(57 days)
No
The description focuses on "coronary physiologic simulation software" and "mathematically derived quantity" computed from a 3D computer model, without mentioning AI, ML, or related concepts. The validation study also focuses on traditional performance metrics.
No.
The device is described as "coronary physiologic simulation software" that provides "FFRct, a mathematically derived quantity" to aid in the "functional evaluation of coronary artery disease." It is intended to support qualified clinicians in "evaluation and assessment of coronary arteries" and is used in conjunction with other diagnostic tests. This indicates it is a diagnostic tool, not a therapeutic one that directly treats or provides therapy.
Yes
The device is described as "coronary physiologic simulation software for the clinical quantitative and qualitative analysis" that provides "FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information" to "support the functional evaluation of coronary artery disease." The results are intended to "support qualified clinicians to aid in the evaluation and assessment of coronary arteries" and used "in conjunction with the patient's clinical history, symptoms, and other diagnostic tests." These statements explicitly indicate its role in diagnosing and evaluating a medical condition.
Yes
The device is described as "coronary physiologic simulation software" that analyzes previously acquired CT DICOM data. There is no mention of any accompanying hardware or hardware components included with the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue. They are used to detect diseases, conditions, or infections.
- Device description: The description clearly states that HeartFlow FFRCT is coronary physiologic simulation software that analyzes previously acquired Computed Tomography DICOM data. This data is image data, not a biological sample taken from the patient.
- Intended Use: The intended use is to support the functional evaluation of coronary artery disease by providing a mathematically derived quantity (FFRCT) from simulated pressure, velocity, and blood flow information obtained from a 3D computer model generated from static coronary CT images. This is an analysis of imaging data, not a test on a biological sample.
Therefore, HeartFlow FFRCT falls under the category of medical imaging analysis software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HeartFlow FFRCT is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFRCT analysis is intended to support the functional evaluation of coronary artery disease.
The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of HeartFlow FFRCT are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.
Product codes
PJA
Device Description
FFRct v2.0 is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries.
The software displays the anatomy combined with function using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment of coronary artery disease.
FFR is independent of imaging equipment, imaging protocols and equipment vendors; the clinical validation report (VOL 003 FFR & V2.0 Clinical Validation Report) includes identification of vendors and equipment used in the clinical validation of the product. This data is summarized in the product labeling, and can be found in the Clinical User Instructions for Use (Attachment VOL 003 Instructions for Use - Customers). HeartFlow FFR-c analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography DICOM data
Anatomical Site
coronary artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified clinicians
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
A detailed summary of clinical studies was provided and reviewed in the K152733 submission. Current submission is the same product (simply a change in indications), and no additional clinical data is being provided. The previous data supports the requested change to the Indications for Use proposed under this 510(k). An abbreviated summary follows.
HeartFlowNXT, a prospective, multicenter, non-randomized study, provided the clinical validation for the initial device de novo clearance, FFR r v1.4 (DEN130025). The current version of software product represented in this 510(k), version 2.0, was clinically validated using the sequestered HeartFlowNXT dataset to evidence equivalence and the data was reviewed in the K152733 submission. The previously reviewed clinical validation results for 2.0 are below; detailed results can be found in Attachments VOL 003 FFR ୯ v2.0 Clinical Validation Report.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
HeartFlowNXT, a prospective, multicenter, non-randomized study, provided the clinical validation for the initial device de novo clearance, FFR r v1.4 (DEN130025). The current version of software product represented in this 510(k), version 2.0, was clinically validated using the sequestered HeartFlowNXT dataset to evidence equivalence and the data was reviewed in the K152733 submission. The previously reviewed clinical validation results for 2.0 are below; detailed results can be found in Attachments VOL 003 FFR ୯ v2.0 Clinical Validation Report.
Primary endpoint success required both sensitivity and specificity hypotheses to be met. The pervessel sensitivity of FFRcr in the ITD population was 84.2% with a lower one-sided 95% Cl of 75.8%. As this was above the protocol specified target goal of 65%, the first null hypothesis was rejected and FFRa was considered to have met the sensitivity target goal. The per-vessel specificity of FFRin the ITD population was 84.9%. The lower one-sided 95% Cl was 80.4% and was above the protocol specified target goal of 55%, therefore the second null hypothesis was rejected and FFRwas considered to have met the specificity target goal.
