Who is the manufacturer of Sim&Size?

Sim&Cure filed the 510(k) submission for Sim&Size (K202322).

What is the FDA product code for Sim&Size?

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

What is the regulatory pathway for Sim&Size?

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

Who can help prepare an FDA 510(k) submission like Sim&Size?

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

Sim&Size

K202322 · Sim&Cure · PZO · Dec 31, 2020 · Radiology

Device Facts

Record ID	K202322
Device Name	Sim&Size
Applicant	Sim&Cure
Product Code	PZO · Radiology
Decision Date	Dec 31, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended 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 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 Story

Sim&Size is a software tool for preoperational planning of neurovascular interventions. It takes 3D rotational angiography DICOM images as input. The software segments neurovascular structures, detects centerlines, and allows clinicians to computationally model the placement of flow-diverter (FD) and intrasaccular devices (ISD). It provides 3D visualization of the vascular tree and simulated implant apposition. Used in clinical settings by physicians, the software assists in selecting optimal implant sizes. It features an in-house finite-element (sacFE) mechanical solver for ISD modeling and a computational algorithm for FD modeling. The output is used by clinicians to inform surgical planning; it does not replace professional judgment. The device is installed on PCs (Windows/Mac) and supports data retrieval from scanner workstations or physical media.

Clinical Evidence

No clinical trials; evidence based on bench testing, in vitro silicone phantom studies, and retrospective in vivo comparisons. Validation confirmed the predictability of the simulation model for new IMDs and the robustness of the new in-house mechanical solver compared to the previous version. All software verification and validation tests passed.

Technological Characteristics

Software-based radiological image processing. Compatible with MS Windows and Mac OS. Features: DICOM import, 3D reconstruction, automatic/manual centerline detection, and computational modeling of implants. Employs an in-house finite-element (sacFE) solver for intrasaccular devices and a computational algorithm for flow-diverters. Cybersecurity controls included. Software level of concern: moderate.

Indications for Use

Indicated for preoperational planning and sizing for neurovascular interventions and surgery, including computational modeling of neurointerventional device placement in cerebral blood vessels.

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 (K190049)

