AccuFFRangio Plus 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 Plus 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

AccuFFRangio Plus is a system that is used to perform calculations in X-ray angiographic images of the coronary arteries. It includes hardware and software (AccuFFRangio) and the hardware of the device which mainly has a display function and provide the software an operation environment. AccuFFRangio Plus is changed from our own legally marketed predicate device AccuFFRangio that is a stand-alone software package. Therefore, the significant change lies in equipping a computer system to the software on a particular mobile cart.

AI/ML Overview

The provided text is a 510(k) summary for the device AccuFFRangio Plus. It primarily focuses on demonstrating substantial equivalence to a predicate device (AccuFFRangio) by highlighting that the core software is unchanged and the modifications are primarily hardware-related. As such, the document does not detail specific acceptance criteria or performance studies for the AI/algorithm itself for several reasons:

The 510(k) is for a hardware modification of an already cleared device. The "significant change" lies in integrating the existing software into a new hardware system (a mobile cart with computer, monitor, etc.). Therefore, the performance data presented primarily addresses the new hardware aspects (electrical safety, EMC, etc.) and leverages the software's previous clearance.
The software (AccuFFRangio) was likely cleared previously. The document states, "The software installed in the subject device is the same as the predicate device." This suggests that the clinical performance and acceptance criteria for the software were established and validated during the predicate device's (AccuFFRangio, K210093) original 510(k) clearance process. This document is not resubmitting that, but relies on it.
The device calculates "quantified results" and "quantification of the pressure drop," not necessarily an AI-driven diagnosis or classification. While the term "AI" or "deep learning" is not explicitly used, the description of "quantified results" and "pressure drop" calculations suggests an analytical tool rather than a traditional diagnostic AI that might have sensitivity/specificity metrics.

Therefore, based solely on the provided text, I cannot provide a detailed response to your request regarding AI acceptance criteria and study proving the device meets them because this information is not present in this specific 510(k) summary. The summary explicitly states: "No clinical testing was necessary to support the device modifications described in this Special 510(k)." and "The following testing was leveraged from the predicate device. The results from the predicate were used to support the subject device the software contained in the AccuFFRangio Plus is the same as the predicate device."

To answer your request, one would need to refer to the original 510(k) submission for the predicate device, AccuFFRangio (K210093), as that is where the software's performance and validation data would have been submitted. This document focuses on the safety and efficacy of the hardware integration and the overall system's continued substantial equivalence.

However, I can extract information related to the general "performance data" presented for the current 510(k), which focuses on the hardware and usability aspects:*

Acceptance Criteria and Study for AccuFFRangio Plus (Hardware-Focused)

As established above, this 510(k) focuses on the hardware modifications. The "acceptance criteria" and "performance" are therefore related to the safety and functionality of the integrated system, not the clinical performance of the underlying software's calculations, as that was established during the predicate device's clearance (K210093).

1. Table of Acceptance Criteria and Reported Device Performance (Hardware & Usability)

Test Category	Acceptance Criteria (Pre-defined)	Reported Device Performance
Electrical Safety	Compliance with IEC 60601-1:2012	All applicable requirements met.
Electromagnetic Compatibility	Compliance with IEC 60601-1-2:2014 (4th ed.)	All emissions and immunity tests passed.
Hardware Verification	Meet internal specifications, incoming inspections of raw materials, and final inspections of finished devices.	All hardware requirements evaluated/tested and found to meet pre-defined acceptance criteria.
Transportation Testing	Compliance with ASTM D4169-16	All tests passed.
Human Factors (Usability)	Safe and effective use by the intended user population, no use errors for critical tasks.	Fifteen qualified participants performed all critical tasks without any use errors. No residual use-related risks identified. Conclusion: can be used safely and effectively.
Accelerated Aging Testing	Meet pre-defined acceptance criteria for service life.	All pre-defined acceptance criteria met. Service life validated to be 5 years.
Labeling Inspection	Compliance with company's quality management system documentation.	All inspections passed.
Software Verification & Validation	Software requirements met, device meets user needs and performs as intended (leveraged from predicate).	Software verification testing in accordance with design requirements. Software validation to ensure user needs are met and performs as intended.
Cybersecurity	Verification of Cybersecurity control and management (leveraged from predicate).	Testing to verify Cybersecurity control and management.

