ElucidVivo A.3

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Elucid Bioimaging Inc. % Doug Shufelt Director of QA and RA 2 Park Plaza, Suite 700 BOSTON MA 02116 Re: K221463 Trade/Device Name: ElucidVivo A.3 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 13, 2022 Received: May 19, 2022 June 17, 2022 Dear Doug Shufelt: 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). 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Sincerely, Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K221463 Device Name ElucidVivo™ A.3 #### Indications for Use (Describe) ElucidVivo 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. ElucidVivo 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 Elucid Vivo 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 ElucidVivo are not intended to provide a diagnosis or clinical recommendations. ElucidVivo is intended as a tool to complement standard of care. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" stroke-width="1" width="15" x="0" y="0"></rect> <line stroke="black" stroke-width="2" x1="2" x2="13" y1="2" y2="13"></line> <line stroke="black" stroke-width="2" x1="13" x2="2" y1="2" y2="13"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" stroke-width="1" width="15" x="0" y="0"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## K221463 idi #### ElucidVivo™ A.3 Special 510(k) Summary #### 510(k) submitter: Elucid 2 Park Plaza, Suite 700 Boston, MA 02116 Ph. 617-304-9520 Fax: 978-468-0527 | Contact person: | Doug Shufelt, Director of QA and RA, Elucid | |----------------------------|------------------------------------------------| | Date prepared: | 16 May 2022 | | Device: | | | Name of device: | ElucidVivo™ A.3 | | Common or usual name: | Image processing system | | Classification name: | Medical image management and processing system | | Regulatory class: | II | | Product code: | LLZ | | Classification Regulation: | 21 C.F.R. § 892.2050 | #### Predicate device: | Manufacturer | Device Name | K-Number | |------------------------|----------------|----------| | Elucid Bioimaging Inc. | vascuCAP A.1.2 | K183012 | Note: The device name was rebranded to ElucidVivo from its predicate device, vascuCAP for business purposes. There are no changes to the indications of use. #### Device Description: ElucidVivo 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. ElucidVivo provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The ElucidVivo software application user interface follows typical clinical workflow patterns to process, review, and analyze digital images. {4}------------------------------------------------ ## K221463 lucidvivo #### Intended Use ElucidVivo 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. ElucidVivo 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 ElucidVivo 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 ElucidVivo are not intended to provide a diagnosis or clinical recommendations. ElucidVivo is intended as a tool to complement standard of care. #### Technological Characteristics Comparing to the Predicate: ElucidVivo™ A.3 has the same intended use as ElucidVivo A.1.2 using the same technological characteristics and features as ElucidVivo A.1.2 but improves measurement performance for Lipid Rich Necrotic Core (LRNC), matrix (MATX) and calcifications (CALC). The algorithm is performing the same measurements as the predicate using the same technology with performance results as stated based on the device changes. This was done: - · By taking into consideration different energy levels and calibrating kVp for measurement of plaque components (calcium, matrix and lipid rich necrotic core). - In the predicate device we have used H&E stain which is commonly used in vascular pathology. Since the predicate device was released, scholarship in the field of pathology has increasingly recognized that using MOVAT stain provides additional fidelity for delineation of LRNC relative to other tissues such as IPH, and hence adopted it for the subject device. {5}------------------------------------------------ ### K221463 # elucid vivo #### Performance Data: 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. The same test protocols (3-DC-1-PM-01 ElucidVivo Verification & Validation Plan) were used in the predicate and subject devices. The two differences between performance tables of A.3 compared to predicate A.1.2 are as follows: - Whereas the primary performance metrics of bias, slope and intercept remain the same, the . secondary metrics used in A.1.2 of quadratic term and R2 are replaced by terms more in conformance with best practice metrology metrics of RMSE and wSD (noting that the term 'difference' is used instead of 'bias' for the tissue composition as also done in the predicate device, to reflect the histology ground truth basis). - The composition performance reflects the test results based on the improved kVp calibration and use of MOVAT stain (as explained in the executive summary of the application). - Independent test data that had been blinded during the prior A.1.2 and preserved this ● release, has been used to avoid inadvertent bias