(60 days)
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
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.
Here's a breakdown of the requested information based on the provided text. Unfortunately, much of the detailed quantitative information for acceptance criteria and study particulars for HICAT Air is not explicitly stated in this 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study like a clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list specific quantitative acceptance criteria (e.g., minimum accuracy percentages, sensitivity, specificity) for the device's performance that were "met." Instead, it relies on demonstrating that HICAT Air's capabilities are comparable to or an improvement upon the predicate devices, particularly for visualization, segmentation accuracy, and measurement accuracy.
Below is a table summarizing the reported device performance as described in the comparison to predicate devices, which can be inferred as the "criteria" it aims to meet or exceed based on the predicates.
| Feature / Metric | Acceptance Criteria (Implied / Predicate-based) | Reported HICAT Air Performance |
|---|---|---|
| Overall Length Measurement Accuracy | 100 µm (based on Primary Predicate: SICAT Function) | 100 µm (Algorithms identical to SICAT Function) |
| Overall Angular Measurement Accuracy | 1 degree (based on Primary Predicate: SICAT Function) | 1 degree (Algorithms identical to SICAT Function) |
| Segmentation Algorithms | Segmentation of anatomical structures using Water Shed (graph-cut algorithm) (based on Primary Predicate: SICAT Function) and segmentation for Dolphin Imaging 11.5 (algorithm unknown but present). Airway segmentation present in Dolphin Imaging 11.5. | Yes, using a segmentation wizard. Algorithm: Water Shed (a type of graph-cut algorithm), identical to SICAT Function. Airway Segmentation of the Airway using the segmentation wizard. |
| Airway Analysis (volume, cross-section, min cross-section) | Present in Reference Predicate: Dolphin Imaging 11.5 (analyze airway by drawing border, program fills and displays airway space, reports volume, locates and measures most constricted spot). | Yes (Calculation of airway volume, airway cross section dimensions, position and size of the area with minimum cross section in airway). |
| Imaging Data Visualization Region | ENT region including the oral-maxillofacial region (based on Reference Predicate: Dolphin Imaging 11.5) and oral-maxillofacial region (based on Primary Predicate: SICAT Function). | ENT region including the oral-maxillofacial region. |
| Safety and Effectiveness | Demonstrated through verification and validation activities and substantial equivalence to predicate devices, ensuring no adverse impact from minor differences. | All verification and validation activities passed; safety and effectiveness demonstrated in context of indications for use. |
Note: The phrase "Algorithms identical to SICAT Function" is frequently used, implying that the performance metrics of SICAT Function are directly applicable to HICAT Air for those features.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions "Special bench testing has been performed with non-clinical data" to verify segmentation performance and calculation of geometric dimensions. However, it does not specify the sample size for this test set.
- Data Provenance: The document states "non-clinical data" was used for special bench testing. There is no information provided on the country of origin of this data, nor if it was retrospective or prospective. It implies simulated or idealized data given the "non-clinical" description.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used to establish ground truth for the test set, nor does it detail their qualifications. The tests appear to be bench tests against pre-defined or simulated "ground truth" rather than expert-derived ground truth on clinical cases.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the "non-clinical data" and "bench testing" description, it's likely that a human adjudication process for complex clinical opinions was not part of this specific testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not explicitly described in the provided text. The submission focuses on demonstrating substantial equivalence through comparison of features, technical characteristics, and performance metrics (like measurement accuracy) to predicate devices, along with internal verification and validation activities. There is no mention of human readers improving with or without AI assistance, or any effect size calculation.
6. Standalone Performance Study
A standalone performance study (algorithm only without human-in-the-loop performance) was performed. The "Special bench testing" mentioned falls under this category, focusing on "segmentation performance of anatomical structures of the airway" and "correct calculation of geometric dimensions of the airway by the airway analysis tool." These tests aim to verify the algorithm's capabilities independently.
