The AngioCloud Service enables visualization and measurement of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery.

General functionalities are provided such as:

Segmentation of neurovascular structures
· Centerline calculation
· Visualization of 3D vascular images
· Measurement and annotation tools
· Case sharing and reporting tools

Information provided by the software is not intended in any way to eliminate, replace, or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

Device Description

The AngioCloud Service is a standalone web-application which intends to receive a 3D rotational angiography (3D-RA) DICOM dataset and provide interactive views to physicians for the visualization and measurement of cerebral vasculatures during preoperational planning. Physicians can query a 3D-RA dataset directly via the AngioCloud Service provided that they have an internet browser with access to the internet. General functionalities are provided such as:

Segmentation of neurovascular structures ●
. Centerline calculation
Visualization of 3D vascular images
. Measurement and annotation tools
Case sharing and reporting tools

The AngioCloud Service runs as a web application on a standard Windows or Mac OS X based computer and can also be accessed on mobile web browsers, but with limited software functionalities enabled. The AngioCloud Service does not use any artificial intelligence or machine learning functionality and the main segmentation algorithm is based on level-set methods. The Visualization Toolkit (VTK) and Vascular Model Toolkit (VMTK) serve as important software libraries that the underlying algorithm of AngioCloud Service leverages for a number of computational operations such as 3D segmentation, geometric analysis, mesh generation, and surface data analysis for image-based modeling of blood vessels. The device does not contact the patient nor does it control any life-sustaining devices. Information provided by the AngioCloud Service is not intended in any way to eliminate, replace, or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

AI/ML Overview

The AngioCloud Service is a web application designed for the visualization and measurement of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. It includes functionalities such as segmentation of neurovascular structures, centerline calculation, visualization of 3D vascular images, measurement and annotation tools, and case sharing and reporting tools. The device does not use artificial intelligence or machine learning. The following describes the acceptance criteria and the study proving the device meets these criteria.

Acceptance Criteria and Reported Device Performance

The performance testing was conducted primarily to evaluate the AngioCloud Service's segmentation module. The acceptance criteria were based on two metrics: Hausdorff Distance (dH) and Dice Coefficient (DC). These metrics were used to compare the segmentations performed by the AngioCloud Service against a reference standard. While specific numeric acceptance thresholds for dH and DC are not provided in the document, the conclusion states that "Both the mean DC and mean dH for each group met the acceptance criteria."

Metric / Functionality	Acceptance Criteria (Implicit)	Reported Device Performance
Segmentation Module
Hausdorff Distance (dH)	Met pre-defined criteria (specific numeric thresholds not provided)	Mean dH for each group met the criteria
Dice Coefficient (DC)	Met pre-defined criteria (specific numeric thresholds not provided)	Mean DC for each group met the criteria
Overall Software Functionalities
DICOM images importation	Verified	Tested and met
Case management	Verified	Tested and met
Auto-segmentation and manual segmentation	Verified	Tested and met
Visualization of 3D vascular images (desktop & mobile)	Verified	Tested and met
Centerline calculation (desktop & mobile)	Verified	Tested and met
Measurements and annotation tool (desktop & mobile)	Verified	Tested and met
Case sharing and reporting tool	Verified	Tested and met

