(181 days)
Not Found
No
The summary describes image processing and computational modeling but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The device is a preoperational planning tool for neurovascular interventions, providing visualization, segmentation, and sizing of implants. It does not directly perform any therapeutic action on the patient.
No.
The device is intended for pre-operational planning and sizing for neurovascular interventions and surgery, and for computationally modeling the placement of neurointerventional devices. It uses visualization and modeling tools, but does not provide a diagnosis. The information provided by the software is explicitly stated as "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."
Yes
The device description explicitly states "The Sim&Size software is a medical device intended to provide a 3D view..." and details its functionalities as software modules. The performance studies focus on software verification and validation, as well as bench testing of the software's computational modeling capabilities, without mentioning any associated hardware components being part of the device itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Sim&Size's Function: Sim&Size operates on imaging data (3D rotational angiography) of the patient's cerebral blood vessels. It processes this image data to visualize structures, perform measurements, and computationally model the placement of devices. It does not analyze biological samples from the patient.
- Intended Use: The intended use is for preoperational planning and sizing for neurovascular interventions and surgery, and for computational modeling of device placement. This is a planning and visualization tool based on imaging, not a diagnostic test performed on a biological sample.
Therefore, Sim&Size falls under the category of a medical device that processes imaging data for surgical planning and visualization, not an In Vitro Diagnostic device.
N/A
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
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.
Product codes
PZO
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 three modules. FDsize is the module that allows to pre-operationally plan the choice of size of flow-diverter devices. IDsize is the module that allows to pre-operationally plan the choice of size of intrasaccular devices. STsize is the module that allows to pre-operationally plan the choice of stent devices.
Associated to these three 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. They are currently seven steps required to choose the optimal size of 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- Choosing the entry point: the user clicks on the entry point to the arterial network in order to retrieve the vessel centerlines.
- Correct automatically or manually the centerline if needed: the user corrects the centerline going 5through 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 wavs: the user can transfer images using an external storage device (i.e.. USB stick) or to retrieve images directly from PACS connectivity 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 follows the instructions indicated in the user manual or using the updater tool SacUpdates that notifies the user, then assists the download and the installation of the last version.
The computational modeling of the following devices is supported by the software:
- In the FDsize module:
- Medtronic Pipeline Flex Embolization Device (PED P100018/S015); o
- Medtronic Pipeline Flex Embolization Device with Shield Technology (P100018/S026); O
- Stryker Surpass Evolve Flow Diverter System (P170024/S003); O
- MicroVention Flow Re-Direction Endoluminal Device System (FRED P180027); O
- MicroVention Flow Re-Direction Endoluminal Device X System (FRED X P180027/S002). O In the IDsize module:
- MicroVention Woven EndoBridge Aneurysm Embolization System (WEB P170032). O
- In the STsize module:
●
- Stryker Neuroform Atlas Stent System (P180031): O
- MicroVention Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr (LVIS and o LVIS Jr - P170013).
The devices referenced here are FDA-approved neurointerventional devices.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray based images for 2D review and 3D reconstruction; 3D rotational angiography
Anatomical Site
Cerebral blood vessels, intracranial aneurysms.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare provider
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing:
- 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.
All new features have been tested and passed. Non-regression testing confirmed no alteration between versions. All continuous, supervised, and acceptance tests passed for version 1.1.2. The tests demonstrate performance and safety are maintained.
Performance Testing - Bench:
FDsize module:
- Verification testing checked that Flow Diverter final length and apposition computed through the software conform to their mathematical definition.
- Validation tests included:
- Experimental bench tests using optical imaging of new IMD devices samples in both unconstrained and constrained configurations.
- In vitro (silicon model) datasets assessing predictability of simulation model by comparing in-vitro and virtual Flow Diverter devices implanted in silicone phantoms based on patient anatomy.
This validation ensured simulation model validity for new IMDs, proper calibration with device geometrical parameters from manufacturers, and assessed predictability of Sim&Size output for new IMDs.
IDsize module:
No change in comparison with predicate device K202322.
STsize module:
- Verification testing for laser cut stents provided through verification of the in-house numerical solver.
- Verification testing for braided stents checked that the IMD final length and apposition computed through the software conform to their mathematical definition.
- Validation tests included:
- Experimental bench tests using optical imaging of new IMD devices samples in both unconstrained and constrained configurations.
- In vitro (silicon model) datasets assessing predictability of simulation model by comparing in-vitro and virtual Stent devices implanted in silicone phantoms based on patient anatomy.
This validation ensured simulation model validity for new stent IMDs, proper calibration with device geometrical parameters from manufacturers, and assessed predictability of Sim&Size output for new IMDs.
All performance testing passed, and Sim&Size software version 1.1.2 met required specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
January 27, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
Sim&Cure Lucile Azéma Quality Assurance and Regulatory Affairs Engineer 95 rue Pierre Flourens, Bâtiment H Montpellier, 34090 France
Re: K212373
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: December 24, 2021 Received: December 30, 2021
Dear Lucile Azéma:
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,
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) K212373
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------ | ----------------------------------------------- |
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3
K212373 510(k) Summary
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: Lucile AZEMA Quality Assurance and Regulatory Affairs Engineer Sim&Cure
Date of Preparation: January 26th, 2022
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
K202322 - 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 three modules. FDsize is the module that allows to pre-operationally plan the choice of size of flow-diverter devices. IDsize is the module that allows to pre-operationally plan the choice of size of intrasaccular devices. STsize is the module that allows to pre-operationally plan the choice of stent devices.
Associated to these three 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. They are currently seven steps required to choose the optimal size of 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- Choosing the entry point: the user clicks on the entry point to the arterial network in order to retrieve the vessel centerlines.
