(120 days)
Not Found
No
The summary describes image visualization and segmentation software with no mention of AI or ML techniques.
No
The device is a software application for visualization, segmentation, and planning, not a device that directly administers therapy or performs a therapeutic function. It aids in the evaluation and planning of treatment options.
Yes
The device is described as a "software system to aid qualified dental professionals with the evaluation of dental treatment options," which implies it is used to assess a patient's condition to determine appropriate treatment, a core function of diagnostics. It visualizes and segments imaging information from medical scanners for this evaluation.
Yes
The device description explicitly states "SICAT Function is a pure software device."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- SICAT Function's Intended Use: The intended use of SICAT Function is for the visualization and segmentation of imaging information (from CT, CBCT, optical impressions, and jaw tracking) of the oral-maxillofacial region. It aids dental professionals in evaluating treatment options and planning.
- Nature of the Data: The input data is imaging data, not biological samples from the body.
- Purpose: The purpose is to aid in treatment planning and evaluation based on anatomical structure and movement, not to diagnose a disease or condition based on analysis of bodily fluids or tissues.
While it's a medical device used in healthcare, its function falls outside the scope of in vitro diagnostics. It's a software tool for image processing and treatment planning based on anatomical imaging.
N/A
Intended Use / Indications for Use
SICAT Function is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. It is also used as a software system to aid qualified dental professionals with the evaluation of dental treatment options. The dental professionals' planning data may be exported from SICAT Function and used as input data for CAD or Rapid Prototyping Systems.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
SICAT Function is a pure software device.
SICAT Function is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or Cone Beam - CT scanners.
This information can be complemented by the imaging information from optical impression systems and jaw tracking devices. The additional information about the exact geometry of the tooth surfaces and the mandibular movement can be visualized together with the radiological data.
SICAT Function is also used as a software system to aid qualified dental professionals with the evaluation and planning of dental treatment options.
The dental professionals' treatment planning information may be exported from SICAT Function to be used as input data for the manufacturing of therapeutic devices such as oral appliances.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or Cone Beam - CT scanners.
optical impression systems
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
For SICAT Function, software verification and validation activities were performed, in accordance with the following Guidances and Standards:
- NEMA PS 3.1 3.20 (2011), Digital Imaging and Communications in Medicine . (DICOM) Set. ·
- ISO 14971 Second edition 2007-03-01, Medical devices - Application of risk management to medical devices.
- IEC 62304 First edition 2006-05, Medical device software Software life cycle . processes.
- ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
- IEC 62366:2007, Medical devices - Application of usability engineering to medical devices
- SMPTE Recommended Practice RP 133-1991: Specifications for Medical . Diagnostic Imaging Test Pattern for Television Monitors and Hard-copy Recording Cameras
- HIPAA 45 CFR Part 160 - General Administrative Requirements
- HIPAA 45 CFR Part 164 - Security and Privacy
- Guidance for the Submission of Premarket Notifications for Medical Image Management Devices. Document issued on: July 27, 2000
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Document issued on: May 11, 2005
- Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf .
- Software Use in Medical Devices, Document issued on: September 9, 1999
- Device Labeling Guidance, March 8, 1991 (G91-1)
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002
- Guidance for Industry, Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, Document issued on: January 14, 2005
- Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management: July 18, 2000
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 correct import, registration and visualization of jaw motion data . and
- to verify the safety and effectiveness of image segmentation features.
Test reports for integration testing, system verification 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 Function 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.
SICAT Implant (K103723), Materialise SimPlant V 12.0 with OMS Module (K033849, K053592, K081402)
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K133320
Page 1 of 6
510(k) Summary for SICAT Function
FEB 2 5 2014
Content and format as required by section 21 CFR 807.92 ( http://www.fda.gov/ MedicalDevices/ DeviceRequlationandGuidance/ HowtoMar ketYourDevice/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 |
October 17th, 2013 Date Prepared:
2. DEVICE NAME AND DEVICE CLASSIFICATION
| Proprietary Name: | SICAT Function |
|---|---|
| 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 Function is a pure software device.
SICAT Function is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or Cone Beam - CT scanners.
