(260 days)
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.
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.
The provided text, a 510(k) Summary for the AccuCTP device, focuses on demonstrating substantial equivalence to a predicate device (RAPID) rather than providing detailed acceptance criteria and the results of a statistically powered clinical study. However, it does outline performance validation activities.
Here's an analysis of the available information regarding acceptance criteria and performance studies, structured according to your request, with limitations noted due to the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Parameter map and Volume results were quantitatively analysed and met the pre-defined pass/fail criteria." However, the specific numerical pre-defined pass/fail criteria are not explicitly stated in this document. The performance is reported in terms of agreement with a "ground truth" (phantom data) and agreement with the predicate device (RAPID CTP).
| Acceptance Criteria (General) | Reported Device Performance (as stated in document) |
|---|---|
| Parameter map results met pre-defined pass/fail criteria | "Parameter map...results were quantitatively analysed and met the pre-defined pass/fail criteria." |
| Volume results met pre-defined pass/fail criteria | "Volume results were quantitatively analysed and met the pre-defined pass/fail criteria." |
| Agreement with ground truth in phantom test | Achieved, "Parameter map and Volume results were quantitatively analysed and met the pre-defined pass/fail criteria." |
| Agreement with predicate device (RAPID CTP) for parameter maps and volume results | 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... met the pre-defined pass/fail criteria." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions a "group of phantoms" for the phantom test and a "calculation performance validation" using data to compare with RAPID CTP. However, the exact numerical sample size (number of CT perfusion studies or phantoms) used in these validation studies is not specified.
- Data Provenance: The document does not specify the country of origin for the data used in the "validation study" that compared AccuCTP to RAPID CTP. It also does not explicitly state whether the data was retrospective or prospective. The phantom study clearly used synthetic data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of human experts to establish ground truth for the test sets.
- For the phantom test, the ground truth was inherently known from the design of the phantoms.
- For the "validation study" comparing AccuCTP to RAPID CTP, the ground truth was effectively the output of the predicate device (RAPID CTP), implying a comparison for concordance rather than independent expert adjudication.
4. Adjudication Method for the Test Set
No adjudication method involving human experts is described since the ground truth for the validation was either known from phantoms or based on the predicate device's output.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, the document does not describe an MRMC study. The validation described focuses on the agreement of AccuCTP's output (parameter maps and volumes) with physical phantoms and with the predicate device's output. There is no mention of human readers or AI assistance in diagnostic tasks.
- Effect Size of Human Improvement: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only) Performance
Yes, the studies described are standalone performance evaluations of the AccuCTP algorithm. The phantom test directly evaluated the algorithm's accuracy against known physical properties, and the comparison with RAPID CTP assessed the algorithm's concordance with another software's output. The device is described as "a standalone software package."
7. Type of Ground Truth Used
- Phantom Test: The ground truth was known physical properties/measurements derived from the design of the phantoms.
- Validation Study (comparison with RAPID CTP): The "ground truth" for this comparison was effectively the results/output of the predicate device (RAPID CTP). This is a comparison of computational results for substantial equivalence, not a clinical ground truth for diagnostic accuracy (e.g., pathology, clinical outcomes).
8. Sample Size for the Training Set
The document does not specify the sample size of the training set used for developing or training the AccuCTP algorithm. Performance data in this section refers to validation testing, not training data.
9. How Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set (if supervised learning was used) was established, as it doesn't discuss the training phase of the algorithm development.
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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
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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
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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 | AccuCTPK220663 | RAPIDK121447 |
| Regulation | LLZ21 CFR §892.2050 | LLZ21 CFR §892.2050 |
| Indications for Use | AccuCTP is an image processingsoftware package to be used bytrained professionals, including butnot limited to physicians andmedical technicians. The softwareruns on a standard off-the-shelfcomputer, and can be used toperform image viewing, processingand analysis of brain images. Dataand images are acquired throughDICOM compliant imaging devices.AccuCTP provides both viewingand analysis capabilities forfunctional and dynamic imagingdatasets acquired with CTPerfusion (CTP), which canvisualize and analyse dynamicimaging data, showing properties ofchanges in contrast over time. Thisfunctionality includes calculation ofparameters related to tissue flow(perfusion) and tissue bloodvolume. | iSchemaView's RAPID is an imageprocessing software package to beused by trained professionals,including but not limited tophysicians and medical technicians.The software runs on a standard"off-the-shelf" computer or a virtualplatform, such as VMware, and canbe used to perform image viewing,processing and analysis of brainimages. Data and images areacquired through DICOM compliantimaging devices.iSchemaView's RAPID providesboth viewing and analysiscapabilities for functional anddynamic imaging datasets acquiredwith CT Perfusion (CT-P) and MRIincluding a Diffusion Weighted MRI(DWI) Module and a DynamicAnalysis Module (dynamiccontrast-enhanced imaging data forMRI and CT).The DWI Module is used tovisualize local water diffusionproperties from the analysis ofdiffusion - weighted MRI data.The Dynamic Analysis Module is |
| ComputerPlatform | Standard off-the-shelf PCworkstation | used for visualization and analysisof dynamic imaging data, showingproperties of changes in contrastover time. This functionalityincludes calculation of parametersrelated to tissue flow (perfusion)and tissue blood volume. |
| Standard off-the-shelf PC workstation/server Virtual platform such as VMware | ||
| FunctionalOverview | AccuCTP is a software packagethat provides for the visualizationand study of changes of tissueperfusion in digital images capturedby CT. AccuCTP provides viewingand quantification. | RAPID is a software package thatprovides for the visualization andstudy of changes of tissue perfusionand diffusion in digital imagescaptured by CT and MRI. RAPIDprovides viewing and quantification. |
| Data Acquisition | Acquires medical image data fromDICOM compliant imaging devicesand modalities | Acquires medical image data fromDICOM compliant imaging devicesand modalities |
| Data/Image Types | DICOM Format | DICOM Format |
| Acquisition andModalitiesFeatures | CT (CT Perfusion) | CT (CT Perfusion) MRI (Perfusion Weighted Images and Diffusion Weighted Images) |
| ComputedParameter Mapsof Perfusion CT | Cerebral blood flow (CBF) | Yes |
| Cerebral blood volume (CBV) | Yes | |
| Mean transit time (MTT) | Yes | |
| Tissue residue function time topeak (Tmax) | Yes | |
| Arterial input function (AIF)/Venousoutput function (VOF) | Yes | |
| Time-course | Yes | |
| Brain mask | Yes | |
| CT Tools | Region of interest (ROI) andVolumetry | Yes |
| Motion correction | Yes | |
| Export perfusion files to localaddress. | Export perfusion and diffusion filesto 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.
§ 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).