(129 days)
No
The summary describes standard image processing techniques for calculating perfusion parameters and identifying abnormalities based on predefined criteria (delayed arrival, decreased blood flow). There is no mention of AI, ML, or any learning-based algorithms.
No.
The primary function of the device is image processing and analysis of CT perfusion scans to provide information for trained professionals, not to directly treat a medical condition.
Yes
Explanation: The device performs image processing to calculate parameters related to tissue flow (perfusion) and tissue blood volume from CT perfusion scans, and identifies abnormalities like delayed arrival and critically decreased cerebral blood flow. These calculations and identifications provide information that can be used to aid in the diagnosis of medical conditions, specifically stroke.
Yes
The device is described as an "image processing software package" that runs on standard computers or virtual platforms and processes data from DICOM-compliant imaging devices. It does not mention any proprietary hardware components included with the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- Device Function: The description clearly states that icobrain ctp is an image processing software package that analyzes Computed Tomography (CT) perfusion scans of the brain. It processes medical images, not biological specimens.
- Intended Use: The intended use is to perform image processing and communication of CT perfusion scans for use by trained professionals. This is consistent with a medical image analysis device, not an IVD.
While the software provides information for diagnostic purposes (related to tissue flow and blood volume in the brain), it does so by analyzing medical images, not by examining biological samples in vitro.
N/A
Intended Use / Indications for Use
icobrain ctp is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VM ware, and can be used to perform image processing, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.
icobrain ctp provides both analysis and communication capabilities for dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated from a raw CTP scan are exported in the standard DICOM format and may be viewed on existing radiological imaging viewers.
Product codes
LLZ
Device Description
The following flowchart illustrates the overall architecture of icobrain ctp.
The input images are CT perfusion images. During the pre-processing, each scan is loaded from the DICOM format: the image data and relevant dicom tags are extracted. The image processing block calculates the perfusion parameters and the volumes of the Tmax abnormality (defined as tissue with delayed arrival) and the CBF abnormality (defined as tissue with delayed arrival and critically decreased cerebral blood flow). Finally, the computed measurements are summarized into an electronic report. Optionally if requested, Tmax and CBF abnormalities segmentations are overlaid on the input images and image volumes of perfusion parameters maps are sent.
Output of icobrain ctp:
Report:
- volume of brain tissue with elevated time to maximum residual function (Tmax abnormality)
- volume of brain tissue with elevated time to maximum residual function and decreased cerebral blood flow (CBF abnormality)
- mismatch volume (difference between Tmax abnormality and CBF abnormality volumes)
- ratio between Tmax abnormality volume and CBF abnormality volume
- the time series of the arterial input function, venous output function and the averaged time density curves in the parenchymal tissue
- the time points/image volumes of the CTP that were excluded because of artefacts (if any)
- temporal mean of the input CT input images with corresponding perfusion parameter maps (time to maximum residual function, cerebral blood flow, cerebral blood volume, mean transit time) at various slices
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals, including but not limited to physicians and medical technicians.
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
The device was tested on a dataset of clinical CTP scans. The subjects upon whom the software was tested include stroke patients. In a first accuracy experiment, the CBF and Tmax abnormality volumes were compared to the corresponding volumes from the reference device. The acceptance criteria were set on the percentile 90 of the volume differences for both the CBF abnormality and the Tmax abnormality. In a second accuracy experiment, the unbiased CBF abnormality volume was compared to ground truth volumes from manually delineated DWI images. The acceptance criteria were set on the percentile 90 of the volume differences. In a third accuracy experiment, the region of interest (ROI) volume was compared to ground truth volumes from manually annotated ROI. The acceptance criteria were set on the percentile 90 of the volume differences. Reproducibility was tested on test and retest CT perfusion images. The retest images were produced by simulating patient motion on the test images. The acceptance criteria were set on the percentile 90 of the volume differences for both the CBF abnormality and the Tmax abnormality.
Additionally, the perfusion parameter maps were tested for accuracy on a digital phantom, generated by simulating tracer kinetic theory, that includes a wide range of clinically relevant values of perfusion parameters (CBV, CBF, MTT) as ground truth. The acceptance criteria were set on the correlation, the percentile 90 absolute difference and the mean relative difference between the ground truth and the estimated values.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested on a simulated dataset (digital phantom) generated by simulating tracer kinetic theory, that includes a wide range of clinically relevant values of perfusion parameters (CBV, CBF, MTT) as ground truth. Correlation, p90 absolute difference and mean relative difference between the output of icobrain ctp device and the ground truth values calculated, and compared to preestablished performance goals based on academic literature.
