Ankyras

K230006 · Mentice Spain S.L. · PZO · Dec 28, 2023 · Radiology

Device Facts

• Record ID: K230006
• Device Name: Ankyras
• Applicant: Mentice Spain S.L.
• Product Code: PZO · Radiology
• Decision Date: Dec 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K230006 · Dec 28, 2023	Ankyras	Mentice Spain S.L.	Retrospective clinical images	Retrospective clinical images were used to evaluate the computational modeling and prediction accuracy of the software by comparing actual clinical flow diverter placement and measurements to the software's virtual simulations.	Retrospective clinical images; Computational modeling validation; Performance testing

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective comparison study	Patients presenting with intracranial aneurysms	Actual clinical flow diverter placement and measurements	Prediction accuracy/error of deployed length, expansion, and porosity of flow diverters

Indications for Use

ANKYRAS enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. ANKYRAS also allows for the ability to computationally model the placement of neurointerventional braided endovascular devices. General functionalities are provided such as: - Segmentation of neurovascular structures - Semi-automatic centerline generation from segmented blood vessels - Visualization of X-ray based images - Placing and sizing tools for braided endovascular devices - Save user data Information provided by the software is not intended in any way to eliminate, replace or substitute for in part, the healthcare provider's judgment and analysis of the patient's condition.

Device Story

ANKYRAS is a software-as-a-medical-device (SaMD) for preoperational planning in neurovascular interventions. Input: 3D Rotational Angiography (3DRA) DICOM images. Operation: Physician segments neurovascular structures; software generates centerlines; user selects FDA-approved flow diverters (FDs) from an internal database. The device performs computational modeling to simulate FD placement, expansion, and porosity within the patient's vessel model. Output: Interactive charts and 3D visualizations of simulated device deployment. Used in clinical settings by physicians to compare different FD devices and positions. The software does not replace clinical judgment; it assists in sizing and planning to potentially improve procedural outcomes.

Clinical Evidence

Bench testing only. Validation included software verification (DICOM import, image processing, cybersecurity) and computational accuracy assessment. Accuracy of simulated device length, expansion, and porosity was validated by comparing virtual placement against physical phantom models and retrospective clinical images of actual flow diverter placements.

Technological Characteristics

Software-based medical image management and processing system. Compatible with MS Windows. Inputs: DICOM 3DRA images. Features: Segmentation, semi-automatic centerline generation, 3D volume rendering, and computational modeling of braided endovascular devices. Data transfer via physical media (USB). No patient contact. Standalone software application.

Indications for Use

Indicated for patients undergoing neurovascular interventions and surgery requiring preoperational planning and sizing of braided endovascular devices.

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

• Sim&Size (Sim&Cure: K190049)

Submission Summary (Full Text)

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December 28, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

MENTICE SPAIN S.L.

Héctor Fernández Responsible Technician and PRRC Rambla de Catalunya 53, 4-H Barcelona. 08007 Spain

Re: K230006

Trade/Device Name: ANKYRAS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: PZO Dated: November 27, 2023 Received: November 29, 2023

Dear Héctor Fernández:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Naira Muradyan -S

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known) K230006

Device Name ANKYRAS

Indications for Use (Describe)

ANKYRAS enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery.

ANKYRAS also allows for the ability to computationally model the placement of neurointerventional braided endovascular devices.

General functionalities are provided such as:

- · Segmentation of neurovascular structures
- · Semi-automatic centerline generation from segmented blood vessels
- · Visualization of X-ray based images
- · Placing and sizing tools for braided endovascular devices
- · Save user data

Information provided by the software is not intended in any way to eliminate, replace or substitute for in part, the healthcare provider's judgment and analysis of the patient's condition.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px"> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size:16px"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary K230006

This 510(k) Summary is being submitted in accordance with the requirements detailed in 21 CFR 807.92.

