(260 days)
Not Found
No
The summary describes traditional image processing and calculation methods based on 2D contour detection and 3D reconstruction, with no mention of AI or ML techniques.
No.
The device is described as software that performs calculations and provides quantitative imaging output to support the assessment of intracranial vessels, but it explicitly states that it is "only for quantitative imaging output but not for diagnosis," and does not directly treat or diagnose a disease.
No
Explanation: The "Device Description" states, "AcculCAS is only for quantitative imaging output but not for diagnosis."
Yes
The device is explicitly described as a "stand-alone software package to run on a PC" and its function is to process existing X-ray angiographic images to provide quantitative measurements and calculations. There is no mention of accompanying hardware components required for its primary function.
Based on the provided information, AcculCAS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- AcculCAS Function: AcculCAS analyzes X-ray angiographic images of intracranial vessels. These are medical images, not biological specimens.
- Intended Use: The intended use is to perform calculations and provide quantitative results based on these images to support the assessment of intracranial vessels. It explicitly states that it is "only for quantitative imaging output but not for diagnosis."
Therefore, AcculCAS falls under the category of medical image processing software, not an IVD.
N/A
Intended Use / Indications for Use
AcculCAS is software intended to be used for performing calculations in X-ray angiographic innages of the intracranial vessels. AcculCAS enables neurointerventionalists to obtain quantifications of one or more lesions in the analyzed intracranial vessel segment. In particular, AccuICAS provides:
· Ouantitative results of intracranial vessel segments based on a 3D reconstructed model:
· Dimensions of the intracranial vessels and lesions;
· Quantification of the pressure gradient (PG) and pressure ratio (PR) in intracranial vessels.
AcculCAS is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of intracranial vessels in X-ray angiographic images.
When the quantified results provided by AcculCAS are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.
Product codes
QHA, LLZ
Device Description
ArteryFlow AcculCAS is designed as a stand-alone software package to run on a PC. This software can read traditional x-ray angiographic images with DICOM format from the local file directory.
AcculCAS is composed of the following analysis workflows: Image Loading, Frame Selection, Vessel Reconstruction and Hemodynamics Calculation for visualization of the target intracranial vessel segment, quantification of morphological parameters and pressure drop of the intracranial vessel segment. AcculCAS is only for quantitative imaging output but not for diagnosis.
AcculCAS calculates the pressure gradient (PG) and pressure ratio (PR) value for the intracranial vessel. To obtain these values for a specific lesion in an intracranial vessel, the user needs to start with Frame Selection using the same vessel under different angulation. In each of these images, a classic 2D intracranial vessel contour detection is performed, after which a reconstruction of the intracranial vessel segment is obtained in 3D space. Based on the 3D reconstruction and patients' mean arterial pressure, the corresponding pressure gradient (PG) and pressure ratio (PR) value at each position can be calculated.
AccuICAS enables neurointerventionalists to obtain accurate anatomical quantifications of one or more lesions in the analyzed intracranial vessel segment, and to assess the best viewing angles which can be helpful for optimal visualization of the lesion.
AcculCAS's outputs mainly include quantitative dimension results of intracranial vessel and lesions segments based on a 3D reconstructed model and quantification of the pressure gradient (PG) and pressure ratio (PR) in intracranial vessels. Besides, other information provided to the end user also belongs to the outputs, such as display of reference vessels and lesions, display of target vessel lumen contour, 3D reconstructed model of intracranial vessels, the diameter stenosis distribution and PG/PR distributions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray angiographic images
Anatomical Site
intracranial vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurointerventionalists / clinical settings
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
Segmentation and reconstruction outputs were verified through the verification of the lumen and reference lumen contours and the verification of 3D model.
Morphological parameters output was verified using three brass phantoms and a dozen clinical data.
The diameter stenosis distribution, as well as the PG and PR distributions, were verified using data from several clinical patients with stenosis lesions.
Hemodynamics calculation was validated by comparing the calculated results with the measured results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software requirements – derived from the intended use and indications for use – as well as risk control measures are verified by system testing. All requirements are tested and all results of the tests performed are summarized in the software test report and especially the requirements coverage matrix of AcculCAS providing traceability between requirements, design and the tests successfully executed.
All outputs of the device have undergone validation to ensure that they support the intended use of the device:
- The segmentation and reconstruction outputs were verified through the verification of the lumen and reference lumen contours and the verification of 3D model.