Related Devices

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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. December 31, 2020 Sim&Cure Caroline Oziel Quality Assurance and Regulatory Affairs Manager 95 rue Pierre Flourens Bâtiment H Montpellier 34090 France Re: K202322 Trade/Device Name: Sim&Size Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: PZO Dated: November 13, 2020 Received: November 25, 2020 Dear Caroline Oziel: 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 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, for 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 Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202322 Device Name Sim&Size Indications for Use (Describe) 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. | 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Sim&Cure. The text "Sim" and "Cure" are written in a light blue font, with a red ampersand (&) between them. Below the logo, the text "SECURE YOUR TREATMENT" is written in a smaller, light blue font. # K202322 510(k) Summarv # 1. Submitter Submitter's Name: Sim&Cure Address: 95 rue Pierre Flourens, Bâtiment H 34090 Montpellier FRANCE Phone: +33 953 43 88 09 Contact Person: Caroline OZIEL Quality Assurance and Regulatory Affairs Manager Sim&Cure Date of Preparation: December 18, 2020 #### 2. Device Information Trade Name: Sim&Size Device Classification Name: Software for Visualization of Vascular Anatomy and Intravascular Devices Common Name: Radiological Image Processing Software Regulation Number: 892.2050 Class: II Product Code: PZO # 3. Predicate Device K190049 - Sim&Size, Sim&Cure. # 4. Device Description The Sim&Size software is a medical device intended to provide a 3D view of the final placement of implants. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of computationally model neurovascular implantable medical devices (IMD) in the artery or in the aneurysm to be treated through endovascular surgery, IMD such as the flow-diverters (FD) and the intrasaccular devices (ISD). Sim&Size is a software designed with two modules. FDsize is the module that allows to preoperationally plan the choice of size of flow-diverter devices. IDsize is the module that allows to preoperationally plan the choice of size of intrasaccular devices. Associated to these two modules, a common module is intended to import DICOM and to provide a 3D reconstruction of the vascular tree in the surgical area. Sim&Size has been simplified as much as possible to guide the user in an intuitive way in order to reduce the total number of actions required and thus to optimize the time taken to obtain the desired results. There are currently seven steps required to choose the optimal size of an IMD to be placed: - 1- Importing the images: the 3D rotational angiography DICOM files are imported. - 2- Selecting of the region of interest (ROI): the user positions and focuses a sphere in the placement zone. - 3- Threshold validation: the user checks the accuracy of the automatically extracted arterial wall. The threshold can be adjusted if needed. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Sim & Cure. The logo is in blue and red, with the words "Sim & Cure" in large, bold letters. Below the logo, the words "SECURE YOUR TREATMENT" are written in smaller letters. The ampersand in the logo is red and shaped like a hook. - 4- Choosing the entry point: the user clicks on the entry point to the arterial network in order to retrieve the vessel centerlines. - 5- Correct automatically or manually the centerline if needed: the user corrects the centerline going through a vessel fusion with the automatic tool or manually. - 6- Initializing the implant: the user selects an IMD reference and the ideal placement zone. - 7- Sizing the implant: IMD apposition is shown by a color chart in the 3D view. The user can change the IMD reference and placement zone to complete the planning for the intervention. Patient images can be imported into Sim&Size in two ways: the user has the ability to transfer images using an external storage device (e.g. USB stick) or to retrieve images directly from Scanners Workstation if the option is enabled (only the retrieve function is possible). The Sim&Size software is compatible with the operating systems MS Windows and Mac OS, when it is first installed a check is done to verify if the user's computer meets the minimum requirements for the use of the software. When a new version of the software is available, the update can be done by the user through a link send by Sim&Cure, the user then follow the instructions indicated in the user manual or by the use of the updater tool SacUpdates that notifies the user, then assists the download and the installation of the last version. The computational modeling of three devices are supported by the software: Medtronic Pipeline Flex Embolization Device (PED - P100018/S015) flow diverter: Stryker Surpass Evolve Flow Diverter System (Evolve - P170024 S003); and Microvention Woven EndoBridge Aneurysm Embolism System (WEB - P170032) intrasaccular devices. The Medtronic Pipeline Flex Embolization Device, Stryker Surpass Evolve Flow Diverter and Microvention Woven EndoBridge Aneurysm Embolism System devices referenced here are FDA-approved neurointerventional devices. # 5. Intended 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 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. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Sim & Cure. The logo is in blue and white, with the ampersand in red. Below the logo is the text "SECURE YOUR TREATMENT" in white. The logo is simple and modern. # 6. Comparison of Technological Characteristics with the predicate device The predicate device for the new version of Sim&Size software is the last version of Sim&Size, cleared per premarket notification K190049. Both versions of Sim&Size have the same indications for use for preoperational planning of neurovascular procedures using existing image data. A summary comparison of technological characteristics is provided below: | Characteristic | Predicate device Sim&Size version 1.0.5 K190049 | Subject device Sim&Size version 1.0.6 This submission K202322 | |-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | 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 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. | Same | | Interface to Image Sources | DICOM Image Data | Same | | Import of Patient Data | Manual through keyboard/mouse, automatic import with image file, study creation list | Same | | List Image Functionality | Deleting, anonymizing, search | Same | | Image Processing | Segmentation by user with clinician review and comment | Same | | 3D Assessment | 3D assessment based on 3D model of the simulated device inside the vessels | Same | | Image and 3D Display | Orthogonal, color volume rendering, 2D slide review, active presets, 3D view of assemblies of devices | Same | | DICOM Support | Read DICOM images from 3D rotational angiography stations | Same | | Computer OS Compatibility | MS Windows and Mac OS | Same | | Characteristic | Predicate device Sim&Size version 1.0.5 K190049 | Subject device Sim&Size version 1.0.6 This submission K202322 | | Data Interchange/Transfer Method | Transfer by physical media; i.e. USB memory stick | Transfer by physical media; i.e. USB memory stick and Scanner Workstations (retrieve function only). | | Output File Format | Local openGL rendering | Same | | Preoperational Planning | Yes | Yes | | Patient Contact | No | No | | Human Intervention for Interpretation of Images | Yes | Yes | | Implantable Medical Device (IMD) Database | IMDs included: - Pipeline™ Flex Embolization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, PMA number P100018/S015) - Woven EndoBridge (WEB) Aneurysm Embolization System (MicroVention, Inc., PMA number P170032). | Addition of one IMD database: - Surpass Evolve Flow Diverter System (Stryker Neurovascular, P170024/ S003). | | Mechanical solver (used for ID module only)* | Ansys solver (off-the-shelf solver) | Sim&Cure Finite-Element (sacFE) solver (in-house solver) | | Fusion correction | Automatic | Automatic and manual | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for Sim & Cure. The logo is white text on a blue background. The ampersand is red. Below the logo is the text "SECURE YOUR TREATMENT". * The FD module doesn't use any mechanical solver but is based on a computational algorithm. No change has been brought to the algorithm on which is based the FDSize module. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Sim & Cure. The words "Sim" and "Cure" are written in a thin, sans-serif font in white, with a red ampersand (&) between them. Below the logo, the words "SECURE YOUR TREATMENT" are written in a smaller, sans-serif font, also in white. The background is blue. # 7. Performance Data The following performance data were performed on Sim&Size in support of the substantial equivalence determination. #### Software Verification and Validation Testing Software verification and validation testing were conducted, and documentation was 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" in section 16. The software for this device was considered as a "moderate" level of concern, since prior to mitigation of hazards, could a failure of the Software Device result in Minor Injury, either to a patient or to a user of the device. The performances tested are the following ones: - Tests of importation of DICOM images. ● - Patient manager tests. ● - Tests of image display and processing. - . Functioning tests for visualization of anatomic reconstruction. - . Report creation and visualization tests. - Fusion correction tests (automatic and manual). - Cybersecurity tests. . The new feature of manual fusion correction has been tested and the tests are passed. The cybersecurity testing has been improved and all the tests are passed. In addition, some non-regression testing is included in our continuous tests in order to check if the addition of new features has not involuntarily induced alteration between versions. There is no regression between the predicate device and the version 1.0.6. All the continuous, supervised and acceptance tests are pass with the version 1.0.6. All these tests are pass and allow to demonstrate that the performance and the safety are maintained between the predicate device and the device object of this submission. #### Performance Testing - Bench The following performances are tested through the Bench tests : functioning tests for computational modeling of neurovascular devices. #### FDsize module - The verification testing checks that the Flow Diverter final length and apposition computed ● through the software are conform to their mathematical definition. - The validation tests are: - Experimental benchtests to perform optical acquisitions of new IMD devices samples in O both unconstrained and constrained configurations. - Realistic in vitro (silicone model) datasets in which the predictability of the O simulation model is assessed comparing in-vitro and virtual Flow Diverters devices implanted in silicone phantom of patients presenting with intracranial aneurysms. - In vivo studies for which the results are based on comparisons between FD implanted in O patients presenting with intracranial aneurysms and virtual FD deployment. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Sim&Cure. The words "Sim" and "Cure" are written in a white sans-serif font, with a red ampersand (&) between them. Below the logo, the words "SECURE YOUR TREATMENT" are written in a smaller, white sans-serif font. The background of the image is blue. These validation testing allows to: - ensure that the simulation model originally implemented is also valid for the new IMD o added. - verify the proper calibration of the simulation model with the device geometrical O parameters that were provided by each of the device manufacturers. - assess the predictability of the product Sim&Size for the new IMDs. O The results obtained in these verification and validation studies allow to demonstrate that the inclusion of the new Implantable Medical Devices databases in the Sim&Size software have no impact on of the safety and performance of the device. #### IDsize module - The verification testing provides the verification and validation of the new in-house mechanical ● solver. The simulation model is based on this solver, for which a variety of verification test cases were performed. The significant amount of performed verification test cases makes us confident about this in-house solver and enables us to rule on the proper verification of the computational model. - The validation tests are: - Experimental benchtests which assess the accuracy of the IDsize computational model in a o well-controlled experimental configuration. - Realistic in vitro (silicone model) datasets in which a comparison is done between O implanted in silicon phantoms of idealized aneurysms anatomies and virtual WEB computationally modeling with Sim&Size. - In vivo studies for which the results are based on comparisons between WEB implanted in O patients presenting with intracranial aneurysms and virtual WEB deployment. These validation testing allows to: - Demonstrate that the new simulation model appeared to be more robust than the old one and o better captures the mechanical behavior of the device when subjected to the compression solicitation than the old simulation model. - Assess the predictability of the product Sim&Size for the Intrasaccular Device WEB. o - Demonstrate that the new and old model provide a similar overall accuracy. O The results presented in these verification and validation studies allow to demonstrate that integration of the new mechanical solver and the model change in the Sim&Size software have no impact on of the safety and performance of the device. All performance testing has been performed and passed. The software Sim&Size in its last version 1.0.6 has met the required specifications for the completed tests. #### 8. Summary Sim&Cure has demonstrated that the Sim&Size is substantially equivalent to its listed predicate device.