The ArtVentive Medical Group Endoluminal Occlusion System (AVMG EOS) is indicated for the percutaneous occlusion of the peripheral arterial and venous vasculature.

Device Description

The ArtVentive Medical Group Endoluminal Occlusion System™ (AVMG EOS™) has been developed for arterial and venous embolizations in the peripheral vasculature. The system consists of three major components: a preloaded implant, the implant carrier catheter, and the guide sheath with removable core. The AVMG EOS™ is intended for single use only.

The implant is made of a Nitinol coil scaffold with an ePTFE occlusion membrane and is designed with radial force sufficient to provide stiffness and strength against the vessel wall and minimize post-deployment migration. The delivery system is made up of the implant carrier catheter and the guide sheath with removable core. The implant carrier catheter contains one implant loaded on the distal end and a deployment handle on the proximal end connected by the shaft. The delivery catheter has a low profile and is flexible to allow for trackability and pushability. The implant itself and catheter's distal end are visible under fluoroscopy.

The guide sheath is a braided shaft with a stiff proximal section and a more flexible distal section to enable tracking through tortuous peripheral vasculature. A radiopaque marker on the sheath is visible under fluoroscopy. The tip of the sheath is tapered to fit over the removable core. The removable core fits inside the guide sheath, exiting out through the distal end. The removable core also has a tapered end for ease of advancement into the blood vessel. The guidewire and core are removed from the guide sheath once it is in position for delivery of the implant.

AI/ML Overview

This document, a 510(k) summary for the ArtVentive Medical Group Endoluminal Occlusion System (EOS)™, describes the device's technical characteristics, intended use, and a comparison to predicate devices, along with performance data to demonstrate substantial equivalence.

Here's an analysis to extract the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative format for specific clinical performance metrics like success rates or complication rates, which are typical for medical device studies that involve human subjects for clinical efficacy. Instead, it focuses on demonstrating substantial equivalence through various bench and animal testing. The "reported device performance" refers to the successful completion and outcomes of these tests.

Performance Metric / Acceptance Criteria (Implied)	Reported Device Performance
Dimensional Design Verification/Validation	Performed as intended, demonstrating compliance.
Sterilization Validation	Successfully validated.
Transit and Package Integrity Testing	Successfully tested.
GLP Chronic Animal Safety Testing	Demonstrated safety (no adverse events reported if passed).
MRI Compatibility	Demonstrated compatibility.
Corrosion Resistance	Successfully tested.
Radial Strength	Performed as intended.
Biocompatibility Testing	Demonstrated biocompatibility.
Substantial Equivalence to Predicate Devices	Achieved, based on intended use, design, technology, materials, and performance (via the above tests).

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

Sample Size for Test Set: The document explicitly mentions "GLP chronic animal safety testing." For such tests, a sample size would typically involve a specific number of animals. However, the exact number is not specified in this document.
Data Provenance: The animal studies were "GLP chronic animal safety testing," implying a controlled laboratory environment. The country of origin is not specified, but given the FDA filing, it's typically either conducted in the US or in facilities compliant with US GLP standards. The study is prospective in nature, as it involves pre-clinical testing of the device for safety.

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

Number of Experts: This information is not provided in the document.
Qualifications of Experts: This information is not provided in the document. For animal studies, ground truth establishment would typically involve veterinary pathologists, toxicologists, and other animal care specialists, but their specific involvement or qualifications are not detailed here.

4. Adjudication Method for the Test Set:

The document describes "GLP chronic animal safety testing," which adheres to Good Laboratory Practice regulations. Adjudication in such studies typically involves independent pathology reviews and data audits. However, the specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human readers interpreting images, not for an embolization system like the AVMG EOS™, which is a therapeutic device.
Effect Size of Human Readers Improvement with AI: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI algorithm.

7. The Type of Ground Truth Used:

For the animal safety testing, the ground truth would be based on histopathology, clinical observations, and potentially laboratory assays from the animal subjects, evaluated by veterinary pathologists and researchers. This is a form of pathology and observational outcomes data.
For the other bench tests (dimensional, sterilization, etc.), the ground truth is established by engineering specifications, standardized test methods, and quantitative measurements.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set" in the computational sense. The manufacturing process and quality control would involve testing individual batches of devices and components, but this is distinct from training an algorithm.

