VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL
Device Facts
| Record ID | K122429 |
|---|---|
| Device Name | VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL |
| Applicant | Object Research Systems (Ors), Inc. |
| Product Code | LLZ · Radiology |
| Decision Date | Nov 28, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, 3rd-Party Reviewed |
Indications for Use
Autoplaque is intended to provide an optimized non-invasive application to analyze coronary anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. Autoplaque is a post processing application option for the ORS Visual platform (K100335). It is a non-invasive diagnostic reading software add-on intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques. The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present. ORS Visual software (K100335) and the Autoplaque add-on must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Typical users of ORS Visual (K100335) and Autoplaque are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
Device Story
Autoplaque and Vessel Analysis are software add-ons for ORS Visual (K100335) platform; designed for post-processing 2D/3D CT Angiographic images. Inputs: DICOM 3.0 compliant CT data. Processing: semi-automatic vessel segmentation; bony structure removal; vessel sizing; plaque density analysis (calcified/non-calcified); stenosis quantification (% area/diameter); vessel tortuosity visualization. Output: visual renderings (MPR, curved MPR, 3D volume, MIP) and quantitative measurements displayed on commercial computer workstations. Used by radiologists/cardiologists in clinical settings to assist in evaluating vascular/coronary anatomy and determining treatment paths. Software provides interactive tools for viewing and analysis; physician retains final diagnostic judgment. Benefits: non-invasive assessment of coronary/vascular disease, plaque burden, and stent procedure planning.
Clinical Evidence
Bench testing only. No clinical data provided. Software verified through extensive testing on various platforms by development/quality control teams and beta testers. Hazard analysis conducted; level of concern classified as moderate. Performance demonstrated against predefined release criteria.
Technological Characteristics
Software-only post-processing application for Windows OS. DICOM 3.1 compliant. Features: 2D/3D visualization (MPR, curved MPR, MIP, volume rendering), semi-automatic vessel segmentation, and quantitative measurement tools. No patient contact. Operates on commercial computer hardware. Level of concern: Moderate.
Indications for Use
Indicated for cardiologists, radiologists, and trained medical professionals to analyze coronary anatomy and pathology, including coronary plaque presence and extent, using CT Angiographic images. Supports stenosis analysis, pre/post stent procedure assessment, and vessel tortuosity visualization. Not for use with mammographic or compressed images.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
- Philips' Comprehensive Cardiac Analysis (CCA) Plaque (K092747)
- Vitrea Version 4.0 with SUREPlaque (K071331)
- GE Advanced Vessel Analysis II (K060779)
Submission Summary (Full Text)
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K 122429
# 5. 510(k) SUMMARY (AUTOPLAQUE)
## NOV 2 8 2012
This summary of safety and effectiveness is being submitted in accordance with 21CFR Part 807, Subpart E, section 807.92.
Submitter's name and contact information Object Research Systems (ORS) inc. 760 St-Paul West, suite 101 Montreal, Quebec, Canada H3C 1M4 Telephone: (514) 843-3861 Fax: (514) 543-5475 Contact: Eric Fournier, Executive Vice President E-mail: efournier@theobjects.com
Date prepared January 31st 2012
II
Trade Name, Common Name and Classification Trade Name: Autoplaque add-on ORS Visual Common Name: Image Processing System, Radiology, Software PACS Classification: Picture Archiving and Communications System, Product code LLZ, Class
## Device Description
The Autoplaque add-on for medical device ORS Visual (K100335) is a post processing analysis software package designed to assist Radiologists, Cardiologists, and other clinicians in the evaluation and assessment of coronary lesions.
Autoplaque is a software post-processing package for the ORS Visual application (K100335). It provides analysis of the vessel lumen and wall and makes it easier to detect findings in the coronary vessels.
The Autoplaque add-on has been extensively tested on a variety of platforms by both members of the development and quality control team and by potential customers serving as beta testers. A hazard analysis has been conducted and the level of concern has been classified as moderate. The release version of the software passed all tests considered critical in terms of patient safety and demonstrated an overall acceptable performance for release as determined by the predefined release criteria.
