(308 days)
Yes
The document explicitly states "AI-based medical device software" multiple times and mentions "trained using deep learning (Al and machine learning)".
No
The device is described as an AI-based medical device software for analysis and assessment of coronary artery disease, intended to support risk assessment and functional evaluation, but not to treat or cure any condition.
Yes
The device "provides anatomic data, plaque identification and characterization, as well as the calculations of FFRCT, a coronary physiological simulation, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images" and is "intended to support the risk assessment and functional evaluation of coronary artery disease." These functions are characteristic of a diagnostic device.
Yes
The device description explicitly states "The HeartFlow Analysis is an Al-based medical device software" and "The HeartFlow Analysis is performed on previously physician-acquired image data and is unrelated to acquisition equipment and clinical workstations," indicating it is a software application that processes existing data and does not include hardware components.
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. They are used outside of the body.
- HeartFlow Analysis Function: The HeartFlow Analysis software processes previously acquired Computed Tomography (CT) DICOM data. This data is image-based and represents the anatomy and function of the coronary arteries within the patient's body.
- No Sample Analysis: The device does not analyze biological samples taken from the patient. It analyzes medical images.
Therefore, the HeartFlow Analysis falls under the category of a medical device software that analyzes imaging data, not an in vitro diagnostic device.
No
The letter does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section states 'Not Found'.
Intended Use / Indications for Use
The HeartFlow Analysis is an AI-based medical device software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for patients with suspected coronary artery disease. It provides anatomic data, plaque identification and characterization, as well as the calculations of FFRCT, a coronary physiological simulation, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. The HeartFlow Analysis is intended to support the risk assessment and functional evaluation of coronary artery disease.
The HeartFlow Analysis is provided to support qualified clinicians to aid in the evaluation and risk assessment of coronary artery disease. The HeartFlow Analysis is 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, LLZ
Device Description
The HeartFlow Analysis is an Al-based medical device 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 in the risk stratification and evaluation of coronary artery disease.
The software displays coronary and functional information using graphics and text, including computed and derived quantities of percent stenosis, plaque volumes, blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease.
The HeartFlow Analysis is performed on previously physician-acquired image data and is unrelated to acquisition equipment and clinical workstations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
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
The core technology remains unchanged from the primary predicate and continues to be trained using deep learning (Al and machine learning) since 2015, to incorporate learnings from the volumes of CT data and studies. All algorithms are then frozen and validated prior to product release.
Description of the test set, sample size, data source, and annotation protocol
Medical device design included testing and evaluation using previously acquired diagnostic images received through HeartFlow sponsored clinical trials.
Summary of Performance Studies
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.
Summaries of pre-clinical studies were reviewed as part of a prior predicate review (K161772, the original predicate of K182035/K190925/K203329). The results concluded the device was acceptable for use.
Results of all current and previously referenced testing conclude the device is acceptable for use.
Key Metrics
Not Found
Predicate Device(s)
HeartFlow FFR – v3 (K203329), Autoplaque add-on ORS Visual (K122429)
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
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October 14, 2022
HeartFlow, Inc. Windi Hary Chief Regulatory and Quality Officer 1400 Seaport Boulevard. Building B Redwood City, California 94063
Re: K213857
Trade/Device Name: HeartFlow Analysis Regulation Number: 21 CFR 870.1415 Regulation Name: Coronary Vascular Physiologic Simulation Software Device Regulatory Class: Class II Product Code: PJA, LLZ Dated: October 11, 2022 Received: October 13, 2022
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. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213857
Device Name HeartFlow Analysis
Indications for Use (Describe)
The HeartFlow Analysis is an AI-based medical device software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for patients with suspected coronary artery disease. It provides anatomic data, plaque identification and characterization, as well as the calculations of FFRCT, a coronary physiological simulation, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. The HeartFlow Analysis is intended to support the risk assessment and functional evaluation of coronary artery disease.
The HeartFlow Analysis is provided to support qualified clinicians to aid in the evaluation and risk assessment of coronary artery disease. The HeartFlow Analysis is 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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This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
1 Submitter Information
| Submitter / Manufacturer Name: | HeartFlow, Inc.
