SurgicalPreview enables visualization and measurement of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. SurgicalPreview also allows for the ability to computationally model the placement and deployment of neurointerventional devices.

General functionalities are provided such as:

Segmentation of neurovascular structures
Automatic centerline detection
Visualization of CT scan images for 2D review and 3D reconstruction
Measurement and annotation tools
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

SurgicalPreview" is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview™ provides a clinical decision support system during the preoperative planning of endovascular surgery.

SurgicalPreview™ enables visualization and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. SurgicalPreview™ also allows for the ability to computationally model the placement and deployment of neurointerventional devices. SurgicalPreview™ can reconstruct 2D scan slices into 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files.

The device does not contact the patient, nor does it control any life sustaining devices. 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 judgement and analysis of the patient's condition.

AI/ML Overview

The provided document, a 510(k) summary for the EndoVantage SurgicalPreview device, does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria. Instead, it relies on a comparison to a predicate device and bench testing for validation of its functionalities.

Here's a breakdown of the information available and what is not available based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or a table of performance metrics. It lists functionalities and describes bench tests, implying that successful completion of these tests (without specific thresholds) is considered acceptable performance.

Functionality Tested	Reported Device Performance
Importation of DICOM images	Tests successfully completed (implied)
Patient manager	Tests successfully completed (implied)
Image display and processing	Tests successfully completed (implied)
Visualization of anatomic reconstruction	Tests successfully completed (implied)
Computational modeling (Codman Enterprise Vascular Reconstruction Device and Pipeline Embolization Device)	Tests successfully completed (implied)
Measurement	Tests successfully completed (implied)
Reports creation and visualization	Tests successfully completed (implied)

2. Sample Size Used for the Test Set and Data Provenance:

The document states that "SurgicalPreview™ underwent bench testing to simulate clinical use." However, it does not specify:

The sample size of cases or images used for these bench tests.
The data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not provide information on:

The number of experts used to establish ground truth for the bench tests.
The qualifications of any such experts.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

The document does not mention an MRMC comparative effectiveness study or any effect size for human readers improving with AI assistance. The device is described as "clinical decision support system" and explicitly states that "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," which suggests it's an aid rather than a replacement for human interpretation.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

The document describes "bench testing" of the software's functionalities. This implies standalone performance testing of the algorithms for tasks like segmentation, centerline detection, visualization, and measurement. However, there's no explicit statement about a "standalone performance study" in the context of clinical accuracy metrics (sensitivity, specificity, etc.) against a clinical ground truth. The device is a "clinical decision support system" with "human intervention for interpretation of images."

7. The Type of Ground Truth Used:

The document mentions "bench testing" for various functionalities. The nature of the ground truth for these tests is not explicitly stated. For example, for measurement tests, it's not clear if the measurements were compared against manually acquired measurements by experts, a physical phantom, or another reference standard.

8. The Sample Size for the Training Set:

The document does not provide any information about a training set or its sample size. The device description suggests algorithmic processes (segmentation, centerline detection, computational modeling) that might involve machine learning, but no details on training data are given.

9. How the Ground Truth for the Training Set was Established:

Since no information on a training set is provided, there is no information on how its ground truth was established.

Summary of what is present:

Device Functionalities: Segmentation, automatic centerline detection, 2D/3D visualization, measurement, annotation, reporting, computational modeling of device placement.
Validation Method: Bench testing to validate specifications, including importation, patient manager, image display/processing, anatomic reconstruction visualization, computational modeling, measurement, and report creation.
Regulatory Conformance: ACR/NEMA DICOM 3.1, ISO 14971:2007, IEC 62304:2006.
Predicate Device: EndoSize (K160376), with similar intended use for preoperational planning and image data processing.
Role of Human Intervention: Explicitly states "Human Intervention for Interpretation of Images: Yes" and that the software does not replace healthcare provider judgment.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 8, 2017

EndoVantage, LLC % H. Semih Oktay, Ph.D. Regulatory Consultant CardioMed Device Consultants, LLC 1783 Forest Drive, Suite 254 Annapolis, Maryland 21401

Re: K171534

Trade/Device Name: SurgicalPreview Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: PZO Dated: October 6, 2017 Received: October 10, 2017

Dear Dr. Oktay:

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

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801); medical device 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.

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.

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,

Nicole G. Ibrahim -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171534

Device Name EndoVantage SurgicalPreview

Indications for Use (Describe)

General functionalities are provided such as:

· Segmentation of neurovascular structures
· Automatic centerline detection
· Visualization of CT scan images for 2D review and 3D reconstruction
· Measurement and annotation tools
· Reporting tools

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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Image /page/3/Picture/0 description: The image shows the logo for Endovantage. The logo is red and features a stylized globe-like graphic on the left side. The text "endovantage" is written in a bold, sans-serif font and is also red.