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## Intended Use:
Autoplaque is intended to provide an optimized non-invasive application to analyze coronary anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.
Autoplaque is a post processing application option for the ORS Visual platform (K100335). It is a non-invasive diagnostic reading software add-on intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques.
The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present.
ORS Visual software (K100335) and the Autoplaque add-on must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications.
Typical users of ORS Visual (K100335) and Autoplaque are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
## Substantially Equivalent Devices
Object Research Systems (ORS) Inc believes that Autoplaque add-on for ORS Visual is substantially equivalent to other commercially available products, specifically:
- . Philips' Comprehensive Cardiac Analysis (CCA) Plaque (K092747)
- Vitrea Version 4.0 with SUREPlaque (K071331)
| Feature | ORS Visual<br>Autoplaque | SUREPlaque | Philips<br>CCA |
|---------------------------------------|------------------------------------------------------------------------------------|------------|----------------|
| Computer Platform | Windows OS | same | same |
| DICOM compliance | DICOM 3.1 | same | same |
| 2D Imaging | Review of coronary structure in<br>2D with MPR, curved MPR and<br>straighten view. | same | same |
| 3D Imaging | Review of coronary structure in<br>3D volume rendering with<br>interactive control | same | same |
| Measurement | 2D measurement tools of vessel<br>diameter and contour | same | same |
| Maximum Intensity<br>Projection (MIP) | MIP with interactive control and<br>clip planes | same | same |
| Multiplanar<br>Reformatting (MPR) | MPR with oblique slicing and<br>variable thickness slabbing | same | same |
| Quantify plaque burden | Yes | same | same |
| Quantify coronary<br>remodeling | Yes | same | same |
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| Feature | ORS Visual<br>Autoplaque | SUREPlaque | Philips<br>CCA |
|---------------------------|----------------------------------------|------------|----------------|
| Lesion characterization | Either as calcified or non-calcified | same | same |
| Lumen segmentation | Semi automatic | Automatic | Automatic |
| Stenosis quantification | % area stenosis<br>% diameter stenosis | Same | same |
| Prescription use | Yes | same | same |
| NCP volume | Yes | same | same |
| CP volume | Yes | same | same |
| Low-density NCP<br>volume | Yes | same | same |
| Intended users | Trained professionals | same | same |
#### Software
Software development for the Autoplaque add-on for ORS Visual software (K100335) follows documented processes for software design, verification testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for this type of medical device.
## Hazard Analysis
Hazard analysis on this product has been tested throughout the definition, design, coding and testing phases of product development and implementation. This process has emphasized:
- · Identification of potential hazards, their causes and effects;
- · Development of methodologies to control the occurrence of hazard and to constrain their effects; and
- · Determine any effect on patient safety and system effectiveness.
The potential hazards associated with this software product re no different than those of other PACS components. These are primarily related to failure of computer system components, and may be variously obviated by decisions taken by the customers of this product. None of these failures are expected to materially contribute to patient death or injury
It is our opinion that there is no hardware or software component, operating in a properly configured environment, whose failure or latent design defect would be expected to result in death or injury of a patient. Thus the "Level of Concern" is Moderate.
#### Technological Characteristics
ORS Visual (K100335) is software that is used with computer hardware to read, render and analyze diagnostic medical images in a user environment. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed.
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## Conclusions
The Autoplaque add-on for ORS visual (K100335) has similar intended uses as the substantially equivalent devices and has very similar technological characteristics to those devices. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device. Thus, Autoplaque add-on for ORS visual (K100335) is substantially equivalent to the commercially available devices (see section 12).
The Autoplaque add-on for the ORS Visual software (K100335) has been extensively tested on a variety of platforms by both members of the development and quality control team and by potential customers serving as beta testers. A hazard analysis has been conducted and the level of concern has been classified as moderate. The release version of the software will be required to pass all tests considered critical in terms of patient safety and demonstrate an overall acceptable performance for release as determined by the predefined release criteria.
