Who is the manufacturer of FEops HEARTguideTM, FEops HEARTguideTM ALPACA?

Feops NV filed the 510(k) submission for FEops HEARTguideTM, FEops HEARTguideTM ALPACA (K223855).

What is the FDA product code for FEops HEARTguideTM, FEops HEARTguideTM ALPACA?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for FEops HEARTguideTM, FEops HEARTguideTM ALPACA?

510(k) clearance (submission type: Traditional).

Does FEops HEARTguideTM, FEops HEARTguideTM ALPACA use AI or machine learning?

Yes. FEops HEARTguideTM, FEops HEARTguideTM ALPACA (K223855) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like FEops HEARTguideTM, FEops HEARTguideTM ALPACA?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like FEops HEARTguideTM, FEops HEARTguideTM ALPACA get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

FEops HEARTguideTM, FEops HEARTguideTM ALPACA

K223855 · Feops NV · QIH · Jun 6, 2023 · Radiology

Device Facts

Record ID	K223855
Device Name	FEops HEARTguideTM, FEops HEARTguideTM ALPACA
Applicant	Feops NV
Product Code	QIH · Radiology
Decision Date	Jun 6, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Left Atrial Appendage Landing Zone Diameter	Nonadaptive machine learning algorithms	Mean difference < ±18%	1.4 ± 4.6% (semi-automatic); 4.1 ± 7.2% (fully automatic)	—	—	Retrospective cohort of 35 cases	>1 (FEops Case analyst)
Left Atrial Appendage Segmentation	Nonadaptive machine learning algorithms	—	0.98 ± 0.01 (semi-automatic); 0.93 ± 0.04 (fully automatic) (Dice score)	—	—	Retrospective cohort of 35 cases	>1 (FEops Case analyst)
Aortic Annulus Perimeter-based Diameter	Nonadaptive machine learning algorithms	Mean difference < ±10%	0.5 ± 1.9%	—	—	Retrospective cohort of 35 cases	>1 (FEops Case analyst)
Aortic Root Segmentation	Nonadaptive machine learning algorithms	—	0.97 ± 0.01 (semi-automatic); 0.96 ± 0.01 (fully automatic) (Dice score)	—	—	Retrospective cohort of 35 cases	>1 (FEops Case analyst)

Indications for Use

FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions. To facilitate the above, FEops HEARTguide™ ALPACA provides general functionality such as: - Segmentation of cardiovascular structures - Visualization and image reconstruction techniques: 2D review, MPR - Measurement and annotation tools - Reporting tools FEops HEARTguide™ ALPACA also allows visualization of output generated by other medical device software (e.g., FEops HEARTguide™ Simulation Application cleared as K214066). The results are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment. FEops HEARTguide™ ALPACA is not intended to replace the implant device instructions for use for final LAAO and TAVI device selection and placement.

Device Story

FEops HEARTguide™ ALPACA is a cloud-based software platform for preprocedural planning of structural heart interventions (LAAO, TAVI). It accepts DICOM-formatted CT images as input. The device utilizes AI-based, non-adaptive machine learning algorithms to perform automated segmentation of cardiovascular structures and identify anatomical landmarks. Clinicians access the results via a web application, which provides 3D visualizations, multi-planar reconstructions (MPR), and measurement tools. The system supports human-in-the-loop workflows where a FEops case analyst performs quality checks on the automated outputs before final clinician review. The output assists clinicians in sizing and planning interventions; it does not replace manufacturer instructions for implant selection. The device benefits patients by providing precise anatomical measurements to optimize procedural planning.

Clinical Evidence

Bench testing only. Performance validated using 70 retrospective cases (35 LAAO, 35 TAVI). LAAO cohort: mean age 76.2y; TAVI cohort: mean age 76.3y. Primary endpoints: mean diameter accuracy of landing zone (LAAO) and aortic annulus (TAVI) compared to manual ground truth. LAAO landing zone mean difference 1.4% (semi-automatic); TAVI annulus mean difference 0.5% (semi-automatic). Dice scores for segmentation ranged 0.93-0.98. Results met predetermined performance goals (±18% for LAAO, ±10% for TAVI).

