Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS

{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). 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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). 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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) | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.6 2.4L5.6 10.4L2.4 7.2L3.2 6.4L5.6 8.8L12.8 1.6L13.6 2.4ZM16 8C16 3.58172 12.4183 0 8 0C3.58172 0 0 3.58172 0 8C0 12.4183 3.58172 16 8 16C12.4183 16 16 12.4183 16 8ZM14.4 8C14.4 11.5392 11.5392 14.4 8 14.4C4.46079 14.4 1.6 11.5392 1.6 8C1.6 4.46079 4.46079 1.6 8 1.6C11.5392 1.6 14.4 4.46079 14.4 8Z" fill="black"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M16 8C16 3.58172 12.4183 0 8 0C3.58172 0 0 3.58172 0 8C0 12.4183 3.58172 16 8 16C12.4183 16 16 12.4183 16 8ZM14.4 8C14.4 11.5392 11.5392 14.4 8 14.4C4.46079 14.4 1.6 11.5392 1.6 8C1.6 4.46079 4.46079 1.6 8 1.6C11.5392 1.6 14.4 4.46079 14.4 8Z" fill="black"></path> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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.<br>1797 Playa Vista<br>San Marcos, CA 92708 | | Company Contact: | Anil Bhalani<br>RA/QA Consultant<br>Phone: 949-596-9001<br>Email: 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<br>(K150402) | #### Device Description: 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. {4}------------------------------------------------ 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. | Manufacturer/ Device | ArtVentive Endoluminal<br>Occlusion System (EOS-X) | ArtVentive Endoluminal<br>Occlusion 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 | | Technological<br>Characteristics | | | | Intended Use | The ArtVentive Endoluminal<br>Occlusion System (EOS-X)TM<br>is intended for arterial and<br>venous embolization in the<br>peripheral vasculature. | The ArtVentive Endoluminal<br>Occlusion System (EOS)TM is<br>intended for arterial and<br>venous embolization in the<br>peripheral vasculature. | | Design Features | Flexible, low profile device<br>for immediate, acute occlusion<br>of the target vessel. The<br>device incorporates an ePTFE<br>cover. Retrievable; may be<br>removed during deployment<br>and re-positioned. Two-stage<br>deployment handle on the<br>proximal end. The catheter has<br>a stiff proximal section for<br>pushability and a flexible<br>distal section for trackability.<br>The deployment handle has a<br>side port to accommodate<br>syringe attachment to flush the<br>catheter of air and to pre-<br>expand the ePTFE membrane<br>before deploying the implant. | Flexible, low profile device<br>for immediate, acute occlusion<br>of the target vessel. The<br>device incorporates an ePTFE<br>cover. Retrievable; may be<br>removed during deployment<br>and re-positioned. Two-stage<br>deployment handle on the<br>proximal end. The catheter has<br>a stiff proximal section for<br>pushability and a flexible<br>distal section for trackability.<br>The deployment handle has a<br>side port to accommodate<br>syringe attachment to flush the<br>catheter of air and to pre-<br>expand the ePTFE membrane<br>before deploying the implant. | | Implant Material | Nitinol coil with an ePTFE<br>polymeric cover | Nitinol coil with an ePTFE<br>polymeric 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 through<br>a guide catheter to target<br>vessel | Via delivery catheter through<br>a guide catheter to target<br>vessel | ## Comparison to Predicate Device: {5}------------------------------------------------ ## Implant and Guide Catheter Selection Matrix: | Implant Size | EOS or EOS-X | Reference Vessel<br>Diameter | Reference ArtVentive Guide<br>Catheter 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.