As specified in the proposed labeling and indications of use, the devices do not support mammographic and compressed images for viewing. Therefore, since the devices do not use compression technique that can result in the loss of data, no measurement of the error of the compressed image relative to the original has been performed (see section 18).
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K122429
# 5. 510(k) SUMMARY (VESSEL ANALYSIS)
This summary of safety and effectiveness is being submitted in accordance with 21CFR Part 807, Subpart E, section 807.92.
Submitter's name and contact information Object Research Systems (ORS) inc. 760 St-Paul West, suite 101 Montreal, Quebec, Canada H3C 1M4 Telephone: (514) 843-3861 Fax: (514) 543-5475 Contact: Eric Fournier, Executive Vice President E-mail: efournier@theobjects.com
Date prepared January 31st 2012
Trade Name, Common Name and Classification
Trade Name: Vessel Analysis add-on ORS Visual Common Name: Image Processing System, Radiology, Software PACS Classification: Picture Archiving and Communications System. Product code LLZ. Class II
## Device Description
The Vessel Analysis add-on (Vessel Analysis) for medical device ORS Visual (K100335) is a post processing analysis software package designed to assist Radiologists, Cardiologists, and other clinicians in the evaluation and assessment of vascular anatomy.
Vessel Analysis is a software post-processing package for the ORS Visual application (K100335). It is an additional tool for the analysis of 2D/3D CT Angiographic images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels which include but are not limited to stenosis analysis, thrombus, pre/post stent procedures and directional vessel tortuosity visualization.
The Vessel Analysis add-on has been extensively tested on a variety of platforms by both members of the development and quality control team and by potential customers serving as beta testers. A hazard analysis has been conducted and the level of concern has been classified as moderate. The release version of the software passed all tests considered critical in terms of
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patient safety and demonstrated an overall acceptable performance for release as determined by the predefined release criteria.
## Intended Use:
Vessel Analysis is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.
Vessel Analysis is a post processing application option for the ORS Visual platform (K100335) family of products and can be used in the analysis of 2D/3D CT Angiography images/data derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular and vascular disease assessment. This software is designed to support the physician in assessment of stenosis analysis, pre/post stent procedure and directional vessel tortuosity visualization.
Vessel Analysis automatic visualization tools provide the users with the capabilities to facilitate segmentation of bony structures for accurate identification of the vessels. Once vessels are visualized, tools are available for sizing the vessel, analyzing calcified and non-calcified blaque to determine the densities of plaque, measure areas of abnormalities within a vessel.
The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present.
ORS Visual software (K100335) and the Vessel Analysis add-on must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications.
Typical users of ORS Visual (K100335) are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others,
#### Substantially Equivalent Devices
Object Research Systems (ORS) Inc believes that Vessel Analysis add-on for ORS Visual is substantially equivalent to other commercially available products, specifically:
| Feature | ORS Visual<br>Vessel Analysis | AVA II | Vital Images |
|-------------------|---------------------------------------------------------------------------------------|--------|--------------|
| Computer Platform | Windows OS | same | same |
| DICOM compliance | DICOM 3.1 | same | same |
| 2D Imaging | Review of vascular<br>structure in 2D with<br>MPR, curved MPR and<br>straighten view. | same | same |
| 3D Imaging | Review of vascular | same | same |
- g GE Advanced Vessel Analysis II (K060779)
- Vital Images Vitrea 4.0 (Vessel probe) (K071331)
510(k) Premarket Notification Object Research Systems (ORS) inc.
.
