(60 days)
No
The document describes image processing and segmentation tools but does not mention AI, ML, or deep learning, nor does it provide details about training or test sets typically associated with AI/ML models.
No
The device aids in diagnosis and treatment planning, and its output can be used to manufacture therapeutic devices, but the device itself does not directly treat a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that HICAT Air is for "Aiding diagnosis in the ear-nose-throat region." Additionally, the "Device Description" section reiterates that it is used "to aid qualified medical professionals with the diagnosis."
Yes
The device description explicitly states "HICAT Air is a pure software device." and describes its function as a software application for visualization, segmentation, and aiding diagnosis/planning based on imaging data. There is no mention of accompanying hardware components included with the device itself.
Based on the provided information, HICAT Air is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- HICAT Air's Function: HICAT Air processes and visualizes imaging data (CT, CBCT, optical impressions) of the ear-nose-throat region. It aids in diagnosis, treatment planning, and comparison of treatment options based on this imaging information. It does not analyze biological specimens.
Therefore, HICAT Air falls under the category of medical imaging software or a medical device software, but not an IVD.
N/A
Intended Use / Indications for Use
HICAT Air is a software application for:
- Aiding diagnosis in the ear-nose-throat region
- Aiding treatment planning in the ear-nose-throat region
- Aiding comparisons of different treatment options
- Aiding treatment planning for oral appliances
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
HICAT Air is a pure software device.
HICAT Air is a software application for the visualization and segmentation of imaging information of the ear-nose-throat (ENT) region.
The imaging data originates from medical scanners such as CT or Cone Beam – CT (CBCT) scanners.
This information can be complemented by the imaging information from optical impression systems. The additional information about the exact geometry of the tooth surfaces can be visualized together with the radiological data.
HICAT Air is also used as a software system to aid qualified medical professionals with the diagnosis, and followed by the evaluation, comparison and planning of ENT treatment options.
The medical professionals' input information and planning data may be exported from HICAT Air to be used as input data for CAD or Rapid Prototyping Systems for the manufacturing of therapeutic devices such as oral devices.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
imaging data originates from medical scanners such as CT or Cone Beam – CT (CBCT) scanners.
imaging information from optical impression systems.
Anatomical Site
ear-nose-throat (ENT) region
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
qualified medical 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 HICAT Air, 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 cvcle . processes.
-
. 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, Doument 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 Offthe-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 ●
-
System Validation Tests
Special bench testing has been performed with non-clinical data:
- to verify the segmentation performance of anatomical structures of the airway ● using a segmentation wizard and
- to verify the correct calculation of geometric dimensions of the airway by the airway analysis tool.
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 HICAT Air passed all verification and validation activities and that safety and effectiveness of the product has been demonstrated in the context of its indications for 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 Function (K133320)
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.
Dolphin Imaging 11.5 (K110430)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 16, 2015
HICAT GmbH % Mr. Frederik Kunze Head of Quality Management and Regulatory Affairs Brunnenallee 6 Bonn, North Rhine - Westphalia 53177 GERMANY
Re: K152661 Trade/Device Name: HICAT Air Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 22, 2015 Received: September 23, 2015
Dear Mr. 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 (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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.
Michael 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
| 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 below. |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | |
| K152661 | |
| Device Name | |
Device Proprietary Name: HICAT Air
Indications for Use (Describe)
HICAT Air is a software application for:
- · Aiding diagnosis in the ear-nose-throat region
- Aiding treatment planning in the ear-nose-throat region
- · Aiding comparisons of different treatment options
- · Aiding treatment planning for oral appliances
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.
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."
| FORM FDA 3881 (8/14) | |
|---|---|
| ---------------------- | -- |
3
510(k) Summary for HICAT Air
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
HICAT GmbH Brunnenallee 6 53177 Bonn Germany
| Establishment
| Registration Number: | HICAT GmbH is not registered yet |
|---|---|
| Telephone: | +49 (228) 854697-38 |
| Facsimile: | +49 (228) 854697-99 |
| Primary Contact: | Mr. Frederik Kunze |
| Secondary Contact: | Dr. Manfred Breuer |
| Date Prepared: | September 14th, 2015 |
2. DEVICE NAME AND DEVICE CLASSIFICATION
| Proprietary Name: | HICAT Air |
|---|---|
| Common/Usual Name: | Radiological Visualization Software for Diagnosis and 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
HICAT Air is a pure software device.
HICAT Air is a software application for the visualization and segmentation of imaging information of the ear-nose-throat (ENT) region.