Study Details

Sample Size and Data Provenance:
- Test Set Sample Size: The document states that "Anatomically relevant phantom models derived from clinical scans were acquired using Siemens (Artis Q with PURE) and Phillips (Allura Xper FD 20/20) Angio suites." The exact number of phantom models or clinical scans used to derive them is not specified.
- Data Provenance: The data used for the test set were "phantom models derived from clinical scans" acquired using Siemens and Phillips Angio suites. The country of origin and whether the data was retrospective or prospective are not explicitly stated. However, the use of "phantom models" implies a controlled, non-patient-specific testing environment, likely based on retrospective clinical data used for model creation.
Number of Experts and Qualifications for Ground Truth:
- The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications.
Adjudication Method for the Test Set:
- The document does not specify any adjudication method used for the test set.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was mentioned. The device does not utilize AI/ML, and the testing focused on the performance of its segmentation module against a reference standard, not on human reader improvement with AI assistance.
Standalone Performance:
- Yes, a standalone performance evaluation was conducted for the segmentation module. The Hausdorff distance (dH) and DICE coefficient (DC) were used to evaluate the algorithm's segmentation performance against a reference standard. The study assesses the device's inherent functionality without human-in-the-loop performance being a primary measure. Human interaction is for adjusting the segmentation threshold ("manual adjust the segmentation threshold" or "Auto" option), but the core performance evaluation metrics (dH, DC) are for the algorithm's output relative to the ground truth.
Type of Ground Truth Used:
- The ground truth for the segmentation performance evaluation was based on a "reference standard" from "anatomically relevant phantom models derived from clinical scans." This implies a highly accurate or 'gold standard' segmentation for these phantom models, likely established through precise measurements or expert consensus on the phantom data, rather than direct pathology or outcomes data from live patients.
Training Set Sample Size:
- The document states that the AngioCloud Service "does not use any artificial intelligence or machine learning functionality." Therefore, there is no "training set" in the context of machine learning model development. The segmentation algorithm is based on "level-set methods" and leverages "The Visualization Toolkit (VTK) and Vascular Model Toolkit (VMTK)."
Ground Truth Establishment for Training Set:
- As there is no AI/ML component, there is no "training set" with ground truth established in the machine learning sense. The underlying algorithms (level-set methods, VTK, VMTK) are established scientific and engineering tools, not trained models requiring annotated ground truth data for learning.

Summary

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AngioCloud, LLC % Bahram Parvinian Founder & Principal Consultant Lighthouse Regulatory Consulting Group, LLC 3 Harrowgate CT POTOMAC MD 20854

April 28, 2022

Re: K211713

Trade/Device Name: AngioCloud Service Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 14, 2022 Received: March 23, 2022

Dear Bahram Parvinian:

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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jessica Lamb, Ph.D. Assistant Director Mammography Ultrasound and Imaging Software Branch Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211713

Device Name AngioCloud Service

Indications for Use (Describe)

The AngioCloud Service enables visualization and measurement of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery.

General functionalities are provided such as:

Segmentation of neurovascular structures
· Centerline calculation
· Visualization of 3D vascular images
· Measurement and annotation tools
· Case sharing and reporting tools

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K211713

Date Prepared

April 25, 2022

Submission Number K211713

510(k) Submitter

AngioCloud, LLC 1 Glenlake Parkway, Suite 200 Atlanta, GA 30328

Official Contact:	James Lewis
Telephone:	+1-803-269-1545
Email:	james@angiocloud.com)

Primary Contact

Bahram Parvinian M.S., Principal Consultant Lighthouse Regulatory Consulting Group LLC Telephone: +1-301-938-7669 Email: bahram(@lighthouseregulatory.com

LLZ

Class II

Device Information

Trade/Proprietary Name	AngioCloud Service
Common Device Name	System, Image processing, Radiological
Classification Name	Medical Image Management and Processing System

21 CFR 892.2050

Regulation Number Product Code Classification

Predicate Device

EndoVantage SurgicalPreview™ (K171534)

Reference Device

Visible Patient Suite (K212896)

Device Description

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Segmentation of neurovascular structures ●
. Centerline calculation
Visualization of 3D vascular images
. Measurement and annotation tools
Case sharing and reporting tools

The computer hardware used to access the web application must meet the following minimum requirements:

Operating System: Windows 10 or later, Linux, Android Lollipop and later, iOS 12 or later, Mac . OS X 10.10 or later
Memory: 4 GB RAM
Hard Disk: At least 200 MB of free hard disk space
Monitor 1024x768 resolution with 16-bit color ●
Web Browser: ●
- Google Chrome: since version 83 o
- Firefox: since version 77 o

Indications for Use

The AngioCloud Service enables visualization and measurement of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery.

