(91 days)
Not Found
No
The summary describes standard image processing algorithms for calculating perfusion parameters and does not mention AI or ML.
No.
The device is described as image processing software for diagnostic purposes, not for treating conditions.
Yes
Explanation: The device performs image processing and analysis of CT perfusion scans of the brain, calculating parameters related to tissue flow and blood volume (CBF, CBV, MTT, TMax). It provides results that are exported in DICOM format and "may be viewed on existing radiological imaging viewers," and "should be viewed through appropriate diagnostic viewers when used in clinical decision making." This indicates its role in providing information for diagnosis.
Yes
The device is explicitly described as a "standalone software package" that runs on standard "off-the-shelf" computers or virtual platforms and processes data from DICOM-compliant imaging devices. It does not include or require specific proprietary hardware components.
Based on the provided information, Viz CTP is not an In Vitro Diagnostic (IVD) device.
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.
- Viz CTP's Function: Viz CTP processes and analyzes medical images (CT perfusion scans of the brain) acquired directly from a patient using an imaging modality. It does not analyze biological specimens.
- Intended Use: The intended use is for image processing, analysis, and communication of CT perfusion scans to aid trained professionals in interpreting these images for diagnostic purposes. This is distinct from analyzing biological samples.
Therefore, Viz CTP falls under the category of medical image processing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Viz CTP is a standalone software package that is comprised of several modules including DICOM receiving and sending modules, a study processor, image analysis algorithm, as well as software system components including a DICOM storage database and system health-monitoring. Viz CTP allows for bi-directional communication of data and may be implemented to allow a DICOM-compliant device to send files directly from the imaging modality, through a node on a local network, or from a PACS server. The device is designed to automatically receive, identify, extract, and analyze a CTP study of the head embedded in DICOM image data. The software outputs parametric maps related to tissue blood flow (perfusion) and tissue blood volume that are written back to the source DICOM. Following such analysis, the software automatically sends the results of analysis to a preconfigured destination point. The software allows for repeated use and continuous processing of data and can be deployed on a supportive infrastructure that meets the minimum system requirements.
Viz CTP image analysis includes calculation of the following perfusion related parameters:
- . Cerebral Blood Flow (CBF)
- Cerebral Blood Volume (CBV) .
- . Mean Transit Time (MTT)
- . Residue function time-to-peak (TMax)
- . Arterial Input Function (AIF)
The primary users of Viz CTP are medical imaging professionals who analyze dynamic CT perfusion studies. The results of image analysis produced by Viz CTP should be viewed through appropriate diagnostic viewers when used in clinical decision making.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (CT) perfusion scans
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
Viz.ai Inc. performed software verification and validation testing of the device and additional performance testing on a commercially available simulated dataset (digital phantom) generated by simulating tracer kinetic theory, and includes a wide range of clinically relevant values of perfusion parameters as ground truth. Correlations between the output of the Viz CTP device and the ground truth values were calculated, and compared to published correlations between the ground truth and the outputs of 7 other commercially available and academic CTP post-processing software.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: Viz CTP complies with DICOM (Digital Imaging and Communications in Medicine), developed by the American College of Radiology and the National Electrical Manufacturers Association. NEM PS 3.1-3.20 (2016). Viz.ai Inc. performed software verification and validation testing of the device and additional performance testing on a commercially available simulated dataset (digital phantom) generated by simulating tracer kinetic theory, and includes a wide range of clinically relevant values of perfusion parameters as ground truth. Correlations between the output of the Viz CTP device and the ground truth values were calculated, and compared to published correlations between the ground truth and the outputs of 7 other commercially available and academic CTP post-processing software. The results of performance testing showed that the Viz CTP device achieved the preestablished performance goals for AIF detection, soft matter extraction, and each perfusion parameter: cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), and time to maximum residue (TMax). Thus, the performance testing demonstrated that the Viz CTP device provides accurate computation of perfusion parameters, similar to other, commercially available or academic software aimed for the computation of the same perfusion parameters. Together with software verification and validation, this performance evaluation demonstrates that the device satisfies all design requirements and device specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Viz.ai, Inc. % Mr. Gregory Ramina Director of Regulatory Affairs 855 El Camino Real Suit 13A-252 PALO ALTO CA 94301
April 20, 2018
Re: K180161
Trade/Device Name: Viz CTP Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 5, 2018 Received: April 5, 2018
Dear Mr. Ramina:
We have reviewed vour 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
Device Name
Viz CTP
Indications for Use (Describe)
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-shelt" computer or a virtual plafform, such as VMware, 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.
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.
| 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) |
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510(k) SUMMARY
Viz.ai, Inc.'s Viz CTP
Applicant Name: Viz.ai, Inc. 855 El Camino Real Suite 13A-252 Palo Alto. CA 94301
Contact Person: Gregory Ramina Director of Regulatory Affairs 343 Texas St San Francisco, CA 94107 Tel. (415) 663-6130 Greg@viz.ai
Date Prepared:
Name of Device: Viz CTP
Common or Usual Name: PACS - Picture Archiving and Communications System
Classification: Classification Panel: Radiology Regulation No: 21 C.F.R. § 892.2050 Regulatory Class: Class II Product Code: LLZ
Predicate Devices
iSchemaView Inc.'s RAPID (K121447)
Device Description
Viz CTP is a standalone software package that is comprised of several modules including DICOM receiving and sending modules, a study processor, image analysis algorithm, as well as software system components including a DICOM storage database and system health-monitoring. Viz CTP allows for bi-directional communication of data and may be implemented to allow a DICOM-compliant device to send files directly from the imaging modality, through a node on a local network, or from a PACS server. The device is designed to automatically receive, identify, extract, and analyze a CTP study of the head embedded in DICOM image data. The software outputs parametric maps related to tissue blood flow (perfusion) and tissue blood volume that are written back to the source DICOM. Following such analysis, the software automatically sends the results of analysis to a preconfigured destination point. The software allows for repeated use and continuous processing of data and
4
can be deployed on a supportive infrastructure that meets the minimum system requirements.