4
- Correct automatically or manually the centerline if needed: the user corrects the centerline going 5through 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 wavs: the user can transfer images using an external storage device (i.e.. USB stick) or to retrieve images directly from PACS connectivity 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 follows the instructions indicated in the user manual or using the updater tool SacUpdates that notifies the user, then assists the download and the installation of the last version.
The computational modeling of the following devices is supported by the software:
- In the FDsize module:
- Medtronic Pipeline Flex Embolization Device (PED P100018/S015); o
- Medtronic Pipeline Flex Embolization Device with Shield Technology (P100018/S026); O
- Stryker Surpass Evolve Flow Diverter System (P170024/S003); O
- MicroVention Flow Re-Direction Endoluminal Device System (FRED P180027); O
- MicroVention Flow Re-Direction Endoluminal Device X System (FRED X P180027/S002). O In the IDsize module:
- MicroVention Woven EndoBridge Aneurysm Embolization System (WEB P170032). O
- In the STsize module:
●
- Stryker Neuroform Atlas Stent System (P180031): O
- MicroVention Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr (LVIS and o LVIS Jr - P170013).
The devices referenced here are FDA-approved neurointerventional devices.
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
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.
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 K202322. 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:
5
| Characteristics | Predicate device
Sim&Size v 1.0.6
K202322 | Subject device
Sim&Size v 1.1.2
This submission K212373 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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 |
| Data Interchange/ Transfer Method | Transfer by physical media; i.e. USB memory stick and PACS connectivity (retrieve function only). | Same |
| Output File Format | Local openGL rendering | Same |
| Preoperational Planning | Yes | Yes |
| Patient Contact | No | No |
| Human Intervention for Interpretation of Images | Yes | Yes |
| Characteristics | Predicate device
Sim&Size v 1.0.6
K202322 | Subject device
Sim&Size v 1.1.2
This submission K212373 |
| STSize Module | No. | Yes
The computational model is based on
the FDsize module for the braided
stents and on the IDsize module for
the laser cut stents. |
| Implantable
Medical Device
(IMD) Database | IMDs included:
- Pipeline™ Flex Embolization Device (Micro
Therapeutics, Inc. d/b/a ev3 Neurovascular,
P100018/S015). - Woven EndoBridge (WEB) Aneurysm
Embolization System (MicroVention, Inc.,
P170032). - Surpass Evolve Flow Diverter System (Stryker
Neurovascular, P170024/S003). | Addition of the following IMDs:
In the FDsize module: - Pipeline™ Flex Embolization Device
with Shield Technology (Micro
Therapeutics, Inc. d/b/a ev3
Neurovascular, P100018/S026). - Flow Re-Direction Endoluminal
Device System (MicroVention, Inc.,
P180027). - Flow Re-Direction Endoluminal
Device X System (MicroVention, Inc.,
P180027/S002).
In the STsize module: - Neuroform Atlas Stent System
(Stryker Neurovascular, P180031). - Low-Profile Visualized Intraluminal
Support (LVIS) and LVIS Jr
(MicroVention, Inc., P170013). |
| Numerical solver | Sim&Cure Finite-Element (sacFE) solver
(in-house solver) | Same |
| Fusion | Automatic and manual | Same |
6
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."
The software for this device was considered as a "moderate" level of concern, since prior to mitigation of hazards, a failure of the software device could result in minor injury, either to a patient or to a user of the device.
The verification and validation tests included:
- 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.
All the new features described have been tested and the tests are passed.
7
In addition, some non-regression testing is included in our continuous tests 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 1.1.2.
All the continuous, supervised and acceptance tests are pass with the version 1.1.2.
The verification and validation tests demonstrate that the performance and the safety are maintained between the predicate and the subject device.
Performance Testing - Bench
The following performance is tested through the bench 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 conform to their mathematical definition.
- . The validation tests included:
- Experimental bench tests using optical imaging of new IMD devices samples in both O unconstrained and constrained configurations.
- In vitro (silicon model) datasets in which the predictability of the simulation model is assessed O comparing in-vitro and virtual Flow Diverter devices implanted in silicone phantom based on anatomy of patients presenting with intracranial aneurysms.
This validation testing allows to:
- Ensure that the simulation model originally implemented is also valid for the new IMD devices o added.
- Verify the proper calibration of the simulation model with the device geometrical parameters O that were provided by each of the IMD device manufacturers.
- Assess the predictability of the Sim&Size output for the new IMDs. O
IDsize module
No change in comparison with predicate device K202322.
STsize module
- . The verification testing for laser cut stents is provided through the verification of the in-house numerical solver.
- The verification testing for braided stents checks that the IMD final length and apposition computed through the software conform to their mathematical definition.
- . The validation tests included:
- Experimental bench tests using optical imaging of new IMD devices samples in both o unconstrained and constrained configurations.
- In vitro (silicon model) datasets in which the predictability of the simulation model is assessed O comparing in-vitro and virtual Stent devices implanted in silicone phantom based on anatomy of patients presenting with intracranial aneurysms.
This validation testing allows to:
- Ensure that the simulation model originally implemented is also valid for the new stent IMDs O added.
- Verify the proper calibration of the simulation model with the device geometrical parameters O that were provided by each of the IMD device manufacturers.
- Assess the predictability of the Sim&Size output for the new IMDs. O
8
All performance testing has been performed and passed. The Sim&Size software version 1.1.2 has met the required specifications for the completed tests.
8. Summary
Sim&Cure has demonstrated that the Sim&Size software device is substantially equivalent to its listed predicate device. The results of the verification and validation tests demonstrate that the inclusion of the new implantable medical device databases in the Sim&Size software does not raise new questions of safety and effectiveness.