AccuFFRangio is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of 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.

Device Description

ArteryFlow® AccuFFRangio 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.

The AccuFFRangio is composed of the following analysis workflows: Image Loading, Frame Selection, Vessel Reconstruction, QCA Vessel Quantification, and AccuFFRangio Calculation for visualization of the target coronary segment, quantification of the stenosis and pressure drop of the coronary seqment. The AccuFFRangio parameter is only for quantitative imaging output but not for diagnosis and the AccuFFRanigo product has a moderate level of concern.

The user can calculate the pressure drop and AccuFFRangio (FFR) value for the coronary vessel. To obtain these values for a specific lesion in a coronary vessel, the user has to start with Frame Selection using two angiographic images from different views. In each of these images, a classic 2D coronary contour detection is performed, after which a reconstruction of the coronary segment is obtained in 3D space. Based on the 3D reconstruction and user input of the aortic pressure, the pressure drop and AccuFFRangio value can be calculated.

AccuFFRangio enables interventional cardiologists to obtain accurate anatomical quantifications of one or more lesions in the analyzed coronary segment, and to assess the best viewing angles which can be helpful for optimal visualization of the lesion during percutaneous coronary intervention (PCI) treatment.

Results can be displayed and generated by the software, which contains patient information, imaging of actual and reference vessel boundaries, dimensions of the vessel sizing, pressure drop, and AccuFFRangio value. The results can be export in PDF format. This functionality is independent of the type of vendor acquisition equipment.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
3D Vessel Reconstruction	Lesion Length Accuracy	Demonstrated similar performance compared to the predicate device QAngio XA 3D (K182611).
	Diameter Stenosis Accuracy	Demonstrated similar performance compared to the predicate device QAngio XA 3D (K182611).
	Area Stenosis Accuracy	Demonstrated similar performance compared to the predicate device QAngio XA 3D (K182611).
	Minimal Lumen Diameter Accuracy	Demonstrated similar performance compared to the predicate device QAngio XA 3D (K182611).
	Reference Diameter Accuracy	Demonstrated similar performance compared to the predicate device QAngio XA 3D (K182611).
AccuFFRangio Calculation	Accuracy (for pressure drop and AccuFFRangio)	Demonstrated similar performance compared to the QFR by the predicate device QAngio XA 3D (K182611).
	Sensitivity (for pressure drop and AccuFFRangio)	Demonstrated similar performance compared to the QFR by the predicate device QAngio XA 3D (K182611).
	Specificity (for pressure drop and AccuFFRangio)	Demonstrated similar performance compared to the QFR by the predicate device QAngio XA 3D (K182611).
	Positive Predictive Value (for pressure drop and AccuFFRangio)	Demonstrated similar performance compared to the QFR by the predicate device QAngio XA 3D (K182611).
	Negative Predictive Value (for pressure drop and AccuFFRangio)	Demonstrated similar performance compared to the QFR by the predicate device QAngio XA 3D (K182611).

Study Details for Acceptance Criteria Proof:

Sample size used for the test set and the data provenance:
- 3D Vessel Reconstruction: "A phantom study had been implemented by using three different types stenosis of brass model." The specific number of images or cases analyzed in this phantom study is not provided.
- AccuFFRangio calculation: "a series of X-ray angiographic dataset with known pressure drops were analyzed." The specific number of cases or images in this dataset is not provided.
- Data Provenance: Not explicitly stated for either study (e.g., country of origin, retrospective/prospective). The phantom study suggests a controlled laboratory environment rather than patient data. The AccuFFRangio Calculation refers to an "X-ray angiographic dataset," implying patient data, but details are missing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of human experts to establish ground truth for the test sets in either the 3D vessel reconstruction or AccuFFRangio calculation studies.
- For the 3D vessel reconstruction, the ground truth was based on "three different types stenosis of brass model," implying a physical model with known dimensions.
- For the AccuFFRangio calculation, the ground truth was established by "X-ray angiographic dataset with known pressure drops." The method by which these "known pressure drops" were determined (e.g., invasive FFR measurements, expert consensus using other clinical data) is not specified, and therefore, the involvement or qualifications of experts are not described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. The studies described do not involve human review for ground truth with an adjudication process.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study is described in the provided text. The studies focus on the standalone performance of the device compared to a predicate device or known physical/physiological values.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the studies described are standalone performance evaluations of the AccuFFRangio software. The text explicitly states that "AccuFFRangio is designed as a stand-alone software package." The performance data section describes evaluating the software's output directly against phantom measurements or known physiological values.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- 3D Vessel Reconstruction: Physical phantom measurements (brass models).
- AccuFFRangio calculation: "Known pressure drops" from an X-ray angiographic dataset. The origin or method of determining these "known pressure drops" is not detailed, so it's not explicitly stated as expert consensus, invasive FFR, or outcomes data.
The sample size for the training set:
- The document does not provide information about the sample size used for the training set of the AccuFFRangio device. The performance data section focuses solely on validation/testing.
How the ground truth for the training set was established:
- As training set details are not provided, how its ground truth was established is also not described in the document.

