(113 days)
HeartFlow FFRc v1.4 (DEN130045)
Not Found
No
The description focuses on mathematical modeling and simulation from static CT images, not on learning from data or using AI/ML techniques. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is a post-processing software that aids in the diagnosis and assessment of coronary artery disease by providing mathematically derived quantities; it does not directly treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" states that the device "provides FFRct, a mathematically derived quantity... intended to support the functional evaluation of coronary artery disease." It also clearly states that "FFRct analysis intended to support the functional evaluation of coronary artery disease" and its results are "provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries." These phrases indicate its role in diagnosing or aiding in the diagnosis of coronary artery disease.
Yes
The device description explicitly states that it is "post-processing image analysis software" and a "tool for the analysis of CT DICOM-compliant cardiac images and data." It does not mention any associated hardware components that are part of the device itself. The input is previously acquired CT DICOM data, which is processed by the software.
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, to detect diseases, conditions, or infections.
- Device Function: The HeartFlow FFRCT software 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 analyzing image data and providing derived quantities. It does not involve testing a biological sample.
Therefore, while it's a medical device used for diagnosis, it falls under the category of medical image analysis software rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
HeartFlow FFRCT is a post-processing 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 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 (comma separated list FDA assigned to the subject device)
PJA
Device Description
FFRc v2.0 is post-processing image analysis 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 - 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 (CT DICOM data), Computed Tomography (cCTA)
Anatomical Site
Coronary arteries
Indicated Patient Age Range
Adult subjects (mean age of 63.7 years in HFNXT study)
Intended User / Care Setting
Qualified clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found. The document primarily describes validation studies using pre-existing datasets.
Description of the test set, sample size, data source, and annotation protocol
HeartFlowNXT Study (for predicate device and re-processed for FFRct v2.0 clinical validation):
- Sample Size: 276 subjects enrolled across 11 sites in 8 countries (Canada, Europe, Asia). Intention-to-diagnose (ITD) population comprised 254 adult subjects.
- Data Source: Prospective, multicenter, non-randomized study. Subjects were scheduled for clinically indicated invasive coronary angiography. Invasive FFR measurements were collected and reviewed by an independent FFR/QCA core laboratory.
- Annotation Protocol: Hemodynamically significant coronary lesions were determined using direct measurement of FFR (≤0.80) during cardiac catheterization as the reference standard. For per-vessel analysis, FFRct was considered diseased if FFRct ≤ 0.80. For per-subject analysis, FFRct was considered diseased if FFRct ≤ 0.80 and site-read cCTA was considered diseased if > 50% stenosis severity.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Validation Study (FFRct v2.0 Clinical Validation which re-processed sequestered HeartFlowNXT data). HeartFlowNXT was a prospective, multicenter, non-randomized study.
Sample Size:
- HeartFlowNXT: 276 subjects enrolled (254 ITD). Direct comparison of invasive FFR and FFRct was performed in 484 vessels.
- FFRct v2.0 Clinical Validation: Used the sequestered HeartFlowNXT dataset (254 ITD subjects, 484 vessels).
Standalone Performance / Key Results (FFRct v2.0 Clinical Validation):
Per-Vessel Analysis:
- Sensitivity: 84.2% (lower one-sided 95% CI of 75.8%). Met target (65%).
- Specificity: 84.9% (lower one-sided 95% CI of 80.4%). Met target (55%).
