(41 days)
Not Found
No
The summary describes a software device for viewing and analyzing medical 3D data and intraoral images, providing tools for root canal analysis and surgical guide planning. There is no mention of AI, ML, or related terms, and the description focuses on visualization and analysis tools rather than automated decision-making or pattern recognition typically associated with AI/ML in medical imaging.
No
The device is described as a "pure software device" intended for "viewing and analyzing medical information" and aiding in diagnosis and treatment planning. It does not directly deliver therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "Aiding diagnosis in the oral-maxillofacial region," indicating its role in the diagnostic process.
Yes
The device description explicitly states "SICAT Endo is a pure software device." The rest of the summary describes software functionalities for viewing, analyzing, and planning based on medical imaging data.
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.
- Device Description: The device description clearly states that SICAT Endo is a pure software device intended for viewing and analyzing medical information from imaging modalities like CBCT, CT, intraoral images, and optical surface data. It provides tools for analyzing root canals and planning surgical guides.
- Intended Use: The intended uses listed are all related to aiding diagnosis, treatment planning, and comparisons based on imaging data, not on analyzing biological samples.
- Input Data: The input data consists of imaging data, not biological samples.
Therefore, SICAT Endo 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
- Aiding diagnosis in the oral-maxillofacial region
- Aiding comparisons of different treatment options
- Aiding endodontic treatment planning
- Aiding treatment planning for endodontic surgical guides
Product codes
LLZ
Device Description
SICAT Endo is a pure software device.
SICAT Endo is a software tool intended for viewing and analyzing medical information:
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
Volumetric X-ray data from Cone Beam CT (CBCT) and CT scanners, intraoral images, 3D optical surface data from optical scanners.
Anatomical Site
Oral-maxillofacial region
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)
Special bench testing has been performed with non-clinical data:
- . to verify the endodontic planning visualization quality and effectiveness
- overall quantitative accuracy of the root canal treatment planning .
Test reports for integration testing, system verification and validation testing and bench testing are included with this premarket notification.
A verification and validation activities summary report provided with this premarket notification concludes that SICAT Endo 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 (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.
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
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
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 | Yes | Yes | | | |
| *3D surface
rendering of
volume data | Yes | No | Yes | | | |
| 2D radiographs
on 3D volumetric
data | Yes | No | No | | | |
| Volume Data Navigation and Manipulation | | | | | | |
| *View
manipulating
tools | Zoom, Pan, Change
of orientation | Zoom, Pan, Change of
orientation | Zoom, Pan,
Change of
orientation | | | |
| *Color
manipulating
tools | Brightness, Contrast | Brightness, Contrast | Brightness,
Contrast | | | |
| *Scrolling
through slices | Yes | Yes | Yes | | | |
| Measurements | | | | | | |
| *Overall Length
Measurement | 100 μm | ± 0.5 mm | 100 μm | | | |
| | 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) | | | |
| Accuracy | | | | | | |
| *Overall Angular
Measurement
Accuracy | 1 degree | $\pm$ 5° | 1 degree | | | |
| | Optical Surface Data Visualization | | | | | |
| *Rendering of
optical surface
data | Yes, 3D | No | Yes, 3D | | | |
| | Optical Surface Data Manipulation | | | | | |
| *Registration of
surface data
(from optical
impressions) to
volume data | Semi-automatic,
using user specified
reference points. | n/a | Semi-automatic,
using user
specified
reference points. | | | |
| | Input / Output (I/O) | | | | | |
| *Volume data
import | DICOM | DICOM | DICOM | | | |
| *Optical surface
data / optical
impression
import | Standard STL format
and proprietary SSI
or SIXD container
format.
