(203 days)
Not Found
No
The summary describes standard image processing and analysis tools without mentioning AI or ML algorithms. The "semi-automatically determine contrasted lumen boundaries" feature could potentially use some form of automated algorithm, but the description doesn't specify it as AI/ML. The lack of mention of training or test sets for AI/ML models further supports this conclusion.
No.
The device is described as an image analysis system intended to assist trained physicians in the stratification of patients with atherosclerosis by processing and visualizing CT images. It explicitly states that "The measurements provided by vascuCAP are not intended to provide a diagnosis or clinical recommendations." and "vascuCAP is intended as a tool to complement standard of care." This indicates it is a diagnostic or assistive tool, not one that directly provides therapy.
No
The intended use explicitly states, "The measurements provided by vascuCAP are not intended to provide a diagnosis or clinical recommendations." Instead, it is a "medical image analysis system" intended to "assist trained physicians in the stratification of patients identified to have atherosclerosis" and is "a tool to complement standard of care."
Yes
The device description explicitly states that vascuCAP is an "image analysis software package" and describes its functions solely in terms of software processing, visualization, and analysis of digital images. There is no mention of any hardware components included with the device.
Based on the provided information, no, 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.
- vascuCAP's Function: vascuCAP is a medical image analysis system that processes and analyzes digital images acquired from CT imaging devices. It works with images of arterial vessels, not biological samples.
- Intended Use: The intended use clearly states it's for processing, reviewing, and analyzing images to assist physicians in stratifying patients with atherosclerosis. It does not involve testing biological samples.
Therefore, vascuCAP falls under the category of medical image analysis software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
vascuCAP is a medical image analysis system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired with contrast from CT imaging devices.
vascuCAP is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis. The software post processes images obtained using a multidetector CT. The package provides tools for the measurement and visualization (color coded maps) of arterial vessels ≥ 4.5mm in diameter.
Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional measurements can be obtained using standard vascuCAP software measuring tools. Clinicians can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Hounsfield unit or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.
The measurements provided by vascuCAP are not intended to provide a diagnosis or clinical recommendations. vascuCAP is intended as a tool to complement standard of care.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
vascuCAP is an image analysis software package for evaluating CT images of arterial vessels ≥ 4.5mm in diameter. It allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from CT scanners. vascuCAP provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and tissue characteristics. The vascuCAP software application user interface follows typical clinical workflow patterns to process, review, and analyze digital images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT imaging devices, multidetector CT
Anatomical Site
Arterial vessels ≥ 4.5mm in diameter
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physicians
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)
Software verification and validation: Software verification consistent with FDA guidance on "General Principles of Software Validation" was conducted, comprising quality planning, requirements analysis, design reviews, software construction, and testing. Verification testing addressed installation and operation qualification, demonstrating that the product meets defined system requirements and features. Validation testing using phantom and clinical images was conducted to address performance qualification of the subject device under typical operating conditions.
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 24, 2017
Elucid Bioimaging, Inc. % Mr. Andrew Buckler President and CEO 225 Main Street Suite 15 WENHAM MA 01984
Re: K163071
Trade/Device Name: vascuCAP Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 18, 2017 Received: May 19, 2017
Dear Mr. Buckler:
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 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 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 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.
Michael D. O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163071
Device Name vascuCAP
Indications for Use (Describe)
vascuCAP is a medical image analysis system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired with contrast from CT imaging devices.
vascuCAP is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis. The software post processes images obtained using a multidetector CT. The package provides tools for the measurement and visualization (color coded maps) of arterial vessels ≥ 4.5mm in diameter.
Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional measurements can be obtained using standard vascuCAP software measuring tools. Clinicians can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Hounsfield unit or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.
The measurements provided by vascuCAP are not intended to provide a diagnosis or clinical recommendations. vascuCAP is intended as a tool to complement standard of care.
| 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) |
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510(K) SUMMARY
| 510(k) SUMMARY | |
|---|---|
| 510(k) submitter: | Elucid Bioimaging, Inc. |
| 225 Main Street, Suite 15 | |
| Wenham, MA 01984 | |
| Ph. 978-468-0508 | |
| Fax: 978-468-0527 | |
| Contact person: | Andrew J. Buckler, President and CEO, Elucid Bioimaging Inc. |
| Date prepared: | |
| Device: | |
| Name of device: | vascuCAP™ |
| Common or usual name: | Image processing system |
| Classification name: | Picture archiving and communications system |
| Regulatory class: | II |
| Product code: | LLZ |
| Predicate device: |
Vital Images, Inc. Vitrea Version 4.0 (K071331)
Device Description:
vascuCAP is an image analysis software package for evaluating CT images of arterial vessels ≥ 4.5mm in diameter. It allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from CT scanners. vascuCAP provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and tissue characteristics. The vascuCAP software application user interface follows typical clinical workflow patterns to process, review, and analyze digital images.
Intended Use:
vascuCAP is a medical image analysis system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired with contrast from CT imaging devices.
vascuCAP is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis. The software post processes images obtained using a multidetector CT. The package provides tools for the measurement and visualization (color coded maps) of arterial vessels ≥ 4.5mm in diameter.
Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional measurements can be obtained using
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standard vascuCAP software measuring tools. Clinicians can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Hounsfield unit or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.
The measurements provided by vascuCAP are not intended to provide a diagnosis or clinical recommendations. vascuCAP is intended as a tool to complement standard of care.
Technological Characteristics Comparing to the Predicate:
The vascuCAP has all the same technological characteristics and features as the Vitrea, Version 4.0, but the predicate Vitrea device has broader applications and, therefore, additional features. Specifically, vascuCAP processes and reviews, and analyzes images from CT scanners and not other modalities, and vascuCAP images arterial vessels ≥ 4.5mm in diameter, whereas the Vitrea images various anatomies including vessels. Additionally, vascuCAP does not have a post-processing application for assessment of the heart and is not intended for use with the St. Jude Ensite system.
Performance Data:
Software verification and validation: Software verification consistent with FDA quidance on "General Principles of Software Validation" was conducted, comprising quality planning, requirements analysis, design reviews, software construction, and testing. Verification testing addressed installation and operation qualification, demonstrating that the product meets defined system requirements and features. Validation testing using phantom and clinical images was conducted to address performance qualification of the subject device under typical operating conditions.
Conclusions:
Based on software verification and validation comprising bench and clinical testing under typical operating conditions, Elucid Bioimaging concludes that vascuCAP is as safe and effective as the predicate device for the intended use.