(128 days)
Not Found
Unknown
The summary mentions "image processing" and "segmentation" which can be performed by traditional algorithms or AI/ML. However, there is no explicit mention of AI, ML, or deep learning in the provided text.
No
The device is intended for automatic labeling, visualization, and volumetric quantification of brain structures for diagnostic purposes, not for providing therapy or treatment.
Yes
The device "icobrain" is intended for "automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT images." This involves providing quantitative measurements (volumes, changes in volumes) of anatomical structures, which are typically used by clinicians to assess conditions and guide diagnoses.
Yes
The device is described as software that processes existing medical images (MR or NCCT) to perform labeling, visualization, and volumetric quantification. There is no mention of accompanying hardware or hardware components being part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The description clearly states that icobrain processes MR or NCCT images, which are medical images of the brain, not biological samples.
- The intended use is for image processing and quantification of brain structures. This is a function performed on medical images, not on biological specimens.
Therefore, icobrain falls under the category of medical imaging software, not an IVD.
N/A
Intended Use / Indications for Use
icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR or NCCT images. icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long.
icobrain cross is intended to provide volumes from MR or NCCT images acquired at a single time point. icobrain long is intended to provide changes in volumes between two MR images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints. The results of icobrain cross cannot be compared with the results of icobrain long.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR or NCCT images.
icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long.
- icobrain cross is intended to provide volumes from MR or NCCT images acquired at a single time point.
- icobrain long is intended to provide changes in volumes between two MR images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints.
The results of icobrain cross cannot be compared with the results of icobrain long.
The overall architecture of icobrain involves input images in DICOM format, followed by preprocessing, image processing, and output generation. The final step generates a report in PDF or DICOM format, and output images in DICOM format.
MR outputs include reports for:
- unnormalized and normalized volumes/volume changes of FLAIR and T1 white matter hyperintensities (total, new, enlarging, shrinking) in different regions (peri-ventricular, juxta-cortical, infra-tentorial, deep white matter, sub-cortical, corpus callosum, brainstem).
- normalized volumes/volume changes of the whole brain, gray matter, cortical gray matter, frontal lobe, temporal lobe, parietal lobe, and hippocampi.
- asymmetry index between the left and right hippocampi.
CT outputs include reports for:
- normalized volume of the whole brain and lateral ventricles (useful for dementia patients).
- unnormalized measurement of midline shift, unnormalized volumes of NCCT hyperdensities (epidural, intraparenchymal, total, largest component), normalized volumes of left and right lateral ventricles and fourth ventricle, normalized volumes of basal cisterns (suprasellar, quadrigeminal, prepontine & ambient), and asymmetry index between left and right lateral ventricle (useful for TBI patients).
Volumes for whole brain, gray matter, cortical gray matter, frontal lobe, temporal lobe, parietal lobe, hippocampi, ventricles, and cisterns are normalized for head size by comparison to a healthy population using a statistical model. Asymmetry index between left and right hippocampi is also compared to a healthy population. Reported FLAIR, T1 white matter hyperintensities, and CT hyperdensities volumes are not normalized.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR or NCCT images
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Performance testing:
- Accuracy experiments: volumes/volume changes are compared to simulated and/or manually labeled ground truth volumes/volume changes.
- Reproducibility experiments: volumes/volume changes are compared on test-retest image datasets.
- A literature review was performed to set relevant acceptance criteria based on the 90th percentile of absolute differences in comparison to the validation threshold. All experiments passed the acceptance criteria.
- The experiments encompassed 463 MR and 618 CT subject datasets in total.
- Subjects included healthy subjects, Alzheimer's disease patients, multiple sclerosis patients, traumatic brain injury patients, depression patients.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Product performance:
- Study type: Accuracy and Reproducibility experiments.
- Sample size: 463 MR and 618 CT subject datasets in total.
- Key results for MR experiments: Averaged Pearson correlation coefficient was 0.91, and intraclass correlation coefficient was 0.90.
- Key results for CT experiments: Averaged Pearson correlation coefficient was 0.94, and intraclass correlation coefficient was 0.93.
- All experiments passed the acceptance criteria, which were based on the 90th percentile of the absolute differences in comparison to the validation threshold.
- Verification tests demonstrate the system as a whole provides all the capabilities necessary to operate according to its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pearson correlation coefficient, intraclass correlation coefficient
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information 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).
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December 13, 2019
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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
icometrix NV % Dirk Smeets VP Clinical Applications Kolonel Begaultlaan 1b/12 3012 Leuven, Vlaams-Brabant BELGIUM
Re: K192130
Trade/Device Name: icobrain Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 10, 2019 Received: October 15, 2019
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
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name icobrain
Indications for Use (Describe)
icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR or NCCT images. icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long.
icobrain cross is intended to provide volumes from MR or NCCT images acquired at a single time point. icobrain long is intended to provide changes in volumes between two MR images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints. The results of icobrain cross cannot be compared with the results of icobrain long.