Technological Characteristics

Cloud-based software for medical image management and processing. Utilizes AI-based, non-adaptive machine learning algorithms for automated segmentation and landmark identification. Inputs: DICOM CT data. Outputs: 3D surfaces, MPR, PDF reports. Connectivity: Cloud-hosted web application. Cybersecurity measures implemented. No hardware components.

Indications for Use

Indicated for preprocedural planning and sizing of structural heart interventions (LAAO and TAVI) in adult patients. Used by qualified clinicians to visualize and measure cardiovascular structures from CT images.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

3mensio Workstation/3mensio Structural Heart/3mensio Vascular (K153736)

Reference Devices

FEops HEARTguide™ Simulation Application (K214066)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION". FEops nv % Mieke Janssen RA Consultant OrthoGrow nv Davincilaan 1 Zaventem, Flemish-Brabant 1930 BELGIUM June 6, 2023 #### Re: K223855 Trade/Device Name: FEops HEARTguide™. FEops HEARTguide™ ALPACA Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: May 17, 2023 Received: May 17, 2023 #### Dear Mieke Janssen: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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, Jessica Lamb Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K223855 Device Name FEops HEARTguide™ FEops HEARTguide™ALPACA #### Indications for Use (Describe) FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions. To facilitate the above, FEops HEARTguide™ ALPACA provides general functionality such as: - · Segmentation of cardiovascular structures - · Visualization and image reconstruction techniques: 2D review, MPR - · Measurement and annotation tools - · Reporting tools FEops HEARTguide™ ALPACA also allows visualization of output generated by other medical device software (e.g., FEops HEARTguide™ Simulation Application cleared as K214066). The results are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment. FEops HEARTguide™ ALPACA is not intended to replace the implant device instructions for use for final LAAO and TAVI device selection and placement. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | <div> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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}------------------------------------------------ Submitter: FEops NV Device: FEops HEARTguideTM ALPACA EOPS its for excellence K223855 # 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: June 6, 2023 ## DEVICE Name & trade name: Common name: Classification name: Regulatory class: Regulation number: Product code: FEops nv 3020703662 Technologiepark 122, 9052 Gent - Zwijnaarde, Belgium +32496564131 Mieke Janssen mieke@ortho-grow.com Peter Mortier peter.mortier@feops.com FEops HEARTguide™, FEops HEARTguide™ ALPACA FEops HEARTguide™ Picture Archiving and Communications System II 21 CFR 892.2050 OIH ## PREDICATE DEVICE The predicate device to which substantial equivalence is claimed: | Trade or proprietary or model name | 3mensio Workstation/3mensio Structural Heart/3mensio Vascular | |------------------------------------|---------------------------------------------------------------| | 510(k) number: | K153736 | | Decision date | May 27, 2016 | | Classification product code | LLZ | | Regulation Number | 21 CFR 892.2050 | | Manufacturer | Pie Medial Imaging BV | Image /page/3/Picture/17 description: The image is a logo for FEOPS, which stands for "insights for excellence". The logo is composed of the word "FEOPS" in large, bold, black letters, with the words "insights for excellence" in smaller, gray letters underneath. To the right of the word "FEOPS" is a vertical gray line, followed by a black speech bubble containing a white icon that resembles an open book or brackets. {4}------------------------------------------------ #### DESCRIPTION AND FUNCTIONING OF THE DEVICE FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions. The software is used in a service-based business model: the customer (clinician) provides the necessary input data, FEops prepares the anatomical analysis, and delivers the results to the customer. The results of the anatomical analysis are provided to the clinician via FEops HEART guide™ ALPACA's web application. They are available in a PDF report and as interactive 3D and DICOM MPR visualizations. The web application is intended to be used by clinicians to review the results as well as to create additional landmarks and related measurements, if needed. ## INTENDED USE FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions. To facilitate the above, FEops HEARTguide™ ALPACA provides general functionality such as: - . Segmentation of cardiovascular