Who is the manufacturer of AneuGuide?

ArteryFlow Technology Co., Ltd. filed the 510(k) submission for AneuGuide (K213838).

What is the FDA product code for AneuGuide?

PZO. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for AneuGuide?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like AneuGuide?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AneuGuide

K213838 · ArteryFlow Technology Co., Ltd. · PZO · Jun 1, 2022 · Radiology

Device Facts

Record ID	K213838
Device Name	AneuGuide
Applicant	ArteryFlow Technology Co., Ltd.
Product Code	PZO · Radiology
Decision Date	Jun 1, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

AneuGuide enables visualization of intracranial vessels for preoperational planning and sizing for neurovascular interventions. AneuGuide also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as: - Segmentation of neurovascular structures . - Automatic centerline detection - . Visualization of X-ray based images for 2D review and 3D reconstruction - . Placing and sizing 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 Story

AneuGuide is a software-based medical image management and processing system used for preoperational planning of neurovascular interventions. It imports DICOM images from 3D rotational angiography; performs segmentation of neurovascular structures; automatically detects vessel centerlines; and reconstructs 3D vascular models. Clinicians use the software to computationally model the placement and estimate the size of flow diverter devices (specifically the Pipeline Flex Embolization Device). The device is operated by clinicians in a clinical setting to assist in surgical planning; it does not perform diagnosis. The output provides a 3D visualization and sizing report, which the clinician uses to inform surgical decision-making and device selection. By simulating device deployment, the software aims to improve the accuracy of pre-operative sizing, potentially benefiting the patient by optimizing the fit of the implanted neurointerventional device.

Clinical Evidence

Bench testing only. Validation included: 1) Comparison of in vitro virtual placement vs. physical placement using silicone phantoms representative of intracranial aneurysms; 2) Validation study comparing simulated deployed length of the Pipeline Flex Embolization Device against actual implanted length in patients. Testing confirmed the software meets design requirements and performance specifications for calculating device deployment length.

Technological Characteristics

Medical image management and processing software; runs on Mac OS; utilizes VTK rendering. Inputs: DICOM images from 3D rotational angiography. Features: segmentation, automatic centerline detection, 3D reconstruction, and device sizing tools. Data transfer via physical media (USB). Software level of concern: moderate.

Indications for Use

Indicated for visualization of intracranial vessels for preoperational planning and sizing for neurovascular interventions in patients requiring neurointerventional device placement.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Sim&Size (K202322)

Reference Devices

Pipeline Flex Embolization Device (P100018/S015)
Woven EndoBridge (WEB) Aneurysm Embolization System (P170032)
Surpass Evolve Flow Diverter System (P170024/S003)