Per-Subject Diagnostic Performance Analysis with FFR ≤ 0.80 as reference standard:
- Diagnostic Accuracy: 80.0% (95% WILSON CI: 74.4%-84.6%)
- Sensitivity: 87.8% (95% WILSON CI: 78.5%-93.5%)
- Specificity: 76.4% (95% WILSON CI: 69.3%-82.3%)
- PPV: 63.1% (95% WILSON CI: 53.5%-71.8%)
- NPV: 93.2% (95% WILSON CI: 87.5%-96.4%)
Comparison to site-read cCTA (per-subject):
- FFRct specificity compared to site-read cCTA demonstrated superior diagnostic ability (p 50% stenosis severity (95% WILSON CI):
- Diagnostic Accuracy: 51.9% (45.5%-58.2%)
- Sensitivity: 93.2% (85.1%-97.1%)
- Specificity: 32.9% (26.1%-40.5%)
- PPV: 39.0% (32.1%-46.3%)
- NPV: 91.4% (81.4%-96.3%)
Other (Pre-clinical):
- Pre-clinical studies of computational methods conducted at Stanford University: extensive bench top experiments and in-vivo animal model validations. Results published in 6 peer-reviewed journal papers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
FFRct v2.0 Clinical Validation (Per-Vessel):
- Sensitivity: 84.2% (95% CI: 75.8%)
- Specificity: 84.9% (95% CI: 80.4%)
FFRct v2.0 Clinical Validation (Per-Subject):
- Diagnostic Accuracy: 80.0% (95% Wilson CI: 74.4%-84.6%)
- Sensitivity: 87.8% (95% Wilson CI: 78.5%-93.5%)
- Specificity: 76.4% (95% Wilson CI: 69.3%-82.3%)
- PPV: 63.1% (95% Wilson CI: 53.5%-71.8%)
- NPV: 93.2% (95% Wilson CI: 87.5%-96.4%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
HeartFlow FFRc v1.4 (DEN130045)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 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 an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2016
Heartflow, Inc. Windi Hary Director Ouality And Regulatory 1400 Seaport Boulevard, Building B Redwood City, California 94063
Re: K152733
Trade/Device Name: FFFRct Regulation Number: 21 CFR 870.1415 Regulation Name: Coronary Physiologic Simulation Software Device Regulatory Class: Class II Product Code: PJA Dated: December 10, 2015 Received: December 11, 2015
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 (QS) 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 vours.
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152733
Device Name FFRct v2.0
Indications for Use (Describe)
HeartFlow FFRCT is a post-processing 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 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 safety and effectiveness 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
Director, 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: September 21, 2015
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 Predicates
HeartFlow FFRc v1.4 (DEN130045) is the identified predicate for the HeartFlow FFR v2.0 product. This is discussed further in VOL_002 SEC 013 Substantial Equivalence.
5.4 Device Description
FFRc v2.0 is post-processing image analysis 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 - analyses are performed on previously physician-acquired
Image /page/3/Picture/18 description: The image shows the logo for HeartFlow. The logo consists of a stylized red heart shape on the left and the word "HeartFlow" in black font on the right. The heart shape is made up of three curved lines that come together to form a heart. The word "HeartFlow" is written in a sans-serif font, and there is a trademark symbol after the word.
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image data and are unrelated to acquisition equipment and clinical workstations.
5.5 Intended Use
HeartFlow FFR -- is a post-processing software for the clinical quantitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFR - a mathematically derived quantity, computed from simulate pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFR - 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 FFR-7 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 (cCTA). FFR- v2.0 is the next generation of the predicate device FFR - v1.4 and has the same technological characteristics.
5.7 Alternative Practices and Procedures
A wide variety of non-invasive cardiac imaging modalities are available for the evaluation of patients with stable known or suspected coronary artery disease (CAD). These tests are aimed at (1) detection of CAD; (2) determining the severity of disease and risk stratification; and (3) helping to clinical decision-making. These modalities include electrocardiography (ECG), guide echocardiography (ECHO), nuclear myocardial perfusion with single-photon emission tomography (SPECT) and positron emission computed tomography (PET), cardiac magnetic resonance imaging (MRI), and computed tomography coronary angiography (cCTA). Each of these modalities can be applied at rest or under stress conditions (exercise or pharmacologic stress). Non-invasive diagnosis of CAD can be accomplished by anatomic imaging of the coronary artery anatomy using cCTA or MRI or functional testing using SPECT, PET, stress ECHO and stress MRI to evaluate myocardial perfusion and/or wall motion abnormalities. While cCTA has primarily been used to detect the presence of anatomically obstructive coronary lesions, hybrid imaging strategies are now available which incorporate functional assessment with MPI stress testing and CT imaging. This is in response to widespread recognition of the need for a non-invasive anatomic-functional test that can identify obstructive atherosclerotic plaques and also determine their functional significance."