This information can be complemented by the imaging information from optical
1
5 510(k) Summary for SICAT Function
impression systems and jaw tracking devices. The additional information about the exact geometry of the tooth surfaces and the mandibular movement can be visualized together with the radiological data.
SICAT Function is also used as a software system to aid qualified dental professionals with the evaluation and planning of dental treatment options.
The dental professionals' treatment planning information may be exported from SICAT Function to be used as input data for the manufacturing of therapeutic devices such as oral appliances.
5. Intended Use
SICAT Function is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. It is also used as a software system to . aid qualified dental professionals with the evaluation of dental treatment options. The dental professionals' planning data may be exported from SICAT Function and used as input data for CAD or Rapid Prototyping Systems.
6. Device Comparison Table
The following table shows a summary of the intended use, technological characteristics, design and function of SICAT Function and the predicate devices.
| SICAT Function
Proposed | SICAT Implant
K103723 | Materialise SimPlant
V 12.0 with OMS
Module (K033849,
K053592, K081402) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Intended Use | | | |
| SICAT Function is a
software application
for the visualization
and segmentation of
imaging information of
the oral-maxillofacial
region. The imaging
data originates from
medical scanners such
as CT or CBCT
scanners. It is also
used as a software
system to aid qualified
dental professionals
with the evaluation of
dental treatment
options. The dental
professionals' planning
data may be exported
from SICAT Function
and used as input data
for CAD or Rapid
Prototyping Systems. | 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. | The SimPlant System is
intended for use as a
software interface and
image segmentation
system for the transfer of
imaging information from
a medical scanner such as
a CT scanner or a
Magnetic Resonance
scanner. It is also
intended as pre-planning
software for dental
implant placement and
surgical treatment.
Materialise Dental's
SimPlant Ortho 3D
software is indicated for
use as a medical front-
end software that can be
used by medically trained
people for the purpose of
visualizing gray value
images. It is intended for
use as a software
interface and image
| |
| SICAT Function
Proposed | SICAT Implant
K103723 | Materialise SimPlant
V 12.0 with OMS
Module (K033849,
K053592, K081402) | |
| segmentation
system for the transfer of
imaging information from
a medical scanner such as
a CT scanner or Magnetic
Resonance scanner. It is
also used as a software
system for
simulating/evaluating
orthodontic treatment i.e.
dental bite options. | | | |
| Technological Characteristics and Function | | | |
| Material | pure software device | pure software device | |
| Operating
system | Windows | Windows | |
| Program-
ming
language | C# and C++ | C++ | |
| Medical Data I/O | | | |
| Volume data
import | DICOM | DICOM | |
| Optical
surface data/
optical
impression
import | Standard STL format
and proprietary SSI
container Format. | Standard STL format and
proprietary OrthoPlex
format. | |
| Jaw motion
tracking data | No | No | |
| Export of
data for CAD
and rapid
proto-typing | Yes | Yes | |
| Medical Data Viewing | | | |
| Data types
visualized | 3D volume data,
optical impressions | 3D volume data, optical
impressions | |
| 2D Slice
Views | axial, coronal, sagittal,
dental panorama,
dental tangential and
cross-sectional slice
views | axial, coronal, sagittal,
dental panorama, dental
cross-sectional slice view,
cephalometric | |
| 3D Volume
rendering | Yes | Yes | |
| 3D Surface
rendering | Yes | Yes | |
| View
manipu-
lating tools | Scroll, Zoom, Pan,
Change of orientation,
Brightness, Contrast | Scroll, Zoom, Pan,
Change of orientation,
Brightness, Contrast | |
| Measure-
ments | Length, Angle, Grey
values | Length, Angle, Grey
values | |
| Segmen-
tation (i.e. of
mandible) | No | Yes, using a segmentation
wizard | |
| SICAT Function
Proposed | SICAT Implant
K103723 | Materialise SimPlant
V 12.0 with OMS
Module (K033849,
K053592, K081402) | |
| Registration
of optical
impression
data to
volume data | Yes | Yes | Yes |
| Evaluation of
occlusion
based on
optical
impression
data | Only visually | No | Yes, color coded |
| Misc. functions | | | |
| Simulation of
orthodontic
procedures,
osteotomies
and
distractions. | No | No | Yes |
| Cephalo-
metric
analysis | No | No | Cephalometric view with
length and angular
measurements and special
tools for different
cephalometric schools. |
| Implant
planning | No | Yes | Yes |
| Soft tissue
simulation
and photo
mapping | No | No | Yes |
2
.