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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Image /page/3/Picture/0 description: The image shows the text 'K192130' in a teal color. The text is displayed in a clear, sans-serif font. The numbers and letters are evenly spaced and easily readable.
Image /page/3/Picture/1 description: The image shows the logo for Icometrix, a company specializing in imaging biomarker expertise. The logo features a stylized brain shape in teal, green, and red on the left. To the right of the brain shape is the company name "icometrix" in bold, black letters, with the tagline "IMAGING BIOMARKER EXPERTS" in smaller, gray letters underneath.
Section 6. 510(k) Summary (icobrain 5.0)
icometrix NV - Kolonel Begauitlaan Ib box 12 - 3012 Leuven - Belgium
info@icometrix.com - www.icometrix.com - T +32 16 369 000
IBAN: BE02 7360 2208 4540 - BIC KRED BE BB - BT
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Doc. 149013088.10 issued on 10 December 2019 11:34
Image /page/4/Picture/1 description: The image shows the word "Approved" in a light gray font. To the left of the word is a green circle with a small portion of the circle missing from the top. The green circle appears to be an indicator that the word "Approved" is associated with.
6.1 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: | 18 Jul 2019 |
6.2 Device
| Device Trade Name: | icobrain |
|---|---|
| Common Name: | Medical Image Processing Software |
| Classification Name: | System, Image processing, Radiological |
| Number: | 892.2050 |
| Product Code: | LLZ |
| Classification Panel: | Radiology |
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6.3 Predicate Device
| Device | icobrain |
|---|---|
| 510(k) Number | K181939 |
| Manufacturer | icometrix NV |
| Common Name: | Medical Image Processing Software |
| Classification Name: | System, Image processing, Radiological |
| Number | 892.2050 |
| Product Code | LLZ |
| Classification Panel: | Radiology |
6.4 Device Description
icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR or NCCT images.
icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long.
- icobrain cross is intended to provide volumes from MR or NCCT images acquired at a single time point.
- icobrain long is intended to provide changes in volumes between two MR images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints.
The results of icobrain cross cannot be compared with the results of icobrain long.
The following flowchart illustrates the overall architecture of icobrain.
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Image /page/6/Figure/0 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. The final step is to generate a final report in PDF or DICOM format, as well as output images in DICOM format.
The input images can be MR images (current icobrain software - KI6I 148 and KI80326) or CT images (current icobrain software - K181939). During the pre-processing, each scan is converted from DICOM format to NIFTI format. The image processing then performs the actual segmentation and calculates the measurements of the brain structures and abnormalities. Finally, the computed measurements are summarized into an electronic report and (some) segmentations are overlaid on the input images.
MR outputs
Report I:
- unnormalized volume and volume changes (total, new, enlarging and shrinking) of FLAIR white matter hyperintensities, in different regions (peri-ventricular, juxta-cortical, infra-tentorial, deep white matter).
- · unnormalized volume and volume changes (total, new, enlarging and shrinking) of TI white matter hyperintensities and hypointensities.
- normalized volume and volume changes of the whole brain (sum of white and gray matter),
- · normalized volume and volume changes of gray matter
Report 2:
- normalized volume and volume changes of the frontal, temporal and parietal lobe
- · normalized volume and volume changes of the hippocampi
- unnormalized volume and volume changes of FLAIR white matter hyperintensities
Report 3:
- unnormalized volume and volume changes (total, new, enlarging and shrinking) of FLAIR white matter hyperintensities, in different regions (sub-cortical, corpus callosum, brainstem)
- · normalized volume and volume changes of the cortical gray matter
- · normalized volume and volume changes of the hippocampi
Report 4:
- unnormalized volume and volume changes (total, new, enlarging and shrinking) of juxtacortical FLAIR white matter hyperintensities
- normalized volume and volume changes of the left and right hippocampi
- · asymmetry index between the left and right hippocampi
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The whole brain, gray matter, cortical gray matter, frontal lobe, temporal lobe, parietal lobe and hippocampal volumes are normalized for head size by comparing to a healthy population using a statistical model. Asymmetry index between the left and right hippocampi is also compared to a healthy population. The reported FLAIR or TI white matter hyperintensities volumes are not normalized since they are not comparable to a reference population.
CT outputs
Report I:
- normalized volume of the whole brain (sum of white and gray matter)
- · normalized volume of the lateral ventricles
This report is useful to be applied in (potential) dementia patients.