The device was tested on a clinical dataset: the accuracy of the TMax and CBF abnormality volumes, the reproducibility of the TMax and CBF abnormalities volumes, the accuracy of the soft tissue segmentation.
All experiments passed the acceptance criteria. In the digital phantom, the correlation for each perfusion parameter was above 0.90.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation, percentile 90 absolute difference, mean relative difference, percentile 90 of the volume differences.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
February 28, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Icometrix NV % Dirk Smeets VP Clinical Applications Kolonel Begaultlaan 1b/12 3012 Leuven BELGIUM
Re: K192962
Trade/Device Name: icobrain-ctp Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: January 24, 2020 Received: January 27, 2020
Dear Dirk Smeets:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192962
Device Name icobrain ctp
Indications for Use (Describe)
icobrain ctp is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VM ware, and can be used to perform image processing, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.
icobrain ctp provides both analysis and communication capabilities for dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated from a raw CTP scan are exported in the standard DICOM format and may be viewed on existing radiological imaging viewers.
| 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."
3
K192962
- 5.1 Submitter
- 5.2 Device
- 5.3 Predicate Device
- 5.4 Device Description
- 5.5 Indications for Use
- 5.6 Comparison with predicate device
- 5.7 Performance testing
5. I Submitter
| Name: | icometrix NV |
|---|---|
| Address: | Kolonel Begaultlaan 1b/12 |
| 3012 Leuven | |
| Belgium | |
| Contact Person: | Dirk Smeets |
| Telephone number: | +32 16 369 000 |
| Fax Number: | N.A. |
| E-mail: | dirk.smeets@icometrix.com |
| Date Prepared: | 28 Feb 2020 |
4
5.2 Device
| Device Trade Name: | icobrain ctp |
|---|---|
| Common Name | Medical Image Processing Software |
| Classification Name | System, Image processing, Radiological |
| Number | 892.2050 |
| Product Code: | LLZ |
| Classification Panel: | Radiology |
Predicate Device 5.3
| Item | Description |
|---|---|
| 510(k) Number | K180161 |
| Device Name | Viz CTP |
| Original Applicant | Viz.ai, Inc. |
| Regulation Number | 21 CFR 892.2050 |
| Classification Product Code | LLZ |
| 510k Review Panel | Radiology |
5.4 Device Description
The following flowchart illustrates the overall architecture of icobrain ctp.
Image /page/4/Figure/6 description: This image is a flowchart that shows the steps involved in image processing. The first step is to input images in DICOM format. The next steps are preprocessing, image processing, and output generation (report/images). The final step is to generate a final report in PDF or DICOM format and output images in DICOM format.
5
The input images are CT perfusion images. During the pre-processing, each scan is loaded from the DICOM format: the image data and relevant dicom tags are extracted. The image processing block calculates the perfusion parameters and the volumes of the Tmax abnormality (defined as tissue with delayed arrival) and the CBF abnormality (defined as tissue with delayed arrival and critically decreased cerebral blood flow). Finally, the computed measurements are summarized into an electronic report. Optionally if requested, Tmax and CBF abnormalities segmentations are overlaid on the input images and image volumes of perfusion parameters maps are sent.
Output of icobrain ctp:
Report:
- volume of brain tissue with elevated time to maximum residual function (Tmax abnormality)
- volume of brain tissue with elevated time to maximum residual function and decreased cerebral blood flow (CBF abnormality)
- mismatch volume (difference between Tmax abnormality and CBF abnormality volumes)
- ratio between Tmax abnormality volume and CBF abnormality volume
- · the time series of the arterial input function, venous output function and the averaged time density curves in the parenchymal tissue
- · the time points/image volumes of the CTP that were excluded because of artefacts (if any)
- temporal mean of the input CT input images with corresponding perfusion parameter maps (time to maximum residual function, cerebral blood flow, cerebral blood volume, mean transit time) at various slices
5.5 Indications for Use
icobrain ctp is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VMware, and can be used to perform image processing, analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.
icobrain ctp provides both analysis and communication capabilities for dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated from a raw CTP scan are exported in the standard DICOM format and may be viewed on existing radiological imaging viewers.