Related Devices

K190049 — Sim&Size · Sim&Cure · Sep 17, 2019
K212373 — Sim&Size · Sim&Cure · Jan 27, 2022
K202322 — Sim&Size · Sim&Cure · Dec 31, 2020
K230006 — Ankyras · Mentice Spain S.L. · Dec 28, 2023
K222664 — Sim&Size · Sim&Cure · Jan 27, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ June 1, 2022 Image /page/0/Picture/1 description: The image shows 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 is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration". ArteryFlow Technology Co., Ltd. Jianping Xiang, Ph.D. General Manager 459 Qianmo Road, Suite C1-501, Binjiang District, 310051 Hangzhou City, Zhejiang Province, China Re: K213838 Trade/Device Name: AneuGuide Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: PZO Dated: April 25, 2022 Received: May 2, 2022 Dear Dr. Xiang: 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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, Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K213838 Device Name AneuGuide ### Indications for Use (Describe) AneuGuide enables visualization of intracranial vessels for preoperational planning and sizing for neurovascular interventions. AneuGuide also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as: - Segmentation of neurovascular structures . - Automatic centerline detection - . Visualization of X-ray based images for 2D review and 3D reconstruction - . Placing and sizing 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. 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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}------------------------------------------------ # K213838: 510(k) Summary This 510(k) Summary of safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92. ## 1. Submitter's Information Submitter: ArteryFlow Technology Co., Ltd. Address: 459 Qianmo Road, Suite C1-501, Binjiang District, 310051 Hangzhou City, Zhejiang Province, China Phone Number: +86-571-86772567 Primary correspondent: Jianping Xiang, PhD, General Manager Email: jianping.xiang@arteryflow.com Secondary correspondent: Ashley Fu, RA Specialist Email: fang.fu@arteryflow.com Date of preparation: April 25, 2022 # 2. Device Information Trade/ Device Name: AneuGuide Common Name: Radiological Image Processing Software Regulatory Class: Class II Regulation Description: Medical Image Management and Processing System, Software for Visualization of Vascular Anatomy and Intravascular Devices Regulation number: 892.2050 Classification Product Code: PZO ## 3. Predicate Device Information Manufacturer: Sim&Cure Device Name: Sim&Size Regulatory Class: Class II Regulation Number: 892.2050 Classification Product Code: PZO 510(k) number: K202322 ## 4. Device Description {4}------------------------------------------------ The AneuGuide software is a medical device intended to provide a 3D view of the final placement of implants. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of computationally modeling the flow diverters (FD) in the artery to be treated through endovascular surgery. AneuGuide is intended to import DICOM images and to provide a 3D reconstruction of the vascular tree in the surgical area. Also, it allows to pre-operationally estimate the size of flow diverter devices. AneuGuide is composed of the following analysis workflows: image loading, selection of the volume of interest (VOI), segmentation threshold adjustment, reconstruction, selection of the region of interest (ROI), selection of the vessel inlet, generation of centerline, initializing the flow diverter, and sizing the flow diverter. The flow diverter supported by the software is the Pipeline Flex Embolization Device (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, PMA: P100018/S015), which is an FDA-approved neurointerventional device. AneuGuide software has a "moderate" level of concern. It is intended only for preoperational planning. It is not intended for diagnosis. #### 5. Intended Use / Indication for Use AneuGuide enables visualization of intracranial vessels for preoperational planning and sizing for neurovascular interventions. AneuGuide also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as: - Seqmentation of neurovascular structures - Automatic centerline detection - Visualization of X-ray based images for 2D review and 3D reconstruction - Placing and sizing 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. {5}------------------------------------------------ # 6. Comparison of Technological Characteristics A comparison of the technological characteristics of the predicate and subject devices is provided in the table below. | Characteristic | Predicate device | Subject device | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Sim&Size K202322 | AneuGuide K213838 | | Indications for Use | Sim&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as: Segmentation of neurovascular structuresAutomatic centerline detectionVisualization of X-Ray based images for 2D review and 3D reconstructionPlacing and sizing toolsReporting toolsInformation 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. | AneuGuide enables visualization of intracranial vessels for preoperational planning and sizing for neurovascular interventions. AneuGuide also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as: Segmentation of neurovascular structuresAutomatic centerline detectionVisualization of X-Ray based images for 2D review and 3D reconstructionPlacing and sizing toolsReporting toolsInformation 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. | | Interface to Image Sources | DICOM Image Data | DICOM Image Data | | Import of Patient Data | Manual through keyboard/mouse, automatic import with image file, study creation list | Same | | List Image Functionality | Deleting, anonymizing, search | Same | | Image Processing | Segmentation by user with clinician review and comment | Same | | | Table 1. General Comparison | | |--|-----------------------------|--| | | | | {6}------------------------------------------------ | 3D Assessment | 3D assessment based on 3D model of the simulated device inside the vessels | Same | |-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | Image and 3D Display | Orthogonal, color volume rendering, 2D slide review, active presets, 3D view of assemblies of devices | Same | | DICOM Support | Read DICOM images from 3D rotational angiography stations | Same | | Computer OS Compatibility | MS Windows and Mac OS | Mac OS | | Data Interchange/Transfer Method | Transfer by physical media, i.e. USB memory stick and Scanner Workstations (retrieve function only) | Transfer by physical media, i.e. USB memory stick | | Output File Format | Local openGL rendering | Local VTK rendering | | Preoperational Planning | Yes | Yes | | Patient Contact | No | No | | Human Intervention for Interpretation of Images | Yes | Yes | | Implantable Medical Device (IMD) Database | - Pipeline™ Flex Embolization Device (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, PMA number P100018/S015) - Woven EndoBridge (WEB) Aneurysm Embolization System (MicroVention, Inc., PMA number P170032) - Surpass Evolve Flow Diverter System (Stryker Neurovascular, P170024/S003). | - Pipeline™ Flex Embolization Device (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, PMA number P100018/S015) | | Fusion correction | Automatic and manual | Manual | # 7. Performance Data The following performance data were performed on AneuGuide in support of the substantial equivalence determination. # Software Verification and Validation Testing Software verification and validation testing were conducted, and documentation was provided {7}------------------------------------------------ as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered as a "moderate" level of concern, since prior to mitigation of hazards, a failure of the software device could result in minor injury to a patient. The following performance tests were conducted: - Tests of importation of DICOM images. - Patient management tests. - Tests of image display and processing. - Functioning tests for visualization of anatomic reconstruction. - Report creation and visualization tests. - Cybersecurity tests. All tests have passed and demonstrate that the software is designed to meet the software requirements and functions as intended. #### Performance Testing - Bench The computational modeling of the Pipeline Flex Embolization Device was tested through two tests: - Using silicone phantoms representative of patients presenting with intracranial aneurysms to compare the in vitro and virtual placement of the flow diverter. - Validation study of the AneuGuide performance comparing the simulated deployed length of the Pipeline Flex Embolization Device with its implanted length in patients with intracranial aneurysms. These validation tests allow to evaluate the performance (error) of the AneuGuide in calculating the deployed length of the Pipeline Flex Embolization Device after implantation. ### 8. Conclusion The AneuGuide has the same intended use and indications for use as the predicate device Sim&Size. Verification and validation testing have produced results consistent with design input requirements. During the development, potential hazards were controlled by the risk management report, including risk analysis, risk mitigation, verification and validation. ArteryFlow Technology concludes that the AneuGuide, intended for preoperational planning but not for diagnosis, is as safe and effective as the predicate device. The differences between the subject and predicate devices do not raise new questions of safety and effectiveness.