Diagnostic Performance of Non-invasive Cardiac Imaging Modalities 5.7.1
The diagnostic performance of non-invasive cardiac imaging modalities for the diagnosis of CAD is typically determined using invasive coronary angiography as the reference standard. The
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 two curved lines that 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 "Flow".
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510(k) Summary
determination of the presence or absence of significant coronary obstruction is usually made on the basis of visual estimates of angiographic percent lumen narrowing using a 50% stenosis threshold. However, it is well known that visual estimates of lumen stenosis have in determining the hemodynamic or functional significance of coronary lesions, particularly for moderate coronary stenoses. The determination, prior to coronary revascularization, of the functional significance of observed coronary lesions has been demonstrated to be the most important factor to influence clinical outcomes.7 8 Patients with hemodynamic or functionally significant-causing stenoses benefit from revascularization" 3 whereas patients with hemodynamically insignificant lesions require no intervention and experience favorable outcomes on medical therapy alone, with myocardial infarction and mortality rates of
Image /page/5/Picture/13 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 font on the right. The heart shape is made up of two curved lines that 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.
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K152733 page 4 of 11
VOL 002 Section 005
- 5.7.1.2 Diagnostic performance of non-invasive cardiac imaging modalities vs Fractional Flow Reserve The diagnostic performance of the various non-invasive cardiac imaging modalities using fractional flow reserve (FFR) as the reference standard is shown on Table 5-2. There is a significant reduction in diagnostic performance when these modalities are compared to FFR rather than visual angiography as the reference standard.
| DIAGNOSTIC PERFORMANCE vs mFFR | SENSITIVITY (%) | SPECIFICITY (%) |
|---|---|---|
| Stress ECHO – Jung 200814 | 46 | 77 |
| MPI-SPECT – Melikian 201015 | 48 | 80 |
| MPI-SPECT – Forster 200916 | 62 | 90 |
| MPI-CT+cCTA – Ko 201217 | 68 | 98 |
| cCTA – Meijboom 20084 | 94 | 48 |
| cCTA – Koo 201118 | 91 | 40 |
| cCTA – Min 201219 | 84 | 42 |
| Coronary angiography, visual – Meijboom 2008 | 55 | 62 |
| Coronary angiography, visual - Park | 66 | 67 |
| Coronary angiography, QCA - Christou meta-analysis 200720 | 78 | 51 |
| Table 5-2. Diagnostic performance: measured FFR as reference standard | |
|---|---|
| -- | ------------------------------------------------------------------------- |
Note: the sensitivity and specificity for visual angiography vs FFR in this study were 55% and 62% respectively; and for quantitative coronary angiography vs FFR were 57% and 69% respectively.
Summary of meta-analyses: A meta-analysis of 31 studies compared the results of quantitative coronary angiography (QCA) and/or non-invasive imaging of the same lesions versus FFR for the determination of the hemodynamic significance of coronary lesions. 0 Across 18 studies (1,522 lesions), QCA had a sensitivity of 78% (95% Cl 67-86%) and specificity of 51% (95% Cl 40-61%). In 21 studies (1,249 lesions) with non-invasive imaging, the sensitivity was 76% (95% CR 69-82%) and specificity was 76% (95%Cl 71-81%). In the 15 studies with SPECT data (976 lesions), sensitivity was 75% (95% Cl 66-82%) and specificity was 77% (95% Cl 70-83%). In 6 studies with stress dobutamine echocardiography (273 lesions) sensitivity was 82% (95% Cl 62-92%) and specificity was 74% (95% CI 66-81%).