associated with reuse of test data which is the reason why we see changes to the tested range in composition performance data compared to predicate device, vascuCAP A.1.2. - The stenosis performance results (Section 21.4) for ElucidVivo A.3 has been quoted as the aggregate of two bins compared to the predicate, vascuCAP A.1.2. Performance testing: Validation testing using phantom and clinical images was conducted to address performance qualification of the subject device under typical operating conditions which is similar to the protocols used for testing performance of predicate device. Clinical images were evaluated using ElucidVivo. Objectives evaluated included calculations of anatomic structure (interchangeability with manual measurements as well as inter- and intra-reader variability) and calculations of tissue characteristics (compared to histopathologic specimens representing ground truth as well inter- and intra-reader variability). As a result of this testing, the following analytic performance metrics have been established *: {6}------------------------------------------------ ### K221463 # elucidvivo | Structure | Lumen Area,<br>tested range 0.3-<br>290.1mm² | Bias: 0.81mm² [0.3, 1.9], Intercept: 0.65mm² [-0.6, 0.9],<br>Slope: 1.01 [0.9, 1.0],<br>RMSE: 2.50 [1.30,2.80], wSD: 2.30 [1.20,2.60] | |-------------|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | | Wall Area,<br>tested range 9.4-<br>448.6mm² | Bias: 0.50mm² [-1.08, 1.29], Intercept: -0.59mm² [-4.1, 2.<br>8.0], Slope: 1.0 [0.99, 1.04], RMSE: 4.10 [2.60,6.60], wSD:<br>3.90 [2.40,6.30] | | | Stenosis,<br>tested range 33-69% | Bias: 6.10 [3.10,8.90], Slope: 0.97 [0.83,1.20], Intercept: 7.90<br>[-4.60,15.00],<br>RMSE: 7.00 [3.60,11.00], wSD: 6.20 [3.20,9.60] | | | Wall Thickness,<br>tested range 1.0-<br>9.0mm | Bias: 0.5mm [0.3, 0.6], Intercept: 0.27mm [-0.1, 0.5],<br>Slope: 1.05 [1.01, 1.1], RMSE: 0.24 [0.17,0.31], wSD: 0.21<br>[0.15,0.28] | | | Plaque Burden,<br>tested range 0.4-1.0<br>(ratio) | Bias: -0.01 [-0.01, .004], Intercept: 0.01 [-0.1, 0.04],<br>Slope: 0.99 [0.9, 1.1], RMSE: 0.018 [0.012,0.038], wSD: 0.017<br>[0.012,0.036] | | Composition | Calcified Area (mm²):<br>Tested range: 0-14 | Difference: -0.06 [-0.09,-0.03], Slope: 0.99 [0.91,1.07],<br>Intercept: -0.04 [-0.08,0.01], RMSE: 1.46 [1.32,1.59], wSD:<br>1.43 [1.31,1.56] | | | LRNC Area (mm²):<br>Tested range: 0-10 | Difference: 0.15 [0.10,0.20], Slope: 0.92 [0.87,0.96], Intercept:<br>0.34 [0.27,0.42], RMSE: 2.79 [2.70,2.89], wSD: 2.76<br>[2.67,2.85] | | | Matrix Area (mm²):<br>Tested range: 4-52 | Difference: 0.02 [-0.22,0.26], Slope: 0.91 [0.88,0.94],<br>Intercept: 1.34 [1.00,1.67], RMSE: 3.77 [3.64,3.89], wSD: 3.58<br>[3.46,3.69] | *brief explanatory notes to help interpret the table: - Tested range indicates the smallest and largest true value for the measurand tested 1. characterize the difference profile over the tested range. - 2. Systematic difference from histopathology for tissue types is estimated relative to pathologist annotation of ex vivo tissue specimens with paired CTA such that ground truth is assessed based on expert interpretation that the relevant scientific and clinical community relies upon for diagnosis or other specific categorization of the studied tissue. The mean tested specimen vessel size is 7.9mm [3.6mm, 12.9mm]. Width of confidence interval follows from: - agreement of pathologists (three independent annotations were used for these 1. results to account for acknowledged discordance in histopathology interpretation), {7}------------------------------------------------ ### K221463 # ucid - 2. certainty of positioning of annotated sections into 3D radiology volume (four combinations resulting from two unique positioners crossed with two independent radiologist users were used for these results to account for differences in judgment on where the annotated section data applies within the in vivo volume, blinded to ElucidVivo results), - 3. relative difficulty of physiologic presentation, and - typical variation experienced across clinically accepted scanning protocols. 4. ** important note regarding stenosis by diameter: given the reliance of stenosis by diameter as being computed from lumen diameters, and the relative difficulty of accurately estimating lumen diameter as the lumens become appreciably smaller than the finite voxel size, the stenosis may be overestimated. This issue is not unique to ElucidVivo but rather a known issue for any interpretation of CTA as lumen size decreases. It is important to follow current clinical training to disregard quantitative calculations of stenosis by diameter from CTA when the lumen is not readily visualized and instead for it to be judged qualitatively. Use of such calculations as %stenosis by area, also available from ElucidVivo, mitigates but does not completely avoid this issue. #### Conclusions: Based on software verification and validation comprising bench and clinical testing under typical operating conditions, Elucid Bioimaging concludes that ElucidVivo™ A.3 is as safe and effective as the predicate device for the intended use.