(51 days)
Not Found
No
The summary describes standard image processing and measurement tools, with no mention of AI, ML, or related concepts. The performance studies focus on traditional validation metrics against phantoms and expert annotations.
No
The device is an image analysis system intended to assist physicians in stratification of patients and provides measurement and visualization tools; it does not directly provide therapy.
No
The "Intended Use / Indications for Use" section explicitly states, "The measurements provided by vascuCAP are not intended to provide a diagnosis or clinical recommendations." Instead, it is intended to "assist trained physicians in the stratification of patients identified to have atherosclerosis" and act as "a tool to complement standard of care."
Yes
The device is described as an "image analysis software package" and the description focuses solely on the software's functionality for processing, reviewing, and analyzing digital images. There is no mention of any accompanying hardware components included with the device.
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. They are used to provide information for diagnosis, monitoring, or screening.
- 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 taken from the body.
- 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.
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
LLZ
Device Description
vascuCAP is an image analysis software package for evaluating CT images of arterial vessels. It allows the processing, review, analysis, communication, and media interchange of multidimensional 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 (carotid artery mentioned in testing)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physicians, clinical setting
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
Performance testing: Validation testing using phantom and clinical images was conducted to address performance qualification of the subject device under typical operating conditions. Clinical images were evaluated using vascuCAP. Objectives evaluated included calculations of anatomic structure (compared to anthropomorphic phantoms) and calculations of tissue characteristics (compared to expert annotation by board certified pathologists of histopathologic specimens).
Phantom experiments: Ground truth for structural measurands and plaque burden assessed using micrometer measurements on anthropomorphic objects.
Clinical images: Ground truth for tissue types estimated relative to pathologist annotation of ex vivo tissue specimens with paired CTA. Three independent pathologist annotations were used for results to account for discordance in histopathology interpretation. For positioning annotated sections into 3D radiology volume, four combinations (two unique positioners crossed with two independent radiologist users) were used to account for differences in judgment on where the annotated section data applies within the in vivo volume, blinded to vascuCAP results.
The mean tested phantom vessel size is 8.7mm [3.9mm]. For stenosis, the mean tested vessel size of the vessels >=5.9mm bin was 5.2mm [3.9mm], and for the vessels =5.9mm: Bias: 3.7% [1.29, 4.47], Intercept: 5.99% [-0.81, 9.93], Slope: 0.96 [0.84, 1.1], Quadratic term: -0.01 [-0.02, 0.01], R²: 0.8034
Vessels
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
December 21, 2018
Elucid Bioimaging, Inc. Andrew Buckler President 225 Main Street, Suite 15 WENHAM, MA 01984
Re: K183012
Trade/Device Name: vascuCAP Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: December 17, 2018 Received: December 17, 2018
Dear Andrew 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hse 2. Nils
for Robert A. 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) K183012
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.
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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K183012
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 CTO, 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:
Elucid Bioimaging Inc. vascuCAP A.1.1 (K163071)
Device Description:
vascuCAP is an image analysis software package for evaluating CT images of arterial vessels. It allows the processing, review, analysis, communication, and media interchange of multidimensional 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.
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 and minimum lumen
4
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:
vascuCAP A.1.2 has all the same technological characteristics and features as vascuCAP A.1, but refines processing algorithms to improve measurement performance.
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.
Performance testing: Validation testing using phantom and clinical images was conducted to address performance qualification of the subject device under typical operating conditions. Clinical images were evaluated using vascuCAP. Objectives evaluated included calculations of anatomic structure (compared to anthropomorphic phantoms) and calculations of tissue characteristics (compared to expert annotation by board certified pathologists of histopathologic specimens). As a result of this testing, the following analytic performance metrics have been established*:
| Structure | Lumen Area,
tested range 0.3 - 290.1mm² | Bias: 0.81mm² [0.3, 1.9], Intercept: 0.65mm² [-0.6, 0.9],
Slope: 1.01 [0.9, 1.0], Quadratic term: 0.0 [0.0, 0.0], R²: 0.9987 |
|-------------|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Wall Area,
tested range 9.4 - 448.6mm² | Bias: 0.50mm² [-1.08, 1.29], Intercept: -0.59mm² [-4.1, 2. 8.0],
Slope: 1.0 [0.99, 1.04], Quadratic term: 0.0 [0.0, 0.0], R²: 0.9974 |
| | Stenosis**,
tested range 33-69% | Vessels ≥5.9mm: Bias: 3.7% [1.29, 4.47], Intercept: 5.99% [-0.81, 9.93],
Slope: 0.96 [0.84, 1.1], Quadratic term: -0.01 [-0.02, 0.01], R²: 0.8034
Vessels