5.8 Marketing History
In July 2011, HeartFlow received CE marking for an earlier version of the FFR- device and began commercialization of FFR & in several European countries and Australia. In November 2014, De Novo request for FFRct v1.4 (DEN130045) was granted by the U.S. Food and Drug Administration. We entered into Japan in 2014 prior to change of regulations and continue to market while the FFRapplication is in process. HeartFlow received Canadian Medical Device License in August 2015. To date, FFR-7 has not been withdrawn from any foreign market for any reason relating to the safety and effectiveness of the device.
5.9 Potential Adverse Effects of the Device on Health
FFR -- is a post-processing analysis of previously acquired CT images, such that there are no potential adverse effects of the device on health to the patient or requesting clinician. Risks related to the accuracy of the results and clinician interpretation/inclusion in their diagnosis and treatment are identified in the product labeling.
5.10 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
HeartFlow, Inc. 1400 Seaport Blvd., Bldg B Redwood City, CA 94063 T +1 (650) 241-1221 www.heartflow.com
Image /page/6/Picture/16 description: The image shows the HeartFlow logo. The logo consists of a stylized heart shape in red, with two curved lines forming the heart. To the right of the heart shape is the word "HeartFlow" in black, sans-serif font. The letters are bold and slightly spaced apart. There is a trademark symbol after the word "Flow".
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product specifications, coding, testing, validating and maintenance.
Validation studies included stress testing, and repeatability testing to ensure the safety and effectiveness of the device.
Software and medical device design validation has been completed. Medical device design included testing and evaluation using previously acquired diagnostic images received through HeartFlow sponsored clinical trials. The results concluded the device was acceptable for use.
Summary of Pre-clinical Studies 5.10.1
Pre-clinical studies of the computational methods underlying HeartFlow's FFRcc technology were conducted at Stanford University in Dr. Charles A. Taylor's laboratory. The solver technology developed at Stanford University was licensed to HeartFlow. The pre-clinical studies performed at Stanford include extensive bench top experiments and in-vivo animal model validations. The results of these studies have been published in 6 peer-reviewed journal papers2126 and are summarized below. Additional pre-clinical studies have not been conducted at HeartFlow, since bench and animal models do not permit evaluation of our technology in relevant anatomic or physiologic models reflecting diseased human coronary vessels. Rather, we have validated our technology against measured fractional flow reserve, the standard of care in-vivo measurement in humans for the determination of hemodynamic significance of coronary lesions.
5.10.2 Summary of Clinical Studies
HeartFlow has conducted three primary clinical studies involving validation of FFR&r to date. These studies were conducted with prior versions of the software. HeartFlowNXT provided the clinical validation for the predicate device, FFRcT v1.4. 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.
5.10.2.1 HeartFlowNXT
HeartFlow analysis of coronary blood flow using coronary CT angiography: NeXt sTeps (the HeartFlowNXT or HFNXT study) was a prospective, multicenter, non-randomized study. The overall objective of the HFNXT study was to determine the diagnostic performance of FFRct, as compared to cCTA alone, for the non-invasive determination of the presence of a hemodynamically significant coronary lesions using direct measurement of FFR (≤0.80) during cardiac catheterization as the reference standard. The rationale and design of the study is in press (Attachment VOL 004 SEC 013 Gaur JCCT 2013) and the study reflects improvements in FFRtechnology (software version v1.4) and a focus on quantitative image-quality analysis.
