(148 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The functionalities described (segmentation, centerline detection, visualization, placing/sizing tools) are common in medical imaging software and do not inherently require AI/ML.
No
The device is a software solution for pre-operational planning and simulation of neurovascular interventions, assisting healthcare providers in sizing and positioning implantable devices, but it does not directly treat or diagnose diseases.
No
The device is described as a tool for preoperational planning and simulation of neurovascular interventions, focused on visualizing blood vessels and modeling device placement and sizing. It explicitly states 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," which indicates it is not used for diagnosing or determining a patient's condition.
Yes
The device is explicitly described as "Software as a Medical Device (SaMD)" and its functionalities are purely computational and visualization-based, operating on existing image data. There is no mention of associated hardware components included with the device.
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 examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used to diagnose, monitor, or screen for diseases or conditions.
- Sim&Size Functionality: Sim&Size's intended use and device description clearly state that it is a software for visualizing cerebral blood vessels and simulating the placement of neurointerventional devices based on imaging data (3D rotational angiography). It does not analyze biological specimens from the patient's body.
- Purpose: The purpose of Sim&Size is for preoperational planning and sizing for neurovascular interventions and surgery, not for diagnosing or monitoring a patient's condition through the analysis of biological samples.
Therefore, Sim&Size falls under the category of a medical device used for image processing and surgical planning, 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 (comma separated list FDA assigned to the subject device)
PZO
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D rotational angiography
Anatomical Site
Cerebral blood vessels (neurovascular structures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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.
- Retrospective in vivo testing, which compares the in vitro retrospective cases with the device simulation.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Sim&Size, K222664
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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)
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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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
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.
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
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.
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.
| | Sim&Size
K222664
(Predicate Device) | Sim&Size
K242124
(Subject Device) | Comparison |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Characteristics | | | |
| 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 | 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 | Same |
| | healthcare provider's judgment and analysis
of the patient's condition. | healthcare provider's judgment and analysis
of the patient's condition. | |
| Patient contact | No | No | Same |
| Human intervention
for
image
interpretation | Yes | Yes | Same |
| Computer
OS | MS Windows
Mac OS | MS Windows
Mac OS | Same |
| Patient
data
management | Import: manual through keyboard/mouse,
and automatic import with an image file,
study creation list.
Export
Deletion
Anonymization
Search. | Import: manual through keyboard/mouse,
and automatic import with an image file,
study creation list.
Export
Deletion
Anonymization
Search. | Same |
| Data interchange | Local files, transfer through physical media
(e.g. USB memory stick) and PACS
connectivity (query/retrieve) | Local files, transfer through physical media
(e.g. USB memory stick) and PACS
connectivity (query/retrieve) | Same |
| DICOM Support | Compatible with DICOM image data from
3D rotational angiography stations. | Compatible with DICOM image data from
3D rotational angiography stations. | Same |
| Image Processing | Segmentation by user. | Segmentation by user. | Same |
| Image display | Orthogonal, color volume rendering, active
presets, 3D view of assemblies of devices. | Orthogonal, color volume rendering, active
presets, 3D view of assemblies of devices. | Same |
| 3D assessment | Assessment based on the 3D model of the
simulated implant in the cerebrovascular:
- Apposition indication of the implant
along the arterial wall/aneurysm wall, - Volume embolization ratio indication of
coil (FCsize module), - Metal surface coverage indication of the
flow diverter (FDsize module), - Reconstructed structure measurements,
- Simulated implant dimensions
measurements. | Assessment based on the 3D model of the
simulated implant in the cerebrovascular: - Apposition indication of the implant
along the arterial wall/aneurysm wall, - Volume embolization ratio indication of
coil (FCsize module), - Metal surface coverage indication of the
flow diverter (FDsize module), - Pull-down maneuver of flow diverter
deployment in fusiform aneurysms
(FDsize module), - Compression indication of the implant
along the aneurysm wall (IDsize), - Reconstructed structure measurements,
- Simulated implant dimensions
measurements. | Similar |
| Implantable
Medical Device
Database | In the FDsize module: - Medtronic Pipeline Flex Embolization
Device (PED – P100018/S15); - 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 FDsize module: - Medtronic Pipeline Flex Embolization
Device (PED – P100018/S15); - Medtronic Pipeline Flex Embolization
Device with Shield Technology (PED2 –
P100018/S026); - Medtronic Pipeline Vantage
Embolization Device with Shield
Technology (PED3 – P100018/S034); - Stryker Surpass Evolve Flow Diverter
System (P170024/S003); - Stryker Surpass Elite Flow Diverter
(P170024/S012); | Similar |
| | In the IDsize module: - Micro Vention Woven EndoBridge
Aneurysm Embolization System (WEB -
P170032).
In the STsize module:
- Stryker Neuroform Atlas Stent System
(P180031/S001); - Micro Vention Low-Profile Visualized
Intraluminal Support and LVIS Jr (LVIS and
LVIS Jr - P170013).
In the FCsize module:
- Medtronic Axium Detachable Coil and
Axium Prime Detachable Coil (K203432); - MicroVention HydroCoil Embolic System
(HES - K161367); | Micro Vention Flow Re-Direction
Endoluminal Device System (FRED -
P180027); - Micro Vention Flow Re-Direction
Endoluminal Device X System (FRED X -
P180027/S002).
In the IDsize module:
- Micro Vention Woven EndoBridge
Aneurysm Embolization System (WEB -
P170032).
In the STsize module:
- Stryker Neuroform Atlas Stent System
(P180031/S001); - MicroVention Low-Profile Visualized
Intraluminal Support and LVIS Jr (LVIS and
LVIS Jr - P170013); - Micro Vention Low-Profile Visualized
Intraluminal Support EVO (LVIS EVO)
(P170013/S004).
In the FCsize module:
- Medtronic Axium Detachable Coil and
Axium Prime Detachable Coil (K233420); - MicroVention HydroCoil Embolic System
(HES - K161367); - Stryker Target and Target XXL
Detachable 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 deployed
device in DCM format | Simulation report in PDF and DCM format.
Arterial reconstruction with the deployed
device in DCM and VTP format. | Similar |
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.