FEops HEARTguide™ is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning.

The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement.

FEops HEARTguide™ is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment.

FEops HEARTguide™ is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.

FEops HEARTguide™ is prescription use only.

Device Description

FEops HEARTguide™ predicts implant frame deformation after percutaneous LAAO device implantation through computer simulation. The predicted deformation provides additional information during LAAO procedural planning.

The simulation is based on a 3D model of the patient anatomy which is generated from 2D medical images of the patient anatomy (multi-slice Cardiac Computed Tomography). The simulation is executed by FEops Case Analysts and run on FEops infrastructure.

The simulation report is created by combining a predefined device model with a patient-specific model of the patient anatomy. This is performed by trained operators at FEops using an internal software platform through an established workflow. The purposely qualified case analysts and quality control analysts process the received medical images of the patient to produce the simulation results.

The simulation results are provided as 2D and numerical data shown in a PDF report and 3D, 2D and numerical data shown in a web-based Viewer application accessible through a standard web browser.

AI/ML Overview

The information provided primarily describes the FEops HEARTguide™ device and its substantial equivalence to a predicate device, focusing on regulatory aspects rather than detailed study results. Given the available text, I can extract and infer some information, but many specific details regarding acceptance criteria and study findings are not explicitly provided.

Here's an attempt to answer your questions based on the provided text, with acknowledgments of what is not present:

1. Table of acceptance criteria and the reported device performance

The document states: "Acceptance criteria were defined using the same method as for the predicate device demonstrating the same clinical meaningfulness." However, the specific acceptance criteria (e.g., a numerical threshold for accuracy, precision, etc.) and the reported device performance values against these criteria are not provided in the given text.

The text generally states that the performance validation testing demonstrated "a similar performance level" and "the performance of the subject device is equivalent to the performance of the predicate device." It also mentions "an assessment of the agreement between the computational model results and clinical data across the full intended operating range."

Without the specific criteria and metrics, a table cannot be fully constructed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The text states: "For both added LAAO devices, the performance study was performed on a cohort with a sample size equal to or larger than the predicate device." The exact number is not specified for either the predicate or the current device.
Data Provenance: The document mentions "clinical data" but does not specify the country of origin or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the given text. The text mentions "qualified clinicians" in the context of device usage and interpretation but not explicitly for ground truth establishment during a performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the given text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document describes the device as "Interventional cardiovascular implant simulation software," which predicts "implant frame deformation." It is intended to support procedural planning and "not intended to replace the simulated device instructions for use for final LAAO device selection and placement." This implies that it is a tool to assist clinicians.

The text mentions "a Human factors evaluation report was provided demonstrating the ability of the user interface and labeling to allow for intended and qualified users to correctly use the device and interpret the provided information." It also says, "To ensure consistency of modeling outputs, the validation was performed with multiple qualified operators using the procedure that will be implemented under anticipated conditions of use..."

However, the text does not explicitly state or present results from a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance, nor does it provide an effect size for such a comparison. The focus is on the device's predictive capability and its agreement with clinical data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is described as "simulation software" operated by "trained operators at FEops using an internal software platform through an established workflow." The "simulation results are provided as 2D and numerical data shown in a PDF report and 3D, 2D and numerical data shown in a web-based Viewer application accessible through a standard web browser." This indicates that the software performs the simulation independently, and its outputs are then presented.

The "performance study" assesses the "agreement between the computational model results and clinical data." This implies a standalone evaluation of the algorithm's predictions against real-world clinical outcomes or measurements. Therefore, it is highly likely that a standalone performance evaluation of the algorithm's predictive capabilities was performed, but the results in raw form are not in the provided text.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)

The document mentions "a comparison of the results to clinical data supporting the indications for use" and "an assessment of the agreement between the computational model results and clinical data." This strongly suggests that clinical data (which could include imaging, procedural findings, or direct measurements from patients after implantation) was used as the ground truth. It does not specify if this clinical data was corroborated by expert consensus, pathology, or specific outcomes data, but "clinical data" is a broad term that would encompass such information.