The study was conducted at 11 sites in 8 countries in Canada, Europe and Asia from September 2012 to August 2013, with 276 subjects enrolled. A total of 254 adult subjects with known or suspected coronary artery disease who were scheduled for clinically indicated invasive coronary angiography comprised the intention-to-diagnose (ITD) population. Subjects had an overall mean age of 63.7 years and 63.8% were men. A total of 22.8% had diabetes mellitus, 68.5% had hypertension, 78.7% had hyperlipidemia, 57.1% were current or former smokers. Also, 77.6% presented with angina in the 30 days prior to enrollment; 77.7% of subjects with angina had stable angina and 22.3% had unstable angina. Only 2% had documented prior history of myocardial infarction and no patients had renal dysfunction, defined as creatinine >1.5 mg/dL. The mean body mass index for enrolled subjects was 25.6 ± 3.7 kg/m². Left ventricular ejection fraction was reported for 76% of the enrolled subjects with a mean value of 61.8%. The time from the cCTA
Image /page/7/Picture/15 description: The image shows the HeartFlow logo. The logo consists of a stylized heart shape in red, with three curved lines forming the heart. To the right of the heart shape is the word "HeartFlow" in black, sans-serif font. The letters are bold and evenly spaced. There is a trademark symbol after the word "HeartFlow".
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scan to the ICA procedure was between 1 to 30 days in 87% of the ITD patients with a mean of 18.1 days. Sublingual or intravenous nitrates were administered in 99.6% of subjects undergoing coronary artery CT scanning. In 78% of the subjects were administered to reduce heart rate prior to scan. The mean calcium score for ITD subjects was 302 (±468) Agatston units. A calcium score was reported for 84.3% of subjects, and of these, 25.7% had a calcium score > 400 Agatston units.
Direct comparison of invasive FFR and FFR and FFR of was performed in 484 vessels. At least one invasive FFR measurement was collected in all ITD subjects with an average of 1.9 measurements per subject. All invasive FFR data was reviewed by an independent FFR/QCA core laboratory.
The primary endpoint was the per-vessel sensitivity and specificity of FFR to detect hemodynamically significant obstruction when FFR was used as the reference standard. The prespecified target goals for sensitivity and specificity were 65% and 55%, respectively.
5.10.2.1.1 HeartFlow NXT study results
Primary endpoint success required both sensitivity and specificity hypotheses to be met. The pervessel sensitivity of FFR o in the ITD population was 83.5% with a lower one-sided 95% Cl of 75.3%. The per-vessel specificity of FFR-- in the ITD population was 85.8% with a lower one-sided 95% Cl of 81.5%. Both of the lower one-sided confidence limits for sensitivity and specificity were above the pre-specified target goals of 65% and 55%, respectively, therefore the primary endpoint was met. Results are shown in Table 5-3 below.
| Table 5-3. HeartFlowNXT Primary Endpoint Results: Per-Vessel Sensitivity and Specificity of FFRCT Intent To |
|---|
| Diagnose Population |
| ESTIMATE, % | LOWER ONE-SIDED 95% | TARGET RATE | MET1 | |
|---|---|---|---|---|
| CONFIDENCE BOUND | NOT MET | |||
| Sensitivity | 83.5% | 75.3% | 65% | MET |
| Specificity | 85.8% | 81.5% | 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 |
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 -- compared to site-read cCTA on the subject level is shown in Table 5-4 below.
Table 5-4. HeartFlowNXT Per-Subject Diagnostic Performance Analysis with FFR ≤ 0.80 as the Reference Standard. Intent to Diagnose Population.
| | FFRCT ≤ 0.80
ESTIMATE % (95% Wilson CI) | SITE-READ cCTA > 50%
ESTIMATE % (95% Wilson CI) |
|---------------------|--------------------------------------------|----------------------------------------------------|
| Diagnostic Accuracy | 81.1% (95.8%-85.4%) | 52.8% (46.6%-58.8%) |
| Sensitivity | 86.3% (77.0%-92.1%) | 93.8% (86.2%-97.3%) |
| Specificity | 78.7% (72.1%-84.2%) | 33.9% (27.3%-41.2%) |
HeartFlow, Inc. 1400 Seaport Blvd., Bldg B Redwood City, CA 94063 T +1 (650) 241-1221 www.heartflow.com
Image /page/8/Picture/15 description: The image shows the HeartFlow logo. The logo consists of a red heart-shaped symbol on the left and the word "HeartFlow" in black on the right. The heart-shaped symbol is made up of two curved lines that form the shape of a heart. The word "HeartFlow" is written in a sans-serif font, and the letters are all capitalized except for the "F" in "Flow".