| SUBMITTER NAME: | MENTICE SPAIN S.L. |
|--------------------|------------------------------------------------------------------|
| SUBMITTER ADDRESS: | Rambla de Catalunya 53, 4-H |
| | 08007 BARCELONA |
| | SPAIN |
| Contact person: | Héctor Fernández |
| | Responsible technician and PRRC |
| Phone: | [phone] |
| e-mail: | [e-mail] |
| Contact person: | Göran Malmberg |
| | Top Manager |
| Phone: | [phone] |
| e-mail: | [e-mail] |
| Date Prepared: | December 26, 2023 |
| DEVICE TRADE NAME: | ANKYRAS |
| COMMON NAME: | Software for Visualization of Vascular Anatomy and Intravascular |
| | Devices |
| DEVICE CLASS: | Class II |
| REGULATION NUMBER: | 892.2050 |
| REGULATION NAME: | Medical Image Management and Processing System |
| PRODUCT CODE: | PZO |
| PREDICATE DEVICE: | Sim&Size (Sim&Cure: K190049) |

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## DEVICE DESCRIPTION

ANKYRAS is a software as a medical device that allows the simulation of neurointerventional braided endovascular devices, such as flow diverters (FDs), and is intended to be used by physicians trained in medical procedures involving percutaneous and intravascular interventions for preoperational planning and sizing for neurovascular interventions and surgery. The software includes a database with FDA-approved FDs: P100018/S015 - Pipeline Flex Embolization Device, Medtronic, Inc.; P170024/S003 - Surpass Evolve Flow Diverter System, Stryker Neurovascular; P180027 - Flow Re-Direction Endoluminal Device (FRED®) System, MicroVention, Inc.

ANKYRAS is intended to be used with 3D Rotational Angiography (3DRA) images. From the 3DRA images the user can extract the target artery vessel model using ANKYRAS segmentation functionality for further analysis and computational modeling (simulation) of the listed above FDs:

- . First, using the vessel model and proximal and distal points selected by the user, ANKYRAS calculates the vessel centerline and displays cross-sectional dimensional information in an interactive chart.
- . Second, using the vessel model, centerline, and dimensions, ANKYRAS simulates the FD devices selected by the user can compare the results between different simulated FD devices and/or different positions including simulated device length, expansion along the centerline, and local porosity.

The information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

ANKYRAS software is intended to be installed on a computer with Windows operating systems.

#### INTENDED USE/INDICATIONS FOR USE

ANKYRAS enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery.

ANKYRAS also allows for the ability to computationally model the placement of neurointerventional braided endovascular devices.

General functionalities are provided such as:

- . Segmentation of neurovascular structures
- . Semi-automatic centerline generation from segmented blood vessels
- . Visualization of X-ray based images
- . Placing and sizing tools for braided endovascular devices
- . Save user data

Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider´s judgment and analysis of the patient´s condition.

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# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

Characteristics and features of ANKYRAS software have been compared to the characteristics and features of the predicate device Sim&Size.

