(129 days)
Not Found
No
The description focuses on "coronary physiologic simulation software" and "mathematically derived quantity" computed from a 3D computer model, without mentioning AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a "coronary physiologic simulation software" intended to "support the functional evaluation of coronary artery disease" and "aid in the evaluation and assessment of coronary arteries." It analyzes existing medical images and provides information to clinicians, but it does not directly treat or provide therapy to patients.
Yes
The device is explicitly stated to "support the functional evaluation of coronary artery disease" and "aid in the evaluation and assessment of coronary arteries," using analysis of previously acquired CT DICOM data.
Yes
The device description explicitly states "FFRct is coronary physiologic simulation software" and describes its function as analyzing CT DICOM data and displaying results. There is no mention of accompanying hardware components being part of the device itself.
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 description clearly states that HeartFlow FFRct is a software that analyzes previously acquired Computed Tomography (CT) DICOM data. It performs a simulation based on this imaging data to derive functional information about the coronary arteries.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. Its input is imaging data, not biological material.
Therefore, while it is a medical device used for diagnosis and assessment, it falls under the category of imaging analysis software rather than 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
FFRcr 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 functional information 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.
FFRcr is independent of imaging equipment, imaging protocols and equipment vendors; the 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. HeartFlow FFRct 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 (CT)
Anatomical Site
coronary arteries
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
Not Found
Summary of Performance 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 device performance.
Software and medical device design validation was completed and reviewed as part of the predicate review (K161772). The results concluded the device was acceptable for use. The study conclusions are not effected by the changes proposed under this 510(k). No additional pre-clinical or clinical data is being provided with this submission.
Key Metrics
Not Found
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/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo, which features a stylized human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration written in blue text.
December 6, 2018
HeartFlow, Inc Windi Hary Senior Vice President, Clinical, Quality and Regulatory 1400 Seaport Boulevard Building B Redwood City, California 94063
Re: K182035
Trade/Device Name: FFRct v 2.18 Regulation Number: 21 CFR 870.1415 Regulation Name: Coronary Vascular Physiologic Simulation Software Device Regulatory Class: Class II Product Code: PJA Dated: November 2, 2018 Received: November 6, 2018
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Shawn W.
Forrest -A
Digitally signed by Shawn W. Forrest -A
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=1300403341,
cn=Shawn W. Forrest -A
Date: 2018.12.06 12:29:07 -05'00'
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 STATEMENT
510(k) Number (if known): _K182035
Device Name: FFRct v 2.18
HeartFlow FFR a coronary 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 FFR ct 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. 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 FFRc; 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.
Prescription Use _____X (Part 21 CFR 801 Subpart D) Over-the-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
HeartFlow, Inc. 1400 Seaport Blvd., Bldg B Redwood City, CA 94063 T +1 (650) 241-1221 www.heartflow.com
Image /page/2/Picture/12 description: The image contains the HeartFlow logo. The logo consists of a stylized blue wave-like design on the left, followed by the text "HeartFlow" in a sans-serif font, also in blue. A small registration mark is present to the upper right of the word "Flow".
FFRcT v 2.18 K182035 2018
3
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). There is no change from the performance submitted as part of the predicate K161772.
Submitter Information 5.1
| Submitter / Manufacturer Name: | HeartFlow, Inc.
1400 Seaport Boulevard, Building B
Redwood City, CA 94063 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Windi Hary, RAC
Senior 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 26, 2018
Device Identification 5.2
| Device Name: | FFRCT v2.18 |
|---|---|
| Device Trade Name: | FFRCT v2.18 |
| 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 FFRcr (K161772) is the identified predicate for this submission, there is no change to the product functionality, architecture, or design. Changes included in this submission are to clarify the product boundary at the application programming interface (API).
There is no change to the product functionality, architecture, or design, however, all of the changes will be reflected in appropriate labeling.
5.4 Device Description
FFRcr 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 functional information 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.
Image /page/3/Picture/18 description: The image contains the logo for HeartFlow. The logo consists of a stylized blue heart shape on the left, followed by the text "HeartFlow" in a matching blue color. The text is in a bold, sans-serif font, and the overall design is clean and modern.
4
FFRcr is independent of imaging equipment, imaging protocols and equipment vendors; the 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. HeartFlow FFRct 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 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. 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 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.
5.5.1 Warnings and Precautions
There are no new or modified warnings and precautions based on the content of this submission whose purpose is to redefinine the product boundary.
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). This product has the same technological characteristics as the FFRcr product submitted and cleared per K161772.
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.
Validation studies included stress testing, and repeatability testing to ensure the device performance.
Software and medical device design validation was completed and reviewed as part of the predicate review (K161772). The results concluded the device was acceptable for use. The study conclusions are not effected by the changes proposed under this 510(k). No additional pre-clinical or clinical data is being provided with this submission.
Image /page/4/Picture/16 description: The image contains the HeartFlow logo. The logo consists of a stylized heart shape on the left and the word "HeartFlow" on the right. The heart shape is made up of curved lines that resemble blood vessels. The word "HeartFlow" is written in a bold, sans-serif font.