Per-subject FFRct specificity compared to site-read cCTA demonstrated superior diagnostic ability (p 50% stenosis severity for site-read cCTA.
The validation study demonstrated good diagnostic performance for FFRcr when all vessels were included, irrespective of size, location, or territory, and across a range of cCTA image quality measures. Further details can be found in VOL 003 FFRct 2.0 Clinical Validation Report.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Per-vessel:
Sensitivity: 84.2% (95% Cl: 75.8%)
Specificity: 84.9% (95% Cl: 80.4%)
Per-subject:
Diagnostic Accuracy: 80.0% (74.4%-84.6%)
Sensitivity: 87.8% (78.5%-93.5%)
Specificity: 76.4% (69.3%-82.3%)
PPV: 63.1% (53.5%-71.8%)
NPV: 93.2% (87.5%-96.4%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1415 Coronary vascular physiologic simulation software device.
(a)
Identification. A coronary vascular physiologic simulation software device is a prescription device that provides simulated functional assessment of blood flow in the coronary vascular system using data extracted from medical device imaging to solve algorithms and yield simulated metrics of physiologic information (e.g., blood flow, coronary flow reserve, fractional flow reserve, myocardial perfusion). A coronary vascular physiologic simulation software device is intended to generate results for use and review by a qualified clinician.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Adequate software verification and validation based on comprehensive hazard analysis, with identification of appropriate mitigations, must be performed, including:
(i) Full characterization of the technical parameters of the software, including:
(A) Any proprietary algorithm(s) used to model the vascular anatomy; and
(B) Adequate description of the expected impact of all applicable image acquisition hardware features and characteristics on performance and any associated minimum specifications;
(ii) Adequate consideration of privacy and security issues in the system design; and
(iii) Adequate mitigation of the impact of failure of any subsystem components (
e.g., signal detection and analysis, data storage, system communications and cybersecurity) with respect to incorrect patient reports and operator failures.(2) Adequate non-clinical performance testing must be provided to demonstrate the validity of computational modeling methods for flow measurement; and
(3) Clinical data supporting the proposed intended use must be provided, including the following:
(i) Output measure(s) must be compared to a clinically acceptable method and must adequately represent the simulated measure(s) the device provides in an accurate and reproducible manner;
(ii) Clinical utility of the device measurement accuracy must be demonstrated by comparison to that of other available diagnostic tests (
e.g., from literature analysis);(iii) Statistical performance of the device within clinical risk strata (
e.g., age, relevant comorbidities, disease stability) must be reported;(iv) The dataset must be adequately representative of the intended use population for the device (
e.g., patients, range of vessel sizes, imaging device models). Any selection criteria or limitations of the samples must be fully described and justified;(v) Statistical methods must consider the predefined endpoints:
(A) Estimates of probabilities of incorrect results must be provided for each endpoint,
(B) Where multiple samples from the same patient are used, statistical analysis must not assume statistical independence without adequate justification, and
(C) The report must provide appropriate confidence intervals for each performance metric;
(vi) Sensitivity and specificity must be characterized across the range of available measurements;
(vii) Agreement of the simulated measure(s) with clinically acceptable measure(s) must be assessed across the full range of measurements;
(viii) Comparison of the measurement performance must be provided across the range of intended image acquisition hardware; and
(ix) If the device uses a cutoff threshold or operates across a spectrum of disease, it must be established prior to validation, and it must be justified as to how it was determined and clinically validated;
(4) Adequate validation must be performed and controls implemented to characterize and ensure consistency (
i.e., repeatability and reproducibility) of measurement outputs:(i) Acceptable incoming image quality control measures and the resulting image rejection rate for the clinical data must be specified, and
(ii) Data must be provided within the clinical validation study or using equivalent datasets demonstrating the consistency (
i.e., repeatability and reproducibility) of the output that is representative of the range of data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment;(A) Testing must be performed using multiple operators meeting planned qualification criteria and using the procedure that will be implemented in the production use of the device, and
(B) The factors (