Viz CTP image analysis includes calculation of the following perfusion related parameters:
- . Cerebral Blood Flow (CBF)
- Cerebral Blood Volume (CBV) .
- . Mean Transit Time (MTT)
- . Residue function time-to-peak (TMax)
- . Arterial Input Function (AIF)
The primary users of Viz CTP are medical imaging professionals who analyze dynamic CT perfusion studies. The results of image analysis produced by Viz CTP should be viewed through appropriate diagnostic viewers when used in clinical decision making.
Intended Use / Indications for Use
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 imaqes 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.
Difference in Indications for Use with Respect to the Predicate Device:
Viz CTP differs from it's predicate, IschemaView's RAPID (K121447), in that the Viz CTP is limited to analysis of CT Perfusion imaging data sets. Viz CTP does not include the functionality, and is therefore not indicated for processing or analyzing images acquired through Magnetic Resonance Imaging (MRI) protocols. As such, Viz CTP is indicated for a subset of functionality when compared with the predicate device, however Viz CTP is indicated for the same functionality as the predicate device with respect to CT Perfusion datasets, i.e. for performing analysis which includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. As Viz CTP is only indicated to be used with CT Perfusion imaging datasets, the difference in indications between Viz CTP and the predicate device limit the Viz CTP's functional or computational capabilities with respect to the device's indicated clinical use to a subset of functionalities provided by the predicate device. These differences,
5
however, between the indications for use of the predicate and Viz CTP devices do not affect the Viz CTP device's diagnostic effect and do not raise any new issues of safety or efficacy.
| Viz CTP | iSchemaView RAPID | |
|---|---|---|
| Product Code | LLZ | LLZ |
| Regulation | 21 C.F.R. § 892.2050 | 21 C.F.R. § 892.2050 |
| Intended Use / | ||
| Indications for | ||
| Use | 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). | ||
| The DWI Module is used to visualize | ||
| local water diffusion properties from the | ||
| analysis of diffusion weighted MRI data. | ||
| The Dynamic Analysis Module is used | ||
| for visualization and analysis of dynamic | ||
| imaging data, showing properties of | ||
| changes in contrast over time. This | ||
| functionality includes calculation of | ||
| parameters related to tissue flow | ||
| (perfusion) and tissue blood volume. | ||
| PACS Functionality | ||
| Basic PACS | ||
| Functions | Yes | Same |
| Computer | Standard "Off-the-Shelf" PC | Same |
| Platform | Workstation or VMWare | |
| DICOM Compliance | Yes | Yes |
| Functional Overview | Viz CTP is a software package that provides for the visualization and study of changes of tissue perfusion in digital images captured by CT. Viz CTP allows viewing and quantification. | Same |
| Data Acquisition | Acquires medical image data from DICOM compliant imaging devices and modalities. | Same |
| Data/Image Types | Computed Tomography (CT) | Same |
| Acquisition and Modalities Features | ||
| CT | CT Perfusion (CTP) | Yes |
| Computed Parameter Maps | ||
| Perfusion CT | Cerebral Blood Flow (CBF) | Yes |
| Cerebral Blood Volume (CBV) | Yes | |
| Mean Transit Time (MTT) | Yes | |
| Tissue residue function time to peak (TMax) | Yes | |
| Measurements/Tools | ||
| CT Tools | Arterial Input Function (AIF) | Yes |
| Brain mask | Yes | |
| Export perfusion files to PACS and DICOM file systems | Yes | |
| Acquire, transmit, process, and store medical images | Yes |
Substantial Equivalence
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Performance Data
Viz CTP complies with DICOM (Digital Imaging and Communications in Medicine), developed by the American College of Radiology and the National Electrical Manufacturers Association. NEM PS 3.1-3.20 (2016).
Viz.ai Inc. performed software verification and validation testing of the device and additional performance testing on a commercially available simulated dataset (digital phantom) generated by simulating tracer kinetic theory, and includes a wide range of clinically relevant values of perfusion parameters as ground truth. Correlations between the output of the Viz CTP device and the ground truth values were calculated, and compared to published correlations between the ground truth and the outputs of 7 other commercially available and academic CTP post-processing software.
The results of performance testing showed that the Viz CTP device achieved the preestablished performance goals for AIF detection, soft matter extraction, and each
7
perfusion parameter: cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), and time to maximum residue (TMax).
Thus, the performance testing demonstrated that the Viz CTP device provides accurate computation of perfusion parameters, similar to other, commercially available or academic software aimed for the computation of the same perfusion parameters. Together with software verification and validation, this performance evaluation demonstrates that the device satisfies all design requirements and device specifications.
Conclusions
The Viz CTP device is as safe and effective as the RAPID (K121447). The Viz CTP has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device with respect to CTP functionalities. The minor differences in indications do not alter the intended diagnostic use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the Viz CTP device and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Viz CTP is as safe and effective as the predicate, iSchemaView's RAPID for performing CTP analysis. Thus, the Viz CTP device is substantially equivalent.