(250 days)
Not Found
No
The document describes image processing, segmentation, and computational modeling, but does not explicitly mention or provide details about the use of AI or ML algorithms.
No
The device is a preoperational planning tool used to visualize blood vessels and model the placement of neurointerventional devices, but it does not directly treat a disease or condition.
No
Explanation: The device is described as software for preoperational planning and visualization of neurointerventional device placement, not for diagnosing a patient's condition. It states that "Information provided by the software is not intended in any way to eliminate, replace or in part, the healthcare provider's judgment and analysis of the patient's condition."
Yes
The device is explicitly described as "software that allows for the preoperational planning" and is intended to be loaded on a personal computer. The description focuses solely on software functionalities and interactions with data and the user, without mentioning any accompanying hardware components that are part of the medical device itself.
Based on the provided information, Sim&Size is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Sim&Size's Function: Sim&Size's intended use and description clearly state that it is software used for preoperational planning and sizing for neurovascular interventions and surgery. It processes imaging data (X-ray based images), not biological samples. It provides visualization, segmentation, measurement, and computational modeling tools to aid healthcare providers in planning procedures and selecting appropriate devices.
- No Biological Sample Analysis: There is no mention of Sim&Size analyzing any biological samples from the patient. Its input is imaging data.
In summary, Sim&Size is a medical device software that falls under the category of medical image processing and planning software, not an IVD.
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 and deployment 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 software that allows for the preoperational planning of medical device sizes for the treatment of intracranial aneurysms. The computational modeling of neurointerventional devices, such as flow diverters and intrasaccular devices, are supported by the software to provide a patient-specific visualization of the deployment of the device from angiographic DICOM data, 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.
The Sim&Size software is intended to be loaded on any Windows- or Mac-OS personal computer. A user license(s) must be purchased from the company in order to use the software after installation. The software also has a training module that offers learning assessments that are relevant to the software.
The software interacts with a patient's DICOM images, the user, and the device. To do so, the graphical interface is organized into three graphical pages (or screens):
- a. Patient selection page
- b. Module selection page
- Simulation page C.
Sim&Size was designed to enable the 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, deployment and apposition of neurointerventional devices.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray based images; DICOM Image Data; 3D rotational angiography stations; CT and enhanced CT
Anatomical Site
cerebral blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found - The software is prescription use and information provided by the software is not intended to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition. This suggests a healthcare professional.
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)
Performance tests on the bench were performed on the Sim&Size. The following were performed:
- Tests of importation of DICOM images
- Patient manager tests
- Tests of image display and processing
- Functioning tests for visualization of anatomic reconstruction
- Functioning tests for computational modeling of currently-approved neurovascular devices
- Physical device deployment testing to verify the computational model
- Report creation and visualization tests
All bench testing has been performed and the software has met the required specifications for the completed tests.
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.
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
Image /page/0/Picture/0 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 17, 2019
Sim&Cure % Scott Blood Regulatory Consultant MEDIcept, LLC 22 Nichols Street #2 Salem, Massachusetts 01970
Re: K190049
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: August 2, 2019 Received: August 6, 2019
Dear Scott Blood:
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,
Brian Pullin, M.S Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190049
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 and deployment 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 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)
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/1 description: The image shows the logo for Sim&Cure. The word "Sim" is in black, followed by a red ampersand and the word "Cure" in black. Below the logo is the text "SECURE YOUR TREATMENT" in a smaller, sans-serif font.
510(k) Summary
1. Sponsor Name
Submitter's Name: Sim&Cure Address: 1682 Rue de la Valsière 34790 Grabels FRANCE Phone: +33 769 51 37 98
Contact Person: Scott Blood Regulatory Consultant MEDIcept 978.729.5978 scottqara@gmail.com
Date of Preparation: September 17, 2019
2. Device Information
| Trade Name: | Sim&Size |
|---|---|
| Common Name: | Radiological Image Processing Software |
| Regulation Number: | 892.2050 |
| Regulation Name: | Picture Archiving and Communications System |
| Class: | II |
| Product Code: | PZO |
3. Predicate Device
K171534 - SurgicalPreview, EndoVantage LLC
4. Device Description
Sim&Size is software that allows for the preoperational planning of medical device sizes for the treatment of intracranial aneurysms. The computational modeling of neurointerventional devices, such as flow diverters and intrasaccular devices, are supported by the software to provide a patient-specific visualization of the deployment of the device from angiographic DICOM data, 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.