8. The sample size for the training set

The document discusses "computational modeling verification and validation activities" and "performance validation testing data," but it does not mention a separate training set or its sample size. The focus is on the validation of the models against clinical data. It describes the software primarily as a "simulation software" based on a "3D model of the patient anatomy," "predefined device model," and "patient-specific model," rather than a machine learning model that would typically have a distinct training set.

9. How the ground truth for the training set was established

Since a training set is not explicitly mentioned for a machine learning context, this question is not applicable based on the provided text. The device performs simulations based on computational models, not necessarily learned from a training set in the typical AI sense.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 25, 2022

FEops nv % Niels Festjens RA Consultant OrthoGrow nv Davincilaan 1 Zaventem, Flemish-Brabant 1930 Belgium

Re: K214066

Trade/Device Name: FEops HEARTguide Regulation Number: 21 CFR 870.1405 Regulation Name: Interventional cardiovascular implant simulation software device Regulatory Class: Class II Product Code: OOI Dated: December 23, 2021 Received: December 27, 2021

Dear Niels Festjens:

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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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.

Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K214066

Device Name FEops HEARTguide

Indications for Use (Describe)

FEops HEARTguide™ is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning.

The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement.

FEops HEARTguide™ is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/3 description: The image shows the logo for FEOPS. The logo consists of the word "FEOPS" in large, bold, black letters, followed by the tagline "insights for excellence" in a smaller, lighter font. To the right of the text is a vertical line, followed by a black speech bubble containing a white icon that resembles an open book or a stylized pair of brackets.

510(K) SUMMARY (21CFR807.92)

SUBMITTER

Company Name: Establishment registration number: Address:

Phone number: Principal contact person: Principal contact e-mail address Additional contact person: Additional contact e-mail address Summary date:

DEVICE

Name & trade name: Classification name:

FEops nv 3020703662 Technologiepark 122, 9052 Gent - Zwijnaarde, Belgium +32486435671 Niels Festjens niels@ortho-grow.com Peter Mortier peter.mortier@feops.com

FEops HEARTguide™ Interventional Cardiovascular Implant Simulation Software Device

PREDICATE DEVICE

The predicate device to which substantial equivalence is claimed:

Trade or proprietary or model name	FEops HEARTguide™
De Novo class II petition:	DEN200030
Decision date	08 SEP 2021
Classification product code	QQI
Regulation Number	870.1405
Manufacturer	FEops NV

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DESCRIPTION AND FUNCTIONING OF THE DEVICE

The simulation results are provided as 2D and numerical data shown in a PDF report and 3D, 2D and numerical data shown in a web-based Viewer application accessible through a standard web browser.

INTENDED USE

FEops HEARTguide™ is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning.

The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement.

FEops HEARTguide™ is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.

FEops HEARTguide™ is prescription use only.

Image /page/4/Picture/13 description: The image is a logo for FEOPS, which stands for "insights for excellence". The logo consists of the word "FEOPS" in large, bold, black letters, followed by the phrase "insights for excellence" in smaller, gray letters. To the right of the text is a vertical line, followed by a black speech bubble containing a white icon that resembles an open book.

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TECHNOLOGICAL CHARACTERISTICS

The subject device shares the same code base as the predicate device and differs in the addition of computer models for two additional LAAO devices, the Abbott Amplatzer Amulet (AMU) and the Boston Scientific Watchman FLX (FLX).