General functionalities are provided such as:

Segmentation of neurovascular structures
Centerline calculation ●
. Visualization of 3D vascular images
Measurement and annotation tools .
Case sharing and reporting tools ●

Comparison of Technological Characteristics with the Predicate Device

The subject device has the same intended use and similar indications for use and technological characteristics (e.g. software for visualization and measurement of cerebral blood vessels for

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preoperative planning) to the predicate device (K171534). The differences in technological characteristics between the subject and predicate devices are explained below. AngioCloud does not believe that these differences raise different questions of safety and effectiveness.

In the predicate device, the input data is a DICOM dataset from all CT scanner vendors, whereas . the subject device only accepts volumetric DICOM data acquired by 3D-RA scanners from the Phillips and Siemens X-ray systems. These technological characteristics have undergone testing to ensure the device is substantially equivalent to the predicate.
In the predicate device, the patient-specific anatomical models that are output by the ● SurgicalPreview™ software are generated by operators who are in-house EndoVantage employees and allow the end-user clinician to review and comment, whereas the subject device generates anatomical models by the Segmentation Engine. The end-user clinician of the subject device can manually adjust the segmentation threshold or choose an 'Auto' option where an estimated segmentation threshold is adopted for segmentation. These technological characteristics have undergone testing to ensure the device is substantially equivalent to the predicate.
The predicate device is not indicated for use on a mobile platform whereas the AngioCloud Service ● is compatible with and can be accessed through a mobile device web browser. Mobile platform access allows for the visualization and sharing of 3D vascular images through the 3D Viewer and for quick ruler and centerline measurements. All other functionalities of the AngioCloud Service are disabled during use on a mobile web browser. This technological characteristic has undergone testing and has been considered as part of the risk assessment to ensure the device is substantially equivalent to the predicate.
The predicate device is not indicated for case sharing, whereas the AngioCloud Service allows for de-identified cases to be shared between authorized users. Case sharing features have been evaluated through the risk assessment and software verification testing to ensure that this technological characteristic is substantially equivalent to the predicate.

The predicate device has the following additional functionalities which AngioCloud Service does not offer:

Volume measurements (e.g. aneurysmal volume)
. Line measurements on aneurysm (e.g. aneurysmal neck width and dome height)
Import patient data via study creation list ●
2D cross-sectional slice review of vessel (e.g. diameter measurement tool) ●
Deployment video tool
Deployment simulation report .

AngioCloud believes that the AngioCloud Service's indications for use and technological characteristics are substantially equivalent to the legally marketed predicate device (K171534) based on the information summarized in Table 1 - Substantial Equivalence Summary.

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Table 1 - Substantial Equivalence Summary
	Subject Device	Primary Predicate Device
Trade Name	AngioCloud Service	SurgicalPreview™
Manufacturer	AngioCloud Inc	Endovantage
510(k) Number	K211713	K171534
Class	II	II
Device ClassificationName	System, Image processing,Radiological	Software For Visualization ofVascular Anatomy AndIntravascular Devices
Regulation Number	892.2050	892.2050
Product Code	LLZ	PZO
Indications for Use	The AngioCloud Service enablesvisualization and measurement ofcerebral blood vessels forpreoperational planning and sizingfor neurovascular interventions andsurgery.General functionalities are providedsuch as:Segmentation ofneurovascular structuresCenterline calculationVisualization of 3Dvascular imagesMeasurement andannotation toolsCase sharing and reportingtoolsInformation provided by thesoftware is not intended in any wayto eliminate, replace, or substitutefor, in whole or in part, thehealthcare provider's judgment andanalysis of the patient's condition.	SurgicalPreview™ enablesvisualization and measurement ofvessels for preoperational planningand sizing for neurovascularinterventions and surgery.SurgicalPreview™ also allows forthe ability to computationally modelthe placement and deployment ofneurointerventional devices.General functionalities are providedsuch as:Segmentation ofneurovascular structuresAutomatic centerlinedetectionVisualization of CT scanimages for 2D review and3D reconstructionMeasurement andannotation toolsReporting toolsInformation provided by thesoftware is not intended in any wayto eliminate, replace, or substitutefor, in whole or in part, thehealthcare provider's judgment andanalysis of the patient's condition.
Interface to ImageSources	3D rotational angiography (3D-RA)DICOM image data	CT DICOM image data
Import of Patient Data	Manual through keyboard/mouse,automatic import with image file	Manual through keyboard/mouse,automatic import with image file,study creation list
List ImageFunctionality	Deleting, anonymizing, search	Same
Image Processing	Segmentation by SegmentationEngine with end-user clinicalreview and comment.	Segmentation by EndoVantageoperator with end-user clinicalreview and comment.
	Subject Device	Primary Predicate Device
	End-user can manually adjust thesegmentation threshold by choosingthe 'Advanced' option or apply anestimated segmentation thresholdby choosing the 'Automatic' option.
3D Assessment	Linear (length and diameter)measurements, centerlinemeasurement	Linear (length and diameter)measurements, volumemeasurements.
Image and 3D Display	Orthogonal, color volumerendering, and 3D visual view ofcenterline	Orthogonal, color volumerendering, 2D slice review, activepresets, 3D view of assemblies ofdevices
DICOM Support	Compatible with 3D-RA DICOMdatasets, storage SCP, importDICOM files, DICOM compliancefor 3D-RA CT, storage SCU,query/retrieve SCU	Compatible with all scanner vendorDICOM datasets, storage SCP,import DICOM files, DICOMcompliance for CT and enhancedCT, import from DICOMDIR,storage SCU, query/retrieve SCU
Computer OSCompatibility	MS Windows and Mac OS	Same
Mobile OSCompatibility	Yes, mobile browser compatiblewith limited functionalities	No
Data Interchange /Transfer Method	Secure Internet File Server	Same
Output File Format	Web browser via WebGL	Same
PreoperationalPlanning	Yes	Same
Patient Contact	No	Same
Human Intervention forInterpretation ofImages	Yes	Same

