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 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

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.

Device Description

Sim&Size is a Software as a Medical Device (SaMD) for simulating neurovascular implantable medical devices. The product enables visualization of cerebral blood vessels for preoperational planning for neurovascular interventions and surgery. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of simulating neurovascular implantable medical devices in the artery or in the aneurysm to be treated through endovascular surgery and provides support in the treatment for the sizing and positioning of implantable medical devices.

Each type of implant device is simulated in a simulation module of Sim&Size:

FDsize, a module that allows pre-operationally planning Flow-Diverter (FD) devices.
IDsize, a module that allows pre-operationally planning Intrasaccular (ID) devices.
STsize, a module that allows pre-operationally planning Stent (ST) devices.
FCsize, a module that allows pre-operationally planning First and filling coils (FC) devices.

Associated with these four modules, a common module is intended to import DICOM and to provide a 3D reconstruction of the vascular tree in the surgical area.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for Sim&Size:

Acceptance Criteria and Device Performance

The provided document highlights performance testing without explicitly stating quantitative acceptance criteria. However, the nature of the tests implies the device must accurately "predictive behavior of the implantable medical device with its theoretical behavior," accurately "compare the device placement in a silicone phantom model with the device simulation," and accurately "compare the in vitro retrospective cases with the device simulation."

Given the context of a 510(k) submission, the implicit acceptance criterion is that the device's performance is substantially equivalent to the predicate device and that the new features do not raise new questions of safety and effectiveness.

Here's a table based on the types of performance tests conducted:

Acceptance Criteria (Implicit)	Reported Device Performance
Verification Testing: Predictive behavior matches theoretical behavior of implantable medical devices.	"Verification testing, which compares the predictive behavior of the implantable medical device with its theoretical behavior." (Implies successful verification based on "Conclusion" stating device "performs as intended.")
Bench Testing: Simulated device placement matches physical placement in a silicone phantom model.	"Bench testing, which compares the device placement in a silicone phantom model with the device simulation." (Implies successful bench testing based on "Conclusion" stating device "performs as intended.")
Retrospective In Vivo Testing: Simulated cases match actual in vivo outcomes (or in vitro representations of retrospective in vivo data).	"Retrospective in vivo testing, which compares the in vitro retrospective cases with the device simulation." (Implies successful retrospective testing based on "Conclusion" stating device "performs as intended.") This suggests the retrospective cases were either in vitro models derived from in vivo data or in vitro analyses of actual in vivo outcomes. The document specifically says "in vitro retrospective cases," which could mean a lab-based re-creation or analysis from real patient data.
Overall Performance: New features do not introduce new safety or effectiveness concerns and the device is substantially equivalent to the predicate.	The Conclusion states: "The subject and predicate devices are substantially equivalent. The results of the verification and validation tests demonstrate that the Sim&Size device performs as intended. The new features added to the subject device do not raise new questions of safety and effectiveness."

Study Details:

Based on the provided document, here's what can be inferred about the studies conducted:

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the document.
- Data Provenance:
  - "Retrospective in vivo testing" suggests real-world patient data, but the phrase "in vitro retrospective cases" implies these were lab-based re-creations or analyses of that data. The specific country of origin is not mentioned, but given the company's address (Montpellier, France), it's plausible the data could originate from Europe, although this is not confirmed.
  - "Bench testing" uses a "silicone phantom model," which is an experimental setup, not clinical data provenance.
  - "Verification testing" involves comparing theoretical behavior, which doesn't involve a dataset in the same way clinical or phantom models do.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The document refers to "theoretical behavior," "silicone phantom model," and "in vitro retrospective cases" as benchmarks, but it doesn't detail how the ground truth for "in vitro retrospective cases" was established or if experts were involved in defining the "theoretical behavior" or validating the phantom results.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study is explicitly mentioned. The device "enables visualization of cerebral blood vessels" and "allows for the ability to computationally model the placement of neurointerventional devices," but it's stated that "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." This indicates it's a tool for assistance, but the document does not detail studies on human reader performance improvement with this AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Verification testing," "Bench testing," and "Retrospective in vivo testing" (comparing simulations to "in vitro retrospective cases") all describe methods that would assess the algorithm's standalone performance without a human in the loop for the actual comparison/measurement, although human input (e.g., in segmentation, placing/sizing tools) is part of the device's intended use. The wording "compares the predictive behavior... with its theoretical behavior" and "compares the device placement... with the device simulation" explicitly refers to the device's performance, implying a standalone assessment of the algorithmic component.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Theoretical Behavior: Used for "Verification testing" (e.g., physical laws, engineering models of device deployment).
- Physical Phantom Model: Used for "Bench testing" (measurements from a physical silicone model).
- "In vitro retrospective cases": Used for "Retrospective in vivo testing." This implies a ground truth derived from actual patient data, analyzed or re-created in a laboratory (in vitro). It's not explicitly stated if this ground truth was pathology or outcomes data, but rather a representation of the in vivo reality.
The sample size for the training set:
- This information is not provided in the document. This section focuses on validation testing, not the training of any underlying models.
How the ground truth for the training set was established:
- This information is not provided as the document does not detail the training process.