2. Sample Size and Data Provenance

Test Set Sample Size:
- Human Factors Testing: 15 qualified participants.
- For other tests (Electrical Safety, EMC, Hardware Verification, Transportation, Accelerated Aging, Labeling), the sample size typically refers to the number of units tested, which isn't explicitly stated but is implicitly "sufficient" to meet the standard requirements.
Data Provenance: Retrospective (leveraging data and conclusions from the predicate device's software clearance). No new clinical data was generated for this specific 510(k). Country of origin is not specified for the original data, but the submitter is from Hangzhou, China.

3. Number of Experts and Qualifications for Ground Truth

Not applicable to the hardware/usability tests described in this document.
For the Human Factors testing, "15 qualified participants" were used. Their specific qualifications (e.g., medical professionals, years of experience) are not detailed here, but they would be representative of the intended users.
For the original software's ground truth establishment (from the predicate device's 510(k)), this information would be detailed in K210093.

4. Adjudication Method for the Test Set

Not applicable for the hardware/usability tests.
For the Human Factors testing, success was determined by the absence of "use errors" during "critical tasks," rather than a formal adjudication process.

5. MRMC Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this 510(k). The document explicitly states "No clinical testing was necessary to support the device modifications described in this Special 510(k)."

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

The software aspect of the device ("AccuFFRangio") is described as a "stand-alone software package" in the predicate description. Therefore, standalone software performance was likely evaluated during the predicate device's (K210093) clearance. This 510(k) document does not provide those details, but leverages that previous data. The "AccuFFRangio Plus" is now an integrated hardware/software system.

7. Type of Ground Truth Used

For the hardware studies, ground truth is based on engineering standards (e.g., IEC, ASTM) and internal quality control specifications.
For the software's calculations (leveraged from the predicate), the type of ground truth (e.g., another device, invasive measurements, expert consensus on imaging) would have been established during K210093. This document describes the device as providing "quantified results of coronary vessel segments based on a 3D reconstructed model" and "Quantification of the pressure drop in coronary vessels," implying quantitative ground truth rather than subjective diagnostic labels.

8. Sample Size for the Training Set

Not applicable to this 510(k) which covers hardware modifications and re-uses existing software.
For the original software development (from the predicate device's 510(k)), this information would be detailed in K210093.

9. How the Ground Truth for the Training Set was Established

Not applicable to this 510(k).
For the original software (from the predicate device's 510(k)), this information would be detailed in K210093.

In summary, this 510(k) submission is a "special 510(k)" for a hardware modification, explicitly relying on the prior clearance of its predicate software. Therefore, the detailed AI/algorithm specific performance data and acceptance criteria you requested are not contained within this document but would be found in the original submission for the predicate device, AccuFFRangio (K210093).

Summary

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March 2, 2023

ArteryFlow Technology Co., Ltd. % Ashley Fu RA Specialist 459 Oianmo Road, Suite C1-501, Binjiang District Hangzhou, ZHEJIANG 310051 CHINA

Re: K230303

Trade/Device Name: AccuFFRangio Plus Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: Class II Product Code: QHA, LLZ Dated: February 3, 2023 Received: February 3, 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

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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,

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

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Indications for Use

510(k) Number (if known) K230303

Device Name AccuFFRangio Plus

Indications for Use (Describe)

AccuFFRangio Plus is indicated for use in clinical settings where validated and repreproducible 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 Plus 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 Special 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: XIANG Jianping, PhD, General Manager

Email: jianping.xiang@arteryflow.com

Secondary correspondent: Ashley Fu, RA Specialist

Email: fang.fu@arteryflow.com

Date of preparation: February 03, 2023

2. Device Information

Trade/ Device Name: AccuFFRangio Plus

Common Name: Radiological Image Processing System

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 Common Name: Radiological Image Processing Software Regulatory Class: Class II Regulation Number: 892.1600 Classification Product Code: QHA

Subsequent Product Code: LLZ

510(k) number: K210093

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4. Device Description

5. Intended Use

AccuFFRangio Plus is a system intended to be used for performing calculations in X-ray angiographic images of the coronary arteries. AccuFFRangio Plus enables interventional cardiologists and researchers to obtain quantifications of one or more lesions in the analyzed coronary vessel seqment. In particular, AccuFFRanqio Plus 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. Indications for Use

When the quantified results provided by AccuFFRangio Plus 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.

