(147 days)
No
The summary describes image processing and computational modeling for device placement and sizing, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The performance studies focus on comparing simulation outputs to theoretical behavior, physical characteristics, and retrospective clinical data, not on evaluating the performance of an AI/ML model.
No
The device is a pre-operational planning and simulation tool for neurovascular interventions, not a device that directly provides therapy. It helps in sizing and placing medical devices but does not deliver any therapeutic agent or action itself.
No
The device is for pre-operative planning and simulation of neurovascular interventions using existing imaging data. It does not perform a direct diagnostic function, but rather helps in treatment planning based on an already established diagnosis. The text 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."
Yes
The device is explicitly described as "Software as a Medical Device (SaMD)" and its functionality is entirely based on processing and visualizing medical images and computationally modeling device placement. There is no mention of accompanying hardware components that are part of the regulated 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 devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Sim&Size's Intended Use: Sim&Size is intended for the visualization of cerebral blood vessels and computational modeling of neurointerventional device placement for preoperational planning. It uses imaging data (3D rotational angiography) of the patient's anatomy, not specimens taken from the body.
- Device Description: The description clearly states it's a Software as a Medical Device (SaMD) for the simulation of neurovascular implantable medical devices. It processes imaging data to aid in planning, not to analyze biological samples.
The device's function is focused on image processing and simulation for surgical planning, which falls outside the scope of In Vitro Diagnostics.
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
Sim&Size is a Software as a Medical Device (SaMD) for the simulation of neurovascular implantable medical devices (IMD). 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 computationally modeling the placement of neurovascular IMD in the artery or in the aneurysm to be treated through endovascular surgery and allows to preoperationally plan the sizing and the positioning of IMD.
Sim&Size includes four modules:
- FDsize module allows to pre-operationally plan the choice of size of flow-diverter devices;
- IDsize module allows to pre-operationally plan the choice of size of intrasaccular devices;
- STsize module allows to pre-operationally plan the choice of stents;
- FCsize module allows to pre-operationally plan the choice of first and filling embolization coils.
Associated to these four modules, a common module is intended to import DICOM images and to provide a 3D reconstruction of the vascular tree in the surgical area.
The computational modeling of the following devices is supported by the software:
- In the FDsize module:
- Medtronic Pipeline Flex Embolization Device (PED P100018/S015);
- Medtronic Pipeline Flex Embolization Device with Shield Technology (PED2 P100018/S026);
- Stryker Surpass Evolve Flow Diverter System (P170024/S003):
- MicroVention Flow Re-Direction Endoluminal Device System (FRED P180027);
- MicroVention Flow Re-Direction Endoluminal Device X System (FRED X P180027/S002).
- In the IDsize module:
- MicroVention Woven EndoBridge Aneurysm Embolization System (WEB P170032).
- In the STsize module:
- Stryker Neuroform Atlas Stent System (P180031);
- MicroVention Low-Profile Visualized Intraluminal Support and LVIS Jr (LVIS and LVIS Jr -P170013)
- In the FCsize module:
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D rotational angiography, X-Ray based images
Anatomical Site
Cerebral blood vessels (neurovascular structures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare provider, preoperational planning for neurovascular interventions and surgery.
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
A non-clinical study has been performed, in which the predictability of the simulation model is assessed comparing in-vitro and virtual coil devices implanted in silicone phantom based on anatomy of patients presenting with intracranial aneurysms.
Two studies using retrospective clinical images have been performed to assess:
- the predictability of the Sim&Size simulations for the Axium (Medtronic) and Hydrogel (MicroVention) embolization coils, comparing the software output (volume embolization ratio) with the measurements taken from retrospective images of previously treated patients.
- the predictability of the Sim&Size simulations for the overlapping flow diverters feature, comparing the software output with the measurements taken from retrospective images of previously treated patients.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of computational modeling of neurovascular devices is tested through bench performance testing.
The verification process consists of comparing the behavior of the implantable medical device with its theoretical behavior.
The validation process consists of checking the physical characteristics of the IMD, which are used as input data for the simulation model.
Additionally, a non-clinical study has been performed, in which the predictability of the simulation model is assessed comparing in-vitro and virtual coil devices implanted in silicone phantom based on anatomy of patients presenting with intracranial aneurysms. The tests met the pre-defined acceptance criteria.
Furthermore, two studies using retrospective clinical images have been performed to assess:
- the predictability of the Sim&Size simulations for the Axium (Medtronic) and Hydrogel (MicroVention) embolization coils, comparing the software output (volume embolization ratio) with the measurements taken from retrospective images of previously treated patients.
- the predictability of the Sim&Size simulations for the overlapping flow diverters feature, comparing the software output with the measurements taken from retrospective images of previously treated patients.
