(57 days)
Not Found
No
The document describes image processing and measurement tools but does not mention AI, ML, or related terms like deep learning or neural networks. The performance studies focus on bench testing of functionalities rather than validation metrics typically associated with AI/ML models.
No
The device is a software solution for reading and interpreting medical images and assisting with pre-operational planning, not for providing direct therapy.
Yes
Explanation: The device provides "additional information to assist them in reading and interpreting DICOM CT scan images" and enables "visualization and measurement of the heart and vessels," which are tasks directly related to diagnosing conditions or planning interventions based on medical images. It also states it "accurately represents different types of tissue, making it easier to diagnose anomalies."
Yes
The device is explicitly described as a "stand-alone software application" that runs on standard computers and processes DICOM CT scan images. There is no mention of accompanying hardware components required for its primary function.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The intended use and device description clearly state that EndoSize processes DICOM CT scan images of the heart and vessels. These are medical images, not biological specimens.
- The purpose of EndoSize is to assist physicians in reading and interpreting medical images for pre-operational planning, sizing for interventions, and postoperative evaluation. This is a function related to medical imaging analysis and surgical planning, not in vitro diagnostic testing.
The description aligns with a medical image analysis and visualization software intended for clinical decision support in the context of cardiovascular interventions.
N/A
Intended Use / Indications for Use
EndoSize is a software solution that is intended to provide Physicians and Clinical Specialists with additional information to assist them in reading and interpreting DICOM CT scan images of structures of the heart and vessels.
EndoSize enables the user to visualize and measure (diameters, lengths, volumes, angles) structures of the heart and vessels.
EndoSize enables visualization and measurement of the heart and vessels for pre-operational planning and sizing for cardiovascular interventions and surgery, and for postoperative evaluation.
General functionalities are provided such as:
. Segmentation of cardiovascular structures
Automatic and manual centerline detection .
Visualization of CT scan images in every planes, 2D review, 3D reconstruction, Volume . Rendering, MPR, Stretched CMPR
. Measurement and annotation tools
Reporting tools .
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
EndoSize is a stand-alone software application that runs on any standard Windows or Mac OSX based computer which meets the minimal requirements. It enables Physicians and Clinical Specialists to select patient CT scan studies from various data sources, view them, and process the images thanks to a comprehensive set of tools. EndoSize is intended to provide a clinical decision support system during the preoperative planning of endovascular surgery.
EndoSize contains five modules dedicated to different types of endovascular interventions, EVAR, FEVAR, TEVAR, TAVI and Peripheral. These modules can be marketed in combination or as separate solutions. It is also possible to market custom versions of EndoSize to Stent manufacturers, based on the modules listed above. The differences between EndoSize and a custom version of EndoSize (user interface, manufacturer logo, manufacturer catalogue included in the software, of a generic module) do not modify neither the functioning nor the safety of the software.
EndoSize enables assessment and measurement of different vascular structures such as vessels, valves, aneurysms, and other anomalies. It provides simple techniques to assess the feasibility of endovascular procedures. EndoSize can combine 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. The software accurately represents different types of tissue, making it easier to diagnose anomalies and plan interventional procedures. It works with DICOM CT scan images and can access multiple DICOM data files and PACS server.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM CT scan images
Anatomical Site
heart and vessels; cardiovascular structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians and Clinical Specialists
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)
Every specification of the EndoSize software is validated by a bench test before release. Bench testing includes:
Tests of Importation of DICOM images
Patient Manager tests .
Tests of image display and processing .
. Functioning tests of the different modules EVAR, TEVAR, FEVAR, TAVI and Peripheral
Measurement tests
Reports creation and exportation 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
K141475
Page 1 of 4.
