Who is the manufacturer of AccuCTP?

ArteryFlow Technology Co., Ltd. filed the 510(k) submission for AccuCTP (K220663).

What is the FDA product code for AccuCTP?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for AccuCTP?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like AccuCTP?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AccuCTP

K220663 · ArteryFlow Technology Co., Ltd. · LLZ · Nov 22, 2022 · Radiology

Device Facts

Record ID	K220663
Device Name	AccuCTP
Applicant	ArteryFlow Technology Co., Ltd.
Product Code	LLZ · Radiology
Decision Date	Nov 22, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

AccuCTP 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, and can be used to perform image viewing, processing and analysis of brain images. Data and images are acquired through DICOM compliant imaging devices. AccuCTP provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CTP), which can visualize and analyze 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.

Device Story

AccuCTP is standalone software for processing DICOM-compliant CT perfusion brain images; operates on standard off-the-shelf PC workstations. Inputs: dynamic CT perfusion datasets. Processing: performs motion correction, cranial removal, and time-intensity analysis to calculate perfusion parameters (CBF, CBV, MTT, Tmax, AIF/VOF). Outputs: threshold maps, time-intensity plots, and volumetric measurements (including rCBF/Tmax mismatch). Used by physicians and technicians in clinical settings to assist in visualizing tissue perfusion changes. Output aids clinical decision-making by providing quantitative perfusion data; benefits patient by facilitating assessment of brain tissue blood flow and volume.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including phantom testing to validate parameter maps and volumes against ground truth, and a comparative validation study against the RAPID predicate. The validation study evaluated agreement in parameter maps and volume results at rCBF<30% and Tmax>6s thresholds. All results met pre-defined pass/fail criteria.

Technological Characteristics

Standalone software; runs on standard off-the-shelf PC workstations. Processes DICOM-compliant CT perfusion data. Core functions: motion correction, cranial removal, volumetry of threshold maps, time-intensity plotting, and perfusion parameter calculation (CBF, CBV, MTT, Tmax).

Indications for Use

Indicated for trained professionals, including physicians and medical technicians, to perform viewing, processing, and analysis of brain images acquired via DICOM-compliant CT perfusion imaging. Used to visualize and analyze dynamic contrast changes to calculate tissue perfusion and blood volume parameters.

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

RAPID (K121447)