	Predicate device	Subject Device	Comparison
Device Name	FEops HEARTguide™	FEops HEARTguide™	/
510(k)/DeNovo Number	DEN200030	K214066	/
Manufacturer	FEops nv	FEops nv	Same
RegulationNumber	21 CFR 870.1405	21 CFR 870.1405	Same
DeviceClassificationName	Interventionalcardiovascularimplantsimulation software device	Interventionalcardiovascularimplantsimulation software device	Same
Common name	FEops HEARTguide™	FEops HEARTguide™	Same
Product Code	QQI	QQI	Same
IntendedUse/Indicationsfor Use	FEops HEARTguide isindicated for patient-specificsimulation of transcatheterleft atrial appendageocclusion (LAAO) deviceimplantation duringprocedural planning.The software performscomputer simulation topredict implant framedeformation to support theevaluation for LAAO devicesize and placement.FEops HEARTguide isintended to be used byqualified clinicians inconjunction with thesimulated deviceinstructions-for-use, thepatient's clinical history,symptoms, and other	FEops HEARTguide isindicated for patient-specificsimulation of transcatheterleft atrial appendageocclusion (LAAO) deviceimplantation duringprocedural planning.The software performscomputer simulation topredict implant framedeformation to support theevaluation for LAAO devicesize and placement.FEops HEARTguide isintended to be used byqualified clinicians inconjunction with thesimulated deviceinstructions-for-use, thepatient's clinical history,symptoms, and other	Same

	preprocedural evaluations, as well as the clinician's professional judgment.FEops HEARTguide is not intended to replace the simulated device's instructions for use for final LAAO device selection and placement.FEops HEARTguide is prescription use only.	preprocedural evaluations, as well as the clinician's professional judgment.FEops HEARTguide is not intended to replace the simulated device's instructions for use for final LAAO device selection and placement.FEops HEARTguide is prescription use only.
PrescriptionUse only	Yes	Yes	Same
Software build	1.4.1	1.4.2	Changes limited to extension of device library and optimization of FLX and AMU modelling strategy
Modellingstrategy	Device specific computational model applied to patient-specific geometry	Device specific computational model applied to patient-specific geometry	Same
Softwarearchitecture	Simulation results prepared by FEops Case Analysts and made available in Web based Viewer	Simulation results prepared by FEops Case Analysts and made available in Web based Viewer	Same
Simulateddevices	1. Boston Scientific WATCHMAN (P130013)	1. Boston Scientific WATCHMAN (P130013)2. Boston Scientific WATCHMAN FLX (P130013/S035)3. Abbott Amplatzer	The subject device library has 2 additional LAA occluders to select. All 3 included LAA occluders are approved for use on the US market.

Image /page/5/Picture/5 description: The image shows the logo for FEOPS, which is written in a bold, sans-serif font. Below the logo, the words "insights for excellence" are written in a smaller, lighter font. The logo is simple and modern, and the words below it suggest that the company is focused on providing insights that help its clients achieve excellence.

Image /page/5/Picture/6 description: The image shows a black and white logo. The logo is a speech bubble with a bracket symbol inside. The bracket symbol is white and the speech bubble is black.

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The provided detailed comparison demonstrates the subject device is substantially equivalent in intended use, design, operating principles, materials and performance characteristics to the primary predicate device. The difference in technological characteristics do not raise new questions of safety and effectiveness.

Image /page/6/Picture/4 description: The image shows the logo for FEOPS, which is a company that provides insights for excellence. The logo consists of the word "FEOPS" in large, bold, black letters, with the words "insights for excellence" in smaller, gray letters below. To the right of the word "FEOPS" is a vertical line, and to the right of the vertical line is a black speech bubble with a white icon inside. The icon inside the speech bubble looks like a stylized open book.