Table 1 - Substantial Equivalence Summary

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Performance Data

AngioCloud Service is designed in conformance with the following FDA recognized consensus standards:

NEMA PS 3.1 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set ●
ISO 14971:2019 Medical Devices Application of Risk Management to Medical Devices ●
IEC 62304:2006/AMD 1:2015 - Medical Device Software - Software Life-Cycle Processes
ISO/IEC 10918-1 First Edition 1994-02-15 Information technology Digital compression and ● coding of continuous-tone still images: Requirements and guidelines
. ANSI/AAMI/IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices

All specifications of the AngioCloud Service are verified by a number of tests before release. Nonclinical testing, including verification tests, evaluated:

DICOM images importation ●
Case management ●
Auto-segmentation and manual segmentation ●

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Visualization of 3D vascular images (on desktop and mobile platforms)
Centerline calculation (on desktop and mobile platforms)
Measurements and annotation tool (on desktop and mobile platforms) ●
Case sharing and reporting tool .

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The AngioCloud Service is considered a "moderate" level of concern, since malfunction of the software could cause a delay in generating information for preoperative planning.

Performance testing was conducted to evaluate the AngioCloud Service segmentation module and the device met the pre-defined acceptance criteria for each performance evaluation metric. Anatomically relevant phantom models derived from clinical scans were acquired using Siemens (Artis Q with PURE) and Phillips (Allura Xper FD 20/20) Angio suites. The scans were segmented using AngioCloud Service's 'Automatic' and 'Advanced' segmentation methods and these segmentations were compared to the reference standard. The Hausdorff distance (dH) and DICE coefficient (DC) were used to evaluate segmentation performance. Both the mean DC and mean dH for each group met the acceptance criteria.

AngioCloud believes that the aforementioned non-clinical testing demonstrates that the AngioCloud Service is designed in such a way that, when used in accordance with its indications for use and labeling, the safety and effectiveness, as well as the performance characteristics of the subject device are substantially equivalent to the predicate device.

Substantial Equivalence Conclusion

AngioCloud Service has the same intended use and performance characteristics as the predicate device. Based on the performance data and software verification testing, it can be concluded that the differences in technological characteristics between the AngioCloud Service and the predicate device do not raise different questions of safety and effectiveness. The indications for use, technological characteristics, and performance characteristics for the AngioCloud Service are assessed to be substantially equivalent to those of the predicate device.

Regulation Number and Section

§ 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).