Endoluminal Occlusion System-EOS by ARTVENTIVE MEDICAL GROUP, INC

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 delivery catheter, and the guide catheter with dilator. The AVMG EOS™ is intended for single use only.

Like the parent ArtVentive Endoluminal Occlusion System - EOS, the proposed 11mm size of the device is comprised of an implant 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 a delivery catheter and the guide catheter with dilator. The implant delivery 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. The implant itself and the catheter's distal end are visible under fluoroscopy.

The guide catheter 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 distal end of the catheter is visible under fluoroscopy. The tip of the guide catheter is tapered to fit over the dilator. The dilator fits inside the guide catheter exiting out through the distal end. The dilator also has a tapered end for ease of advancement into the blood vessel. The guidewire and dilator are removed from the guide catheter once it is in position for delivery of the implant.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA regarding the ArtVentive Medical Group's Endoluminal Occlusion System (EOS). It primarily establishes substantial equivalence to a predicate device rather than detailing a clinical study with acceptance criteria in the typical sense of a diagnostic or accuracy study.

However, based on the provided text, we can piece together what functioned as "acceptance criteria" through performance data and a comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence to Predicate Device:	The 11mm size of the delivery catheter/implant and 7.5 Fr size of the guide catheter of the ArtVentive Endoluminal Occlusion System – EOS™ are substantially equivalent to the predicate device when used according to its intended use. This equivalence was based on information demonstrating shared technological characteristics, mechanism of action, intended use, and physical characteristics.
Performance as Intended:	Bench studies indicate that the ArtVentive Endoluminal Occlusion System with the 11mm size of the delivery catheter/implant and 7.5mm size of the guide catheter as well as with minor design modifications made to the 5mm and 8mm parent devices perform as intended.
Verification & Validation for Added Sizes (11mm) and Modifications (5mm, 8mm):	The following testing was repeated for the additional sizes of the device (11mm diameter): dimensional and functional design verification/validation, MRI compatibility, corrosion, and radial strength.The design verification and validation testing was repeated as necessary for the minor design modifications to the cleared 5mm and 8mm delivery catheter/implant and the 6 Fr guide catheter.
Material Equivalence: Nitinol coil with an ePTFE polymeric cover	The device uses a Nitinol coil with an ePTFE polymeric cover, which is the same as the predicate device.
Design Features Equivalence: Flexibility, low profile, immediate/acute occlusion, ePTFE cover, retrievability, two-stage deployment handle, stiff proximal/flexible distal catheter sections, side port for flushing/pre-expansion.	The device is described with flexible, low profile for immediate, acute occlusion, incorporates an ePTFE cover, is retrievable, has a two-stage deployment handle, a stiff proximal section for pushability and a flexible distal section for trackability, and a side port to accommodate syringe attachment to flush and pre-expand the ePTFE membrane. These features are directly compared and found to be the same as the predicate device.
Mechanical Detachment Method Equivalence: Mechanical in nature	The detachment mechanism is mechanical in nature, same as the predicate device.
Treatment Method Equivalence: Permanent Implant	The treatment method is described as a permanent implant, same as the predicate device.
Application Method Equivalence: Via delivery catheter through guide catheter to target vessel	The device is applied via a delivery catheter through a guide catheter to the target vessel, same as the predicate device.

2. Sample size used for the test set and the data provenance

The document explicitly states "Bench studies" and "design verification and validation testing." This indicates in-vitro or laboratory testing rather than testing on human or animal subjects. Therefore, human test set sample size and provenance information is not applicable. The data provenance would be from internal laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the document describes bench testing and design verification/validation, not a study requiring expert clinical assessment for ground truth. The "ground truth" here would be defined by engineering specifications and predicate device performance characteristics.

4. Adjudication method for the test set

This is not applicable as the document describes bench testing and design verification/validation, not a study requiring adjudication of expert opinions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes bench studies and design verification/validation directly comparing the device characteristics to a predicate, not a study involving human readers' performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to a device, not an algorithm. Therefore, an algorithm-only standalone performance study is not applicable. The device's performance was evaluated in bench studies (standalone performance relative to engineering specifications and predicate device).

7. The type of ground truth used

The ground truth used for this submission is implicitly based on:

Engineering specifications and design requirements: The device's physical dimensions, material properties, and functional capabilities (e.g., radial strength, trackability) were measured and compared against established requirements.
Predicate device characteristics: The device was compared feature-by-feature (technological characteristics, mechanism of action, intended use, physical characteristics, materials, detachment method, application method) to a legally marketed predicate device (K133924 ArtVentive Medical Group, Inc./EOS).
Performance "as intended": Demonstrating that the device performs according to its designed function in bench tests.

8. The sample size for the training set

This document describes a 510(k) submission focused on proving substantial equivalence based on bench testing and design verification. It details the device's characteristics and compares them to a predicate. There is no mention of a "training set" in the context of machine learning or AI, as this is a medical device approval based on physical and functional characteristics.

9. How the ground truth for the training set was established

As there is no mention of a "training set", this question is not applicable.