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PERFORMANCE DATA

The 510(k)-submission includes data to demonstrate the Special Controls defined in 21CFR870.1405 are implemented, including:

-Software verification, validation, and hazard analysis, with identification of appropriate mitigations, including full verification and validation of the software according to the predefined software specifications with detail expected for a moderate level of concern software,
A detailed credibility assessment of the device models demonstrating computational modeling verification and validation activities have been performed to establish the predictive capability of the device for its indications for use. The applied methods and results are similar to the activities performed for the predicate device,
The provided performance validation testing data shows the applied methods are similar to the methods applied for the design validation of the predicate device and a similar performance level has been demonstrated. The data includes a comparison of the results to clinical data supporting the indications for use to demonstrate accuracy and clinical meaningfulness of the simulations, an assessment of the agreement between the computational model results and clinical data across the full intended operating range, a justification of the endpoints and sample sizes determination and clinical meaningfulness
To ensure consistency of modeling outputs, the validation was performed with multiple qualified operators using the procedure that will be implemented under anticipated conditions of use and the factors which were held constant where identified.
-A detailed description of the computations and statistical analyses used to evaluate the data is included in the 510(k) submission,
A Human factors evaluation report was provided demonstrating the ability of the user interface and labeling to allow for intended and qualified users to correctly use the device and interpret the provided information
Device labeling is included in the submission which includes warnings that identify anatomy and image acquisition factors that may impact simulation results, provide cautionary guidance for interpretation of the provided simulation results, describes the device simulation inputs and outputs, and key assumptions made in the simulation and determination of simulated outputs as well as the computational modeling performance of the device for presented simulation outputs, and the supporting evidence for this performance

For both added LAAO devices, the performance study was performed on a cohort with a sample size equal to or larger than the predicate device. Acceptance criteria were defined using the same method as for the predicate device demonstrating the same clinical meaningfulness. The same type of measurements and an identical statistical analysis was performed. This demonstrates the performance of the subject device is equivalent to the performance of the predicate device.

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SUMMARY

The characteristics that determine the functionality and performance of FEops HEARTguide™, the subject device, are substantially equivalent to the predicate device cleared under DEN200030. The testing indicates that the subject device is as safe, as effective, and performs as well as the predicate.

Image /page/8/Picture/4 description: The image shows the logo for FEOPS. The logo consists of the word "FEOPS" in large, bold, black letters, with the tagline "insights for excellence" in smaller, gray letters underneath. To the right of the wordmark is a vertical gray line, followed by a black speech bubble containing a white icon that resembles an open book.

Regulation Number and Section

§ 870.1405 Interventional cardiovascular implant simulation software device.

(a)
Identification. An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient's cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software verification, validation, and hazard analysis, with identification of appropriate mitigations, must be performed, including a full verification and validation of the software according to the predefined software specifications.
(2) Computational modeling verification and validation activities must be performed to establish the predictive capability of the device for its indications for use.
(3) Performance validation testing must be provided to demonstrate the accuracy and clinical relevance of the modeling methods for the intended implantation simulations, including the following:
(i) Computational modeling results must be compared to clinical data supporting the indications for use to demonstrate accuracy and clinical meaningfulness of the simulations;
(ii) Agreement between computational modeling results and clinical data must be assessed and demonstrated across the full intended operating range (
e.g., full range of patient population, implant device sizes and patient anatomic morphologies). Any selection criteria or limitations of the samples must be described and justified;(iii) Endpoints (
e.g., performance goals) and sample sizes established must be justified as to how they were determined and why they are clinically meaningful; and(iv) Validation must be performed and controls implemented to characterize and ensure consistency (
i.e., repeatability and reproducibility) of modeling outputs:(A) Testing must be performed using multiple qualified operators and using the procedure that will be implemented under anticipated conditions of use; 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.(4) Human factors evaluation must be performed to evaluate the ability of the user interface and labeling to allow for intended users to correctly use the device and interpret the provided information.
(5) Device labeling must be provided that describes the following:
(i) Warnings that identify anatomy and image acquisition factors that may impact simulation results and provide cautionary guidance for interpretation of the provided simulation results;
(ii) Device simulation inputs and outputs, and key assumptions made in the simulation and determination of simulated outputs; and
(iii) The computational modeling performance of the device for presented simulation outputs, and the supporting evidence for this performance.