(260 days)
No
The document describes standard image processing and analysis techniques for CT Perfusion data, without mentioning AI or ML algorithms. The performance studies compare the device to a predicate device using traditional validation methods, not AI/ML specific metrics or datasets.
No
The device is an image processing software for viewing and analyzing brain images from CT scans. It is used for diagnosis and analysis, not for treatment or therapy.
Yes
Explanation: The device performs image viewing, processing, and analysis of brain images acquired through DICOM compliant imaging devices. It calculates parameters related to tissue blood volume and performs analysis like volumetry of threshold maps and measurement of mismatch between rCBF and Tmax threshold volumes, all of which are diagnostic functions. The "Intended Use" explicitly states it's for use by trained professionals including physicians to analyze functional and dynamic imaging datasets.
Yes
The device is explicitly described as a "standalone software package" that runs on a "standard off-the-shelf computer" and processes data from DICOM compliant imaging devices. There is no mention of proprietary hardware included with the device.
Based on the provided information, AccuCTP is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- AccuCTP's Function: AccuCTP processes and analyzes images acquired from a CT scanner. It does not interact with or analyze biological specimens taken from the patient. Its input is image data (DICOM files), not biological samples.
- Intended Use: The intended use describes image processing, viewing, and analysis of brain images from CT-P scans. This is focused on interpreting imaging data, not analyzing biological samples.
Therefore, AccuCTP falls under the category of medical image processing software, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
LLZ
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Perfusion (CT-P)
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals, including but not limited to physicians and medical technicians. Use on a standard off-the-shelf computer.
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
Not Found
Summary of Performance Studies
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 rCBF6s thresholds. Parameter map and Volume results were quantitatively analysed and met the pre-defined pass/fail criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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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
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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.
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
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Indications for Use
510(k) Number (if known)
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)
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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 rCBF6s 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
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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
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| 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.