Predicate Devices

Reference Devices

P100018/S015, P170024/S003, P180027

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on computational modeling and simulation based on user input and pre-defined device parameters, not learning from data.

Therapeutic

No
The device is described as a software for preoperational planning and sizing for neurovascular interventions and surgery, enabling visualization and computational modeling of devices. It does not directly provide therapy.

Diagnostic

No

ANKYRAS is a preoperational planning and sizing tool for neurovascular interventions and surgery, simulating the placement and sizing of endovascular devices. It does not diagnose conditions or diseases. The software explicitly states that the information provided 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."

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "ANKYRAS is a software as a medical device". The summary focuses entirely on software functionalities, testing, and installation on a standard computer operating system, with no mention of proprietary hardware components included with the device.

IVD (In Vitro Diagnostic)

Based on the provided information, ANKYRAS is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
ANKYRAS's Function: ANKYRAS processes medical images (3D Rotational Angiography) of cerebral blood vessels and performs computational modeling for preoperational planning and sizing of neurointerventional devices. It does not analyze biological specimens.
Intended Use: The intended use clearly states visualization and planning based on imaging data, not analysis of biological samples.

Therefore, ANKYRAS falls under the category of medical imaging software or surgical planning software, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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:

SegmentIon 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.

Product codes

PZO

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray based images, 3D Rotational Angiography (3DRA) images

Anatomical Site

cerebral blood vessels / neurovascular structures

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physicians trained in medical procedures involving percutaneous and intravascular interventions

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

Not Found

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

Sim&Size (Sim&Cure: K190049)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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:	+34 658 17 38 80
e-mail:	hector.fernandez@mentice.com
Contact person:	Göran Malmberg
	Top Manager
Phone:	+34 933 28 39 64
e-mail:	Goran.Malmberg@mentice.com
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
ANKYRAS
(MENTICE SPAIN S.L.) | Predicate Device
Sim&Size
(Sim&Cure) | Comments |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Characteristic | | | |
| Regulatory Information | | | |
| Regulatory Class | Class II | Class II | Same |
| Classification name | Software for
Visualization of Vascular
Anatomy and
Intravascular Devices | Software for
Visualization of
Vascular Anatomy and
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
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 | Sim&Size enables
visualization of
cerebral blood vessels
for preoperational
planning and sizing for
neurovascular
interventions and
surgery.

Sim&Size also allows
for the ability to
computationally
model the placement
and deployment of
neurointerventional
devices.

General
functionalities are
provided such as:
• Segmentation of
neurovascular
structures
• Automatic
centerline
detection
• Visualization of X-
Ray based images
for 2D review and
3D reconstruction
• Placing and sizing
tools
• Reporting tools | Similar |
| Characteristic | Proposed Device
ANKYRAS
(MENTICE SPAIN S.L.) | Predicate Device
Sim&Size
(Sim&Cure) | Comments |
| | braided
endovascular
devices
• Save user data

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

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7

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).