Summary

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September 10, 2021

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: 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.

ArteryFlow Technology Co., Ltd. % Ashley Fu International Registeration Engineer 459 Oianmo Road, Suite C1-501, Binjiang District Hangzhou. Zhejiang 310051 CHINA

Re: K210093

Trade/Device Name: AccuFFFRangio Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: Class II Product Code: QHA, LLZ Dated: August 12, 2021 Received: August 16, 2021

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

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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 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,

, for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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)

K210093

Device Name

AccuFFRangio

Indications for Use (Describe)

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.

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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Tab #06 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 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, Registration engineer

Email: fang.fu@arteryflow.com

Date of preparation: January 05, 2021

2. Device Information

Trade/ Device Name: AccuFFRangio

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: Medis medical imaging systems bv

Device Name: QANGIO XA 3D

Regulatory Class: Class II

Regulation Number: 892.1600

Classification Product Code: QHA

Subsequent Product Code: LLZ

510(k) number: K182611

4. Device Description

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ArteryFlow® AccuFFRangio 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.

5. Intended Use

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.

6. Indication for Use

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.

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7. 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	AccuFFRangio	QANGIO XA 3D
Manufacturer	ArteryFlow Technology Co., Ltd.	Medis medical imaging systems bv
510(k) No.	-	K182611
Product Code	QHA, LLZ	QHA, LLZ
Regulation No.	892.1600	892.1600
Class	II	II
Level of Concernof the software	Moderate	Moderate
Intended Use and Indications for Use
Intended Use	AccuFFRangio is softwareintended to be used for performingcalculations in X-ray angiographicimages of the coronary arteries.AccuFFRangio enablesinterventional cardiologists toobtain quantifications of one ormore lesions in the analyzedcoronary vessel segment. Inparticular, AccuFFRangioprovides:Quantitative results ofcoronary vessel segmentsbased on a 3D reconstructedmodel;Dimensions of thecardiovascular vessels andlesions;Quantification of the pressuredrop in coronary vessels.	QANGIO XA 3D is softwareintended to be used for performingcalculations in X-ray angiographicimages of the coronary arteries.QANGIO XA 3D enablesinterventional cardiologists andresearchers to obtainquantifications of one or morelesions in the analyzed coronaryvessel segment. In particular,QANGIO XA 3D provides:Quantitative results ofcoronary vessel segmentsbased on a 3D reconstructedmodel;Dimensions of thecardiovascular vessels andlesions;Quantification of the pressuredrop in coronary vessels.
Indication for use	AccuFFRangio is indicated for usein clinical settings where validatedand reproducible quantified resultsare needed to support theassessment of coronary vessels inX-ray angiographic images, for useon individual patients withcoronary artery disease	QANGIO XA 3D is indicated foruse in clinical settings wherevalidated and reproduciblequantified results are needed tosupport the assessment ofcoronary vessels in X-rayangiographic images, for use onindividual patients with coronary

	When the quantified resultsprovided by AccuFFRangio areused in a clinical setting on X-rayimages of an individual patient, theresults are only intended for use bythe responsible clinicians.	artery disease.When the quantified resultsprovided by QANGIO XA 3D areused in a clinical setting on X-rayimages of an individual patient, theresults are only intended for use bythe responsible clinicians.
Technological Characteristics
Data type	● X-ray angiographic data inDICOM format(vendor-independent)	● X-ray angiographic data inDICOM format(vendor-independent)
Import of patientdata	● Automatically load informationfrom patient's DICOM file;● Manual through keyboard	● Automatically load informationfrom patient's DICOM file;● Manual through keyboard
Image display	● 2D X-ray image visualizationwith embedded ECG signal;● 3D reconstruction of thevessel segment based on 2X-ray images;● Graph for actual andreference vessel diameterwith vessel longitudinalposition;● Graph for AccuFFRangio(FFR) value with vessellongitudinal position;● AccuFFRangio (FFR) value iscolored on the 3Dreconstructed vessel segmentmodel.	● 2D X-ray image visualizationwith embedded ECG signal;● 3D reconstruction of thevessel segment based on 2X-ray images;● Graph for actual andreference vessel diameterwith vessel longitudinalposition;● Graph for QFR (FFR) valuewith vessel longitudinalposition;● QFR (FFR) value is coloredon the 3D reconstructedvessel segment model.
Centerline andcontour definition	● Manual and semi-automaticcenterline definition basedcontour detection of coronaryvessel;● Contour correction andrestriction	● Manual and semi-automaticcenterline definition basedcontour detection of coronaryand peripheral vessel;● Contour correction andrestriction
Image assessment	● Manual and automaticcalibration;● Vessel dimensions(diameters, areas, lengths);● Automatic stenosisassessment;● Pressure drop calculation incoronary vessel	● Manual and automaticcalibration;● Vessel dimensions(diameters, areas, lengths);● Automatic stenosisassessment;● Pressure drop calculation incoronary vessel