Features and
Algorithms identical
to SICAT Implant. | No | Standard STL
format and
proprietary SSI. | | | |
| *Data
Compression | Lossless ZIP
compression | n/a | Lossless ZIP
compression | | | |
| Export of data for
realization of
planned therapy | Yes | No | Yes | | | |
| *Marking of root
canal pathways | Yes | Yes | No | | | |
| Planning of
drillpaths | Yes | No | Yes | | | |
| Programming Language | | | | | | |
| | SICAT Endo | C# and C++ | 3D Endo, Dentsply
Sirona
(marketed in EU /
USA cleared under
510(k) K171115) | no data available | SICAT
Implant,
SICAT
(marketed in
EU / USA
cleared under
510(k) number
K103723) | C# and C++ |
| Minimum Technical Requirements | | | | | | |
| PC Hardware
requirements
(minimum) | Operating System:
Windows 7 64-bit
SP1+ "Platform
Update" KB2670838,
Windows 8 64-bit
(Desktop), Windows
8.1 64-bit (Desktop),
Windows 10 64-bit
CPU: Quad Core 2.3
GHz
RAM: 8 GB
HDD: 20 GB free
space
Video card: 1 GB
RAM (dedicated),
must support
DirectX 11 or higher,
feat driver WDDM
1.0 or higher, e.g.
NVidia GTX 960
(2GB RAM)
Screen: 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
XG-DirectDental-
Plug-In: Sidexis XG:
Version 2.6.1 (64
Bit) or Sidexis 4, V
4.1.2 (64 Bit)
Additional
requirements when
running as SIDEXIS
4 Module: SIDEXIS | Operation systems:
Windows 7, 8.1 or 10;
64-bit
Processor: 3rd
Generation Intel®
Core™ Processors or
higher
RAM: 4 GB or more
Free disk space: 20
GB or more
Graphical card
requirements: On-
board Intel® HD
Graphics 2500 or
higher
Screen resolution:
1024 x 768 or better
Open GL
requirements: Version
3.2 or higher | Operating
System:
Windows XP
Professional (32-
bit) with SP3 and
.NET 2.0
Runtime
Libraries or
Windows Vista
Business (32-bit)
with SP2 or
Windows 7
Professional (32-
bit or 64-bit)
with SP1
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 | | | |
5
6
7
8
9
10
11
| 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) |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| 4: Sirona Planning
API V4 (starting with
SIDEXIS V 4.2) | | |
- for functions and algorithms used in SICAT Implant and SICAT Endo having the same principle;
Missing features of SICAT Endo compared to the predicate device SICAT Implant are connected to implant planning. This does not impact the safety and effectiveness of SICAT Endo concerning the visualization of imaging information and treatment planning and evaluation.
Except for the CPR view the software algorithms used in SICAT Endo are similar to the predicate device SICAT Implant. Performance testing has been used to validate the safety and effectiveness of the SICAT Endo device in comparison to the predicate device 3D Endo regarding endodontic planning features, including the CPR view.
7. Non-Clinical Performance Testing and Verification and Validation Activities
For SICAT Endo, 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
- AAMI/ANSI/IEC 62304:2006, Medical device software Software life cycle processes ●
- IEC 62366-1, Medical devices Application of usability engineering to medical ● devices
- ISO 14971:2007, Medical devices Application of risk management to medical . devices.
Among others the following verification and validation activities were performed:
- Design Validation/Reviews ●
- Unit Tests .
- Code Reviews ●
- Usability Tests ●
- Integration Tests ●
- System Verification Tests ●
- User Site Tests .
Special bench testing has been performed with non-clinical data:
- . to verify the endodontic planning visualization quality and effectiveness
- overall quantitative accuracy of the root canal treatment planning .
Test reports for integration testing, system verification and validation testing and bench testing are included with this premarket notification.
12
A verification and validation activities summary report provided with this premarket notification concludes that SICAT Endo 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 Endo is considered to be comparable in design, material and function to the predicate devices. It is believed to perform as well as the predicate devices for the visualization of imaging data together with optical impression data, the diagnostic purpose, and the technological approach of planning drill canals and the evaluation of dental treatment options. Any minor differences between SICAT Endo and the predicate devices do not effect safety and effectiveness.