7. Type of Ground Truth Used (for standalone testing)
For the standalone "Special bench testing," the ground truth likely involved known or simulated anatomical structures with precise geometric dimensions to verify segmentation and measurement accuracy. The term "non-clinical data" supports this interpretation, suggesting synthetic data, phantoms, or highly characterized datasets where definitive measurements and segmentations are pre-established rather than derived from expert consensus on complex, variable clinical cases or pathology.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. As HICAT Air is described primarily as a "radiological visualization software for diagnosis and treatment planning" with identical algorithms to a predicate for many features, and its segmentation logic is based on a "Water Shed (a type of graph-cut algorithm)," it is possible that it does not involve a machine learning model that requires a "training set" in the conventional sense, or if it does, the details are not included in this summary.
9. How Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied for a machine learning model that would require one, there is no information provided on how ground truth for a training set was established.
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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.
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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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See 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.
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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) | |
|---|---|
| ---------------------- | -- |
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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
| EstablishmentRegistration 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 TreatmentPlanning |
| 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.
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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 AirProposed | Reference predicateDolphin Imaging 11.5(K110430) | Primary predicateSICAT Function(K133320) |
|---|---|---|
| Common / Usual Name | ||
| Radiological VisualizationSoftware for Diagnosis andTreatment Planning | Not available | Radiological VisualizationSoftware for Diagnosis andDental Treatment Planning |
| Device Description | ||
| HICAT Air is a pure softwaredevice. HICAT Air is asoftware application for thevisualization andsegmentation of imaginginformation of the ear-nose-throat (ENT) region. Theimaging data originates frommedical scanners such as CTor Cone Beam – CT (CBCT)scanners. | Dolphin Imaging is a puresoftware device. DolphinImaging is a softwareapplication for thevisualization of imaginginformation of the oral-maxillofacial region. Theimaging data originatesfrom medical scannerssuch as CT or DVTscanners. | SICAT Function is a puresoftware device. SICATFunction is a softwareapplication for thevisualization andsegmentation of imaginginformation of the oral-maxillofacial region. Theimaging data originates frommedical scanners such as CTor Cone Beam - CT scanners. |
| This information can becomplemented by theimaging information fromoptical impression systems.The additional informationabout the exact geometry of | Dolphin Imaging softwareis designed for capturing,storing and presentingpatient images andassisting in treatmentplanning and case | This information can becomplemented by theimaging information fromoptical impression systemsand jaw tracking devices. Theadditional information about |
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| HICAT AirProposed | Reference predicateDolphin Imaging 11.5(K110430) | Primary predicateSICAT Function(K133320) |
|---|---|---|