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| Feature . | ORS Visual<br>Vessel Analysis | AVA II | Vital Images |
|---------------------------------------|-----------------------------------------------------------------|--------|--------------|
| | structure in 3D volume<br>rendering with<br>interactive control | | |
| Measurement | 2D measurement tools<br>of vessel diameter and<br>contour | same | same |
| Maximum Intensity<br>Projection (MIP) | MIP with interactive<br>control and clip planes | same | same |
| Multiplanar Reformatting<br>(MPR) | MPR with oblique slicing<br>and variable thickness<br>slabbing | same | same |
| Prescription use | Yes | same | same |
| Intended users | Trained professionals | same | same |
## Software
Software development for the Vessel Analysis add-on for ORS Visual software (K100335) follows documented processes for software design, verification testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for this type of medical device.
#### Hazard Analysis
Hazard analysis on this product has been tested throughout the definition, design, coding and testing phases of product development and implementation. This process has emphasized:
- · Identification of potential hazards, their causes and effects;
- · Development of methodologies to control the occurrence of hazard and to constrain their effects; and
- · Determine any effect on patient safety and system effectiveness.
The potential hazards associated with this software product are no different than those of other PACS components. These are primarily related to failure of computer system components, and may be variously obviated by decisions taken by the customers of this product. None of these failures are expected to materially contribute to patient death or injury
It is our opinion that there is no hardware or software component, operating in a properly configured environment, whose failure or latent design defect would be expected to result in death or injury of a patient. Thus the "Level of Concern" is Moderate.
## Technological Characteristics
Vessel Analysis add-on for ORS Visual (K100335) is software that is used with computer hardware to read, render and analyze diagnostic medical images in a user environment. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent.human interprets images and information being displayed.
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## Conclusions
The Vessel Analysis add-on for ORS Visual (K100335) has similar intended uses as the substantially equivalent devices and has very similar technological characteristics to those devices. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device. Thus, Vessel Analysis add-on for ORS Visual (K100335) is substantially equivalent to the commercially available devices (see section 12).
The Vessel Analysis add-on for the ORS Visual software (K100335) has been extensively tested on a variety of platforms by both members of the development and quality control team and by potential customers serving as beta testers. A hazard analysis has been conducted and the level of concern has been classified as moderate. The release version of the software will be required to pass all tests considered critical in terms of patient safety and demonstrate an overall acceptable performance for release as determined by the predefined release criteria.
As specified in the proposed labeling and indications of use, the devices do not support mammographic and compressed images for viewing. Therefore, since the devices do not use compression technique that can result in the loss of data, no measurement of the error of the compressed image relative to the original has been performed (see section 18).
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November 28, 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Object Research Systems (ORS) Inc. % Mr. Jeff D. Rongero Senior Project Engineer UL LLC 12 Laboratory Drive Research Triangle, NC 27709
Re: K122429
Trade/Device Name: Vessel Analysis and Autoplaque for ORS Visual Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code:. LLZ Dated: November 9, 2012 Received: November 13, 2012
Dear Mr. Rongero:
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.
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
{9}------------------------------------------------
#### Page 2 - Mr. Jeff D. Rongero
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Michael D. O'Hara
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# 4. INDICATIONS FOR USE
## 510(k) Number: Unknown
## Device Name: Vessel Analysis for ORS Visual
## Indications for Use:
Vessel Analysis is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.
Vessel Analysis is a post processing application option for the ORS Visual (K100335) platform family of products and can be used in the analysis of 2D/3D CT Angiography images/data derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular and vascular disease assessment. This software is designed to support the physician in assessment of stenosis analysis, pre/post stent procedure and directional vessel tortuosity visualization.
Vessel Analysis automatic visualization tools provide the users with the capabilities to facilitate segmentation of bony structures for accurate identification of the vessels. Once vessels are visualized, tools are available for sizing the vessel, analyzing calcified and non-calcified plaque to determine the densities of plaque within a coronary artery, measure areas of abnormalities within a vessel.
The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present.
ORS Visual software (K100335) and the Vessel Analysis add-on must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Typical users of Vessel Analysis and ORS Visual (K100335) are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
Prescription Use X (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)
Mihail Doth
(Division Sign Off)
Division of Radiological He
Office of In Vitro Diagnostics and Radiological Health
510(k)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Premarket Notification Object Research Systems (ORS) inc.
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