e.g., medical imaging dataset, operator) must be identified regarding which were held constant and which were varied during the evaluation, and a description must be provided for the computations and statistical analyses used to evaluate the data;(5) Human factors evaluation and validation must be provided to demonstrate adequate performance of the user interface to allow for users to accurately measure intended parameters, particularly where parameter settings that have impact on measurements require significant user intervention; and
(6) Device labeling must be provided that adequately describes the following:
(i) The device's intended use, including the type of imaging data used, what the device measures and outputs to the user, whether the measure is qualitative or quantitative, the clinical indications for which it is to be used, and the specific population for which the device use is intended;
(ii) Appropriate warnings specifying the intended patient population, identifying anatomy and image acquisition factors that may impact measurement results, and providing cautionary guidance for interpretation of the provided measurements;
(iii) Key assumptions made in the calculation and determination of simulated measurements;
(iv) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance. Per-vessel clinical performance, including where applicable localized performance according to vessel and segment, must be included as well as a characterization of the measurement error across the expected range of measurement for key parameters based on the clinical data;
(v) A detailed description of the patients studied in the clinical validation (
e.g., age, gender, race or ethnicity, clinical stability, current treatment regimen) as well as procedural details of the clinical study (e.g., scanner representation, calcium scores, use of beta-blockers or nitrates); and(vi) Where significant human interface is necessary for accurate analysis, adequately detailed description of the analysis procedure using the device and any data features that could affect accuracy of results.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design that suggests movement or progress.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Auqust 24, 2016
HeartFlow, Inc. Windi Hary Vice President, Clinical, Quality and Regulatory 1400 Seaport Boulevard Building B Redwood City, CA 94063
Re: K161772
Trade/Device Name: FFRCT v2.0 Regulation Number: 21 CFR 870.1415 Regulation Name: Coronary Physiologic Simulation Software Device Regulatory Class: Class II Product Code: PJA Dated: June 22, 2016 Received: June 28, 2016
Dear Windi Hary:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161772
Device Name FFRct v2.0
Indications for Use (Describe)
HeartFlow FFRCT is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFRCT analysis is intended to support the functional evaluation of coronary artery disease.
The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of HeartFlow FFRCT are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.
| 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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5.0 510(K) SUMMARY
This 510(k) summary of device performance information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
Submitter Information 5.1
| Submitter /
Manufacturer Name: | HeartFlow, Inc.
1400 Seaport Boulevard, Building B
Redwood City, CA 94063 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Windi Hary, RAC
Vice President, Clinical, Quality and Regulatory
HeartFlow, Inc.
1400 Seaport Boulevard, Bldg B
Redwood City, CA 94063
T +1 (650) 241-1250
F +1 (650) 368-2564
whary@heartflow.com |
Date Prepared: June 22, 2016
5.2 Device Identification
| Device Name: | FFRCT v2.0 |
|---|---|
| Device Trade Name: | FFRCT v2.0 |
| Common Name: | HeartFlow FFRCT |
| Classification Name: | Coronary Physiologic Simulation Software |
| Device | |
| Product Code: | PJA |
| Product Class: | Class II (21 CFR 870.1415) |
5.3 Predicate and Description of Change
HeartFlow FFRc v2.0 (K152733) is the identified predicate for this submission, there is no product change only a change to the indications for use.
Original K152733 cleared indications for use are below, and redlined to show the proposed changes under review. This change is supported by the same data that was submitted under the predicate 510(k).
HeartFlow FFRcr is a post-processingcoronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRc7, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFRcr analysis is intended to support the functional evaluation of coronary artery disease.
The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of HeartFlow FFRcrare intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.
Image /page/3/Picture/16 description: The image shows the HeartFlow logo. The logo consists of a stylized red heart shape on the left and the word "HeartFlow" in black text on the right. The heart shape is made up of two curved lines that come together to form the shape of a heart. The word "HeartFlow" is written in a sans-serif font, and there is a trademark symbol after the word.
FFRct v 2.0 510(k) Submission 2016
4
5.4 Device Description
FFRct v2.0 is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries.
