be manually
adjusted. | No | Panoramic view
(ray sum) based
on a panoramic
curve.
Panoramic curve
can be manually
adjusted. | | | | | Curved Planar
Reformation | Curved planar
reformation based | Yes | None | | | | | | SICAT Endo | 3D Endo, Dentsply
Sirona
(marketed in EU /
USA cleared under
510(k) K171115) | SICAT
Implant,
SICAT
(marketed in
EU / USA
cleared under
510(k) number
K103723) | | | | | (CPR) also called
Multi Planar
Reformation
(MPR) that is
less precise | on a spline
positioned within the
volume. By
positioning the
spline the view is
adjusted.
No equidistant scale. | | | | | | | *Panoramic slice | Movable "Panoramic
Slicing Window"
embedded in
panoramic view | No | Movable
"Panoramic
Slicing Window"
embedded in
panoramic view | | | | | *TSA and LSA | Transversal slice
(TSA) and
longitudinal slice
(LSA), both with
respect to
panoramic curve | Transversal slice | Transversal slice
(TSA) and
longitudinal slice
(LSA), both with
respect to
panoramic curve | | | | | *3D volume
rendering | Yes… --- **Source:** [https://fda.innolitics.com/device/K180262](https://fda.innolitics.com/device/K180262) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com