| the tooth surfaces can bevisualized together with theradiological data.HICAT Air is also used as asoftware system to aidqualified medicalprofessionals with thediagnosis, and followed bythe evaluation, comparisonand planning of ENTtreatment options.The medical professionals'input information andplanning data may beexported from HICAT Air tobe used as input data forCAD or Rapid PrototypingSystems for themanufacturing of therapeuticdevices such as oral devices. | diagnosis. Resultsproduced by the software'sdiagnostic and treatmentplanning tools aredependent on theinterpretation of trainedand licensed practitioners.Acquisition of 2D imagedata can be performedfrom multiple types ofdevices, including digitalradiography devices suchas x-ray machines, genericimaging devices thatsupport the TWAINinterface standard, such asflatbed scanners andstandard image file formats(Jpeg, Bitmap, etc.) storedon a computer, cameramemory card or similar.The following features areavailable:Import from a variety of 3Ddataset formats (DICOM)High-quality, fast 3DrenderingThree-dimensional airwaysegmentation and analysisin the ear-nose throat-regionAirway analysis:Analyze the airway bydrawing a border aroundyour selected portion of thevolumetric scan; theprogram will automaticallyfill in and display all theairway space within thatborder, then report backtelling you the volume ofairway space in cubicmillimeters. It will alsolocate, display andmeasure, in squaremillimeters, the mostconstricted spot of thatairway.Cross sections in Multiple | the exact geometry of thetooth surfaces and themandibular movement can bevisualized together with theradiological data.SICAT Function is also usedas a software system to aidqualified dental professionalswith the evaluation andplanning of dental treatmentoptions.The dental professionals'treatment planninginformation may be exportedfrom SICAT Function to beused as input data for CAD orRapid Prototyping Systemsfor the manufacturing oftherapeutic devices such asoral appliances. |
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| HICAT AirProposed | Reference predicateDolphin Imaging 11.5(K110430) | Primary predicateSICAT Function(K133320) | |
|---|---|---|---|
| Planar View (MPV)Precise volume orientation | |||
| Volume stitching:Combine two separatevolumes into one2D facial photo wrap ontovolume | |||
| Volume-to-volumesuperimposition | |||
| 3D nerve marking | |||
| TMJ analysis | |||
| Generate cephalometricand panoramic radiographs | |||
| 3D-2D measurements:distance, angle and area | |||
| Create animated movieswith automated scripts | |||
| Design image layouts andreports | |||
| Images export to otherapplications | |||
| 3D implant treatmentplanning and simulation | |||
| Distinguish biologicalstructures via theirradiolucency with aHounsfield Unit measuringtool | |||
| Indications for Use | |||
| Indications forUse | HICAT Air is a softwareapplication for:• Aiding diagnosis in theear-nose-throat region.• Aiding treatmentplanning in the ear-nose-throat region.• Aiding comparisons ofdifferent treatmentoptions.• Aiding treatmentplanning for oralappliances | Intended Use Statement of510(k) Summary K110430:"Dolphin Imaging softwareis designed for use byspecialized dental practicesfor capturing, storing andpresenting patient imagesand assisting in treatmentplanning and casediagnosis. Resultsproduced by the software'sdiagnostic and treatmentplanning tools are | Indications for UseStatement of 510(k)Summary K133320:SICAT Function is a softwareapplication for thevisualization andsegmentation of imaginginformation of the oral-maxillofacial region. Theimaging data originates frommedical scanners such as CTor CBCT scanners. It is alsoused as a software system to |
| dependent on theinterpretation of trained | aid qualified dentalprofessionals with the |
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| HICAT AirProposed | Reference predicateDolphin Imaging 11.5(K110430) | Primary predicateSICAT 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 typesvisualized | 3D volume data, opticalimpressions | 3D volume data, 2Dradiological x-ray data,images and photographs | 3D volume data, opticalimpressions, jaw motiontracking data |
| Imaging datavisualizationregion | ENT region including theoral-maxillofacial region | ENT region including theoral-maxillofacial region | oral-maxillofacial region |
| Viewing Modes | |||
| Orthogonal slices | Axial, coronal, sagittalFeatures and algorithms areidentical to SICAT Function. | Axial, coronal, sagittal | Axial, coronal, sagittal |