The software displays the anatomy combined with function using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment of coronary artery disease.
FFR is independent of imaging equipment, imaging protocols and equipment vendors; the clinical validation report (VOL 003 FFR & V2.0 Clinical Validation Report) includes identification of vendors and equipment used in the clinical validation of the product. This data is summarized in the product labeling, and can be found in the Clinical User Instructions for Use (Attachment VOL 003 Instructions for Use - Customers). HeartFlow FFR-c analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
5.5 Intended Use
HeartFlow FFRct is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRc. a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFRcr analysis is intended to support the functional evaluation of coronary artery disease.
The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of HeartFlow FFR-are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.
5.5.1 Contraindications
The FFRct v2.0 Customer Instructions for Use (VOL 003 Instructions for Use - Customers) clearly identify for which patient populations and CT scanner manufacturers the product has been clinically validated.
5.5.2 Warnings and Precautions
The warnings and precautions can be found in the FFRct v2.0 product labeling (VOL 003 Instructions for Use – Customers).
5.6 Technological Characteristics of Device
The HeartFlow FFRct device is a software medical device that allows for the quantitative and qualitative analysis of Coronary Computed Tomography (CTA). This product has the same technological characteristics as the FFRct v2.0 product submitted and cleared per K152733.
5.7 Summary of Studies
The software was designed, developed, tested and validated according to written procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validating and maintenance.
HeartFlow, Inc. 1400 Seaport Blvd., Bldg B Redwood City, CA 94063 T +1 (650) 241-1221 www.heartflow.com
Image /page/4/Picture/19 description: The image shows the HeartFlow logo. The logo consists of a stylized red heart shape on the left and the word "HeartFlow" in black text on the right. The heart shape is made up of three curved lines that overlap each other. The word "HeartFlow" is written in a sans-serif font, and there is a trademark symbol after the word.
FFRct v 2.0 510(k) Submission 2016
5
Validation studies included stress testing, and repeatability testing to ensure the device performance.
Software and medical device design validation was completed as part of the predicate review (K152733). The results concluded the device was acceptable for use. The previously submitted data summarized below supports the requested change to the Indications for Use proposed under this 510(k).
5.7.1 Summary of Pre-clinical Studies
A summary of pre-clinical studies was provided and reviewed in the K152733 submission. Current submission is the same product (simply a change in indications), and no additional pre-clinical data is being provided. The previous data supports the requested change to the Indications for Use proposed under this 510(k).
5.7.2 Summary of Clinical Studies
A detailed summary of clinical studies was provided and reviewed in the K152733 submission. Current submission is the same product (simply a change in indications), and no additional clinical data is being provided. The previous data supports the requested change to the Indications for Use proposed under this 510(k). An abbreviated summary follows.
HeartFlowNXT, a prospective, multicenter, non-randomized study, provided the clinical validation for the initial device de novo clearance, FFR r v1.4 (DEN130025). The current version of software product represented in this 510(k), version 2.0, was clinically validated using the sequestered HeartFlowNXT dataset to evidence equivalence and the data was reviewed in the K152733 submission. The previously reviewed clinical validation results for 2.0 are below; detailed results can be found in Attachments VOL 003 FFR ୯ v2.0 Clinical Validation Report.
Primary endpoint success required both sensitivity and specificity hypotheses to be met. The pervessel sensitivity of FFRcr in the ITD population was 84.2% with a lower one-sided 95% Cl of 75.8%. As this was above the protocol specified target goal of 65%, the first null hypothesis was rejected and FFRa was considered to have met the sensitivity target goal. The per-vessel specificity of FFRin the ITD population was 84.9%. The lower one-sided 95% Cl was 80.4% and was above the protocol specified target goal of 55%, therefore the second null hypothesis was rejected and FFRwas considered to have met the specificity target goal.