The Sim&Size software is intended to be loaded on any Windows- or Mac-OS personal computer. A user license(s) must be purchased from the company in order to use the software
4
Image /page/4/Picture/0 description: The image is a logo for Sim&Cure. The word "Sim" is in black, followed by a red ampersand. The word "Cure" is in black. Below the logo is the text "SECURE YOUR TREATMENT" in a smaller font size.
after installation. The software also has a training module that offers learning assessments that are relevant to the software.
The software interacts with a patient's DICOM images, the user, and the device. To do so, the graphical interface is organized into three graphical pages (or screens):
- a. Patient selection page
- b. Module selection page
- Simulation page C.
Sim&Size was designed to enable the 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, deployment and apposition of 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 and deployment 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
The predicate device for the Sim&Size software is SurgicalPreview™, cleared per premarket notification K171534. Both Sim&Size and SurgicalPreview have the same indications for use for preoperational planning of neurovascular procedures using existing image data. A summary comparison of technological characteristics in provided below:
| Characteristic | Predicate device
SurgicalPreview
K171534 | Subject device
Sim&Size
This submission |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | SurgicalPreview enables visualization
and measurement of cerebral blood
vessels for preoperational planning and | Sim&Size enables visualization of
cerebral blood vessels for
preoperational planning and sizing for |
| Characteristic | Predicate device
SurgicalPreview
K171534 | Subject device
Sim&Size
This submission |
| | sizing for neurovascular interventions
and surgery. SurgicalPreview also
allows for the ability to computationally
model the placement and deployment of
neurointerventional devices.
General functionalities are provided
such as:
• Segmentation of neurovascular
structures
• Automatic centerline detection
• Visualization of CT scan images for
2D review and 3D reconstruction
• Measurement and annotation 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 | neurovascular interventions and
surgery. Sim&Size also allows for the
ability to computationally model the
placement and deployment 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 |
| 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 | Linear (length and diameter)
measurements, volume measurements | 3D assessment based on 3D model of
the simulated device inside the vessels |
| Image and 3D Display | Orthogonal, color volume rendering, 2D
slide review, active presets, 3D view of
assemblies of devices | Same |
| DICOM Support | Compatible with all scanner vendor
DICOM datasets, storage SCP, import
DICOM files, DICOM compliance for
CT and enhanced CT, import from
DICOMDIR, storage SCU,
query/retrieve SCU | DICOM compliance for CT and
enhanced CT, Read DICOM images
from 3D rotational angiography
stations |
| Computer OS
Compatibility | MS Windows and Mac OS | Same |
| Data
Interchange/Transfer | Secure Internet File Server | Transfer by physical media; i.e. USB
memory stick |
| Characteristic | Predicate device
SurgicalPreview
K171534 | Subject device
Sim&Size
This submission |
| Output File Format | Web browser via WebGL | Local openGL rendering |
| Preoperational
Planning | Yes | Yes |
| Patient Contact | No | No |
| Human Intervention
for Interpretation of
Images | Yes | Yes |
5
Sim&Cure Secure Your Treatment
6
7. Performance Testing
Performance tests on the bench were performed on the Sim&Size. The following were performed:
- Tests of importation of DICOM images ●
- Patient manager tests
- Tests of image display and processing
- Functioning tests for visualization of anatomic reconstruction
- . Functioning tests for computational modeling of currently-approved neurovascular devices
- Physical device deployment testing to verify the computational model .
- . Report creation and visualization tests
All bench testing has been performed and the software has met the required specifications for the completed tests.
9. Summary
Sim&Cure has demonstrated that the Sim&Size is substantially equivalent to its listed predicate device.