FFR calculation	AccuFFRangio provides aquantification parameter calledAccuFFRangio.	QANGIO XA 3D provides aquantification parameter calledQFR.
Storage of results	● Printout● Images● PDF	● Printout● Images● PDF
Different technological Characteristics
Gap 1	With ECG display in the imagepane	ECG display in a separate pane
Gap 2	The vessel is colored by stenosispercentage in red to blue	The vessel is colored by stenosispercentage in red to white
Gap 3	When visualizing the reconstructedvessel segment, there is a bodyicon to show the relative positionfor the vessel segment.	In QAngio XA 3D, there is a boxicon to show the relative positionfor the vessel segment.
	Image: vessel segment	Image: vessel segment
Gap 4	In the calculated vessel FFRdistribution, users can easily pointthe position by the curser and thespecific AccuFFRangio value willshow up.	In QAngio XA 3D, the user needsto move four "checking disk" andlook at the FFR value in theleft-bottom window.
Gap 5	Software operation environment:● Microsoft Windows 7, SP1,32 and 64-bit version● Microsoft Windows 8.1, 32and 64-bit version● Microsoft Windows 10, 32and 64-bit version● Linux Ubuntu16.04 and18.04, 32 and 64-bit version	Software operation environment:● Microsoft Windows 7, SP1,32 and 64-bit version● Microsoft Windows 8.1, 32and 64-bit version● Microsoft Windows 10, 32and 64-bit version● Microsoft Windows Server2008 R2, SP1, 64-bit version● Microsoft Windows Server2012 R2, 64-bit version● Microsoft Windows Server2016, 64-bit version

Table 1 General Comparison

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AccuFFRangio has the same intended use and indications for use as the predicate devices QANGIO XA 3D (K182611). The basic features in technological characteristics are the same, such as same types of data format, same method for importing patient data, similar

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display of image, same definition for centerline and contour, same method for Image assessment, same output for 3D reconstruction and the calculation of the pressure drop, etc.

AccuFFRanqio is a quantitative imaging output device, like the QANGIO XA 3D. Though above five differences concerning the display pattern (gap 1), display interface (gap 2-3), specific operate method on showing result (gap 4) and software operating system (gap 5) do exist, they do not affect the function and safety of AccuFFRangio.

8. Performance Data

System 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 statement and especially the requirements coverage matrix of AccuFFRangio providing traceability between requirements and the tests successfully executed.

The main functionality (including 3D vessel reconstruction, the calculation of the pressure drop and AccuFFRangio) have all been validated:

3D vessel reconstruction: A phantom study had been implemented by using three different types stenosis of brass model. This phantom test was to evaluate the accuracy of the 3D quantitative coronary angiography (QCA) of AccuFFRangio software. The following software technical parameters were validated, namely, lesion length accuracy, diameter stenosis accuracy, area stenosis accuracy, minimal lumen diameter accuracy and reference diameter accuracy. This demonstrated that the quantitative coronary angiography for coronary vessel have similar performance compare to the predicate device QAngio XA 3D (K182611).
AccuFFRanqio calculation: To confirm the performance of the pressure drop and AccuFFRangio (FFR) calculation in the coronary vessel, a series of X-ray angiographic dataset with known pressure drops were analyzed. The functionality of pressure drop and AccuFFRangio calculation for the new device is based on 3D reconstruction out of two angiographic images. The results, including accuracy, sensitivity, specificity, positive predictive value and negative predictive value for per-vessel were calculated. The results demonstrated that the quantification of AccuFFRangio in coronary vessel have similar performance compare to the QFR by the predicate device QAngio XA 3D (K182611).

9. Conclusion

AccuFFRangio product manufactured by our company shares the same intended use, and indications for use with QAnqio XA 3D by Medis.

Testing, validation and verification have produced results consistent with design input requirements. AccuFFRangio is a software-only device for which there are no applicable mandatory performance standards.

During the development, potential hazards were controlled by a risk management report, including risk analysis, risk mitigation, verification and validation.

ArteryFlow technology concludes that the AccuFFRangio is only for quantitative imaging

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output but not for diagnosis, and it is a safe and effective medical device as its predicate device. The use of AccuFFRangio does not change the intended use of X-ray angiography acquisition, nor does the use of this software results in any new potential hazards.

Regulation Number and Section

§ 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.