1
10 (K) SUMMARY (20 OFR 807 82 (GN) 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
| Manufacturer Name: | Therenva SAS
Centre d'Innovation Technologique
Niv. O du CCP
2 rue Henri Le Guilloux
35000 Rennes
FRANCE |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cemil Göksu, CEO
Tel : +33 2 99 28 37 51
Fax : +33 2 99 28 95 88
E-mail : cemil.goksu@therenva.com |
| Official Correspondant : | |
| Establishment Registration Number: | Awaiting acceptance of this 510k |
| Date prepared: | 12/19/2013 |
| Trade Name: | EndoSize |
| Regulation Class | Class II (21 CFR 892.2050, LLZ) |
Identification of Predicate Device:
| Device Classification Name | Picture Archiving
Communications System |
|----------------------------|--------------------------------------------|
| Regulation Number | 892.2050 |
| 510(k) Number | K120367 |
| Device Name | 3mensio Workstation |
| Product Code | LLZ |
| Decision | SUBSTANTIALLY
EQUIVALENT (SE) |
Picture Archiving Communications System
Device Description:
Classification Name:
EndoSize is a stand-alone software application that runs on any standard Windows or Mac OSX based computer which meets the minimal requirements. It enables Physicians and Clinical Specialists to select patient CT scan studies from various data sources, view them, and process the images thanks to a comprehensive set of tools. EndoSize is intended to provide a clinical decision support system during the preoperative planning of endovascular surgery.
EndoSize contains five modules dedicated to different types of endovascular interventions, EVAR, FEVAR, TEVAR, TAVI and Peripheral. These modules can be marketed in combination or as separate solutions. It is also possible to market custom versions of EndoSize to Stent manufacturers, based on the modules listed above. The differences between EndoSize and a custom version of EndoSize (user interface, manufacturer logo, manufacturer catalogue included in the software, of a generic module) do not modify neither the functioning nor the safety of the software.
1
EndoSize enables assessment and measurement of different vascular structures such as vessels, valves, aneurysms, and other anomalies. It provides simple techniques to assess the feasibility of endovascular procedures. EndoSize can combine 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. The software accurately represents different types of tissue, making it easier to diagnose anomalies and plan interventional procedures. It works with DICOM CT scan images and can access multiple DICOM data files and PACS server.
Intended Use:
EndoSize is a software solution that is intended to provide Physicians and Clinical Specialists with additional information to assist them in reading and interpreting DICOM CT scan images of structures of the heart and vessels.
EndoSize enables the user to visualize and measure (diameters, lengths, volumes, angles) structures of the heart and vessels.
Indications for Use:
EndoSize enables visualization and measurement of the heart and vessels for preoperational planning and sizing for cardiovascular interventions and surgery, and for postoperative evaluation.
General functionalities are provided such as:
- . Segmentation of cardiovascular structures
- Automatic and manual centerline detection .
- Visualization of CT scan images in every planes, 2D review, 3D reconstruction, Volume . Rendering, MPR, Stretched CMPR
- . Measurement and annotation tools
- Reporting tools .
Technological Characteristics:
EndoSize is a software-only device that runs on a standard computer that meets the minimum requirements. It can use local DICOM files or distant PACS server. The device does not contact the patient, nor does it control any life sustaining devices. The information and measurements displayed, exported or printed are validated and interpreted by Physicians.
EndoSize complies with the DICOM voluntary standards (ACR/NEMA Digital Imaging and Communication in Medicine).
Performance Data:
The subject device is designed in conformance with:
- ACR/NEMA Digital Imaging Communication in Medicine (DICOM) Version 3.1 .
- ISO 14971:2012 Medical devices Application of risk management to medical devices .
- IEC 62304:2006 Medical device software Software life-cycle processes
Every specification of the EndoSize software is validated by a bench test before release. Bench testing includes:
2
- Tests of Importation of DICOM images �
2
- Patient Manager tests .
- Tests of image display and processing .
- . Functioning tests of the different modules EVAR, TEVAR, FEVAR, TAVI and Peripheral
- Measurement tests t
·
- Reports creation and exportation tests .
