FEops HEARTguide

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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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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 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. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 | {4}------------------------------------------------ # DESCRIPTION AND FUNCTIONING OF THE DEVICE 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. # 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 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. 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. {5}------------------------------------------------ # 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)/De<br>Novo Number | DEN200030 | K214066 | / | | Manufacturer | FEops nv | FEops nv | Same | | Regulation<br>Number | 21 CFR 870.1405 | 21 CFR 870.1405 | Same | | Device<br>Classification<br>Name | Interventional<br>cardiovascular<br>implant<br>simulation software device | Interventional<br>cardiovascular<br>implant<br>simulation software device | Same | | Common name | FEops HEARTguide™ | FEops HEARTguide™ | Same | | Product Code | QQI | QQI | Same | | Intended<br>Use/Indications<br>for Use | FEops HEARTguide is<br>indicated for patient-specific<br>simulation of transcatheter<br>left atrial appendage<br>occlusion (LAAO) device<br>implantation during<br>procedural planning.<br><br>The software performs<br>computer simulation to<br>predict implant frame<br>deformation to support the<br>evaluation for LAAO device<br>size and placement.<br><br>FEops HEARTguide is<br>intended to be used by<br>qualified clinicians in<br>conjunction with the<br>simulated device<br>instructions-for-use, the<br>patient's clinical history,<br>symptoms, and other | FEops HEARTguide is<br>indicated for patient-specific<br>simulation of transcatheter<br>left atrial appendage<br>occlusion (LAAO) device<br>implantation during<br>procedural planning.<br><br>The software performs<br>computer simulation to<br>predict implant frame<br>deformation to support the<br>evaluation for LAAO device<br>size and placement.<br><br>FEops HEARTguide is<br>intended to be used by<br>qualified clinicians in<br>conjunction with the<br>simulated device<br>instructions-for-use, the<br>patient's clinical history,<br>symptoms, and other | Same | | | | | | | | preprocedural evaluations, as well as the clinician's professional judgment.<br><br>FEops HEARTguide is not intended to replace the simulated device's instructions for use for final LAAO device selection and placement.<br><br>FEops HEARTguide is prescription use only. | preprocedural evaluations, as well as the clinician's professional judgment.<br><br>FEops HEARTguide is not intended to replace the simulated device's instructions for use for final LAAO device selection and placement.<br><br>FEops HEARTguide is prescription use only. | | | Prescription<br>Use 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 | | Modelling<br>strategy | Device specific computational model applied to patient-specific geometry | Device specific computational model applied to patient-specific geometry | Same | | Software<br>architecture | 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 | | Simulated<br>devices | 1. Boston Scientific WATCHMAN (P130013) | 1. Boston Scientific WATCHMAN (P130013)<br>2. Boston Scientific WATCHMAN FLX (P130013/S035)<br>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. {6}------------------------------------------------ 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. {7}------------------------------------------------ # 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. {8}------------------------------------------------ ## 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.