4
The imaging data originates from medical scanners such as CT or Cone Beam – CT (CBCT) scanners.
This information can be complemented by the imaging information from optical impression systems. The additional information about the exact geometry of the tooth surfaces can be visualized together with the radiological data.
HICAT Air is also used as a software system to aid qualified medical professionals with the diagnosis, and followed by the evaluation, comparison and planning of ENT treatment options.
The medical professionals' input information and planning data may be exported from HICAT Air to be used as input data for CAD or Rapid Prototyping Systems for the manufacturing of therapeutic devices such as oral devices.
5. Indications for Use
HICAT Air is a software application for:
- Aiding diagnosis in the ear-nose-throat region
- Aiding treatment planning in the ear-nose-throat region
- Aiding comparisons of different treatment options
- Aiding treatment planning for oral appliances
6. Device Comparison Table
The following table shows a summary of the indications for use, technological characteristics, design and function of HICAT Air and the predicate devices.
| HICAT Air
Proposed | Reference predicate
Dolphin Imaging 11.5
(K110430) | Primary predicate
SICAT Function
(K133320) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common / Usual Name | | |
| Radiological Visualization
Software for Diagnosis and
Treatment Planning | Not available | Radiological Visualization
Software for Diagnosis and
Dental Treatment Planning |
| Device Description | | |
| HICAT Air is a pure software
device. HICAT Air is a
software application for the
visualization and
segmentation of imaging
information of the ear-nose-
throat (ENT) region. The
imaging data originates from
medical scanners such as CT
or Cone Beam – CT (CBCT)
scanners. | Dolphin Imaging is a pure
software device. Dolphin
Imaging 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 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.
The additional information
about the exact geometry of | Dolphin Imaging software
is designed for capturing,
storing and presenting
patient images and
assisting in treatment
planning and case | This information can be
complemented by the
imaging information from
optical impression systems
and jaw tracking devices. The
additional information about |
5
| HICAT Air
Proposed | Reference predicate
Dolphin Imaging 11.5
(K110430) | Primary predicate
SICAT Function
(K133320) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| the tooth surfaces can be
visualized together with the
radiological data.
HICAT Air is also used as a
software system to aid
qualified medical
professionals with the
diagnosis, and followed by
the evaluation, comparison
and planning of ENT
treatment options.
The medical professionals'
input information and
planning data may be
exported from HICAT Air to
be used as input data for
CAD or Rapid Prototyping
Systems for the
manufacturing of therapeutic
devices such as oral devices. | diagnosis. Results
produced by the software's
diagnostic and treatment
planning tools are
dependent on the
interpretation of trained
and licensed practitioners.
Acquisition of 2D image
data can be performed
from multiple types of
devices, including digital
radiography devices such
as x-ray machines, generic
imaging devices that
support the TWAIN
interface standard, such as
flatbed scanners and
standard image file formats
(Jpeg, Bitmap, etc.) stored
on a computer, camera
memory card or similar.
The following features are
available:
Import from a variety of 3D
dataset formats (DICOM)
High-quality, fast 3D
rendering
Three-dimensional airway
segmentation and analysis
in the ear-nose throat-
region
Airway analysis:
Analyze the airway by
drawing a border around
your selected portion of the
volumetric scan; the
program will automatically
fill in and display all the
airway space within that
border, then report back
telling you the volume of
airway space in cubic
millimeters. It will also
locate, display and
measure, in square
millimeters, the most
constricted spot of that
airway.
Cross sections in Multiple | 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 CAD or
Rapid Prototyping Systems
for the manufacturing of
therapeutic devices such as
oral appliances. |
6
| | HICAT Air
Proposed | Reference predicate
Dolphin Imaging 11.5
(K110430) | Primary predicate
SICAT Function
(K133320) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Planar View (MPV)
Precise volume orientation | |
| | | Volume stitching:
Combine two separate
volumes into one
2D facial photo wrap onto
volume | |
| | | Volume-to-volume
superimposition | |
| | | 3D nerve marking | |
| | | TMJ analysis | |
| | | Generate cephalometric
and panoramic radiographs | |
| | | 3D-2D measurements:
distance, angle and area | |
| | | Create animated movies
with automated scripts | |
| | | Design image layouts and
reports | |
| | | Images export to other
applications | |
| | | 3D implant treatment
planning and simulation | |
| | | Distinguish biological
structures via their
radiolucency with a
Hounsfield Unit measuring
tool | |
| Indications for Use | | | |
| Indications for
Use | HICAT Air is a software
application for:
• Aiding diagnosis in the
ear-nose-throat region.