Predicate Device Comparison:
EndoSize has similar intended use and technical features of the predicate device listed above. The differences between the devices do not raise any questions with respect to the safety and effectiveness of the subject device.
| New Device | Predicate Device |
|---|---|
| EndoSize | 3mensio Workstation |
| Therenva | Pie Medical Imaging |
| K120367 | |
| Interface to image sources: | Interface to image sources: |
| DICOM image data | DICOM image data |
| Import of Patient Data: | Import of Patient Data: |
| Manual through keyboard/mouse | Manual through keyboard/mouse |
| Automatic import with image file | Automatic import with image file |
| Study List Creation | Study List Creation |
| Study list image functionality: | Study list image functionality: |
| Exporting | Exporting |
| Deleting | Deleting |
| Anonymizing | Anonymizing |
| Search | Search |
| Image Processing: | Image Processing: |
| Realign orthogonal MPRS | Realign orthogonal MPRS |
| Segmentation toolset: | Segmentation toolset: |
| Automatic segmentation | Automatic segmentation |
| Automatic centerline | Automatic centerline |
| Manual centerline | Manual centerline |
| Centerline editing | Centerline editing |
| Undo/redo operations | Undo/redo operations |
| Volume sculpting | Volume sculpting |
| Image assessment: | Image assessment: |
| Linear (length and diameter) and angular | |
| measurements | Linear (length and diameter), angular and ROI |
| measurements | |
| Volume measurements | Volume measurements |
| C-Arm angulation calculation | C-Arm angulation calculation |
| Test annotations on snapshots | Text and arrow annotations |
| Calcium scoring for assessment of calcium in the | |
| aortic root | Calcium scoring for assessment of calcium in |
| the aortic root | |
| Image display: | Image display: |
| Orthogonal, oblique, double oblique, curved, | |
| cross-curved, stretched MPR rendering | Orthogonal, oblique, double oblique, curved, |
| cross-curved, stretched MPR rendering | |
| MIP volume rendering | MIP, AvelP, MinIP and color volume slabs |
| Color volume rendering | MIP volume rendering |
3
Page 4 of 4
4
| 2D slice review | Color volume rendering |
|---|---|
| Endoscopic view | Greyscale volume rendering |
| Interactive VOI clipping | 2D slice review and stack comparison |
| Multi-tissue color and opacity control | 4D cine |
| Active presets | Interactive VOI clipping |
| User-defined presets | Multi-tissue color and opacity control |
| DICOM Support: | DICOM Support: |
| Compatible with all scanner vendor DICOM datasets | Compatible with all scanner vendor DICOM datasets |
| Storage SCP | Storage SCP |
| Import DICOM files | Import DICOM files |
| DICOM compliance for CT and enhanced CT | DICOM compliance for CT, enhanced CT, MRI, enhanced MRI, XA, Nuclear Medicine, CR, SC, and Ultrasound images |
| Import from DICOMDIR | Import from DICOMDIR |
| Storage SCU | Storage SCU |
| Query/retrieve SCU | Query/retrieve SCU |
| Storage of Results | Automatic grouping of images into volumes |
| Windows printing or send to PACS | |
| Printout | Storage of Results |
| Session state | Printout |
| PDF format | Session state |
| MS Windows | PDF format |
| DICOM PDF report | |
| Mac OSX | MS Windows |
Conclusion
The EndoSize software is substantially equivalent to the predicate software in terms of intended use, indications for use and technical characteristics. The EndoSize software has successfully undergone every bench testing designed to simulate clinical use.
Based on the information supplied in this 510(k), THERENVA SAS concludes that EndoSize is substantially equivalent to the predicate device and is safe and effective.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drig Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2014
Therenva SAS % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K141475
Trade/Device Name: EndoSize Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications svstem Regulatory Class: II Product Code: LLZ Dated: July 1, 2014 Received: July 2, 2014
Dear Mr. Job:
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. 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 docs 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 cither 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 complics 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2-Mr. Job
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name EndoSize
Indications for Use (Describe)
EndoSize enables visualization and measurement of the heart and vessels for pre-operational planning and sizing for cardiovascular interventions and surgery, and for postoperative evaluation.
General functionalities are provided such as:
· Segmentation of cardiovascular structures
· Automatic and manual centerline detection
• Visualization of CT scan images in every planes, 2D review, 3D reconstruction, Volume Rendering, MPR, Streiched CMPR
· Measurement and annotation tools
· Reporting tools
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 807 Subpart C) |
| [x] | [] |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FORM FDA 3881 (6/13) | Page 1 of 2 | PSC Publishing Serman (101) 443-6740 EF |
|---|---|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | 182 22 | |
| FOR FDA USE ONLY | ||