The ArtVentive Endoluminal Occlusion System (EOS-X) has been developed for arterial and venous embolization in the peripheral vasculature. The system consists of three major components: a preloaded implant, the delivery catheter, and the guide catheter with dilator. The EOS-X is intended for single use only.

Like the predicate ArtVentive Endoluminal Occlusion System (EOS)™, the ArtVentive Endoluminal Occlusion System (EOS-X) 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 and pushability. 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 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

The provided text describes the ArtVentive Endoluminal Occlusion System (EOS-X), a vascular embolization device, and its substantial equivalence to a predicate device (ArtVentive Endoluminal Occlusion System, EOS). However, the document does not contain acceptance criteria for device performance, nor details of a study proving the device meets specific performance criteria in the way requested (e.g., using metrics like sensitivity, specificity, or accuracy compared to a ground truth).

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared device (ArtVentive Endoluminal Occlusion System, EOS). This is a common regulatory pathway for medical devices in the US, where a new device can be cleared if it is shown to be as safe and effective as a legally marketed predicate device.

The "study" referenced in this document is primarily a series of engineering performance studies and design verification/validation testing. This testing is to ensure the new device, particularly the new 16mm size and minor design modifications to existing sizes, performs as intended and is comparable to the predicate.

Here's an attempt to answer your questions based on the provided text, while acknowledging the absence of some requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of performance metrics (like accuracy, sensitivity, or specificity) or numerical thresholds for clinical outcomes. The "reported device performance" is described as performing "as intended" and being "substantially equivalent" to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Function as intended	Performed as intended
Substantially equivalent to predicate device (EOS)	The ArtVentive Endoluminal Occlusion System (EOS-X) is substantially equivalent to its predicate device, the ArtVentive Endoluminal Occlusion System (EOS).
Maintain original device performance for modified sizes (5, 8, 11mm)	Design modifications made to the EOS-X device in sizes 5mm, 8mm and 11mm delivery catheter/implant and associated guide catheters are also substantially equivalent to the predicate device when used according to its intended use.
New 16mm size functions similarly	The larger size 16mm delivery catheter/implant is also similar to the other smaller models of EOS and EOS-X in technological characteristics, mechanism of action, intended use and physical characteristics.
MRI compatibility	Testing was repeated for MRI compatibility. (No specific results provided, but implies it met previous standards).
Corrosion resistance	Testing was repeated for corrosion. (No specific results provided, but implies it met previous standards).
Radial strength	Testing was repeated for radial strength. (No specific results provided, but implies it met previous standards).
Dimensional and functional design verification/validation	Testing was repeated for dimensional and functional design verification/validation. (Implies successful completion).

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

The document explicitly states "Engineering Performance Studies" and "design verification/validation testing." These are typically bench and pre-clinical tests, not clinical studies with human patient data. Therefore, concepts like country of origin for patient data or retrospective/prospective designations are not applicable. The sample sizes for these engineering tests are not specified in the provided text.

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

This type of information is generally relevant for clinical studies where expert consensus or diagnostic accuracy is being assessed. Given that the document refers to engineering and design verification/validation tests, there is no mention of external experts establishing a "ground truth" for a test set in the conventional clinical sense. The ground truth for engineering tests would be defined by established manufacturing specifications, industry standards, and the performance characteristics of the predicate device.

4. Adjudication method for the test set

Not applicable, as this is typically used in clinical studies involving human interpretation or subjective measurements. The engineering tests would likely have objective pass/fail criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device described is a physical vascular embolization system, not an AI-assisted diagnostic tool.

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

Not applicable. As above, this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the engineering performance studies and design verification/validation, the "ground truth" would be defined by:

Design specifications and requirements: The device's components and overall system must meet predetermined engineering and material specifications.
Performance of the predicate device: The EOS-X is compared to the established performance of its predicate, EOS.
Industry standards and regulatory guidelines: The device must conform to relevant standards for medical devices of its type.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning algorithm.

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

Not applicable.

In summary, the provided document details the regulatory clearance of a medical device (ArtVentive Endoluminal Occlusion System, EOS-X) via the 510(k) pathway, which relies on demonstrating substantial equivalence to a predicate device. The "studies" referenced are engineering performance tests and design verification/validation to ensure the new device, including a new size and minor modifications, performs comparably to the predicate. It does not contain information about clinical trials, acceptance criteria based on clinical performance metrics, or the involvement of human experts in establishing ground truth for a test set in the context of diagnostic accuracy.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 1, 2022

ArtVentive Medical Group, Inc. Anil Bhalani RA/OA Consultant 1797 Playa Vista San Marcos, California 92708

Re: K212057

Trade/Device Name: Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: January 26, 2022 Received: January 31, 2022

Dear Anil Bhalani:

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

{1}------------------------------------------------

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 (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,

Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K212057

Device Name

Endoluminal Occlusion System (EOS-X)

Indications for Use (Describe)

The ArtVentive Endoluminal Occlusion System - EOS-X is indicated for arterial and venous embolization in the peripheral 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)

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}------------------------------------------------

