(16 days)
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.
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
The provided document does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or quantitative performance metrics typically found in clinical validation studies for medical devices. The document is a 510(k) summary for the "Endovascular Stent Planning Software," primarily focusing on its substantial equivalence to predicate devices.
However, based on the provided text, I can infer the general nature of the "acceptance criteria" and the "study" conducted.
Inferred Acceptance Criteria:
The acceptance criteria appear to be implicitly related to the software functioning as intended, providing accurate segmentation and measurements, and not introducing new safety or effectiveness concerns compared to predicate devices. Specific quantitative metrics are not provided.
Inferred Study:
The "study" described is primarily focused on software verification and validation testing, rather than a clinical performance study with human subjects.
Here's a breakdown of the requested information based on the provided text, with many fields being "Not Applicable" or "Not Provided" due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Software features function according to requirements. | "Software testing was completed to insure the Endovascular Stent Planning Software features function according to the requirements." |
| Interacts without impact to existing Vitrea functionality. | "Software testing was completed to insure the Endovascular Stent Planning Software features function according to the requirements and interact without impact to existing functionality." |
| No new questions regarding safety or effectiveness. | "Minor technological differences do not raise any new questions regarding safety or effectiveness of the device." |
| Performs as intended. | "The Vitrea Endovascular Stent Planning Software application performs as intended..." |
| No unacceptable risks to the intended patient population/user. | "...and presents with no unacceptable risks to the intended patient population or end user." |
| Substantial equivalence to predicate devices. | "The test results support a determination of substantial equivalence." and "Vitrea Endovascular Stent Planning Software is substantially equivalent to the predicate devices." (This is the ultimate regulatory "acceptance criterion" for a 510(k) submission). Accuracy of automated segmentation and measurements; user's ability to verify and correct results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The "test set" likely refers to data used for internal software testing. There's no mention of a patient-specific dataset size.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. Given this was a software validation, ground truth might have been established by engineering specifications or clinical experts during development, but details are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not described or referenced. The submission focuses on substantial equivalence through technological comparison and software validation, not clinical efficacy with human readers.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as no such study was performed or reported. The device is an "assistance" tool, but its impact on human reader performance was not quantified in this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: The document describes the device's capabilities, such as "Automated segmentation of the aortic vessel" and "Automatic initialization of endovascular measurements." The user "can review... verify and correct the results." This implies there is an automated component (standalone algorithm) whose output serves as a starting point for the human user. However, no specific standalone performance metrics (e.g., accuracy of automated segmentation or initial measurements without correction) are provided. The "study" was about software functionality.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated. For software testing, ground truth would likely be defined by:
- Engineering specifications/requirements: To verify that the software outputs match predefined specifications for segmentation, measurement initialization, and report generation.
- Potentially, expert review: To confirm that the automated outputs (segmentation, initial measurements) are clinically reasonable and align with expert understanding, before user correction. However, this is inferred, not explicit.
8. The Sample Size for the Training Set
- Sample Size (Training Set): Not applicable or not specified. This document describes a software that performs image processing and measurement initialization. It's not explicitly stated as a machine learning or AI-driven system that requires a distinct "training set" in the modern sense. While it has "automated segmentation," the methodology (e.g., rule-based, traditional image processing, or early AI) and any associated training data are not detailed.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment (Training Set): Not applicable or not specified, as a distinct training set for an AI model is not mentioned. If the "automated segmentation" involves machine learning, the method for establishing ground truth for any potential training data is not described.
Summary of Device and Evidence:
The "Endovascular Stent Planning Software" provides tools for visualization and measurement of aortic vessels for stent planning. The primary evidence presented in this 510(k) summary for its "acceptance" is that it underwent software verification and validation testing to ensure it functions according to requirements, interacts without negatively impacting existing software functionality, and performs as intended without unacceptable risks. The submission relies heavily on demonstrating substantial equivalence to previously cleared predicate devices, suggesting that the technological characteristics and intended use are similar enough that no new clinical performance studies were deemed necessary to establish safety and effectiveness for a regulatory decision.
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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 300Minnetonka, 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 ImageProcessing Software | Vital Images, Inc | K071331 |
| Vitrea2, version 2.1 | Vital Images, Inc | K002519 |
| Preview® Treatment PlanningSoftware | MEDICAL MEDIA SYSTEMS,INC | K040852 |
| GE AVA II/Vessel Xpress(AVA II/Vessel Xpress) | GE HealthCareWaukesha, WI | K060779 |
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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.
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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.
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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
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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
§ 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).