Related Devices

K201573 — Brain Perfusion (BP) application · Philips Medical Systems Nederland B.V. · Aug 17, 2021
K192962 — icobrain-ctp · Icometrix NV · Feb 28, 2020
K180161 — Viz CTP · Viz. Ai, Inc. · Apr 20, 2018
K231353 — AccuCTP Pro · ArteryFlow Technology Co., Ltd. · Sep 14, 2023
K223555 — Brainomix 360 e-CTP · Brainomix Limited · Jun 1, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. ArteryFlow Technology Co., Ltd. % Ashley Fu RA Specialist 459 Qianmo Road, Suite C1-501, Binjiang District, Hangzhou, Zhejiang 310051 CHINA ## Re: K220663 November 22, 2022 Trade/Device Name: AccuCTP Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: October 18, 2022 Received: October 18, 2022 Dear Ashley Fu: 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. Jessica Lamb Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220663 Device Name AccuCTP Indications for Use (Describe) AccuCTP 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, and can be used to perform image viewing, processing and analysis of brain images. Data and images are acquired through DICOM compliant imaging devices. AccuCTP provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CT-P), which can visualize and analyze dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue blood volume. 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." Form Approved: OMB No. 0910-0120 PSC Publishing Services (301) 443-6740 BR {3}------------------------------------------------ ## K220663: 510(k) Summary This 510(k) Summary of safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92. ### 1. Submitter's Information Submitter: ArteryFlow Technology Co., Ltd. Address: 459 Qianmo Road, Suite C1-501, Binjiang District, 310051 Hangzhou City, Zhejiang Province, China Phone Number: +86-571-86772567 Primary correspondent: Xiang Jianping, PhD, General Manager Email: jianping.xiang@arteryflow.com Secondary correspondent: Ashley Fu, RA Specialist Email: fang.fu@arteryflow.com Date of preparation: October 18, 2022 ### 2. Device Information Trade/ Device Name: AccuCTP Common Name: Radiological Image Processing Software Regulatory Class: Class II Regulation Description: Medical image management and processing system Regulation number: 892.2050 Classification Product Code: LLZ #### 3. Predicate Device Information Manufacturer: iSchemaView, Inc. Device Name: RAPID Regulatory Class: Class II Regulation Number: 892.2050 Classification Product Code: LLZ 510(k) number: K121447 #### 4. Device Description AccuCTP is a standalone software package that provides visualization and study of changes of tissue perfusion in digital images captured by CT (Computed Tomography). The software provides viewing, quantification, analysis and reporting capabilities, and it allows {4}------------------------------------------------ repeated use and continuous processing of data and can be deployed on a supportive customer's PC that meets the minimum system requirements. AccuCTP works with the DICOM compliant medical image data. AccuCTP provides tools for performing the following types of analysis: - volumetry of threshold maps . - time intensity plots for dynamic time courses . - . measurement of mismatch between rCBF and Tmax threshold volumes obtained from the same scan. #### 5. Indications for Use AccuCTP 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, and can be used to perform image viewing, processing and analysis of brain images. Data and images are acquired through DICOM compliant imaging devices. AccuCTP provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CTP), which can visualize and analyze 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. #### 6. Performance Data Software verification and validation testing have been performed in support that AccuCTP satisfies all design specifications and provides accurate computation of output parameters. During the development, potential hazards were controlled by the risk management report, including risk analysis, risk mitigation, verification and validation. AccuCTP have conducted a phantom test and a validation study of the performance to validate the core algorithm through parameter maps and volumes validation. Besides, filtering and cranial removal have also been validated. In the phantom test, a group of phantoms was designed to validate the parameter maps and volume compared with ground truth. Parameter map and Volume results were quantitatively analysed and met the pre-defined pass/fail criteria. In the validation study, a calculation performance validation was conducted to evaluate the agreement between AccuCTP and RAPID CTP in calculating the parameter maps as well as the volume results at the rCBF<30% and Tmax>6s thresholds. Parameter map and Volume results were quantitatively analysed and met the pre-defined pass/fail criteria. Performance data demonstrates that AccuCTP is as safe and effective as iSchemaView's RAPID for performing CTP analysis. #### 7. Substantial Equivalence AccuCTP is a generic tool without being disease-specific and it enables the users to {5}------------------------------------------------ manually select the outputted threshold values. AccuCTP does not have diagnostic implications and has same intended use compared with predicate device. AccuCTP shares the same principle of operation and technological characteristics as RAPID (K121447) with respects to CTP functionalities. The minor differences in indications do not alter the intended use of the device, and the minor technological differences raise no new issues of safety or effectiveness. A comparison of the technological characteristics of the predicate and subject device is given in the table below. | Parameter | Subject device | Predicate device | |-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | AccuCTP K220663 | RAPID K121447 | | Regulation | LLZ 21 CFR §892.2050 | LLZ 21 CFR §892.2050 | | Indications for Use | AccuCTP 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, and can be used to perform image viewing, processing and analysis of brain images. Data and images are acquired through DICOM compliant imaging devices. AccuCTP provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CTP), which can visualize and analyse 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. | 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 (CT-P) 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 | | Computer Platform | Standard off-the-shelf PC workstation | 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. | | | | Standard off-the-shelf PC workstation/server Virtual platform such as VMware | | Functional Overview | AccuCTP is a software package that provides for the visualization and study of changes of tissue perfusion in digital images captured by CT. AccuCTP provides viewing and quantification. | RAPID is a software package that provides for the visualization and study of changes of tissue perfusion and diffusion in digital images captured by CT and MRI. RAPID provides viewing and quantification. | | Data Acquisition | Acquires medical image data from DICOM compliant imaging devices and modalities | Acquires medical image data from DICOM compliant imaging devices and modalities | | Data/Image Types | DICOM Format | DICOM Format | | Acquisition and Modalities Features | CT (CT Perfusion) | CT (CT Perfusion) MRI (Perfusion Weighted Images and Diffusion Weighted Images) | | Computed Parameter Maps of 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 | | | Arterial input function (AIF)/Venous output function (VOF) | Yes | | | Time-course | Yes | | | Brain mask | Yes | | CT Tools | Region of interest (ROI) and Volumetry | Yes | | | Motion correction | Yes | | | Export perfusion files to local address. | Export perfusion and diffusion files to PACS and DICOM file systems | | | Acquire, transmit, process, and | Yes | ### Table 1 General Comparison {6}------------------------------------------------ {7}------------------------------------------------ | | | store medical images | | | |--|--|----------------------|--|--| |--|--|----------------------|--|--| # 8. Conclusion AccuCTP has same intended use and is as safe and effective as the predicate device RAPID (K121447). The differences between the subject and predicate devices do not raise new questions of safety and effectiveness. Thus, the AccuCTP is substantially equivalent.