Summary

{0}------------------------------------------------

December 14, 2024

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 the FDA logo, which 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.

Sim&Cure Colette Maurin Regulatory Affairs and Ouality Assurance Director 95 rue Pierre Flourens, Batiment H Montpellier, 34090 France

Re: K242124

Trade/Device Name: Sim&Size Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PZO Dated: July 19, 2024 Received: July 19, 2024

Dear Colette Maurin:

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"

{1}------------------------------------------------

(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).

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 OS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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).

{2}------------------------------------------------

Sincerely,

Michael Mcknight -S

for Sara S. Thompson, D.V.M. 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

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K242124

Device Name Sim&Size

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

and the same of the same of the same of the same of the same of

Image /page/4/Picture/1 description: The image is a logo for Sim&Cure. The words "Sim" and "Cure" are in white font, with a red ampersand (&) between them. Below the company name is the text "SECURE YOUR TREATMENT" in white font. The background is a dark blue color.

510(k) Summary K242124

1 Submitter

Submitter's Name: Sim&Cure Address: 95 Rue Pierre Flourens, Bâtiment H 34090 Montpellier FRANCE Phone: +33 9 53 43 88 09 Contact Person: Ms. Colette Maurin Senior Director, Regulatory Affairs & Quality Assurance Date Prepared: December 04th, 2024

2 Device

Device Trade Name: Sim&Size Common Name: Medical image management and processing system Classification Name: Software for Visualization of Vascular Anatomy and Intravascular Devices Regulation Number: 892.2050 Product Code: PZO

Predicate Device 3

Sim&Size, K222664. This predicate has not been subject to a recall.

4 Device description

Each type of implant device is simulated in a simulation module of Sim&Size:

FDsize, a module that allows pre-operationally planning Flow-Diverter (FD) devices.
IDsize, a module that allows pre-operationally planning Intrasaccular (ID) devices.
STsize, a module that allows pre-operationally planning Stent (ST) devices.
FCsize, a module that allows pre-operationally planning First and filling coils (FC) devices.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image is a logo for Sim&Cure. The words "Sim" and "Cure" are written in white, with a red ampersand (&) in between. Below the company name, the words "SECURE YOUR TREATMENT" are written in white.

Comments of the super of the super of the state of the state of the see

Associated with these four modules, a common module is intended to import DICOM and to provide a 3D reconstruction of the vascular tree in the surgical area.

5 Intended Use / Indications for Use

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 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

Comparison of technological characteristics with the predicate device 6

Sim&Size is a standalone software device that runs on a standard computer. Sim&Size is not intended for use on mobile devices. Sim&Size can use local DICOM files or retrieve them from distant PACS servers. The device does not come into contact with the patient or control any life-support equipment. 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. In the following comparison table, the devices/functions in bold font are newly added.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image is a logo for Sim & Cure. The words "Sim" and "Cure" are in white font, with a red ampersand (&) in between. Below the logo, the words "SECURE YOUR TREATMENT" are written in white font.

イベルではなくなるとなるとなるかなると、その他なのですが、その場になるとなるのだと

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image is a logo for Sim & Cure. The words "Sim" and "Cure" are in white font, with a red ampersand (&) between them. Below the company name is the text "SECURE YOUR TREATMENT" in a smaller white font. The background of the logo is blue.

and the same of the same of the same of the same of the

Performance Data 7

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".

Non-clinical bench performance testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions". The testing program comprised the following elements:

Verification testing, which compares the predictive behavior of the implantable medical device with its theoretical behavior.
Bench testing, which compares the device placement in a silicone phantom model with the device simulation.

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for Sim & Cure. The words "Sim" and "Cure" are written in white, with a red ampersand (&) between them. Below the company name is the text "SECURE YOUR TREATMENT" in white. The background is a dark blue color.

THULSSEE CALLES CONTRACT CONSTITUTION SECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULT

Retrospective in vivo testing, which compares the in vitro retrospective cases with the device . simulation.

Conclusion 8

The subject and predicate devices are substantially equivalent. The results of the verification and validation tests demonstrate that the Sim&Size device performs as intended. The new features added to the subject device do not raise new questions of safety and effectiveness.

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).