331 E. Evelyn Ave
Mountain View, CA 94041 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Windi Hary, RAC
Chief Regulatory and Quality Officer
HeartFlow, Inc.
331 E. Evelyn Ave,
Mountain View, CA 94041
T +1 (650) 241-1250
F +1 (650) 368-2564
whary@heartflow.com |
| Additional Contact Person: | James R. Davis
Director, Regulatory Affairs
HeartFlow, Inc.
T +1 (650) 241-1250
F +1 (650) 368-2564
jdavis@heartflow.com |
| Date Prepared: | April 20, 2022 |
2 Device Identification
| Product Name | HeartFlow
Analysis | Common Name | FFRct |
|---------------------------------------------------------------------------------|-----------------------|----------------|-------------------------------------------------------------|
| Product Feature Description | Product Code | Classification | Classification Name |
| FFRct | PJA-Primary | 870.1415 | Coronary vascular physiologic
simulation software device |
| PreRead (Anatomy extracted
from FFRct 3D model) and
system plaque volumes | LLZ-Secondary | 892.2050 | Medical image management
and processing system |
4
| Plaque characterization
presented with FFRct model
(automated AI/ML detection) | LLZ-Secondary | 892.2050 | Medical image management
and processing system |
|--------------------------------------------------------------------------------------|---------------|----------|-------------------------------------------------------------|
| Planner | PJA-Secondary | 870.1415 | Coronary vascular physiologic
simulation software device |
3 Predicates
HeartFlow FFR -- v3 (K203329) is the identified primary predicate and Autoplaque add-on ORS Visual (K122429) is an additional predicate for this submission.
4 Device Description
The HeartFlow Analysis is an Al-based medical device 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 in the risk stratification and evaluation of coronary artery disease.
The software displays coronary and functional information using graphics and text, including computed and derived quantities of percent stenosis, plaque volumes, blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease.
The HeartFlow Analysis is performed on previously physician-acquired image data and is unrelated to acquisition equipment and clinical workstations.
5 Indications for Use
The HeartFlow Analysis is an Al-based medical device software for the clinical quantitative and qualitative analysis of previously acquired Tomography DICOM data for patients with suspected coronary artery disease. It provides anatomic data, plaque identification and characterization, as well as the calculations of FFRCT, a coronary physiological simulation, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. The HeartFlow Analysis is intended to support the risk assessment and functional evaluation of coronary artery disease.
The HeartFlow Analysis is provided to support qualified clinicians to aid in the evaluation and risk assessment of coronary artery disease. The HeartFlow Analysis is 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.
6 Technological Characteristics of Device
The HeartFlow Analysis is a software medical device that allows for the quantitative analysis of Coronary Computed Tomography (cCTA). The predicates and this product have the same technological characteristics.
The core technology remains unchanged from the primary predicate and continues to be trained using deep learning (Al and machine learning) since 2015, to incorporate learnings from the volumes of CT data and studies. All algorithms are then frozen and validated prior to product release. There are no differences between the subject device and the predicates with respect to intended use.
| | FFRCT v3 (primary
predicate) | Autoplaque (predicate) | FFRCT v3.plus |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K203329 | K122429 | K213857 |
| | FFRCT v3 (primary
predicate) | Autoplaque (predicate) | FFRCT v3.plus |
| Manufacturer | HeartFlow, Inc. | Object Research Systems,
Inc. | HeartFlow, Inc. |
| Regulation
Number | 870.1415 | 892.2050 | 870.1415 |
| Regulation
Name | Coronary Physiologic
Simulation Software
Device | System, Image Processing,
Radiological | Coronary Physiologic
Simulation Software Device |
| Classification | Class II | Class II | Class II |
| Device Common
Name | HeartFlow FFRCT | Image Processing
System,
Radiology,Software
PACS | HeartFlow Analysis |
| Product Code | PJA | LLZ | PJA |
| Functions | -Extract anatomic data
from digital cardiac
images for the display
and visualization of the
anatomy of patient's
coronary arteries
-Compute FFRct | -Users of Autoplaque can
edit the lumen and
vessel walls of the
suggested
segmentation.
-Users are provided with
image viewing tools to
aid in their analysis.
