icobrain-ctp

K192962 · Icometrix NV · LLZ · Feb 28, 2020 · Radiology

Device Facts

• Record ID: K192962
• Device Name: icobrain-ctp
• Applicant: Icometrix NV
• Product Code: LLZ · Radiology
• Decision Date: Feb 28, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

icobrain ctp is image processing software for brain CT perfusion (CTP) scans; inputs are DICOM-compliant dynamic imaging datasets. Software performs pre-processing (loading scans, extracting tags), calculates perfusion parameters (CBF, CBV, MTT, Tmax), and identifies Tmax and CBF abnormalities. Outputs include an electronic report (PDF/DICOM) containing abnormality volumes, mismatch volume/ratio, time series data, and perfusion parameter maps. Used in clinical settings by physicians/technicians; results viewed on standard radiological viewers to assist in stroke assessment and clinical decision-making. Benefits include automated quantification of tissue perfusion to aid diagnosis.

Clinical Evidence

Performance validated via digital phantom (simulated tracer kinetic theory) and clinical stroke patient datasets. Accuracy metrics (correlation, p90 absolute difference, mean relative difference) for perfusion parameters (CBV, CBF, MTT) and abnormality volumes (Tmax, CBF) met pre-established acceptance criteria based on literature. Digital phantom correlations >0.90. Reproducibility tested via test-retest with simulated motion. Software verification and validation confirmed design requirements met.

Technological Characteristics

Software-based image processing; runs on off-the-shelf hardware or virtual platforms (e.g., VMware). Inputs/outputs via DICOM. Calculates perfusion parameters (CBF, CBV, MTT, Tmax) using tracer kinetic theory. Standalone software package; no hardware components.

Indications for Use

Indicated for trained professionals, including physicians and medical technicians, to perform image processing, analysis, and communication of brain CT perfusion scans in patients, including stroke patients.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Viz CTP (K180161)

Reference Devices

• RAPID (K121447)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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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# 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) | |
|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 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<br>3012 Leuven<br>Belgium |
| Contact Person: | Dirk Smeets |
| Telephone number: | [phone] |
| Fax Number: | N.A. |
| E-mail: | [e-mail] |
| Date Prepared: | 28 Feb 2020 |

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## 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.

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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.

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# 5.6 Comparison with predicate device

| | Device to market | Proposed predicate device | Proposed Reference device |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Trade Name | icobrain ctp | Viz CTP | RAPID |
| Common<br>Name | Medical Image Processing Software | Picture archiving and communications system | Picture archiving and communications<br>system |
| 510(k)<br>Number | K192962 | K180161 | K121447 |
| Manufacturer | icometrix NV | Viz.ai, Inc. | iSchemaView, Inc. |
| | Kolonel Begaultlaan Ib / 12<br>3012 Leuven<br>BELGIUM | 855 El Camino Real Suite 13A-252<br>Palo Alto, CA 94301 | 323 Olmsted Road<br>Stanford, CA 94305 |
| Regulation<br>Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Device<br>Classification<br>Name | System, Image processing,<br>Radiological | System, Image processing, Radiological | System, Image processing, Radiological |
| Product<br>Code | LLZ | LLZ | LLZ |
| Regulatory<br>Class | II | II | II |
| Classification<br>Panel | Radiology | Radiology | Radiology |
| Indications<br>for use | icobrain ctp is an image processing<br>software package to be used by<br>trained professionals, including but<br>not limited to physicians and<br>medical technicians. The software<br>runs on a standard "off-the-shelf"<br>computer or a virtual platform,<br>such as VMware, and can be used<br>to perform image processing,<br>analysis, and communication of<br>computed tomography (CT)<br>perfusion scans of the brain. Data<br>and images are acquired through<br>DICOM-compliant imaging devices.<br><br>icobrain ctp provides both analysis<br>and communication capabilities for<br>dynamic imaging datasets that are<br>acquired with CT Perfusion imaging<br>protocols. Analysis includes<br>calculation of parameters related to<br>tissue flow (perfusion) and tissue<br>blood volume. Results of image<br>processing which include CT<br>perfusion parameter maps<br>generated from a raw CTP scan are<br>exported in the standard DICOM<br>format and may be viewed on<br>existing radiological imaging viewers. | Viz CTP is an image processing software<br>package to be used by trained professionals,<br>including but not limited to physicians and<br>medical technicians. The software runs on a<br>standard "off-the-shelf" computer or a virtual<br>platform, such as VMware, and can be used<br>to perform image processing, analysis, and<br>communication of computed tomography<br>(CT) perfusion scans of the brain. Data and<br>images are acquired through DICOM-<br>compliant imaging devices.<br><br>Viz CTP provides both analysis and<br>communication capabilities for dynamic<br>imaging datasets that are acquired with CT<br>Perfusion imaging protocols. Analysis<br>includes calculation of parameters related to<br>tissue flow (perfusion) and tissue blood<br>volume. Results of image processing which<br>include CT perfusion parameter maps<br>generated from a raw CTP scan are<br>exported in the standard DICOM format<br>and may be viewed on existing radiological<br>imaging viewers. | iSchemaView's RAPID is an image<br>processing software package to be used<br>by trained professionals, including but not<br>limited to physicians and medical<br>technicians. The software runs on a<br>standard "off-the-shelf" computer or a<br>virtual platform, such as VMware, and can<br>be used to perform image viewing,<br>processing and analysis of brain images.<br>Data and images are acquired through<br>DICOM compliant imaging devices.<br><br>iSchemaView's RAPID provides both<br>viewing and analysis capabilities for<br>functional and dynamic imaging datasets<br>acquired with CT Perfusion and MRI<br>including a Diffusion Weighted MRI<br>(DWI) Module and a Dynamic Analysis<br>Module (dynamic contrast enhanced<br>imaging data for MRI and CT). |
| Basic PACS<br>functions | Yes | Yes | Yes |
| Computer<br>platform | Standard "off-the-shelf" computer<br>or a virtual platform. | Same | Same |
| DICOM<br>compliance | Yes | Yes | Yes |
| Functional<br>overview | icobrain ctp is a software package<br>that provides for the quantification<br>and visualization of the perfusion of<br>tissue based on dynamic contrast<br>enhanced CT images. | Same | Automatic analysis for functional and<br>dynamic imaging datasets acquired with<br>CT Perfusion and MRI including a<br>Diffusion Weighted MRI (DWI) Module<br>and a Dynamic Analysis Module (dynamic<br>contrast enhanced imaging data for MRI<br>and CT). |
| Data<br>Acquisition | Acquires medical image data from<br>DICOM compliant imaging devices<br>and modalities. | Same | Same |
| Data/Image<br>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…