structures - Visualization and image reconstruction techniques: 2D review, MPR . - . Measurement and annotation tools - . Reporting tools FEops HEARTguide™ ALPACA also allows visualization of output generated by other medical device software (e.g. FEops HEARTguide™ Simulation Application cleared as K214066). The results are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional iudgment. FEops HEARTguide™ ALPACA is not intended to replace the implant device instructions for use for final LAAO and TAVI device selection and placement. Image /page/4/Picture/16 description: The image is a logo for FEOPS, which stands for "insights for excellence". The logo is composed of the word "FEOPS" in large, bold, black letters, with the words "insights for excellence" in smaller, gray letters underneath. To the right of the word "FEOPS" is a vertical gray line, followed by a black speech bubble with a white icon inside. The icon appears to be a stylized book or document. {5}------------------------------------------------ # TECHNOLOGICAL CHARACTERISTICS Both the subject device and the predicate device are intended for visualization of medical images of the heart and allow analysis of structures of the heart and vessels. Both devices are to be used for preprocedural planning and sizing of transcatheter cardiovascular interventions. Both devices enable automatic image segmentation for which the output is reviewed and adapted if needed. The predicate device includes additional functionality for post-operative evaluation of structural heart interventions as well as tools to support clinical diagnosis by quantifying calcifications and dimensions in coronary arteries. | | Subject device | Predicate device | Comparison | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | FEops HEARTguide™ ALPACATM | 3mensio Workstation/3mensio Structural Heart/3mensio Vascular | / | | 510(k) Number | / | K153736 | / | | Manufacturer | FEops NV | Pie Medical Imaging BV | / | | Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | same | | Device Classification Name | Picture archiving and communications system | Picture archiving and communications system | same | | Common Name | | 3mensio Workstation | / | | Product Code | QIH | LLZ | Similar, the subject device implements artificial intelligence including nonadaptive machine learning algorithms | | Intended use | FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions. | 3mensio Workstation is a software solution that is intended to provide Cardiologists, Radiologists and Clinical Specialists additional information to aid them in reading and interpreting DICOM compliant medical images of | Same, both the subject and predicate device share the same intended use, in that they enable visualization of medical images of the heart, and analysis of structures of the heart and vessels. | Image /page/5/Picture/5 description: The image contains 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 tagline "insights for excellence" in smaller, gray letters underneath. To the right of the text is a black speech bubble containing a stylized image of an open book. {6}------------------------------------------------ | To facilitate the above, FEops HEARTguide™ ALPACA provides general functionality such as: Segmentation of cardiovascular structures Visualization and image reconstruction techniques: 2D review, MPR Measurement and annotation tools Reporting tools FEops HEARTguide™ ALPACA also allows visualization of output generated by other medical device software (e.g. FEops HEARTguide™ Simulation Application cleared as K214066). The results are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment. | structures of the heart and vessels. 3mensio Structural Heart enables the user to: Visualize and measure (diameters, lengths, areas, volumes, angles) structures of the heart and vessels, Quantify calcium (volume, density) 3mensio Vascular enables the user to: Visualize and assess stenosis, aneurisms and vascular structures Measure the dimensions of vessels (diameters, lengths, areas, volumes, angles) | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| Image /page/6/Picture/3 description: The image shows the logo for FEOPS. The logo has the word "FEOPS" in bold, black letters. Below the word is the phrase "insights for excellence" in a smaller, gray font. To the right of the word is a black circle with a white book icon inside of it. {7}------------------------------------------------ | | FEops HEARTguide™ ALPACA is not intended to replace the implant device instructions for use for final LAAO and TAVI device selection and placement. | | | |----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions. To facilitate the above, FEops HEARTguide™ ALPACA