| | Proposed Device<br>ANKYRAS<br>(MENTICE SPAIN S.L.) | Predicate Device<br>Sim&Size<br>(Sim&Cure) | Comments |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Characteristic | | | |
| Regulatory Information | | | |
| Regulatory Class | Class II | Class II | Same |
| Classification name | Software for<br>Visualization of Vascular<br>Anatomy and<br>Intravascular Devices | Software for<br>Visualization of<br>Vascular Anatomy and<br>Intravascular Devices | Same |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Product Code | PZO | PZO | Same |
| 510(k) Number | K230006 | K190049 | - |
| Indications for Use | ANKYRAS enables<br>visualization of cerebral<br>blood vessels for<br>preoperational planning<br>and sizing for<br>neurovascular<br>interventions and<br>surgery.<br><br>ANKYRAS also allows for<br>the ability to<br>computationally model<br>the placement of<br>neurointerventional<br>braided endovascular<br>devices.<br><br>General functionalities<br>are provided such as:<br>• Segmentation of<br>neurovascular<br>structures<br>• Semi-automatic<br>centerline<br>generation from<br>segmented<br>blood vessels<br>• Visualization of<br>X-ray based<br>images<br>• Placing and<br>sizing tools for | Sim&Size enables<br>visualization of<br>cerebral blood vessels<br>for preoperational<br>planning and sizing for<br>neurovascular<br>interventions and<br>surgery.<br><br>Sim&Size also allows<br>for the ability to<br>computationally<br>model the placement<br>and deployment of<br>neurointerventional<br>devices.<br><br>General<br>functionalities are<br>provided such as:<br>• Segmentation of<br>neurovascular<br>structures<br>• Automatic<br>centerline<br>detection<br>• Visualization of X-<br>Ray based images<br>for 2D review and<br>3D reconstruction<br>• Placing and sizing<br>tools<br>• Reporting tools | Similar |
| Characteristic | Proposed Device<br>ANKYRAS<br>(MENTICE SPAIN S.L.) | Predicate Device<br>Sim&Size<br>(Sim&Cure) | Comments |
| | braided<br>endovascular<br>devices<br>• Save user data<br><br>Information provided by<br>the software is not<br>intended in any way to<br>eliminate, replace or<br>substitute for, in whole<br>or in part, the healthcare<br>provider's judgment and<br>analysis of the patient's<br>condition. | Information provided<br>by the software is not<br>intended in any way<br>to eliminate, replace<br>or substitute for, in<br>whole or in part, the<br>healthcare provider's<br>judgment and analysis<br>of the patient's<br>condition. | |
| Technical Characteristics | | | |
| Computer OS Compatibility | MS Windows | MS Windows and Mac<br>OS | ANKYRAS is<br>compatible<br>with MS<br>Windows<br>only |
| Interface to Image Sources | DICOM Image Data | DICOM Image Data | Same |
| Import of Patient Data | Manual through<br>keyboard/mouse,<br>automatic import with<br>image file or<br>morphological mesh,<br>study creation list. | Manual through<br>keyboard/mouse,<br>automatic import with<br>image file, study<br>creation list. | Similar |
| Image Processing | Segmentation and use<br>by physician. | Segmentation and use<br>by physician. | Same |
| 3D Assessment | 3D assessment based on<br>3D model of the<br>simulated endovascular<br>braided device inside<br>the vessels. | 3D assessment based<br>on 3D model of the<br>simulated<br>neurointerventional<br>device inside the<br>vessels. | Same |
| Image and 3D Display | Orthogonal, color<br>volume rendering, 2D<br>slide review, active<br>presets, 3D view of<br>assemblies of<br>endovascular braided<br>devices. | Orthogonal, color<br>volume rendering, 2D<br>slide review, active<br>presets, 3D view of<br>assemblies of<br>devices. | Same |
| DICOM Support | Read DICOM images<br>from 3D rotational<br>angiography (3DRA). | DICOM compliance for<br>CT and<br>enhanced CT, read<br>DICOM images from<br>3D rotational | Similar |
| Characteristic | Proposed Device<br>ANKYRAS<br>(MENTICE SPAIN S.L.) | Predicate Device<br>Sim&Size<br>(Sim&Cure) | Comments |
| | | angiography stations. | |
| Data<br>Interchange / Transfer<br>Method | Transfer by physical<br>media; i.e. USB<br>memory stick. | Transfer by physical<br>media; i.e. USB<br>memory stick. | Same |
| Output File Format | Local openGL rendering | Local openGL rendering | Same |
| Preoperational<br>Planning | Yes | Yes | Same |
| Patient Contact | No | No | Same |
| Human Intervention<br>for Interpretation of Images | Yes | Yes | Same |

Table 1: Summary of comparison of characteristics and features – proposed and predicate devices.

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### Performance Testing

The following verification and validation tests were performed on ANKYRAS in support of the substantial equivalence to the predicate.

Software verification and validation tests were conducted and documentation was provided as recommended by FDA, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

The following tests were conducted:

- Tests of importation of DICOM images. ●
- Patient list management tests.
- Tests of image display and processing.
- Functioning tests for visualization of anatomic reconstruction. ●
- Save user data and visualization tests.
- Cybersecurity tests.

All tests have passed and demonstrate that the software is designed to meet the software requirements.

The computational modeling and prediction accuracy/error of deployed length, expansion, and porosity of the selected flow diverters by ANKYRAS was evaluated through the following two tests:

- . Using physical phantoms representative of anatomy of patients presenting with intracranial aneurysms to compare the in vitro placement and measurement of flow diverters to virtual flow diverter placement and outputs by ANKYRAS.
- Using retrospective clinical images to compare the placement and measurements of actual flow diverters to virtual flow diverter placement and outputs by ANKYRAS.

### Conclusions

ANKYRAS (subject device) and Sim&Size (predicate device) have similar indications for use and similar technological characteristics. The differences between the technological characteristics do not raise different questions of safety and effectiveness. The verification, and performance testing of ANKYRAS demonstrate that the device performs as intended.

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MENTICE SPAIN S.L. concludes that the ANKYRAS (subject device) is substantially equivalent to the Sim&Size (predicate device).