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

Not applicable. As a physical device, there is no "training set" in the context of machine learning. The "ground truth" for its design and manufacturing would be established by engineering specifications, material standards, and validated manufacturing processes.

Summary of Device Performance Study:

The primary study mentioned is GLP chronic animal safety testing, alongside various bench studies (dimensional verification, sterilization, transit/package integrity, MRI compatibility, corrosion, radial strength, and biocompatibility). These studies collectively aim to demonstrate the safety and functional performance of the ArtVentive Medical Group Endoluminal Occlusion System (AVMG EOS™), thereby proving its substantial equivalence to existing predicate devices (AGA Medical/Amplatzer® Vascular Plug II, AGA Medical/Amplatzer® Vascular Plug 4, and Reverse Medical MVP™ Micro Vascular Plug System). The document emphasizes that these tests indicate the device performs as intended and that differences between it and the predicates do not raise any significant safety or effectiveness issues.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 3, 2014

ArtVentive Medical Group, Inc. % Roberta Hines Northwest Clinical Research Group, Inc. 24125 85th Avenue SE Woodinville, WA 98072

Re: K133924

Trade/Device Name: Endoluminal Occlusion System (EOS)TM Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 22, 2014 Received: October 24, 2014

Dear Roberta Hines:

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -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) K133924

Device Name Endoluminal Occlusion System (EOS)™

Indications for Use (Describe)

The ArtVentive Medical Group Endoluminal Occlusion System (AVMG EOS) is indicated for the percutaneous occlusion of the peripheral arterial and venous vasculature.

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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K133924

510(k) Summar

In accordance with 21 CFR 807.92 (Summary):

A summary of the information regarding the safety and effectiveness of the ArtVentive Medical Group Endoluminal Occlusion System (AVMG EOS™), as required by the Safe Medical Device Amendments of 1990, is provided as follows:

510(k) Summary for the
ArtVentive Medical Group Endoluminal Occlusion System™
1. Applicant:	ArtVentive Medical Group, Inc.
2. Address:	ArtVentive Medical Group, Inc.2766 Gateway RoadCarlsbad, CA 92009
3. Sponsor Contact Person:	Leon Rudakov, PhD., President and CTO
4. Telephone:E-mail:	650-465-5259leonrudakov@artventivemedical.com
5. 510(k) Summary PreparationDate:	December 2, 2014
6. Device Trade Name:	Endoluminal Occlusion System (EOS)™
7. Common Name:	Vascular Embolization Device
8. Classification Name:	Device Embolization, Vascular(21 CFR 870.3300, Product Code: KRD)
9. Legally Marketed PredicateDevices:	AGA Medical/Amplatzer® Vascular Plug II (K071125)AGA Medical/Amplatzer® Vascular Plug 4 (K113658)Reverse Medical MVP™ Micro Vascular Plug System (K123803)

10. Description of the ArtVentive Medical Group - Endoluminal Occlusion System (EOS™):

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11. Comparison to Predicate Devices:

Manufacturer /Device	ArtVentive Medical Group,Inc./EOS	AGA Medical / Amplatzer®Vascular Plug II	AGA Medical / Amplatzer®Vascular Plug 4	Reverse Medical MVP™ MicroVascular Plug System
510(k) Number	K133924	K071125	K113658	K123803
Application / ProductCode	21 CFR 870.3300 (KRD)	21 CFR 870.3300 (KRD)	21 CFR 870.3300 (KRD)	21 CFR 870.3300 (KRD)
FDA Classification	Class II	Class II	Class II	Class II
TechnologicalCharacteristics
Intended Use	The ArtVentive EOS™ is intendedfor arterial and venousembolizations in the peripheralvasculature.	The AMPLATZER® VascularPlug II is indicated for arterialand venous embolizations inthe peripheral vasculature.	The AMPLATZER Vascular Plug4 is indicated for arterial andvenous embolizations in theperipheral vasculature.	The Reverse Medical MVP™ MicroVascular Plug System is intended foruse to obstruct or reduce the rate ofblood flow in the peripheralvasculature.
Design Features	Flexible, low profile device forimmediate, acute occlusion of thetarget vessel. The deviceincorporates an ePTFE cover.Retrievable; may be removedduring deployment and re-positioned.Two-stage deployment handle onthe proximal end. The catheter hasa stiff proximal section forpushability and a flexible distalsection for trackability. Thedeployment handle has a side portto accommodate syringeattachment to flush the catheter ofair and to pre-expand the ePTFEmembrane before deploying theimplant.	Unique multi-segmented,multi-layered designsignificantly reduces occlusiontime for transcatheterembolization procedures. Thethree adjustable lobes of theAMPLATZER Vascular Plug IIare designed for enhancedconformability to vessellanding zones. May berepositioned. Multiplevascular plugs may be used toocclude vessel.	The AMPLATZER® VascularPlug 4 is delivered through a0.038 diagnostic catheter.The flexible mesh and thefloppy distal section of thedelivery wire enable thedevice to travel throughtortuous anatomy with easewhile the multi-layered,double-lobed design providesrapid embolization. May berepositioned.	The MVP Device is ovoid-shape,comprised of nitinol and secured atboth ends with platinum markerbands. The device incorporates aPTFE partial cover. The proximalmarker band attaches to a wire thatpushes the device through acommercially availablemicrocatheter to the intendedtreatment site. The "delivery wire"detaches from the MVP Device byelectrolytic means after deploymentwith the Reverse MedicalDetachment System. Fullresheathability enables precisedelivery.The MVP System is packaged as asingle unit with the MVP Device,introducer sheath and detachabledelivery wire. The system is providedsterile, non-pyrogenic, and isintended for single use only.
Material	Nitinol coil with an ePTFEpolymeric cover	Nitinol mesh	Nitinol mesh with aradiopaque marker band	Nitinol coil with an ePTFE polymericpartial cover and platinum markerbands
Detachment	Mechanical in nature	Mechanical in nature	Mechanical in nature	Electrolytic means of deployment

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Manufacturer /Device	ArtVentive Medical Group,Inc./EOS	AGA Medical / Amplatzer®Vascular Plug II	AGA Medical / Amplatzer®Vascular Plug 4	Reverse Medical MVPT™ MicroVascular Plug System
Sizes	Diameter(mm)585mm diameter for target vesseldiameter3.0mm - 5.0mm8mm diameter for target vesseldiameter 4.5mm - 8.0mm)	Length(mm)1120	Diameter(mm)346810121416182022	Length(mm)6667791012141618	Diameter(mm)45678	Length(mm)10.010.511.012.513.5	Diameter(mm)5.36.55.3 mm diameter used for targetvessel diameter 1.5-3.0 mm6.5 diameter used for target vesseldiameter 3.0-5.0 mm	Length(mm)1212
Treatment Method	Permanent Implant	Permanent Implant		Permanent Implant		Permanent Implant
How Applied	Via catheter through guide sheath toto target vessel	Via guiding catheter to thetarget vessel		Via guiding catheter to thetarget vessel		Via catheter through guide sheath totarget vessel

12. Intended use of the ArtVentive Medical Group - Endoluminal Occlusion System (EOS)™:

The ArtVentive Medical Group Endoluminal Occlusion System™ (AVMG EOS™) is indicated for arterial and venous embolizations in the peripheral vasculature.

13. Performance Data:

Bench studies indicate that the ArtVentive Medical Group's EOS™ device performs as intended. The following testing was performed: dimensional design verification/validation, sterilization validation, transit and package integrity testing, GLP chronic animal safety testing, MRI compatibility, corrosion, radial strength and biocompatibility testing.

14. Substantial Equivalence:

The performance of the ArtVentive EOS demonstrates that the product is substantially equivalent to the performance of the predicate devices. The equivalence was shown through component materials and specifications, performance, biocompatibility testing, and sterilization validation. The AVMG EOS is substantially equivalent in intended use, design, technology/principles of operation, materials, and performance to the predicate devices. Differences between the devices do not raise any significant issues of safety or effectiveness.

Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).