- Morphological parameters output by AcculCAS was verified using three brass phantoms and a dozen clinical data.
- The diameter stenosis distribution, as well as the PG and PR distributions, were verified using data from several clinical patients with stenosis lesions.
- Hemodynamics calculation was validated by comparing the calculated results with the measured results. The comparison showed good correlation and agreement between the calculated and measured pressure gradients (PG) and pressure ratios (PR).
All of these tests met the predefined criteria, indicating that the AcculCAS algorithm is accurate, and the device is clinically acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K210093, AccuFFRangio
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
February 28, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health and Human Services seal. The right side of the logo features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
ArteryFlow Technology Co., Ltd. % Ashley Fu RA Specialist 459 Oianmo Road, Suite C1-501, Binjiang District, Hangzhou, ZHEJIANG 310051 CHINA
Re: K221711
Trade/Device Name: AccuICAS Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II Product Code: QHA, LLZ Dated: January 17, 2023 Received: January 18, 2023
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221711
Device Name AccuICAS
Indications for Use (Describe)
AcculCAS is software intended to be used for performing calculations in X-ray angiographic innages of the intracranial vessels. AcculCAS enables neurointerventionalists to obtain quantifications of one or more lesions in the analyzed intracranial vessel segment. In particular, AccuICAS provides:
· Ouantitative results of intracranial vessel segments based on a 3D reconstructed model:
· Dimensions of the intracranial vessels and lesions;
· Quantification of the pressure gradient (PG) and pressure ratio (PR) in intracranial vessels.
AcculCAS is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of intracranial vessels in X-ray angiographic images.
When the quantified results provided by AcculCAS are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Tab #06 510(k) Summary
This summary of 510(k) 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: Jianping Xiang, PhD, General Manager
Email: jianping.xiang@arteryflow.com
Secondary correspondent: Ashley Fu, RA Specialist
Email: fang.fu@arteryflow.com
Date of preparation: February 28, 2023
2. Device Information
Trade/ Device Name: AcculCAS
Common Name: Radiological Image Processing Software
Regulatory Class: Class II
Regulation Description: Angiographic X-ray system
Regulation number: 892.1600
Classification Product Code: QHA
Subsequent Product Code: LLZ
3. Predicate Device Information
Manufacturer: ArteryFlow Technology Co., Ltd.
Device Name: AccuFFRangio
Regulatory Class: Class II
Regulation Number: 892.1600
Classification Product Code: QHA
Subsequent Product Code: LLZ
510(k) number: K210093
4. Device Description
4
ArteryFlow AcculCAS is designed as a stand-alone software package to run on a PC. This software can read traditional x-ray angiographic images with DICOM format from the local file directory.
AcculCAS is composed of the following analysis workflows: Image Loading, Frame Selection, Vessel Reconstruction and Hemodynamics Calculation for visualization of the target intracranial vessel segment, quantification of morphological parameters and pressure drop of the intracranial vessel segment. AcculCAS is only for quantitative imaging output but not for diagnosis.
AcculCAS calculates the pressure gradient (PG) and pressure ratio (PR) value for the intracranial vessel. To obtain these values for a specific lesion in an intracranial vessel, the user needs to start with Frame Selection using the same vessel under different angulation. In each of these images, a classic 2D intracranial vessel contour detection is performed, after which a reconstruction of the intracranial vessel segment is obtained in 3D space. Based on the 3D reconstruction and patients' mean arterial pressure, the corresponding pressure gradient (PG) and pressure ratio (PR) value at each position can be calculated.
AcculCAS enables neurointerventionalists to obtain accurate anatomical quantifications of one or more lesions in the analyzed intracranial vessel segment, and to assess the best viewing angles which can be helpful for optimal visualization of the lesion.
AcculCAS's outputs mainly include quantitative dimension results of intracranial vessel and lesions segments based on a 3D reconstructed model and quantification of the pressure gradient (PG) and pressure ratio (PR) in intracranial vessels. Besides, other information provided to the end user also belongs to the outputs, such as display of reference vessels and lesions, display of target vessel lumen contour, 3D reconstructed model of intracranial vessels, the diameter stenosis distribution and PG/PR distributions.