-Plaque and stenosis
measurements are
output based on the
combination of fully
user-editable
segmentation and user-
placed demarcations of
coronary artery
characteristics. | -Extract anatomical and
plaque data from digital
cardiac images for the
display and visualization
of the anatomy of
patient's coronary
arteries
-Compute FFRct |
| Intended use | -Review of CT
angiographic images
to confirm the
coronary vessels
-Semi-automated tools
for extraction of
anatomic data
(including heart
structures) for
coronary physiologic
simulation to aid in
diagnosis of coronary
artery disease | -Provide a non-invasive
application to analyze
coronary anatomy and
pathology
-Post processing
application option for
the ORS visual platform
(K100335).
-A non-invasive
diagnostic reading
software add-on
intended for use by
cardiologists and
radiologists as an | -Review of CT
angiographic images to
confirm the coronary
vessels
-Semi-automated tools
for extraction of anatomic
data (including heart
structures) for coronary
physiologic simulation to
aid in diagnosis of
coronary artery disease
-Centerline detection |
| | FFRCT v3 (primary
predicate) | Autoplaque (predicate) | FFRCT v3.plus |
| | -Centerline detection
-Provides additional
data derived from
coronary CT anatomy
and pathology
-Provide simulated
hemodynamic
information | interactive tool for
viewing and analyzing
cardiac CT data for
determining the
presence and extent of
coronary plaques.
-ORS Visual software
(K100335) and the
Autoplaque add-on must
be installed on a suitable
commercial computer
platform. | -Provides additional data
derived from coronary CT
anatomy and pathology
-Provide simulated
hemodynamic
information |
| Data source
(input) | CT | CT | CT |
| Output/
Accessibility | Graphic and text
results of coronary
anatomy and
simulated data are
accessed via a device
with internet
connectivity | Graphic and text results
provided on a suitable
commercial computer
platform. It is the user's
responsibility to ensure the
monitor quality and ambient
light conditions are
consistent with the clinical
applications. | Graphic and text results of
coronary anatomy and
simulated data are accessed
via a device with internet
connectivity |
| Physical
characteristics | -Non-invasive software
package
-DICOM compatible | -Software installed and
used by the user
-Suitable commercial
computer platform | -Non-invasive software
package
-DICOM compatible |
| Safety | Clinician review and
assessment of analysis
prior to use as
supplemental
diagnostic aid | Clinician review, and assessment of analysis
prior to use as supplemental
diagnostic aid | Clinician review and
assessment of analysis prior
to use as supplemental
diagnostic aid |
Table 5-1. Predicate Device Comparison
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6
Table 5-2. Predicate Device Feature Comparison
| Feature | FFRct v3
(primary
predicate) | Autoplaque
(predicate) | FFRct
v3.plus
(subject) |
|----------------------------------------------------------------------|------------------------------------|---------------------------|-------------------------------|
| Presentation of CT images for confirmation of
extracted model | x | | x |
| Automatic extraction of anatomic data from CT
images for analysis | x | x | x |
| Modeled stenosis and plaque* information | | x (user edit) | x |
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| Volume rendering based on centerlines | x | x | |
|---|---|---|---|
| Automatic/Semi-automatic lumen boundary | |||
| determination | x | x (user edit) | x |
| Annotate, tag, measure and record selected views | x | x (user edit) | x |
| View the coronary vessels | x | x (user edit) | x |
| Modify anatomic model to remove luminal | |||
| narrowing(s) | x | x | |
| Expose interim calculations used as input of FFRct | |||
| (e.g., mass and volume) | x | x | |
| Calculate functional parameters of the heart (e.g., | |||
| Fractional Flow Reserve, %myo) | x | x | |
| Visualize plaque information* | x (user edit) | x | |
| Graphic and text results | x | x | x |
*Anatomical plaque calculation and visualization is supported by comparison to the Autoplaque predicate device
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.
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.
Summaries of pre-clinical studies were reviewed as part of a prior predicate review (K161772, the original predicate of K182035/K190925/K203329). The results concluded the device was acceptable for use.
Results of all current and previously referenced testing conclude the device is acceptable for use.
8 Conclusion
The conclusions drawn from the testing demonstrate that the device is as safe, as effective, and performs as well as the legally marketed devices identified in section 2 above.