provides general functionality such as: Segmentation of cardiovascular structures Visualization and image reconstruction techniques: 2D review, MPR Measurement and annotation tools Reporting tools FEops HEARTguide™ ALPACA also allows visualization of output generated by other medical device software | 3mensio Workstation enables visualization and measurement of structure of the heart and vessels for: Preoperational planning and sizing for cardiovascular interventions and surgery Postoperative evaluation Support of clinical diagnosis by quantifying dimensions in coronary arteries Support of clinical diagnosis by quantifying calcifications (calcium scoring) in the coronary arteries To facilitate the above, the 3mensio Workstation provides general functionality such as: | Similar, Both devices are indicated to be used for preprocedural planning and sizing of structural heart interventions. Whereas the subject device solely focuses on preprocedural planning, the predicate device additionally includes functionality for postoperative evaluation of structural heart interventions. This does not impact the indication for use for preprocedural planning. The predicate device also supports clinical diagnosis by quantifying calcifications and quantifying dimensions in coronary arteries. This functionality is not present in the subject device. | | | FEops (e.g. HEARTguide™ Simulation Application cleared as K214066). | - Segmentation of cardiovascular structures - Automatic and manual centerline detection - Visualization and image reconstruction techniques: 2D review, Volume rendering, MPR, Curved MPR, Stretched CMPR, Slabbing, MIP, AIP, MinIP - Measurement and annotation tools - Reporting tools | | | | The results are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment. | | | | | FEops HEARTguide™ ALPACA is not intended to replace the implant device instructions for use for final LAAO and TAVI device selection and placement. | | | | Prescription Use | Yes | Yes | same | | DICOM visualization (including MPR) | Yes, CT data in DICOM format | Yes, CT data in DICOM format | same | | Image segmentation | Segmentation functionality based on artificial intelligence including nonadaptive machine learning, followed by human supervision and a quality check by a FEops Case analyst. | 3mensio enables automatic segmentation | Similar, both devices include human- supervised automated segmentation functionality. Both devices include the option for the physician to review the segmentation. | | 3D Visualization | FEops HEARTguide ALPACA includes 3D visualization of medical | 3mensio includes 3D visualization of medical | Similar | | | images (using 3D surfaces). | images (volume rendering). | | | Landmark identification and measurements | Both manual and AI supported functions for landmark identification. | Both manual and AI supported functions for landmark identification. | Same | | Scope - Structural heart interventions | Transcatheter heart interventions | Transcatheter heart interventions | Same, both devices are limited to transcatheter interventions. | | Functionality for post- intervention evaluation | No | Yes | The predicate device includes functionality for post-intervention evaluation. This functionality is absent in the subject device. | | Verification and Validation | Software verification and validation was performed. Documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Design verification confirmed that the system requirements were implemented correctly. Design validation established that the FEops HEARTguide ALPACA conforms to the intended use and defined user needs, demonstrating the safety | Verification showed that the system requirements – derived from the intended use and indications for use – were implemented correctly, demonstrating the effectiveness of the device. A validation plan for the final validation of the release build was executed on the final build. A test report comparing the numerical results of the device compared with the predicate devices was generated. | Same | | | and effectiveness of the subject device. | | | | Cloud-based | Yes | No, 3mensio is a traditional software package, to be installed on a specific computer | Different, while the subject device is cloud- based, the predicate device is a traditional software package to be installed on a specific computer. FEops HEARTguideTM ALPACA is subject to cybersecurity measures (see Section 16). | | Reporting tools | FEops HEARTguide generates pdf reports | 3mensio generates pdf reports | Same | Image /page/7/Picture/3 description: The image shows the logo for FEOPS, which is written in bold, black letters. 