3
5 510(k) Summary for SICAT Function
Missing features of SICAT Function compared to the predicate devices are connected to implant planning, i.e. the planning feature itself and the measurement of grey values, and to the planning of orthognatic surgery, i.e. the simulation of orthodontic procedures, osteotomies and distraction, soft tissue simulation and the cephalometric analysis. This does not impact the safety and effectiveness of SICAT Function concerning the visualization and segmentation of imaging information and the evaluation of other dental treatment options.
Additional features of SICAT Function compared to the predicate devices are the import and visualization of jaw motion data. Performance testing has been used to validate the safety and effectiveness of SICAT Function related to the import and visualization of jaw motion data.
The predicate device SICAT Implant does not provide features for the segmentation of imaging information and for jaw motion data. Otherwise the software algorithms used in SICAT Function are identical to the predicate device SICAT Implant. Performance testing has been used to validate the safety and effectiveness of the SJCAT Function segmentation features in comparison to the predicate device Simplant.
7. Non-Clinical Performance Testing and Verification and Validation Activities
For SICAT Function, software verification and validation activities were performed, in accordance with the following Guidances and Standards:
- NEMA PS 3.1 3.20 (2011), Digital Imaging and Communications in Medicine . (DICOM) Set. ·
4
- 510(k) Summary for SICAT Function 5
- . ISO 14971 Second edition 2007-03-01, Medical devices - Application of risk management to medical devices.
- IEC 62304 First edition 2006-05, Medical device software Software life cycle . processes.
- . ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
- ◆ IEC 62366:2007, Medical devices - Application of usability engineering to medical devices
- SMPTE Recommended Practice RP 133-1991: Specifications for Medical . Diagnostic Imaging Test Pattern for Television Monitors and Hard-copy Recording Cameras
- ◆ HIPAA 45 CFR Part 160 - General Administrative Requirements
- . HIPAA 45 CFR Part 164 - Security and Privacy
- ◆ Guidance for the Submission of Premarket Notifications for Medical Image Management Devices. Document issued on: July 27, 2000
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Document issued on: May 11, 2005
- Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf .
- . Software Use in Medical Devices, Document issued on: September 9, 1999
- . Device Labeling Guidance, March 8, 1991 (G91-1)
- . General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002
- . Guidance for Industry, Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, Document issued on: January 14, 2005
- . Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management: July 18, 2000
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 correct import, registration and visualization of jaw motion data . and
- . to verify the safety and effectiveness of image segmentation features.
October 17th, 2013
5
5 510(k) Summary for SICAT Function
K133320
Page 6 of 6
Test reports for integration testing, system verification 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 Function 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 Function is considered to be substantially equivalent in design, material and function to the predicate devices. It is believed to perform as well as the predicate devices for the visualization and segmentation of imaging information and the evaluation of dental treatment options. Accordingly we respectfully request the Agency to find this traditional 510(k) premarket notification to be Substantially Equivalent.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three wave-like lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2014
SICAT GMBH & CO. KG % OLAF TEICHERT THIRD PARTY REVIEWER TUV SUD AMERICA INC. 1775 OLD HWY 8 NW, STE 104 NEW BRIGHTON MN 25112
Re: K133320
Trade/Device Name: Sicat Function Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 16, 2014 Received: January 22, 2014
Dear Mr. Teichert:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
7
Page 2-Mr. Teichert
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133320
Device Name Sicat Function
Indications for Use (Describe)
SICAT Function is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. It is also used as a software system to aid qualified dental professionals with the evaluation of dental treatment options. The dental professionals' planning data may be exported from SICAT Function and used as input data for CAD or Rapid Prototyping Systems.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Sm.h.7)
FORM FDA 3881 (1/14)
9
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