6
5.6 Comparison with predicate device
| Device to market | Proposed predicate device | Proposed Reference device | |
|---|---|---|---|
| Device | |||
| Trade Name | icobrain ctp | Viz CTP | RAPID |
| Common | |||
| Name | Medical Image Processing Software | Picture archiving and communications system | Picture archiving and communications |
| system | |||
| 510(k) | |||
| Number | K192962 | K180161 | K121447 |
| Manufacturer | icometrix NV | Viz.ai, Inc. | iSchemaView, Inc. |
| Kolonel Begaultlaan Ib / 12 | |||
| 3012 Leuven | |||
| BELGIUM | 855 El Camino Real Suite 13A-252 | ||
| Palo Alto, CA 94301 | 323 Olmsted Road | ||
| Stanford, CA 94305 | |||
| Regulation | |||
| Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Device | |||
| Classification | |||
| Name | System, Image processing, | ||
| Radiological | System, Image processing, Radiological | System, Image processing, Radiological | |
| Product | |||
| Code | LLZ | LLZ | LLZ |
| Regulatory | |||
| Class | II | II | II |
| Classification | |||
| Panel | Radiology | Radiology | Radiology |
| Indications | |||
| for use | icobrain ctp is an image processing | ||
| software package to be used by | |||
| trained professionals, including but | |||
| not limited to physicians and | |||
| medical technicians. The software | |||
| runs on a standard "off-the-shelf" | |||
| computer or a virtual platform, | |||
| such as VMware, and can be used | |||
| to perform image processing, | |||
| analysis, and communication of | |||
| computed tomography (CT) | |||
| perfusion scans of the brain. Data | |||
| and images are acquired through | |||
| DICOM-compliant imaging devices. |
icobrain ctp provides both analysis
and communication capabilities for
dynamic imaging datasets that are
acquired with CT Perfusion imaging
protocols. Analysis includes
calculation of parameters related to
tissue flow (perfusion) and tissue
blood volume. Results of image
processing which include CT
perfusion parameter maps
generated from a raw CTP scan are
exported in the standard DICOM
format and may be viewed on
existing radiological imaging viewers. | Viz CTP is an image processing software
package to be used by trained professionals,
including but not limited to physicians and
medical technicians. The software runs on a
standard "off-the-shelf" computer or a virtual
platform, such as VMware, and can be used
to perform image processing, analysis, and
communication of computed tomography
(CT) perfusion scans of the brain. Data and
images are acquired through DICOM-
compliant imaging devices.
Viz CTP provides both analysis and
communication capabilities for dynamic
imaging datasets that are acquired with CT
Perfusion imaging protocols. Analysis
includes calculation of parameters related to
tissue flow (perfusion) and tissue blood
volume. Results of image processing which
include CT perfusion parameter maps
generated from a raw CTP scan are
exported in the standard DICOM format
and may be viewed on existing radiological
imaging viewers. | iSchemaView's RAPID is an image
processing software package to be used
by trained professionals, including but not
limited to physicians and medical
technicians. The software runs on a
standard "off-the-shelf" computer or a
virtual platform, such as VMware, and can
be used to perform image viewing,
processing and analysis of brain images.
Data and images are acquired through
DICOM compliant imaging devices.
iSchemaView's RAPID provides both
viewing and analysis capabilities for
functional and dynamic imaging datasets
acquired with CT Perfusion and MRI
including a Diffusion Weighted MRI
(DWI) Module and a Dynamic Analysis
Module (dynamic contrast enhanced
imaging data for MRI and CT). |
| Basic PACS
functions | Yes | Yes | Yes |
| Computer
platform | Standard "off-the-shelf" computer
or a virtual platform. | Same | Same |
| DICOM
compliance | Yes | Yes | Yes |
| Functional
overview | icobrain ctp is a software package
that provides for the quantification
and visualization of the perfusion of
tissue based on dynamic contrast
enhanced CT images. | Same | Automatic analysis for functional and
dynamic imaging datasets acquired with
CT Perfusion and MRI including a
Diffusion Weighted MRI (DWI) Module
and a Dynamic Analysis Module (dynamic
contrast enhanced imaging data for MRI
and CT). |
| Data
Acquisition | Acquires medical image data from
DICOM compliant imaging devices
and modalities. | Same | Same |
| Data/Image
Types | Computed Tomography (CT) | Same | CT and MR scanner |
| Acquisition and Modalities Features | | | |
| CT | CT Perfusion | Yes | Yes |
| Computed Parameter Maps | | | |
| Perfusion CT | Cerebral Blood Flow (CBF) | Yes | Yes |
| | Cerebral Blood Volume (CBV) | Yes | Yes |
| | Mean Transit Time (MTT) | Yes | Yes |
| | Tissue residue function time to
peak (TMax) | Yes | Yes |
| Measurements/Tools | | | |
| | Arterial Input Function (AIF) /
Venous Output Function (VOF) | Same | Same |
| | Brain mask | Same | Same |
| | Export perfusion files to PACS and
DICOM file systems | Same | Same |
| | Acquire, transmit, process, and
store medical images | Same | Same |
| Volumetry | | | |
| Default
Tmax
abnormality | Tmax > 6s | Same | Same |
| Default CBF
abnormality | CBF 6s) - (CBF 6s) / (CBF