Report 2:
- unnormalized measurement of the midline shift, i.e. the shift of the brain past its center line
- unnormalized volumes of NCCT hyperdensities (epidural, intraparenchymal and their total); and largest hyperdensity component
- normalized volumes of the left and right lateral ventricles, and of the fourth ventricle
- · normalized volumes of basal cistems (suprasellar, quadrigeminal, prepontine & ambient)
- · asymmetry index between the left and right lateral ventricle
This report is useful to be applied in (potential) TBI patients.
The whole brain, ventricles and cisterns volumes are normalized for head size by comparing to a healthy population using a statistical model. The reported CT hyperdensities volumes are not normalized since they are not comparable to a reference population.
6.5 Intended use
icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR or NCCT images.
icobrain consists of two distinct image processing pipelines: icobrain cross and icobrain long.
- icobrain cross is intended to provide volumes from MR or NCCT images acquired at a single time point.
- icobrain long is intended to provide changes in volumes between two MR images that were acquired on the same scanner, with the same image acquisition protocol and with same contrast at two different timepoints.
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The results of icobrain cross cannot be compared with the results of icobrain long.
This intended use of the modified device is equal to the intended use of the previously cleared predicate device [K181939].
6.6 Device modifications
icobrain 5.0 is an update of the icobrain 4.0 (the predicate device). The modifications of the device mostly include new measurements of brain segmentable structures, new output reports, new output images, and new output format.
New measurements:
- · normalized volume and volume changes of the the left and right hippocampi,
- · unnormalized volumes of NCCT hyperdensities in different regions (epidural, intraparenchymal and their total); and largest hyperdensity component,
- · normalized volumes of the left and right lateral ventricles, and of the fourth ventricle.
These new measurements, together with the original measurements, are now included in the previously available report types, as well as a new report type for MR input.
New output images include:
- · the segmentation of NCCT hyperdensities, color-coded for the region and overlaid on the input NCCT image,
- · the segmentation of the left and right lateral ventricles, and of the fourth ventricle, overlaid on the input NCCT image.
New output formats:
- DICOM structured report representation of a natural language report
- DICOM encapsulated PDF representation of a natural language report
6.7 Performance testing
Quality and safety
icobrain has been designed, developed and tested in accordance with the following product and process standards:
- ISO I 497 I :2007 Medical devices Application of risk management to medical devices
- · IEC 62304:2006 Medical device software Software life-cycle processes
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- IEC 62366:2014 Medical devices Application of usability engineering to medical devices
- · ISO 12052:2006 Digital imaging and communication in medicine (DICOM)
- · CFR 21 part 820 Quality System Regulation for Medical Devices
- · ISO 13485:2016 Medical devices Quality management systems
The changes made in icobrain compared to the original device do not affect the safety of the device. This conclusion is based on:
- Failure mode and effects analysis on the added functionality.
- Risk category classification of new software components.
Product performance
To demonstrate the performance of icobrain, the measured volumes and volume changes of the segmentable brain structures are validated for accuracy and reproducibility. The subjects upon whom the device was tested include healthy subjects, Alzheimer's disease patients, multiple sclerosis patients, traumatic brain injury patients, depression patients.
In the accuracy experiments, the volumes / volume changes are compared to simulated and/or manually labeled ground truth volumes / volume changes; in the reproducibility experiments, the volumes / volume changes are compared on test-retest image data sets. A literature review has been performed to set relevant acceptance criteria for each type of experiment. The acceptance criteria were based on the 900 percentile of the absolute differences in comparison to the validation threshold. All experiments passed the acceptance criteria.
The experiments encompassed 463 MR and 618 CT subject datasets in total. Averaged over all MR experiments, the Pearson correlation coefficient between the compared measurements was 0.91 and the intraclass correlation coefficient was 0.90. Averaged over all CT experiments, the Pearson correlation coefficient between the compared measurements was 0.94 and the intraclass correlation coefficient was 0.93.
Besides the validation experiments, verification tests demonstrate the system as a whole provides all the capabilities necessary to operate according to its intended use.
6.8 Conclusions
Because of the identical intended use same and technological characteristics, icobrain 5.0 is substantially equivalent to a device (icobrain 4.0) that has been approved in the United States. The performance testing demonstrates that icobrain 5.0 is as safe and effective as the predicate device.
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| Declarations: | • This summary includes only information that is also covered in the body of the 510(k).
• This summary does not contain any puffery or unsubstantiated labeling claims.
• This summary does not contain any raw data, i.e., contains only summary data.
• This summary does not contain any trade secret or confidential commercial information.
• This summary does not contain any patient identification information. |
| --------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
This document is reviewed and approved by Dirk Smeets, Vice President Clinical Applications of ico metrix, based on the present data and information.
| Signature | Date |
|---|---|
| 26 Jul 2019 |