| | ESTIMATE, % | LOWER ONE-SIDED 95%
CONFIDENCE BOUND | TARGET RATE | MET¹ / NOT MET |
|----------------------------------------------------------------------|-------------|-----------------------------------------|-------------|----------------|
| Sensitivity | 84.2% | 75.8% | 65% | MET |
| Specificity | 84.9% | 80.4% | 55% | MET |
| FFR is used as the reference standard | | | | |
| FFRCT: Diseased if hemodynamically-significant obstruction is ≤ 0.80 | | | | |
| FFR: Diseased if hemodynamically-significant obstruction is ≤ 0.80 | | | | |
| ¹MET if 95% LCL > Target Rate | | | | |
| Table 5-1. Primary Endpoint Analysis: Per-Vessel Sensitivity of FFR- v2.0.2 Intent To | ||
|---|---|---|
| Diagnose Population |
Per-subject FFRct specificity compared to site-read cCTA demonstrated superior diagnostic ability (p 50% stenosis severity for site-read cCTA. Diagnostic performance of FFR-read
HeartFlow, Inc. 1400 Seaport Blvd., Bldg B Redwood City, CA 94063 T +1 (650) 241-1221 www.heartflow.com
Image /page/5/Picture/15 description: The image shows the HeartFlow logo. The logo consists of a stylized heart shape made up of three curved lines in red, placed to the left of the word "HeartFlow" in black font. A trademark symbol is placed to the upper right of the word "HeartFlow".
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cCTA on the subject level is shown in the table below.
| | FFRCT ≤ 0.80
ESTIMATE % (95% WILSON CI) | SITE-READ CCTA > 50%
ESTIMATE % (95% WILSON CI) |
|---------------------|--------------------------------------------|----------------------------------------------------|
| Diagnostic Accuracy | 80.0% (74.4%-84.6%) | 51.9% (45.5%-58.2%) |
| Sensitivity | 87.8% (78.5%-93.5%) | 93.2% (85.1%-97.1%) |
| Specificity | 76.4% (69.3%-82.3%) | 32.9% (26.1%-40.5%) |
| PPV | 63.1% (53.5%-71.8%) | 39.0% (32.1%-46.3%) |
| NPV | 93.2% (87.5%-96.4%) | 91.4% (81.4%-96.3%) |
Table 5-2. HeartFlowNXT Per-Subject Diagnostic Performance Analysis with FFR ≤ 0.80 as the Reference Standard. Intent to Diagnose Population.
The validation study demonstrated good diagnostic performance for FFRcr when all vessels were included, irrespective of size, location, or territory, and across a range of cCTA image quality measures. Further details can be found in VOL 003 FFRct 2.0 Clinical Validation Report.
5.8 Conclusions Drawn from Studies
5.8.1 Effectiveness Conclusions
Based on multiple studies conducted with FFRct and confirmed by clinical validation, FFRcr analysis is additive to cCTA review alone by the physician when compared to an invasively measured standard. The study conclusions are not affected by the Indications for Use proposed under this 510(k).
5.8.2 Safety Conclusions
Safety was not a primary objective evaluated in any study conducted by HeartFlow given the noninvasive nature of the device; FFR is just an additional data point for consideration in patient diagnosis and treatment. Data collected in HeartFlow's studies, and commercially, has not raised any new issues related to safety of FFRcr. The study conclusions are not affected by the change to the Indications for Use proposed under this 510(k).
5.8.3 Benefit-Risk Conclusions
FFR c analysis provides one additional data point to clinicians diagnosing coronary artery disease and can be performed without additional imaging, added radiation, modification of Society recommended image acquisition protocols, or administration of additional medications. The risks associated with FFRct are the same as all other non-invasive tests, a false negative or positive result. Given the increased specificity offered by FFRcr over cCTA alone the benefits of using FFRcr far outweigh the risks. The study conclusions are not affected by the change to the Indications for Use proposed under this 510(k).
HeartFlow, Inc. 1400 Seaport Blvd., Bldg B Redwood City, CA 94063 T +1 (650) 241-1221 www.heartflow.com
Image /page/6/Picture/15 description: The image shows the HeartFlow logo. The logo consists of a stylized heart shape in red on the left, followed by the word "HeartFlow" in black. The heart shape is formed by two curved lines that come together at the bottom to form a point. The word "HeartFlow" is written in a sans-serif font, and there is a trademark symbol after the word.
FFRct v 2.0 510(k) Submission 2016