• Aiding treatment
planning in the ear-
nose-throat region.
• Aiding comparisons of
different treatment
options.
• Aiding treatment
planning for oral
appliances | Intended Use Statement of
510(k) Summary K110430:
"Dolphin Imaging software
is designed for use by
specialized dental practices
for capturing, storing and
presenting patient images
and assisting in treatment
planning and case
diagnosis. Results
produced by the software's
diagnostic and treatment
planning tools are | Indications for Use
Statement of 510(k)
Summary K133320:
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 |
| | | dependent on the
interpretation of trained | aid qualified dental
professionals with the |
7
| | HICAT Air
Proposed | Reference predicate
Dolphin Imaging 11.5
(K110430) | Primary predicate
SICAT Function
(K133320) |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | and licensed practitioners."
Product information from Appendix B-2 indicates among others: Aiding diagnosis in the ENT-region Aiding treatment planning in the ENT-region Aiding comparisons of different treatment options | 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. |
| Contraindications | none | unknown | none |
| | Medical Data Viewing | | |
| Data types
visualized | 3D volume data, optical
impressions | 3D volume data, 2D
radiological x-ray data,
images and photographs | 3D volume data, optical
impressions, jaw motion
tracking data |
| Imaging data
visualization
region | ENT region including the
oral-maxillofacial region | ENT region including the
oral-maxillofacial region | oral-maxillofacial region |
| | Viewing Modes | | |
| Orthogonal slices | Axial, coronal, sagittal
Features and algorithms are
identical to SICAT Function. | Axial, coronal, sagittal | Axial, coronal, sagittal |
| Special Dental
View:
Panoramic View | Panoramic view (ray sum)
based on a panoramic curve.
Panoramic curve can be
manually adjusted.
(available in the optical
impression registration
window)
Features and Algorithms are
identical to SICAT Function. | Yes | Panoramic view (ray sum)
based on a panoramic curve.
Panoramic curve can be
manually adjusted. |
| Special dental
view:
Cephalometric
View | No | Yes | No |
| Special dental
views:
TSA and LSA | Transversal slice (TSA) and
longitudinal slice (LSA), both
with respect to panoramic
curve.
(available in the optical
impression registration
window)
Features and Algorithms
identical to SICAT Function | Single transversal slices are
generated. | Transversal slice (TSA) and
longitudinal slice (LSA), both
with respect to panoramic
curve. |
| 3D volume
rendering | Yes, volume rendering using
a standard and well
established ray-casting
algorithm with integration
along rays, and volume
rendering utilizing standard | Yes | Yes |
8
| | HICAT Air
Proposed | Reference predicate
Dolphin Imaging 11.5
(K110430) | Primary predicate
SICAT Function
(K133320) |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| 3D surface
rendering of
volume data | shader based slicing
algorithms available on
typical consumer graphics
hardware.
Yes, using a standard and
well established front-to-
back ray-casting algorithm
with an iso-surface
threshold. | Yes | No |
| View
manipulating
tools | Zoom, Pan, Change of
orientation
Features and Algorithms
identical to SICAT Function | Yes | Zoom, Pan, Change of
orientation |
| Color
manipulating
tools | Brightness, Contrast
Features and Algorithms
identical to SICAT Function | Yes | Brightness, Contrast |
| Scrolling through
slices | For all slices
Features and Algorithms
identical to SICAT Function | Yes | For all slices (including
panoramic slicing window) |
| 3D volume
clipping | Yes
Features and Algorithms
identical to SICAT Function | Yes | Yes |
| Length
measurement | Yes
Features and Algorithms
identical to SICAT Function | Yes | Yes |
| Area
measurement | Yes | Yes | No |
| Angle
measurement | Yes
Features and Algorithms
identical to SICAT Function | Yes | Yes |
| Overall Length
Measurement
Accuracy | 100 µm
Algorithms identical to SICAT
Function | unknown | 100 μm |
| Overall Angular
Measurement
Accuracy | 1 degree
Algorithms identical to SICAT
Function | unknown | 1 degree |
| Segmentation of Anatomical Structures | | | |
| Segmentation of
anatomical
structures | Yes, using a segmentation
wizard.
Algorithm: Water Shed (a
type of graph-cut algorithm,
which is identical to SICAT
Function ) | Yes
Segmentation algorithm is
unknown. | Yes, using a segmentation
wizard.
Algorithm: Water Shed (a
type of graph-cut algorithm) |
| Airway
Segmentation | Airway Segmentation of the
Airway using the
segmentation wizard. | Yes
Segmentation algorithm is
unknown. | No |
| Segmentation of
mandible and
fossa | No | No | Yes, using a segmentation
wizard.