Summary

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

September 25, 2015

ArtVentive Medical Group, Inc. % Roberta Hines Northwest Clinical Research Group, Inc. 19836 NE 125th Place Woodinville, WA 98077

Re: K150402

Trade/Device Name: Endoluminal Occlusion System (EOS) Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: August 25, 2015 Received: August 27, 2015

Dear Ms. 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) K150402

Device Name Endoluminal Occlusion System (EOS)

Indications for Use (Describe)

The ArtVentive Endoluminal Occlusion System (EOS) is intended for arterial and venous embolization in the peripheral vasculature.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

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 Road Carlsbad, CA 92009 3. Sponsor Contact Leon Rudakov, PhD., President and CTO Person: 4. Telephone: 650-465-5259 E-mail: leonrudakov@artventivemedical.com 5. 510(k) Summary February 9, 2015 Preparation Date: Endoluminal Occlusion System (EOS)™ 6. Device Trade Name: 7. Common Name: Vascular Embolization Device 8. Classification Name: Device Embolization, Vascular (21 CFR 870.3300, Product Code: KRD) ArtVentive Medical Endoluminal Occlusion System (EOS)™ 9. Legally Marketed Predicate Devices:

Description of the ArtVentive Medical Group - Endoluminal Occlusion System (EOS™): 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 delivery catheter, and the guide catheter with dilator. The AVMG EOS™ is intended for single use only.

Like the parent ArtVentive Endoluminal Occlusion System - EOS, the proposed 11mm size of the device is comprised of an implant made of a Nitinol coil scaffold with an ePTFE occlusion membrane

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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 a delivery catheter and the guide catheter with dilator. The implant delivery 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. The implant itself and the catheter's distal end are visible under fluoroscopy.

Manufacturer/ Device	ArtVentive Medical Group,Inc./EOS	ArtVentive Medical Group, Inc./EOS
		K133924
510(k) Number	K150402
Application /Product Code	21 CFR 870.3300 (KRD)	21 CFR 870.3300 (KRD)
FDAClassification	Class II	Class II
TechnologicalCharacteristics
Intended Use	The ArtVentive EOS™ is intended forarterial and venous embolizations in theperipheral vasculature.	The ArtVentive EOS™ is intended for arterial andvenous embolizations in the peripheralvasculature.
Design Features	Flexible, low profile device for immediate,acute occlusion of the target vessel. Thedevice incorporates an ePTFE cover.Retrievable; may be removed duringdeployment and re-positioned.Two-stage deployment handle on the proximalend. The catheter has a stiff proximal sectionfor pushability and a flexible distal section fortrackability. The deployment handle has aside port to accommodate syringe attachmentto flush the catheter of air and to pre-expandthe ePTFE membrane before deploying theimplant.	Flexible, low profile device for immediate, acuteocclusion of the target vessel. The deviceincorporates an ePTFE cover. Retrievable; maybe removed during deployment and re-positioned.Two-stage deployment handle on the proximal end.The catheter has a stiff proximal section forpushability and a flexible distal section fortrackability. The deployment handle has a side portto accommodate syringe attachment to flush thecatheter of air and to pre-expand the ePTFEmembrane before deploying the implant.
Material	Nitinol coil with an ePTFE polymeric cover	Nitinol coil with an ePTFE polymeric cover

11. Comparison to Predicate Device:

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Detachment	Mechanical in nature	Mechanical in nature
Sizes	Diameter (mm)Length (mm)51182011275mm diameter for target vessel diameter3.0mm - 5.0mm8mm diameter for target vessel diameter4.5mm - 8.0mm11mm diameter for target vessel diameter7.5mm - 11mm	Diameter (mm)Length (mm)5118205mm diameter for target vessel diameter3.0mm - 5.0mm8mm diameter for target vessel diameter 4.5mm - 8.0mm
	TreatmentMethod	Permanent Implant
How Applied	Via delivery catheter through guide catheter to target vessel	Via delivery catheter through guide catheter to target 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 Endoluminal Occlusion System with the 11mm size of the delivery catheter/implant and 7.5mm size of the guide catheter as well as with the minor design modifications made to the 5mm and 8mm parent devices perform as intended. The following testing was repeated for the additional sizes of the device: dimensional and functional design verification/validation, MRI compatibility, corrosion, and radial strength. The design verification and validation testing was repeated as necessary for the minor design modifications to the cleared 5mm and 8mm delivery catheter/implant and the 6 Fr quide catheter. The review of the technological characteristics, indications for use, and verification and validation information provided in the 510(k) Premarket Notification demonstrates that the ArtVentive Medical Group Endoluminal Occlusion System - EOS™ is substantially equivalent to its predicate device.

14. Substantial Equivalence:

The 11mm size of the delivery catheter/implant and 7.5 Fr size of the guide catheter of the ArtVentive Endoluminal Occlusion System – EOS™ are substantially equivalent to the predicate device when used according to its intended use. The equivalence was based on the information provided in this 510(k) Premarket Notification which demonstrates that these added sizes of the ArtVentive Endoluminal System share the same technological characteristics, mechanism of action, intended use and physical

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characteristics when compared to its predicate. The minor design modifications made to the parent device in sizes 5mm and 8mm delivery catheter/implant and 6 Fr guide catheter are also substantially equivalent to the predicate device when used according to its intended use. The equivalence was based on repeating the applicable design verification and validation testing.

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).