(16 days)
Not Found
Unknown
The description mentions "Automated segmentation" and "Automatic initialization of endovascular measurements," which could potentially be implemented using AI/ML techniques, but the document does not explicitly state the use of AI, ML, or related terms like DNN. Without further information or explicit mention, it's impossible to definitively confirm the presence of AI/ML.
No
This device is a diagnostic and planning tool for medical professionals to analyze existing images and plan stent procedures; it does not directly treat or prevent a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "Vitrea® is a medical diagnostic system" and that the Endovascular Stent Planning Software assists "medical professionals in the analysis, treatment and follow-up of aortic vascular disorders". While it also aids in treatment planning, its fundamental role in analysis and follow-up using medical images positions it as a diagnostic device.
Yes
The device is described as "Endovascular Stent Planning Software, an application module for the Vitrea software," and its function is solely the processing, analysis, and visualization of existing CT images. There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Vitrea Endovascular Stent Planning Software processes and analyzes medical images (CT scans) acquired from within the body. It assists medical professionals in planning procedures based on anatomical structures and measurements derived from these images.
- Lack of Biological Sample Analysis: The device does not involve the analysis of any biological samples taken from the patient.
Therefore, the device falls under the category of medical image processing and analysis software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. In addition, Vitrea has the following additional indication:
The Endovascular Stent Planning Software application is intended for use with CT (computed tomography) images to assist medical professionals in the analysis, treatment and follow-up of aortic vascular disorders that may require a stent procedure. The software provides 3D segmentation of the aorta and initializes stent measurements based on a template provided by the stent manufacturers. The user can review the 2D and 3D images, verify and correct the results of the segmentation and initialization, and generate a report with the stent measurements.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The Endovascular Stent Planning Software, an application module for the Vitrea software, enables visualization and measurements of the aortic vessel for evaluation, treatment and follow up for aortic vascular disorders that may require a stent procedure. It has the following features:
- Automated segmentation of the aortic vessel, including thrombus .
- Custom and manufacturer-recommended stent-graft worksheets and report . templates for stent sizing
- Automatic initialization of endovascular measurements (diameters, lengths, . angles, volumes) based on the stent template selection, with easy centerline and contour editing tools
- Workflows for pre-treatment (stent, surgery) planning and post-treatment . follow up, including a side-by-side comparative review layout
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT (computed tomography) images
Anatomical Site
aortic vessel, aorta
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
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)
The software was designed, developed and tested according to written procedures. Software testing was completed to insure the Endovascular Stent Planning Software features function according to the requirements and interact without impact to existing functionality. The test results support a determination of substantial equivalence.
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.
K071331, K002519, K040852, K060779
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
K091498
Page 1 of 2
JUN - 5 2009
2. 510(K) SUMMARY AS REQUIRED BY 21 CFR 807.92
510(k) Number: K
Date Prepared: May 5, 2009
| SUBMITTER INFORMATION | ||
|---|---|---|
| Submitter: | Vital Images, Inc. | Contact Person |
| Street Address: | 5850 Opus Parkway Suite 300 | |
| Minnetonka, MN 55343-4414 | Darin Busch | |
| Establishment registration: | 2134213 | Manager, Regulatory Affairs |
| Phone: (952) 487-9680 | ||
| Fax: (952) 487-9510 | ||
| Email: dbusch@vitalimages.com |
DEVICE INFORMATION
| Trade Name | Endovascular Stent Planning Software |
|---|---|
| Common Name | Radiological Image Processing Software |
| Classification Name | System, Image Processing, Radiological |
| Regulation /Product Code | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Classification: | Class II |
| Device Panel: | Radiology |
The Endovascular Stent Planning Software is substantially equivalent to the following predicate devices.
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| Vitrea®, Version 4.0 Medical Image | ||
| Processing Software | Vital Images, Inc | K071331 |
| Vitrea2, version 2.1 | Vital Images, Inc | K002519 |
| Preview® Treatment Planning | ||
| Software | MEDICAL MEDIA SYSTEMS, | |
| INC | K040852 | |
| GE AVA II/Vessel Xpress | ||
| (AVA II/Vessel Xpress) | GE HealthCare | |
| Waukesha, WI | K060779 |
1
KC91498
Page 2 of 2
2.1. Device Description
The Endovascular Stent Planning Software, an application module for the Vitrea software, enables visualization and measurements of the aortic vessel for evaluation, treatment and follow up for aortic vascular disorders that may require a stent procedure. It has the following features:
- Automated segmentation of the aortic vessel, including thrombus .
- Custom and manufacturer-recommended stent-graft worksheets and report . templates for stent sizing
- Automatic initialization of endovascular measurements (diameters, lengths, . angles, volumes) based on the stent template selection, with easy centerline and contour editing tools
- Workflows for pre-treatment (stent, surgery) planning and post-treatment . follow up, including a side-by-side comparative review layout
2.2. Intended Use/Indications for Use
Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. In addition, Vitrea has the following additional indication:
The Endovascular Stent Planning Software application is intended for use with CT (computed tomography) images to assist medical professionals in the analysis, treatment and follow-up of aortic vascular disorders that may require a stent procedure. The software provides 3D segmentation of the aorta and initializes stent measurements based on a template provided by the stent manufacturers. The user can review the 2D and 3D images, verify and correct the results of the segmentation and initialization, and generate a report with the stent measurements.
2.3. Summary of Testing
The software was designed, developed and tested according to written procedures. Software testing was completed to insure the Endovascular Stent Planning Software features function according to the requirements and interact without impact to existing functionality. The test results support a determination of substantial equivalence.
2.4. Conclusions
Vitrea Endovascular Stent Planning software has similar intended use as the predicate devices and essentially identical technological characteristics. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device. The Vitrea Endovascular Stent Planning Software application performs as intended, and presents with no unacceptable risks to the intended patient population or end user. Vitrea Endovascular Stent Planning Software is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of four stylized human figures in profile, arranged in a stacked formation. The figures are depicted in a simple, abstract manner.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IIIN - 5 2009
Vital Images, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K091498
Trade/Device Name: Vitrea® Endovascular Stent Planning Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class:_II Product Code; LLZ Dated: May 19, 2009
Received: May 20, 2009
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 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 (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.
3
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology). | (240)-276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Samme M. Marre
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1. INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known): K09/498
Device Name: Vitrea® Endovascular Stent Planning Software
Indications for Use:
Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. Vitrea has the following additional indication:
The Endovascular Stent Planning Software application is intended for use with CT (computed tomography) images to assist medical professionals in the analysis, treatment and follow-up of aortic vascular disorders that may require a stent procedure. The software provides 3D segmentation of the aorta and initializes stent measurements based on a template provided by the stent manufacturers. The user can review the 2D and 3D images, verify and correct the results of the segmentation and initialization, and generate a report with the stent measurements.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helene
(Division'Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number