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. {8}------------------------------------------------ Submitter: FEops NV Device: FEops HEARTguide™ ALPACA Image /page/8/Picture/3 description: The image shows the logo for FEOPS, which is written in bold, black letters. Below the logo, the words "insights for excellence" are written in a smaller, lighter font. To the right of the logo, there is a black icon that resembles a speech bubble with curly brackets inside. {9}------------------------------------------------ Image /page/9/Picture/3 description: The image shows the logo for FEOPS, which is a company that provides insights for excellence. The logo is composed of the word "FEOPS" in large, bold, black letters, with the tagline "insights for excellence" in smaller, gray letters below. To the right of the text is a black speech bubble icon with a white "C" inside. {10}------------------------------------------------ The provided detailed comparison demonstrates the subject device is substantially equivalent in intended use, design, operating principles and performance characteristics to the predicate device. Image /page/10/Picture/4 description: The image is a logo for FEOPS, which stands for "insights for excellence". The logo is composed of the word "FEOPS" in large, bold, black letters, with the tagline "insights for excellence" in smaller, gray letters below. To the right of the wordmark is a black speech bubble containing a white icon that resembles an open book or brackets. {11}------------------------------------------------ ## PERFORMANCE DATA Non-clinical performance data was included in the 510(k)-submission demonstrating FEops HEARTguide™ ALPACA has been validated for its intended use and is substantial equivalent to the predicate device. Software verification and validation was performed, and documentation was provided following the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This includes verification against defined requirements, and validation against user needs. In addition, documentation following "Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions" was provided to demonstrate the performance of the quantitative imaging function included within FEops HEARTguide™ ALPACA. The results of the accuracy or performance validation are summarized below. For LAAO, a study was performed on a cohort of 35 representative retrospective cases, during which quantitative outputs of FEops HEARTguide™ ALPACA were compared with manually annotated data (i.e. ground truth). The age of the studied cohort is 76.2±8.7y (50-92y), 51% were male subjects, and the LAA morphology was chicken wing (43%), reversed chicken wing (11%) or non-angulated (46%). Recent datasets representative for the intended population were used in this test cohort, covering different CT manufacturers, imaging parameters (e.g. slice thickness) and regions. No datasets were included that were used for training the AI models. A performance goal was set for the mean diameter of the semi-automatically identified landing zone, as this is considered the most important landmark for the pre-operative planning of LAAO procedures. The maximum allowed difference in percentage must be less than the predetermined performance goal of ±18%. The Bland-Altman analysis conducted on the mean diameter of the landing zone provided the following results for the semi-automatic and fully automatic outputs respectively: | | Semi-automatic output | Fully automatic output | |------------------------------------------|-----------------------|------------------------| | Mean of differences (%) | 1.4 ± 4.6 | 4.1 ± 7.2 | | Confidence interval (CI) on the mean (%) | (-0.2, 2.9) | (1.6, 6.6) | | Inferior Limit of Agreement (LoA) (%) | -7.7 | -10.1 | | Superior LoA (%) | 10.4 | 18.3 | Image /page/11/Picture/8 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 black speech bubble containing a white icon that resembles an open book or document. {12}------------------------------------------------ | CI on inferior LoA (%) | (-10.5, -5.0) | (-14.4, -5.8) | |------------------------|---------------|---------------| | CI on superior LoA (%) | (7.7, 13.2) | (14.0, 22.6) | For the semi-automatically identified landing zone, the lower limit of the CI calculated on the inferior LoA (-10.5%) and the upper limit of the CI calculated on the superior LoA (13.2%) are within the maximum allowed difference of ±18%, so the performance goal has been met. For all quantitative output, consistent performance has been observed for all relevant subgroups including CT manufacturers, imaging parameter, patient sex and age as well as LAA morphology. The segmentation output was compared with manually annotated data (i.e. ground truth) by calculating the dice score on the region of interest: the region of the left atrium