| Special DentalView:Panoramic View | Panoramic view (ray sum)based on a panoramic curve.Panoramic curve can bemanually adjusted.(available in the opticalimpression registrationwindow)Features and Algorithms areidentical to SICAT Function. | Yes | Panoramic view (ray sum)based on a panoramic curve.Panoramic curve can bemanually adjusted. |
| Special dentalview:CephalometricView | No | Yes | No |
| Special dentalviews:TSA and LSA | Transversal slice (TSA) andlongitudinal slice (LSA), bothwith respect to panoramiccurve.(available in the opticalimpression registrationwindow)Features and Algorithmsidentical to SICAT Function | Single transversal slices aregenerated. | Transversal slice (TSA) andlongitudinal slice (LSA), bothwith respect to panoramiccurve. |
| 3D volumerendering | Yes, volume rendering usinga standard and wellestablished ray-castingalgorithm with integrationalong rays, and volumerendering utilizing standard | Yes | Yes |
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| HICAT AirProposed | Reference predicateDolphin Imaging 11.5(K110430) | Primary predicateSICAT Function(K133320) | |
|---|---|---|---|
| 3D surfacerendering ofvolume data | shader based slicingalgorithms available ontypical consumer graphicshardware.Yes, using a standard andwell established front-to-back ray-casting algorithmwith an iso-surfacethreshold. | Yes | No |
| Viewmanipulatingtools | Zoom, Pan, Change oforientationFeatures and Algorithmsidentical to SICAT Function | Yes | Zoom, Pan, Change oforientation |
| Colormanipulatingtools | Brightness, ContrastFeatures and Algorithmsidentical to SICAT Function | Yes | Brightness, Contrast |
| Scrolling throughslices | For all slicesFeatures and Algorithmsidentical to SICAT Function | Yes | For all slices (includingpanoramic slicing window) |
| 3D volumeclipping | YesFeatures and Algorithmsidentical to SICAT Function | Yes | Yes |
| Lengthmeasurement | YesFeatures and Algorithmsidentical to SICAT Function | Yes | Yes |
| Areameasurement | Yes | Yes | No |
| Anglemeasurement | YesFeatures and Algorithmsidentical to SICAT Function | Yes | Yes |
| Overall LengthMeasurementAccuracy | 100 µmAlgorithms identical to SICATFunction | unknown | 100 μm |
| Overall AngularMeasurementAccuracy | 1 degreeAlgorithms identical to SICATFunction | unknown | 1 degree |
| Segmentation of Anatomical Structures | |||
| Segmentation ofanatomicalstructures | Yes, using a segmentationwizard.Algorithm: Water Shed (atype of graph-cut algorithm,which is identical to SICATFunction ) | YesSegmentation algorithm isunknown. | Yes, using a segmentationwizard.Algorithm: Water Shed (atype of graph-cut algorithm) |
| AirwaySegmentation | Airway Segmentation of theAirway using thesegmentation wizard. | YesSegmentation algorithm isunknown. | No |
| Segmentation ofmandible andfossa | No | No | Yes, using a segmentationwizard.Algorithm: Water Shed (atype of graph-cut algorithm) |
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| HICAT AirProposed | Reference predicateDolphin Imaging 11.5(K110430) | Primary predicateSICAT Function(K133320) | |
|---|---|---|---|
| Mesh texturing ofthe segmentedairway | The Airway is texturized by astandard algorithm. | Yes | No |
| Optical Impression Data Visualization | |||
| Opticalimpression(maxilla,mandible, or apart thereof) | Optical impression (maxilla,mandible, or a part thereof) | No | Optical impression (maxilla,mandible, or a part thereof) |
| Polygonal mesh in 3D viewand panorama view, cutthrough polygonal mesh(contour) in slice viewFeatures and Algorithmsidentical to SICAT Function. | Polygonal mesh in 3D viewand panorama view, cutthrough polygonal mesh(contour) in slice view | ||
| Opticalimpression name | A list view in a dedicatedtoolbar contains the namesof all loaded opticalimpressions.Features and Algorithmsidentical to SICAT Function. | No | A list view in a dedicatedtoolbar contains the namesof all loaded opticalimpressions. |
| Show/Hide anoptical impression | YesVisibility applies to all viewssimultaneously.Algorithms identical to SICATFunction. | No | YesVisibility applies to all viewssimultaneously. |
| Optical Impression Data Manipulation | |||