Algorithm: Water Shed (a
type of graph-cut algorithm) |
9
| | HICAT Air
Proposed | Reference predicate
Dolphin Imaging 11.5
(K110430) | Primary predicate
SICAT Function
(K133320) |
|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mesh texturing of
the segmented
airway | The Airway is texturized by a
standard algorithm. | Yes | No |
| | Optical Impression Data Visualization | | |
| Optical
impression
(maxilla,
mandible, or a
part thereof) | Optical impression (maxilla,
mandible, or a part thereof) | No | Optical impression (maxilla,
mandible, or a part thereof) |
| | Polygonal mesh in 3D view
and panorama view, cut
through polygonal mesh
(contour) in slice view
Features and Algorithms
identical to SICAT Function. | | Polygonal mesh in 3D view
and panorama view, cut
through polygonal mesh
(contour) in slice view |
| Optical
impression name | A list view in a dedicated
toolbar contains the names
of all loaded optical
impressions.
Features and Algorithms
identical to SICAT Function. | No | A list view in a dedicated
toolbar contains the names
of all loaded optical
impressions. |
| Show/Hide an
optical impression | Yes
Visibility applies to all views
simultaneously.
Algorithms identical to SICAT
Function. | No | Yes
Visibility applies to all views
simultaneously. |
| | Optical Impression Data Manipulation | | |
| Registration of
surface data
(from optical
impressions) to
volume data | Semi-automatic, using user
specified reference points.
Features and Algorithms
identical to SICAT Function. | No | 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.
Features and Algorithms
identical to SICAT Function. | No | Restart of the registration
with a different set of
reference points. |
| Delete | Yes
Features and Algorithms
identical to SICAT Function. | No | Yes |
| | 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 Function. | No | Standard STL format and
proprietary SSI or SIXD
container format. |
| Data
Import/Export
Data Compression | A "study" consisting of
planning data (including
segmentation information),
volume data, optical surface
data may be exported and
imported in a SICAT
proprietary format.
Lossless ZIP compression | No | A "study" consisting of
planning data (including
segmentation information),
volume data, jaw motion
data and optical surface data
may be exported and
imported in a SICAT
proprietary format. |
10
| | HICAT Air
Proposed | Reference predicate
Dolphin Imaging 11.5
(K110430) | Primary predicate
SICAT Function
(K133320) |
|------------------------------------------------------------------------------------------------------|---------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------|
| | Features and Algorithms
identical to SICAT Function. | | Lossless ZIP compression |
| Export of data for
CAD and rapid
proto-typing | Yes | No | Yes |
| | | Misc. functions | |
| Soft tissue
simulation with
photo mapping | No | Yes | No |
| Cross sections in
Multiple Planar
View (MPV) | No | Yes | No |
| Volume stitching:
Combine two
separate volumes
into one | No | Yes | No |
| 2D facial photo
wrap onto volume | No | Yes | No |
| Volume-to-
volume
superimposition | No | Yes | No |
| 3D nerve marking | No | Yes | No |
| Generate
panoramic
radiographs | Yes | Yes | Yes |
| Generate
cephalometric
radiographs | No | Yes | No |
| Create animated
movies with
automated scripts | No | Yes | No |
| Design and print
handout reports | Yes | Yes | No |
| Image export to
other applications | Yes | Yes | Yes |
| Main Functions | | | |
| Three-
dimensional
airway
segmentation and
analysis in the
ear-nose throat-
region | Yes
Image: 3D airway rendering | Yes
Image: Display of airway volume and most constricted area | No |
| Airway
Visualization | 3D surface rendering | 3D surface rendering | No |
| Airway Analysis:
Calculation of | Yes | Yes | No |
11
| | HICAT Air
Proposed | Reference predicate
Dolphin Imaging 11.5
(K110430) | Primary predicate
SICAT Function
(K133320) |
|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| airway volume | Yes | Yes | No |
| Airway Analysis:
Calculation of the
airway cross
section
dimensions | Yes | Yes | No |
| Airway Analysis:
Calculation of the
position and size
of the area with
minimum cross
section in airway | Yes | Yes | No |
| Simulation of
orthodontic
procedures,
osteotomies and
distractions | No | Yes | No |
| Cephalometric
analysis | No | Yes | No |
| TMJ analysis | No | Yes | Yes |
| 3D implant
treatment
planning and
simulation | No | Yes | No |
| | | Programming Language | |
| | C# and C++ | Unknown | C# and C++ |
| | | System Requirements | |
| PC Hardware
Requirements
(Minimum) | | Minimum Imaging
Requirements (Rev 05/15) | |