510(k) SUMMARY

ArtVentive Endoluminal Occlusion System (EOS-X)™

510(k) Number	K212057
Applicant:	ArtVentive Medical Group, Inc.1797 Playa VistaSan Marcos, CA 92708
Company Contact:	Anil BhalaniRA/QA ConsultantPhone: 949-596-9001Email: anilbhalani@artventivemedical.com
Date Summary Prepared:	June 25, 2021
Device Trade Name:	ArtVentive Endoluminal Occlusion System (EOS-X)TM
Common/Classification Name:	Vascular embolization device, Class II
Regulation Number/Name:	21 CFR §870.3300 - Vascular embolization device
Review Panel:	Cardiovascular
Product Code:	KRD
Predicate Devices:	Endoluminal Occlusion System (EOS)TM(K150402)

Device Description:

{4}------------------------------------------------

Manufacturer/ Device	ArtVentive EndoluminalOcclusion System (EOS-X)	ArtVentive EndoluminalOcclusion System (EOS)
510(k) Number	K212057	K150402
Application / Product Code	21 CFR 870.3300 (KRD)	21 CFR 870.3300 (KRD)
FDA Classification	Class II	Class II
TechnologicalCharacteristics
Intended Use	The ArtVentive EndoluminalOcclusion System (EOS-X)TMis intended for arterial andvenous embolization in theperipheral vasculature.	The ArtVentive EndoluminalOcclusion System (EOS)TM isintended for arterial andvenous embolization in theperipheral vasculature.
Design Features	Flexible, low profile devicefor immediate, acute occlusionof the target vessel. Thedevice incorporates an ePTFEcover. Retrievable; may beremoved during deploymentand re-positioned. Two-stagedeployment handle on theproximal end. The catheter hasa stiff proximal section forpushability and a flexibledistal section for trackability.The deployment handle has aside port to accommodatesyringe attachment to flush thecatheter of air and to pre-expand the ePTFE membranebefore deploying the implant.	Flexible, low profile devicefor immediate, acute occlusionof the target vessel. Thedevice incorporates an ePTFEcover. Retrievable; may beremoved during deploymentand re-positioned. Two-stagedeployment handle on theproximal end. The catheter hasa stiff proximal section forpushability and a flexibledistal section for trackability.The deployment handle has aside port to accommodatesyringe attachment to flush thecatheter of air and to pre-expand the ePTFE membranebefore deploying the implant.
Implant Material	Nitinol coil with an ePTFEpolymeric cover	Nitinol coil with an ePTFEpolymeric cover
Detachment	Mechanical in nature	Mechanical in nature
Implant Size	5mm, 8mm, 11mm, 16mm	5mm, 8mm, 11mm
Treatment Method	Permanent Implant	Permanent Implant
How Applied	Via delivery catheter througha guide catheter to targetvessel	Via delivery catheter througha guide catheter to targetvessel

Comparison to Predicate Device:

{5}------------------------------------------------

Implant and Guide Catheter Selection Matrix:

Implant Size	EOS or EOS-X	Reference VesselDiameter	Reference ArtVentive GuideCatheter Compatibility
5mm	EOS-X	2.0mm - 5mm	4F or larger
8mm	EOS-X	4.5mm - 8mm	5F or larger
11mm	EOS-X	7.5mm - 11mm	6F or larger
16mm	EOS-X	10.5mm - 16mm	6F or larger
5mm	EOS	3.0 mm - 5.0mm	6F or larger
8mm	EOS	4.5mm - 8mm	6F or larger
11mm	EOS	7.5mm - 11mm	7.5F or larger

Indications for Use:

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

Contraindications:

· Implantation in proximity to high motility (locomotor) muscles

Intended Use:

The ArtVentive Endoluminal Occlusion System (EOS-X) has been developed for arterial and venous embolization in the peripheral vasculature. The device is provided sterile and is intended for a single use only. It is intended to be placed in the peripheral vasculature using a guide catheter of appropriate size.

Technological Characteristics:

The Fundamental Scientific Technology of the previously cleared predicate device, The ArtVentive Endoluminal Occlusion System (EOS) via K992189 is substantially equivalent to The ArtVentive Endoluminal Occlusion System (EOS-X).

Performance Data Summary:

Engineering Performance Studies conducted demonstrated that the ArtVentive Endoluminal Occlusion System (EOS-X) which adds a larger16mm size of delivery catheter/implant for use with the 6F size guide catheter as well as the minor design modifications made to the 5mm and 8mm and 11mm sizes as compared to its predicate performed 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 were also repeated as necessary for the design modifications to the previously cleared 5mm and 8mm delivery catheter/implant and the 6 Fr guide 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-X is substantially equivalent to its predicate device.

{6}------------------------------------------------

Substantial Equivalence:

The ArtVentive Endoluminal Occlusion System (EOS-X) is substantially equivalent to its predicate device, the ArtVentive Endoluminal Occlusion System (EOS) and introduces no new safety and effectiveness issues when used as instructed by accompanying labels and labelling.

The substantial equivalence is based on the information provided in this 510(k) Premarket Notification which demonstrates that the EOS-X and EOS have equivalent technological characteristics, mechanism of action, intended use and physical characteristics. The design modifications made to the EOS-X device in sizes 5mm, 8mm and 11mm delivery catheter/ implant and associated guide catheters are also substantially equivalent to the predicate device when used according to its intended use. The larger size 16mm delivery catheter/implant is also similar to the other smaller models of EOS and EOS-X in technological characteristics, mechanism of action, intended use and physical characteristics. The equivalence is based on repeating the applicable design verification and validation testing.

Conclusion:

Information in this 510(k) submission demonstrates that the ArtVentive Endoluminal Occlusion System (EOS-X) is substantially equivalent to its predicate device.

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).