	Sim&SizeK222664(Predicate Device)	Sim&SizeK242124(Subject Device)	Comparison
Characteristics
Intended Use /Indications for Use	Sim&Size enables visualization of cerebralblood vessels for preoperational planning andsizing for neurovascular interventions andsurgery. Sim&Size also allows for the abilityto computationally model the placement ofneurointerventional devices.General functionalities are provided such as:• Segmentation of neurovascular structures• Automatic centerline detection• Visualization of X-ray based images for2D review and 3D reconstruction• Placing and sizing tools• Reporting toolsInformation provided by the software is notintended in any way to eliminate, replace orsubstitute for, in whole or in part, the	Sim&Size enables visualization of cerebralblood vessels for preoperational planning andsizing for neurovascular interventions andsurgery. Sim&Size also allows for the abilityto computationally model the placement ofneurointerventional devices.General functionalities are provided such as:• Segmentation of neurovascular structures• Automatic centerline detection• Visualization of X-ray based images for2D review and 3D reconstruction• Placing and sizing tools• Reporting toolsInformation provided by the software is notintended in any way to eliminate, replace orsubstitute for, in whole or in part, the	Same
	healthcare provider's judgment and analysisof the patient's condition.	healthcare provider's judgment and analysisof the patient's condition.
Patient contact	No	No	Same
Human interventionforimageinterpretation	Yes	Yes	Same
ComputerOS	MS WindowsMac OS	MS WindowsMac OS	Same
Patientdatamanagement	Import: manual through keyboard/mouse,and automatic import with an image file,study creation list.ExportDeletionAnonymizationSearch.	Import: manual through keyboard/mouse,and automatic import with an image file,study creation list.ExportDeletionAnonymizationSearch.	Same
Data interchange	Local files, transfer through physical media(e.g. USB memory stick) and PACSconnectivity (query/retrieve)	Local files, transfer through physical media(e.g. USB memory stick) and PACSconnectivity (query/retrieve)	Same
DICOM Support	Compatible with DICOM image data from3D rotational angiography stations.	Compatible with DICOM image data from3D rotational angiography stations.	Same
Image Processing	Segmentation by user.	Segmentation by user.	Same
Image display	Orthogonal, color volume rendering, activepresets, 3D view of assemblies of devices.	Orthogonal, color volume rendering, activepresets, 3D view of assemblies of devices.	Same
3D assessment	Assessment based on the 3D model of thesimulated implant in the cerebrovascular:- Apposition indication of the implantalong the arterial wall/aneurysm wall,- Volume embolization ratio indication ofcoil (FCsize module),- Metal surface coverage indication of theflow diverter (FDsize module),- Reconstructed structure measurements,- Simulated implant dimensionsmeasurements.	Assessment based on the 3D model of thesimulated implant in the cerebrovascular:- Apposition indication of the implantalong the arterial wall/aneurysm wall,- Volume embolization ratio indication ofcoil (FCsize module),- Metal surface coverage indication of theflow diverter (FDsize module),- Pull-down maneuver of flow diverterdeployment in fusiform aneurysms(FDsize module),- Compression indication of the implantalong the aneurysm wall (IDsize),- Reconstructed structure measurements,- Simulated implant dimensionsmeasurements.	Similar
ImplantableMedical DeviceDatabase	In the FDsize module:- Medtronic Pipeline Flex EmbolizationDevice (PED – P100018/S15);- Medtronic Pipeline Flex EmbolizationDevice with Shield Technology (PED2 –P100018/S026);- Stryker Surpass Evolve Flow DiverterSystem (P170024/S003);- MicroVention Flow Re-DirectionEndoluminal Device System (FRED –P180027);- MicroVention Flow Re-DirectionEndoluminal Device X System (FRED X –P180027/S002);	In the FDsize module:- Medtronic Pipeline Flex EmbolizationDevice (PED – P100018/S15);- Medtronic Pipeline Flex EmbolizationDevice with Shield Technology (PED2 –P100018/S026);- Medtronic Pipeline VantageEmbolization Device with ShieldTechnology (PED3 – P100018/S034);- Stryker Surpass Evolve Flow DiverterSystem (P170024/S003);- Stryker Surpass Elite Flow Diverter(P170024/S012);	Similar
	In the IDsize module:- Micro Vention Woven EndoBridgeAneurysm Embolization System (WEB -P170032).In the STsize module:- Stryker Neuroform Atlas Stent System(P180031/S001);- Micro Vention Low-Profile VisualizedIntraluminal Support and LVIS Jr (LVIS andLVIS Jr - P170013).In the FCsize module:- Medtronic Axium Detachable Coil andAxium Prime Detachable Coil (K203432);- MicroVention HydroCoil Embolic System(HES - K161367);	Micro Vention Flow Re-DirectionEndoluminal Device System (FRED -P180027);- Micro Vention Flow Re-DirectionEndoluminal Device X System (FRED X -P180027/S002).In the IDsize module:- Micro Vention Woven EndoBridgeAneurysm Embolization System (WEB -P170032).In the STsize module:- Stryker Neuroform Atlas Stent System(P180031/S001);- MicroVention Low-Profile VisualizedIntraluminal Support and LVIS Jr (LVIS andLVIS Jr - P170013);- Micro Vention Low-Profile VisualizedIntraluminal Support EVO (LVIS EVO)(P170013/S004).In the FCsize module:- Medtronic Axium Detachable Coil andAxium Prime Detachable Coil (K233420);- MicroVention HydroCoil Embolic System(HES - K161367);- Stryker Target and Target XXLDetachable Coils (K161429);- Stryker Target Tetra Detachable Coils(K222533);- Balt Optima Coil System (K223386).
Results output	Simulation report in PDF and DCM format.Arterial reconstruction with the deployeddevice in DCM format	Simulation report in PDF and DCM format.Arterial reconstruction with the deployeddevice in DCM and VTP format.	Similar