| | CPU: 2,0 GHz Dualcore | CPU: Intel® Core 2 | CPU: 1 GHz |
| | RAM: 4 GB | RAM: 2 GB (4 GB for
Dolphin 3D) | RAM: 1 GB |
| | HDD: 5 GB free space | HDD: 20 GB free space | HDD: 5 GB free space |
| | Video card: Dedicated,
DirectX 10 or higher
512 MB video memory
Shader Model 3
"INTZ"-Surfaces
Current driver | Video card:
resolution 1024 x768
at 24-bit color | Video card: Dedicated,
128 MB video memory
Shader Model 3
"INTZ"-Surfaces
Current driver |
| | Monitor: 1280x1024 pixel
resolution | Monitor: 17" | Monitor: 1280 x 1024 pixels
resolution |
| | Network: Ethernet, 100
Mbits/s | Network: none | Network: Ethernet, 100
Mbit/s |
| | Printer for patient
consultation: 300 dpi; paper
sizes DIN A4 or US Letter | Printer: 720 dpi color inkjet
Camera: 3 mega pixel
with camera card reader | Input devices: Keyboard,
mouse |
12
| | HICAT Air
Proposed | Reference predicate
Dolphin Imaging 11.5
(K110430) | Primary predicate
SICAT Function
(K133320) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Input devices: keyboard, mouse | Internet Broadband
connection
Virus protection coverage
DVD-Rom drive required
Scanner: 150dpi for x-rays,
300dpi for photos | |
| PC Software
Requirements
(Minimum) | Operating system:
Windows 7 (32 bit or 64 bit)
Windows 8 (64 bit)
Windows 8.1 (64 bit) | Operating system:
Windows Vista or higher | Operating system:
Windows XP (32 bit) with
SP3
Windows Vista (32 bit or 64 bit)
Windows 7 (32 bit or 64 bit)
Windows 8 (32 bit or 64-bit) |
| | Web browser:
Microsoft Internet Explorer 9
or higher
Mozilla Firefox 10 or higher
Google Chrome 10 or higher
Apple Safari 5 or higher
JavaScript has to be
activated
PDF viewer:
with support for PDF | Word processor:
MS-Word 2003 or higher | |
| | standard 1.7, for example
Adobe Reader 8 or higher | | |
| | | Compliance to Standards and Guidance | |
| | •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.
• AAMI/ANSI/IEC
62366:2007/(R)2013,
Medical devices - Application
of usability engineering to
medical devices
•SMPTE Recommended
Practice RP 133-1991: | unknown | •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 |
13
| HICAT Air
Proposed | Reference predicate
Dolphin Imaging 11.5
(K110430) | Primary predicate
SICAT Function
(K133320) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | | 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 |
Missing features of HICAT Air compared to the predicate devices are connected to the simulation of orthodontic procedures, osteotomies and distractions, to cephalometric
14
analysis, to TMJ analysis and to implant treatment planning and simulation. This does not have an impact on the safety and effectiveness of HICAT Air concerning the visualization and segmentation of imaging information and the evaluation of treatment options.
HICAT Air and the two predicate devices, SICAT Function and Dolphin Imaging 11.5, are software devices for visualization and segmentation of imaging information. Additional features of HICAT Air compared to the predicate device SICAT Function is the analysis in the ear-nose-throat region, particularly the airway analysis, including the threedimensional airway seqmentation and visualization. However the software algorithms used in HICAT Air are identical to the predicate device SICAT Function. Performance testing has been used to validate the safety and effectiveness of the HCAT Air seqmentation features in comparison to the predicate device Dolphin Imaging 11.5.
7. Non-Clinical Performance Testing and Verification and Validation Activities
For HICAT Air, 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 cvcle . processes.
- . 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, Doument 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 Offthe-Shelf (OTS) Software, Document issued on: January 14, 2005
15
-
. 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 ●
-
System Validation Tests
Special bench testing has been performed with non-clinical data:
- to verify the segmentation performance of anatomical structures of the airway ● using a segmentation wizard and
- to verify the correct calculation of geometric dimensions of the airway by the airway analysis tool.
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 HICAT Air passed all verification and validation activities and that safety and effectiveness of the product has been demonstrated in the context of its indications for use.
8. Conclusion
Based on the information and supporting documentation provided in this premarket notification, HICAT Air 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 treatment options. Any minor differences between HICAT Air and the predicate devices do not effect safety and performance.