| Registration ofsurface data(from opticalimpressions) tovolume data | Semi-automatic, using userspecified reference points.Features and Algorithmsidentical to SICAT Function. | No | Semi-automatic, using userspecified reference points. |
| Fine tuning theaccuracy of theregistration | Restart of the registrationwith a different set ofreference points.Features and Algorithmsidentical to SICAT Function. | No | Restart of the registrationwith a different set ofreference points. |
| Delete | YesFeatures and Algorithmsidentical to SICAT Function. | No | Yes |
| I/O | |||
| Volume dataimport | DICOM | DICOM | DICOM |
| Optical surfacedata / opticalimpression import | Standard STL format andproprietary SSI or SIXDcontainer format.Features and Algorithmsidentical to SICAT Function. | No | Standard STL format andproprietary SSI or SIXDcontainer format. |
| DataImport/ExportData Compression | A "study" consisting ofplanning data (includingsegmentation information),volume data, optical surfacedata may be exported andimported in a SICATproprietary format.Lossless ZIP compression | No | A "study" consisting ofplanning data (includingsegmentation information),volume data, jaw motiondata and optical surface datamay be exported andimported in a SICATproprietary format. |
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| HICAT AirProposed | Reference predicateDolphin Imaging 11.5(K110430) | Primary predicateSICAT Function(K133320) | |
|---|---|---|---|
| Features and Algorithmsidentical to SICAT Function. | Lossless ZIP compression | ||
| Export of data forCAD and rapidproto-typing | Yes | No | Yes |
| Misc. functions | |||
| Soft tissuesimulation withphoto mapping | No | Yes | No |
| Cross sections inMultiple PlanarView (MPV) | No | Yes | No |
| Volume stitching:Combine twoseparate volumesinto one | No | Yes | No |
| 2D facial photowrap onto volume | No | Yes | No |
| Volume-to-volumesuperimposition | No | Yes | No |
| 3D nerve marking | No | Yes | No |
| Generatepanoramicradiographs | Yes | Yes | Yes |
| Generatecephalometricradiographs | No | Yes | No |
| Create animatedmovies withautomated scripts | No | Yes | No |
| Design and printhandout reports | Yes | Yes | No |
| Image export toother applications | Yes | Yes | Yes |
| Main Functions | |||
| Three-dimensionalairwaysegmentation andanalysis in theear-nose throat-region | YesImage: 3D airway rendering | YesImage: Display of airway volume and most constricted area | No |
| AirwayVisualization | 3D surface rendering | 3D surface rendering | No |
| Airway Analysis:Calculation of | Yes | Yes | No |
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| HICAT AirProposed | Reference predicateDolphin Imaging 11.5(K110430) | Primary predicateSICAT Function(K133320) | |
|---|---|---|---|
| airway volume | Yes | Yes | No |
| Airway Analysis:Calculation of theairway crosssectiondimensions | Yes | Yes | No |
| Airway Analysis:Calculation of theposition and sizeof the area withminimum crosssection in airway | Yes | Yes | No |
| Simulation oforthodonticprocedures,osteotomies anddistractions | No | Yes | No |
| Cephalometricanalysis | No | Yes | No |
| TMJ analysis | No | Yes | Yes |
| 3D implanttreatmentplanning andsimulation | No | Yes | No |
| Programming Language | |||
| C# and C++ | Unknown | C# and C++ | |
| System Requirements | |||
| PC HardwareRequirements(Minimum) | Minimum ImagingRequirements (Rev 05/15) | ||
| CPU: 2,0 GHz Dualcore | CPU: Intel® Core 2 | CPU: 1 GHz | |
| RAM: 4 GB | RAM: 2 GB (4 GB forDolphin 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 higher512 MB video memoryShader Model 3"INTZ"-SurfacesCurrent driver | Video card:resolution 1024 x768at 24-bit color | Video card: Dedicated,128 MB video memoryShader Model 3"INTZ"-SurfacesCurrent driver | |
| Monitor: 1280x1024 pixelresolution | Monitor: 17" | Monitor: 1280 x 1024 pixelsresolution | |
| Network: Ethernet, 100Mbits/s | Network: none | Network: Ethernet, 100Mbit/s | |
| Printer for patientconsultation: 300 dpi; papersizes DIN A4 or US Letter | Printer: 720 dpi color inkjetCamera: 3 mega pixelwith camera card reader | Input devices: Keyboard,mouse |
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| HICAT AirProposed | Reference predicateDolphin Imaging 11.5(K110430) | Primary predicateSICAT Function(K133320) | |