containing the ostium and the main part of the left atrial appendage. | | Semi-automatic output | Fully automatic output | |--------------------|-----------------------|------------------------| | Mean dice score | $0.98 \pm 0.01$ | $0.93 \pm 0.04$ | | Minimum Dice score | 0.95 | 0.83 | | Maximum Dice score | 0.99 | 0.97 | | Median Dice score | 0.98 | 0.94 | For TAVI, a study was performed on a cohort of 35 representative retrospective cases, during which quantitative outputs of FEops HEARTguide™ ALPACA were compared with manually annotated data (i.e. ground truth). The age of the studied cohort is 76.3±9.5y (48-91y), 46% were male subjects, and the aortic valve morphology was tricuspid in 74% of cases. Recent datasets representative for the intended population were used in this test cohort, covering different CT manufacturers, imaging parameters (e.g. slice thickness) and regions. No datasets were included that were used for training the AI models. A performance goal was set for the perimeter-based diameter of the semi-automatically identified aortic annulus, as this is considered the most important landmark for the pre-operative planning of TAVI procedures. The maximum allowed difference in percentage must be less than the predetermined performance goal of ±10%. Please note that there is no automatically calculated perimeter-based diameter of the aortic annulus, as the algorithm only identifies the annular plane, and the measurement itself requires a manual action. Image /page/12/Picture/8 description: The image is a logo for FEOPS, which stands for "insights for excellence". The logo is composed of the word "FEOPS" in bold, black letters, with the words "insights for excellence" in a smaller, gray font underneath. To the right of the wordmark is a vertical line, followed by a black speech bubble containing a white icon that resembles an open book or brackets. The overall design is clean and modern. {13}------------------------------------------------ The Bland-Altman analysis conducted on the perimeter-based diameter of the aortic annulus provided the following results: | | Semi-automatic output | |------------------------------------------|-----------------------| | Mean of differences (%) | 0.5 ± 1.9 | | Confidence interval (CI) on the mean (%) | (-0.1, 1.2) | | Inferior Limit of Agreement (LoA) (%) | -3.2 | | Superior LoA (%) | 4.2 | | CI on inferior LoA (%) | (-4.3, -2.1) | | CI on superior LoA (%) | (3.1, 5.3) | The lower limit of the CI calculated on the inferior LoA (-4.3%) and the upper limit of the CI calculated on the superior LoA (5.3%) are within the maximum allowed difference of ±10%, so the performance goal has been met. For all quantitative output, consistent performance has been observed for all relevant subgroups including CT manufacturers, imaging parameter, patient sex and age as well as aortic valve morphology. The segmentation output was compared with manually annotated data (i.e. ground truth) by calculating the dice score on the region of interest: the region of the aortic root, including the ascending aorta and the left ventricle. | | Semi-automatic output | Fully automatic output | |--------------------|-----------------------|------------------------| | Mean dice score | 0.97 ± 0.01 | 0.96 ± 0.01 | | Minimum Dice score | 0.92 | 0.92 | | Maximum Dice score | 0.99 | 0.98 | | Median Dice score | 0.97 | 0.96 | # SUMMARY The characteristics that determine the functionality and performance of FEops HEART guide™ ALPACA, the subject device, are substantially equivalent to the predicate device cleared under Image /page/13/Picture/8 description: The image is a logo for FEOPS, which stands for "insights for excellence". The logo is composed 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 black speech bubble with a white book icon inside. The book icon is stylized with brackets on the top and bottom. {14}------------------------------------------------ K153736. The testing indicates that the subject device is as safe, as effective, and performs as well as the predicate. Image /page/14/Picture/3 description: The image is a logo for FEOPS, which stands for "insights for excellence". The logo is composed of the word "FEOPS" in large, bold, black letters, with the words "insights for excellence" in a smaller, lighter font underneath. To the right of the text is a black speech bubble containing a white icon that resembles an open book or document with stylized brackets.

FEops HEARTguideTM, FEops HEARTguideTM ALPACA

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FEops HEARTguideTM, FEops HEARTguideTM ALPACA

Device Facts

AI Performance

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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