5. Indications for Use
AcculCAS is software intended to be used for performing calculations in X-ray angiographic images of the intracranial vessels. AcculCAS enables neurointerventionalists to obtain quantifications of one or more lesions in the analyzed intracranial vessel segment. In particular, AcculCAS provides:
- Quantitative results of intracranial vessel seqments based on a 3D reconstructed model:
- Dimensions of the intracranial vessels and lesions;
- Quantification of the pressure gradient (PG) and pressure ratio (PR) in intracranial vessels.
AcculCAS is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of intracranial vessels in X-ray angiographic images.
When the quantified results provided by AcculCAS are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible
5
clinicians.
6. Technological Characteristic Comparison
A comparison of the technological characteristics of the predicate and subject device is given in the table below.
| Item | New device | Predicate device |
|---|---|---|
| Device name | AccuICAS | AccuFFRangio |
| Manufacturer | ArteryFlow Technology Co., Ltd. | ArteryFlow Technology Co., Ltd. |
| 510(k) No. | - | K210093 |
| Product Code | QHA, LLZ | QHA, LLZ |
| Regulation No. | 892.1600 | 892.1600 |
| Class | II | II |
| Level of Concern | ||
| of the software | Moderate | Moderate |
| Intended use / | ||
| Indications for use | Indications for Use | |
| AccuICAS is software intended to | ||
| be used for performing | ||
| calculations in X-ray angiographic | ||
| images of the intracranial | ||
| vessels. AccuICAS enables | ||
| neurointerventionalists to obtain | ||
| quantifications of one or more | ||
| lesions in the analyzed | ||
| intracranial vessel segment. In | ||
| particular, AccuICAS provides: | ||
| Quantitative results of | ||
| intracranial vessel segments | ||
| based on a 3D reconstructed | ||
| model;Dimensions of the | ||
| intracranial vessels and | ||
| lesions;Quantification of the | ||
| pressure gradient (PG) and | ||
| pressure ratio (PR) in | ||
| intracranial vessels.AccuICAS is indicated for use in | ||
| clinical settings where validated | ||
| and reproducible quantified | ||
| results are needed to support the | ||
| assessment of intracranial | ||
| vessels in X-ray angiographic | AccuFFRangio is software | |
| intended to be used for | ||
| performing calculations in X-ray | ||
| angiographic images of the | ||
| coronary arteries. | ||
| AccuFFRangio enables | ||
| interventional cardiologists to | ||
| obtain quantifications of one or | ||
| more lesions in the analyzed | ||
| coronary vessel segment. In | ||
| particular, AccuFFRangio | ||
| provides: | ||
| Quantitative results of | ||
| coronary vessel segments | ||
| based on a 3D reconstructed | ||
| model;Dimensions of the | ||
| cardiovascular vessels and | ||
| lesions;Quantification of the | ||
| pressure drop in coronary | ||
| vessels.AccuFFRangio is indicated for | ||
| use in clinical settings where | ||
| validated and reproducible | ||
| quantified results are needed to | ||
| support the assessment of | ||
| images. | ||
| When the quantified results | ||
| provided by AccuICAS are used | ||
| in a clinical setting on X-ray | ||
| images of an individual patient, | ||
| the results are only intended for | ||
| use by the responsible clinicians. | coronary vessels in X-ray | |
| angiographic images, for use on | ||
| individual patients with coronary | ||
| artery disease. | ||
| When the quantified results | ||
| provided by AccuFFRangio are | ||
| used in a clinical setting on X-ray | ||
| images of an individual patient, | ||
| the results are only intended for | ||
| use by the responsible clinicians. | ||
| Technological Characteristics | ||
| Data type | ● X-ray angiographic data in | |
| DICOM format (vendor- | ||
| independent) | ● X-ray angiographic data in | |
| DICOM format (vendor- | ||
| independent) | ||
| Import of patient | ||
| data | ● Automatically load | |
| information from patient's | ||
| DICOM file; | ||
| ● Manual through keyboard | ● Automatically load | |
| information from patient's | ||
| DICOM file; | ||
| ● Manual through keyboard | ||
| Image display | ● 2D X-ray image visualization | |
| ● 3D reconstruction of the | ||
| vessel segment based on 2 | ||
| X-ray images; | ||
| ● Graph for actual and | ||
| reference vessel diameter | ||
| with vessel longitudinal | ||
| position; | ||
| ● Graph for hemodynamics | ||
| parameter value (PG/PR) | ||
| with vessel longitudinal | ||
| position; | ||
| ● Hemodynamics parameter | ||
| value (PG/PR) is colored on | ||
| the 3D reconstructed vessel | ||
| segment model. | ● 2D X-ray image visualization | |
