(165 days)
Yes
The summary explicitly states "Mentions AI, DNN, or ML: Yes" and provides performance data for "Fully automatic output" which is characteristic of AI/ML-driven processes like segmentation.
No
Explanation: The device is intended for preprocedural planning, sizing, visualization, and measurement of cardiac structures for interventions, not for direct therapeutic use on a patient.
Yes
Explanation: The device is described as enabling "visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions." This involves analyzing medical imaging data to provide information for clinical decision-making, which is a core function of a diagnostic device. While it states it's "not intended to replace the implant device instructions for use for final LAAO and TAVI device selection and placement," its primary use in deriving measurements and visualizations for planning contributes to the diagnostic process by informing clinical judgments.
Yes
The device is described as a web application that processes input data (CT scans) and provides results and visualizations. The description focuses solely on the software's functionality and delivery method, with no mention of accompanying hardware components required for its operation beyond standard computing devices.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that FEops HEARTguide™ ALPACA processes CT data of the heart and vessels. This is imaging data, not a biological specimen.
- The purpose is preprocedural planning and sizing based on anatomical visualization and measurement. This is a diagnostic imaging tool used for planning medical procedures, not for analyzing biological samples to diagnose a disease or condition.
The device falls under the category of medical device software used for image processing and analysis in the context of structural heart interventions.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" is explicitly marked "Not Found."
Intended Use / 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.
Product codes
QIH
Device Description
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.
Mentions image processing
Medical image management and processing system
Mentions AI, DNN, or ML
Similar, the subject device implements artificial intelligence including nonadaptive machine learning algorithms
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.
Landmark identification and measurements: Both manual and AI supported functions for landmark identification.
Input Imaging Modality
DICOM visualization (including MPR): Yes, CT data in DICOM format
Anatomical Site
Structures of the heart and vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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
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.
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
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 for semi-automatic output showed: Mean of differences (%) 1.4 ± 4.6, CI on the mean (%) (-0.2, 2.9), Inferior Limit of Agreement (LoA) (%) -7.7, Superior LoA (%) 10.4, CI on inferior LoA (%) (-10.5, -5.0), CI on superior LoA (%) (7.7, 13.2).
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. For semi-automatic output: Mean dice score 0.98 ± 0.01, Minimum Dice score 0.95, Maximum Dice score 0.99, Median Dice score 0.98. For fully automatic output: Mean dice score 0.93 ± 0.04, Minimum Dice score 0.83, Maximum Dice score 0.97, Median Dice score 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).
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%.
The Bland-Altman analysis conducted on the perimeter-based diameter of the aortic annulus for semi-automatic output showed: 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. For semi-automatic output: Mean dice score 0.97 ± 0.01, Minimum Dice score 0.92, Maximum Dice score 0.99, Median Dice score 0.97. For fully automatic output: Mean dice score 0.96 ± 0.01, Minimum Dice score 0.92, Maximum Dice score 0.98, Median Dice score 0.96.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
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) | |
|---|---|
| ☒ 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
Submitter: FEops NV Device: FEops HEARTguideTM ALPACA
EOPS
its for excellence
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.