The results of the verification and validation tests demonstrate that the device performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Volume embolization ratio
Predicate Device(s)
Reference Device(s)
P100018/S015, P100018/S026, P170024/S003, P180027, P180027/S002, P170032, P180031, P170013, K203432, K161367
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, 2023
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 text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
Sim&Cure Colette Maurin Senior Director, Regulatory Affairs and Quality Assurance 95 rue Pierre Flourens, Bâtiment H Montpellier, 34090 France
Re: K222664
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 28, 2022 Received: December 28, 2022
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 (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
1
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 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 (OS) 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 -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
Enclosure
2
Indications for Use
510(k) Number (if known) K222664
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)
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Image /page/3/Picture/0 description: The image is a logo for Sim & Cure. The logo is white and red text on a blue background. The text reads "Sim & Cure" on the top line and "SECURE YOUR TREATMENT" on the second line. The ampersand in the first line is red.
K222664 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: Ms. Colette Maurin Senior Director, Regulatory Affairs & Quality Assurance
Date of Preparation: January 25th, 2023
2. Device Information
Trade Name: Sim&Size Device Classification Name: Software for Visualization of Vascular Anatomy and Intravascular Devices Common Name: Medical image management and processing system Regulation Number: 892.2050 Class: II Product Code: PZO
3. Predicate Device
K212373 - Sim&Size, Sim&Cure.
4. Device Description
Sim&Size is a Software as a Medical Device (SaMD) for the simulation of neurovascular implantable medical devices (IMD). 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 computationally modeling the placement of neurovascular IMD in the artery or in the aneurysm to be treated through endovascular surgery and allows to preoperationally plan the sizing and the positioning of IMD.
Sim&Size includes four modules:
- FDsize module allows to pre-operationally plan the choice of size of flow-diverter devices;
- IDsize module allows to pre-operationally plan the choice of size of intrasaccular devices;
- STsize module allows to pre-operationally plan the choice of stents;
- FCsize module allows to pre-operationally plan the choice of first and filling embolization coils.
Associated to these four modules, a common module is intended to import DICOM images and to provide a 3D reconstruction of the vascular tree in the surgical area.
The computational modeling of the following devices is supported by the software:
- In the FDsize module:
- Medtronic Pipeline Flex Embolization Device (PED P100018/S015);
4
Image /page/4/Picture/0 description: The image shows the logo for Sim & Cure. The logo is white and red and is set against a blue background. Below the logo is the text "SECURE YOUR TREATMENT" in white.
- Medtronic Pipeline Flex Embolization Device with Shield Technology (PED2 P100018/S026);
- Stryker Surpass Evolve Flow Diverter System (P170024/S003):
- MicroVention Flow Re-Direction Endoluminal Device System (FRED P180027);
- MicroVention Flow Re-Direction Endoluminal Device X System (FRED X P180027/S002).
- In the IDsize module:
- MicroVention Woven EndoBridge Aneurysm Embolization System (WEB P170032).
- In the STsize module:
- Stryker Neuroform Atlas Stent System (P180031);
- MicroVention Low-Profile Visualized Intraluminal Support and LVIS Jr (LVIS and LVIS Jr -P170013)
- In the FCsize module:
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. Indications for Use Comparison
The predicate device for the new version of Sim&Size software is the prior version of Sim&Size, cleared per premarket notification K212373. Both versions of Sim&Size have the same indications for use for preoperational planning of neurovascular procedures using existing image data.
7. Comparison of Technological Characteristics
Compared to the predicate device, which is the prior version of Sim&Size cleared per premarket notification K212373, the new version of Sim&Size subject of this submission includes:
- . New FCsize module. This module allows to pre-onerationally plan the choice of first and filling coils. The computational modeling of the following embolization coils is supported by the software:
- Automated region of interest initialization, vessel wall threshold, and vessel entry point features ● have been added, which should be further verified by the user and can be adjusted, if necessary.
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Image /page/5/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, sans-serif font. The background of the image is blue.
- Ability to computationally model overlapped flow-diverters. ●
Performance testing and verification and validation activities performed have demonstrated that the device performs as intended. The differences in technological characteristics do not raise new questions of safety and effectiveness of the device.
8. Performance Data
The performance testing of the subject device was developed using the following FDA guidance, "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions," issued on December 20, 2019.
The performance of computational modeling of neurovascular devices is tested through bench performance testing.
The verification process consists of comparing the behavior of the implantable medical device with its theoretical behavior.
The validation process consists of checking the physical characteristics of the IMD, which are used as input data for the simulation model.
Additionally, a non-clinical study has been performed, in which the predictability of the simulation model is assessed comparing in-vitro and virtual coil devices implanted in silicone phantom based on anatomy of patients presenting with intracranial aneurysms. The tests met the pre-defined acceptance criteria.
Furthermore, two studies using retrospective clinical images have been performed to assess:
- the predictability of the Sim&Size simulations for the Axium (Medtronic) and Hydrogel (MicroVention) embolization coils, comparing the software output (volume embolization ratio) with the measurements taken from retrospective images of previously treated patients.
- the predictability of the Sim&Size simulations for the overlapping flow diverters feature, comparing the software output with the measurements taken from retrospective images of previously treated patients.
9. 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 device performs as intended. The inclusion of the new FCsize module in the Sim&Size software and other new features do not raise new questions of safety and effectiveness.