SurgicalPreview™

510(k) SUMMARY	K171534
Submitter:	EndoVantage, LLC8444 N. 90th StreetSuite 125Scottsdale, AZ 85258
Contact Person:	Robert S. GreenPresidentPhone: (480) 291-5031Email: simulate@endovantage.com
Summary Date:	October 6, 2017
Device Trade Name:	SurgicalPreviewTM
Device Common Name:	Radiological Image Processing Software
Device Classification Name:	Software for visualization of vascular anatomy andintravascular devices
Regulatory Description:	Picture Archiving and Communication System
Regulation Number:	21 CFR 892.2050
Product Code:	PZO
Regulatory Classification:	Class II
Predicate Device:	EndoSize (K160376)

Device Description

The device does not contact the patient, nor does it control any life sustaining devices. Information provided by the software is not intended in any way to eliminate, replace or

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Image /page/4/Picture/1 description: The image shows the logo for Endovantage. The logo features a stylized globe-like graphic on the left, with red lines forming a grid pattern. To the right of the graphic is the word "endovantage" in red, with a slightly blurred effect. The font is sans-serif and appears to be bolded.

substitute for, in whole or in part, the healthcare provider's judgement and analysis of the patient's condition.

Indications for Use

SurgicalPreview™ enables visualization and measurement of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. SurgicalPreview™ also allows for the ability to computationally model the placement and deployment of neurointerventional devices.

General functionalities are provided such as:

Segmentation of neurovascular structures ●
Automatic centerline detection
Visualization of CT scan images for 2D review and 3D reconstruction ●
Measurement and annotation tools ●
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 judgement and analysis of the patient's condition.

Technological Characteristics

SurgicalPreview™ is a software-only device that runs on a standard computer that meets the minimum requirements. SurgicalPreview™ is not intended for use on mobile devices.

SurgicalPreview™ can use local DICOM files. The device does not contact the patient, nor does it control any life sustaining devices. 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 judgement and analysis of the patient's condition.

Performance Data

The subject device is designed in conformance with:

ACR/NEMA Digital Imaging Communications in Medicine (DICOM) Version 3.1 ●
ISO 14971:2007 Medical Devices Application of Risk Management to Medical ● Devices
IEC 62304:2006 Medical Device Software Software Life-Cycle Processes ●

All specifications of the SurgicalPreview™ software are validated by a bench test before release. Bench testing includes:

Tests of importation of DICOM images ●
Patient manager tests
Tests of image display and processing
Functioning tests for visualization of anatomic reconstruction
Functioning tests for computational modeling of Codman Enterprise Vascular Reconstruction Device and Pipeline Embolization Device

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Image /page/5/Picture/0 description: The image shows the word "endovantage" in red font. The word is written in a stylized font, with the letters connected to each other. There is a graphic to the left of the word that looks like a red dome with a gray grid pattern on it. The word "endovantage" is the main focus of the image.

Measurement tests ●
Reports creation and visualization tests ●

Predicate Device Comparison

The predicate device for the SurgicalPreview™ software is EndoSize (K160376). Both SurgicalPreview™ and its predicate device have similar intended use for preoperational planning of endovascular procedures using image data from a medical scanner. A summary comparison of technological characteristics is provided in Table 1.

Characteristic	SurgicalPreviewTM	Predicate: EndoSize
510(k) Number	K171534	K160376
Indications for Use	SurgicalPreviewTM enables visualizationand measurement of vessels forpreoperational planning and sizing forneurovascular interventions and surgery.SurgicalPreviewTM also allows for theability to computationally model theplacement and deployment ofneurointerventional devices.	EndoSize enables visualization andmeasurement of structures of theheart and vessels for preoperationalplanning and sizing forcardiovascular interventions andsurgery, and for postoperativeevaluation
Interface to ImageSources	DICOM image data	Same
Import of Patient Data	Manual through keyboard/mouse,automatic import with image file, studycreation list	Same
List Image Functionality	Deleting, anonymizing, search	Same
Image Processing	Segmentation by EndoVantage operatorwith end-user clinician review andcomment	By clinician
3D Assessment	Linear (length and diameter)measurements, volume measurements	Same
Image and 3D Display	Orthogonal, color volume rendering, 2Dslice review, active presets, 3D view ofassemblies of devices	Same
DICOM Support	Compatible with all scanner vendorDICOM datasets, storage SCP, importDICOM files, DICOM compliance forCT and enhanced CT, import fromDICOMDIR, storage SCU,query/retrieve SCU	Same
Computer OSCompatibility	MS Windows and Mac OS	Same
Data Interchange /Transfer Method	Secure Internet File Server	Personal computer
Output File Format	Web browser via WebGL	Personal computer
Characteristic	SurgicalPreviewTM	Predicate: EndoSize
Preoperational Planning	Yes	Same
Patient Contact	No	Same
Human Intervention forInterpretation of Images	Yes	Same

Table 1 - SurgicalPreviewTM and Predicate Comparative Analysis

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Substantial Equivalence Conclusion

Based on the information provided in this 510(k) submission, SurgicalPreview™™ has the same intended use as the predicate device. SurgicalPreview™ underwent bench testing to simulate clinical use. The performance data and software verification results demonstrated that the differences in technological characteristics between SurgicalPreview™ and the predicate device do not raise different questions of safety and effectiveness and that SurgicalPreview™™ should perform as intended in the specified use conditions. Endo Vantage concludes that SurgicalPreview™ is substantially equivalent to the predicate device identified in this submission.

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).