| ● 3D reconstruction of the | ||
| vessel segment based on 2 | ||
| X-ray images; | ||
| ● Graph for actual and | ||
| reference vessel diameter | ||
| with vessel longitudinal | ||
| position; | ||
| ● Graph for AccuFFRangio | ||
| (FFR) value with vessel | ||
| longitudinal position; | ||
| ● AccuFFRangio (FFR) value | ||
| is colored on the 3D | ||
| reconstructed vessel | ||
| segment model. | ||
| Centerline | ||
| and | ||
| contour definition | ● Manual and semi-automatic | |
| centerline definition based | ||
| on contour detection of | ||
| vessel; | ||
| ● Contour correction and | ||
| restriction | ● Manual and semi-automatic | |
| centerline definition based | ||
| on contour detection of | ||
| vessel; | ||
| ● Contour correction and | ||
| restriction | ||
| Image | ||
| assessment | ● Manual and automatic | |
| calibration; | ||
| ● Vessel dimensions | ● Manual and automatic | |
| calibration; | ||
| ● Vessel dimensions | ||
| assessment; | ||
| • Pressure drop calculation in | ||
| intracranial vessel | assessment; | |
| • Pressure drop calculation in | ||
| coronary vessel | ||
| Storage of results | • Printout | |
| • Images | ||
| • Printout | ||
| • Images | ||
| Software | ||
| operation | ||
| environment | • Linux Ubuntu 18.04, 64-bit | |
| version | ||
| • Microsoft Windows 10, 64-bit | ||
| version | ||
| • MacOS 11.4, 64-bit version | • Linux Ubuntu16.04 and | |
| 18.04, 32 and 64-bit version | ||
| • Microsoft Windows 7, SP1, | ||
| 32 and 64-bit version | ||
| • Microsoft Windows 8.1, 32 | ||
| and 64-bit version | ||
| • Microsoft Windows 10, 32 | ||
| and 64-bit version |
Table 1 General Comparison
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7
AcculCAS is a quantitative imaging output device as the predicate devices. AcculCAS share the same intended use of performing calculations in X-ray angiographic images with the predicate device AccuFFRangio (K210093). Both products could enable medical professionals to obtain quantifications of one or more lesions based on a 3D reconstructed model and dimensions of vessels. The main outputs of both are morphological parameters and hemodynamics parameters.
Besides, AcculCAS has same software algorithms and technical characteristics with predicate device AccuFFRangio (K210093).
The minor gaps exist in lesion location of indications for use, intended patient population and software operating environment. However, the differences are not critical to the intended use of the device, and do not affect the safety and effectiveness of the device when used as labeled.
7. Performance Data
Software requirements – derived from the intended use and indications for use – as well as risk control measures are verified by system testing. All requirements are tested and all results of the tests performed are summarized in the software test report and especially the requirements coverage matrix of AcculCAS providing traceability between requirements, design and the tests successfully executed.
All outputs of the device have undergone validation to ensure that they support the intended use of the device:
- The segmentation and reconstruction outputs were verified through the verification of the lumen and reference lumen contours and the verification of 3D model.
- Morphological parameters output by AcculCAS was verified using three brass phantoms and a dozen clinical data.
- The diameter stenosis distribution, as well as the PG and PR distributions, were verified using data from several clinical patients with stenosis lesions.
8
- Hemodynamics calculation was validated by comparing the calculated results with the measured results. The comparison showed good correlation and agreement between the calculated and measured pressure gradients (PG) and pressure ratios (PR).
All of these tests met the predefined criteria, indicating that the AcculCAS algorithm is accurate, and the device is clinically acceptable.
8. Conclusion
Based on the information provided in this submission, AcculCAS shares same intended use, software algorithms and technical characteristics with the predicate device AccuFFRangio (K210093).
Verification and validation testing have produced results consistent with design input requirements. During the development, potential hazards were controlled by a risk management report, including risk analysis, risk mitigation and validation.
ArteryFlow Technology concludes that AcculCAS, intended only for quantitative imaging output but not for diagnosis, is as safe and effective as its predicate device. The difference between the subject and predicate devices do not raise new questions of safety and effectiveness.