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510(k) Summary
page 5-7 of 11
| PPV | 65.1% (55.6%-73.5%) | 39.5% (32.8%-46.6%) |
|---|---|---|
| NPV | 92.6% (87.2%-95.8%) | 92.2% (83.0%-96.6%) |
The HeartFlowNXT study demonstrated good diagnostic performance for FFRণ when all vessels were included, irrespective of size, location, or territory, and across a range of cCTA image quality Further detail on the HeartFlowNXT study is provided in Attachment VOL 003 measures. HeartFlowNXT Clinical Study Report.
Select published articles and in process manuscripts may be found in VOL 004.
5.10.2.2 FFRct v2.0 Clinical Validation
The sequestered HeartFlowNXT data was re-processed with FFRc- v2.0, and analyzed per the HeartFlowNXT statistical analysis plan to demonstrate product equivalence through clinical validation. A summary of the results is presented below and in the Customer IFU (Attachments VOL 003 Instructions for Use – Customers); detailed results can be found in Attachments VOL 003 FFRct v2.0 Clinical Validation Report.
5.10.2.2.1 FFR ~ v2.0 Clinical Validation Results
Primary endpoint success required both sensitivity and specificity hypotheses to be met. The pervessel sensitivity of FFRcc 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 FFR- 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.
Table 5-5. Primary Endpoint Analysis: Per-Vessel Sensitivity and Specificity of FFR-cr v2.0.2 Intent To Diagnose Population
| | 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 | | | | |
Per-subject FFR - specificity compared to site-read cCTA demonstrated superior diagnostic ability (p 50% stenosis severity for site-read cCTA. Diagnostic performance of FFR - compared to site-read cCTA on the subject level is shown in Table 5-6.
HeartFlow, Inc. 1400 Seaport Blvd., Bldg B Redwood City, CA 94063 T +1 (650) 241-1221 www.heartflow.com
Image /page/9/Picture/15 description: The image shows the logo for HeartFlow. 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 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.
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| | 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 5-6. 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 FFR -- 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.
5.11 Conclusions Drawn from Studies
5.11.1 Effectiveness Conclusions
Based on multiple studies conducted with FFRct and confirmed by clinical validation, FFRcc analysis is additive to cCTA review alone by the physician when compared to an invasively measured standard.
5.11.2 Safety Conclusions
Safety was not a primary objective evaluated in any study conducted by HeartFlow given the noninvasive nature of the device; FFRc 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 FFRcT.
5.11.3 Benefit-Risk Conclusions
FFR -- 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 FFR - are the same as all other non-invasive tests, a false negative or positive result. Given the increased specificity offered by FFR over CCTA alone the benefits of using FFRfar outweigh the risks.
HeartFlow, Inc. 1400 Seaport Blvd., Bldg B Redwood City, CA 94063 T +1 (650) 241-1221 www.heartflow.com
Image /page/10/Picture/15 description: The image shows the logo for HeartFlow. The logo consists of a stylized red heart shape on the left, followed by the word "HeartFlow" in black text. A small trademark symbol is located to the upper right of the word "HeartFlow".
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5.12 Bibliography
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Image /page/11/Picture/17 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 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.
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HeartFlow, Inc. 1400 Seaport Blvd., Bldg B Redwood City, CA 94063 T +1 (650) 241-1221 www.heartflow.com
Image /page/12/Picture/19 description: The image shows the logo for HeartFlow. The logo consists of a stylized red heart shape on the left, followed by the word "HeartFlow" in black text. The heart shape is made up of two curved lines that come together at the bottom to form the point of the heart.
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510(k) Summary
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HeartFlow, Inc. 1400 Seaport Blvd., Bldg B Redwood City, CA 94063 T +1 (650) 241-1221 www.heartflow.com