|---|---|---|---|
| Input devices: keyboard, mouse | Internet BroadbandconnectionVirus protection coverageDVD-Rom drive requiredScanner: 150dpi for x-rays,300dpi for photos | ||
| PC SoftwareRequirements(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) withSP3Windows 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 9or higherMozilla Firefox 10 or higherGoogle Chrome 10 or higherApple Safari 5 or higherJavaScript has to beactivatedPDF viewer:with support for PDF | Word processor:MS-Word 2003 or higher | ||
| standard 1.7, for exampleAdobe Reader 8 or higher | |||
| Compliance to Standards and Guidance | |||
| •NEMA PS 3.1 - 3.20 (2011),Digital Imaging andCommunications in Medicine(DICOM) Set.•ISO 14971 Second edition2007-03-01, Medical devices- Application of riskmanagement to medicaldevices.•IEC 62304 First edition2006-05, Medical devicesoftware - Software life cycleprocesses.• AAMI/ANSI/IEC62366:2007/(R)2013,Medical devices - Applicationof usability engineering tomedical devices•SMPTE RecommendedPractice RP 133-1991: | unknown | •NEMA PS 3.1 - 3.20 (2011),Digital Imaging andCommunications in Medicine(DICOM) Set.•ISO 14971 Second edition2007-03-01, Medical devices- Application of riskmanagement to medicaldevices.•IEC 62304 First edition2006-05, Medical devicesoftware - Software life cycleprocesses.•ANSI/AAMI ES60601-1:2005/(R)2012 andC1:2009/(r)2012 andA2:2010/(r)2012(Consolidated Text) Medicalelectrical equipment - Part 1:General requirements forbasic safety and essential |
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| HICAT AirProposed | Reference predicateDolphin Imaging 11.5(K110430) | Primary predicateSICAT Function(K133320) |
|---|---|---|
| Diagnostic Imaging TestPattern for TelevisionMonitors and Hard-copyRecording Cameras· HIPAA 45 CFR Part 160 –General AdministrativeRequirements· HIPAA 45 CFR Part 164 -Security and Privacy•Guidance for theSubmission of PremarketNotifications for MedicalImage Management Devices,Document issued on: July27, 2000•Guidance for the Content ofPremarket Submissions forSoftware Contained inMedical Devices, Documentissued on: May 11, 2005·Guidance for Industry, FDAReviewers and Complianceon Off-The-Shelf SoftwareUse in Medical Devices,Document issued on:September 9, 1999·Device Labeling Guidance,March 8, 1991 (G91-1)•General Principles ofSoftware Validation; FinalGuidance for Industry andFDA Staff, Document issuedon: January 11, 2002•Guidance for Industry,Cybersecurity for NetworkedMedical Devices ContainingOff-the-Shelf (OTS)Software, Document issuedon: January 14, 2005·Medical Device Use-Safety:Incorporating HumanFactors Engineering into RiskManagement: July 18, 2000 | performance (IEC 60601-1:2005, MOD).•IEC 62366:2007, Medicaldevices - Application ofusability engineering tomedical devices·SMPTE RecommendedPractice RP 133-1991:Specifications for MedicalDiagnostic Imaging TestPattern for TelevisionMonitors and Hard-copyRecording Cameras· HIPAA 45 CFR Part 160 –General AdministrativeRequirements· HIPAA 45 CFR Part 164 -Security and Privacy·Guidance for theSubmission of PremarketNotifications for MedicalImage Management Devices,Document issued on: July27, 2000·Guidance for the Content ofPremarket Submissions forSoftware Contained inMedical Devices, Documentissued on: May 11, 2005·Guidance for Industry, FDAReviewers and Complianceon Off-The-Shelf SoftwareUse in Medical Devices,Document issued on:September 9, 1999·Device Labeling Guidance,March 8, 1991 (G91-1)•General Principles ofSoftware Validation; FinalGuidance for Industry andFDA Staff, Document issuedon: January 11, 2002·Guidance for Industry,Cybersecurity for NetworkedMedical Devices ContainingOff-the-Shelf (OTS)Software, Document issuedon: January 14, 2005·Medical Device Use-Safety:Incorporating Human Factors | |
| Engineering into RiskManagement: 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
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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
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-
. 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.
§ 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).