7. Technological Characteristic Comparison

Compared to the predicate device AccuFFRangio, intended use and indications for use of subject device remain unchanged. The software installed in the subject device is the same as the predicate device. The features and technology of the software part are the same as the predicate device.

The difference lies in the addition of the hardware part. AccuFFRangio Plus has changed to an integrity with software and hardware. The hardware mainly equips a computer system on a mobile cart. The detailed comparisons of differences are provided in the following table:

	Subject Device	Predicate Device
Feature	AccuFFRangio Plus(Hardware with software)	AccuFFRangio(Stand-alonesoftware)

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Monitor	The monitor converts signaloutputted from hostcomputer to visible image,and user can operate basedon the informationdisplayed.	N/A
Mouse	Mouse is the inputcomponent, user can locateregion of interest with themouse, buttons, and roller.	N/A
Keyboard	User can input data throughkeyboard.	N/A
Host computer	The predicate software isinstalled within it.	N/A
Monitor mount	Adjust the height of themonitor when necessary.	N/A
Equipment shell	It is equipped with powerswitch, USB port, cablepost, heat vent,equipotential terminal andpower socket and switch.	N/A
Casters	Four casters with brakemake the product mobile,improving the flexibility andsafety.	N/A

8. Performance Data to Support Substantial Equivalence

The hardware modifications to the AccuFFRangio Plus was implemented under the design controls that are compliant with 21 CFR 820.30. A risk analysis was conducted in accordance with ISO 14971:2019 Medical devices - Application of risk management to medical devices to assess the risks and risk mitigations for the device hardware modifications. Based on this risk assessment, the following verification tests were identified and conducted. All tests met the pre-defined acceptance criteria and were passed.

Electrical Safety Testing: The AccuFFRangio Plus was evaluated and found to be in compliance with the applicable requirements of IEC 60601-1:2012, "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance." All emissions and immunity tests were passed.

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Electromagnetic Compatibility Testing: The AccuFFRangio Plus was tested and found to be in compliance with the applicable requirements of IEC 60601-1-2:2014 (4th edition), "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests."

Hardware Verification Testing: The AccuFFRangio Plus underwent testing per internal specifications through incoming inspections of raw materials and final inspections of finished devices. All hardware requirements of the system were evaluated/tested and found to meet the pre-defined acceptance criteria.

Transportation Testing: The AccuFFRangio Plus was shipped in a padded, wooden box. Transportation testing was conducted in accordance with ASTM D4169-16, "Standard Practice for Performance Testing of Shipping Containers and Systems." All tests were passed.

Human Factors Testing: Usability testing of the modified AccuFFRangio Plus and its operator manual was conducted in accordance with IEC 62366-1:2015, "Application of usability engineering to medical devices". Fifteen qualified participants performed all critical tasks necessary to validate the usability of AccuFFRangio Plus and user manual without any use errors. The conclusion of the testing was that the AccuFFRangio Plus can be used safely and effectively by the intended user population. No residual use-related risks were identified.

Accelerated Aging Testing: Accelerated aging testing was conducted in accordance with IEC 62506:2013, "Methods for product accelerated testing". All pre-defined acceptance criteria were met and the service life of the device is validated to be 5 years.

Labeling Inspection: Labeling inspection was conducted to in accordance with documentation of the company's quality management system. All inspections were passed.

No clinical testing was necessary to support the device modifications described in this Special 510(k).

The following testing was leveraged from the predicate device. The results from the predicate were used to support the subject device the software contained in the AccuFFRangio Plus is the same as the predicate device.

Test	Test description	Applicable standard(s)
Software verificationand validation	Software verification testing inaccordance with the designrequirements to ensure that thesoftware requirements were met.Software validation test to ensurethe device meet user needs andperform as intended.	FDA Guidance, "Guidance forthe Content of PremarketSubmissions for softwareContained in Medical Device"
Cybersecurity	Testing to verify Cybersecuritycontrol and management.	Cybersecurity asrecommended in FDA

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		guidance, “Content ofPremarket Submission forManagement ofCybersecurity in MedicalDevice”
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9. Conclusion

AccuFFRangio Plus shares the same intended use, and indications for use with AccuFFRangio. Besides, the software application of the device is totally the same as the predicate device. The information and testing presented demonstrate that AccuFFRangio Plus is clinically feasible, and the performance is substantially equivalent to the original ArteryFlow AccuFFRangio cleared device under K210093.

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.