ENDOLUMINAL OCCLUSION SYSTEM (EOS)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with the head tilted upwards. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | <div> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |------------------------------------------------------------------------------------------------------| | <div> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo is clean and modern, with a focus on the company's name and medical focus. ## 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.<br>2766 Gateway Road<br>Carlsbad, CA 92009 | | 3. Sponsor Contact Person: | Leon Rudakov, PhD., President and CTO | | 4. Telephone:<br>E-mail: | 650-465-5259<br>leonrudakov@artventivemedical.com | | 5. 510(k) Summary Preparation<br>Date: | December 2, 2014 | | 6. Device Trade Name: | Endoluminal Occlusion System (EOS)™ | | 7. Common Name: | Vascular Embolization Device | | 8. Classification Name: | Device Embolization, Vascular<br>(21 CFR 870.3300, Product Code: KRD) | | 9. Legally Marketed Predicate<br>Devices: | AGA Medical/Amplatzer® Vascular Plug II (K071125)<br>AGA Medical/Amplatzer® Vascular Plug 4 (K113658)<br>Reverse Medical MVP™ Micro Vascular Plug System (K123803) | ### 10. 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 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. {4}------------------------------------------------ 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. #### 11. Comparison to Predicate Devices: | Manufacturer /<br>Device | ArtVentive Medical Group,<br>Inc./EOS | AGA Medical / Amplatzer®<br>Vascular Plug II | AGA Medical / Amplatzer®<br>Vascular Plug 4 | Reverse Medical MVP™ Micro<br>Vascular Plug System | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K133924 | K071125 | K113658 | K123803 | | Application / Product<br>Code | 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 | | Technological<br>Characteristics | | | | | | Intended Use | The ArtVentive EOS™ is intended<br>for arterial and venous<br>embolizations in the peripheral<br>vasculature. | The AMPLATZER® Vascular<br>Plug II is indicated for arterial<br>and venous embolizations in<br>the peripheral vasculature. | The AMPLATZER Vascular Plug<br>4 is indicated for arterial and<br>venous embolizations in the<br>peripheral vasculature. | The Reverse Medical MVP™ Micro<br>Vascular Plug System is intended for<br>use to obstruct or reduce the rate of<br>blood flow in the peripheral<br>vasculature. | | Design Features | Flexible, low profile device for<br>immediate, acute occlusion of the<br>target vessel. The device<br>incorporates an ePTFE cover.<br>Retrievable; may be removed<br>during deployment and re-<br>positioned.<br>Two-stage deployment handle on<br>the proximal end. The catheter has<br>a stiff proximal section for<br>pushability and a flexible distal<br>section for trackability. The<br>deployment handle has a side port<br>to accommodate syringe<br>attachment to flush the catheter of<br>air and to pre-expand the ePTFE<br>membrane before deploying the<br>implant. | Unique multi-segmented,<br>multi-layered design<br>significantly reduces occlusion<br>time for transcatheter<br>embolization procedures. The<br>three adjustable lobes of the<br>AMPLATZER Vascular Plug II<br>are designed for enhanced<br>conformability to vessel<br>landing zones. May be<br>repositioned. Multiple<br>vascular plugs may be used to<br>occlude vessel. | The AMPLATZER® Vascular<br>Plug 4 is delivered through a<br>0.038 diagnostic catheter.<br>The flexible mesh and the<br>floppy distal section of the<br>delivery wire enable the<br>device to travel through<br>tortuous anatomy with ease<br>while the multi-layered,<br>double-lobed design provides<br>rapid embolization. May be<br>repositioned. | The MVP Device is ovoid-shape,<br>comprised of nitinol and secured at<br>both ends with platinum marker<br>bands. The device incorporates a<br>PTFE partial cover. The proximal<br>marker band attaches to a wire that<br>pushes the device through a<br>commercially available<br>microcatheter to the intended<br>treatment site. The "delivery wire"<br>detaches from the MVP Device by<br>electrolytic means after deployment<br>with the Reverse Medical<br>Detachment System. Full<br>resheathability enables precise<br>delivery.<br>The MVP System is packaged as a<br>single unit with the MVP Device,<br>introducer sheath and detachable<br>delivery wire. The system is provided<br>sterile, non-pyrogenic, and is<br>intended for single use only. | | Material | Nitinol coil with an ePTFE<br>polymeric cover | Nitinol mesh | Nitinol mesh with a<br>radiopaque marker band | Nitinol coil with an ePTFE polymeric<br>partial cover and platinum marker<br>bands | | Detachment | Mechanical in nature | Mechanical in nature | Mechanical in nature | Electrolytic means of deployment | {5}------------------------------------------------ | Manufacturer /<br>Device | ArtVentive Medical Group,<br>Inc./EOS | AGA Medical / Amplatzer®<br>Vascular Plug II | AGA Medical / Amplatzer®<br>Vascular Plug 4 | Reverse Medical MVPT™ Micro<br>Vascular Plug System | | | | | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Sizes | Diameter<br>(mm)<br>5<br>8<br>5mm diameter for target vessel<br>diameter<br>3.0mm - 5.0mm<br>8mm diameter for target vessel<br>diameter 4.5mm - 8.0mm) | Length<br>(mm)<br>11<br>20 | Diameter<br>(mm)<br>3<br>4<br>6<br>8<br>10<br>12<br>14<br>16<br>18<br>20<br>22 | Length<br>(mm)<br>6<br>6<br>6<br>7<br>7<br>9<br>10<br>12<br>14<br>16<br>18 | Diameter<br>(mm)<br>4<br>5<br>6<br>7<br>8 | Length<br>(mm)<br>10.0<br>10.5<br>11.0<br>12.5<br>13.5 | Diameter<br>(mm)<br>5.3<br>6.5<br>5.3 mm diameter used for target<br>vessel diameter 1.5-3.0 mm<br>6.5 diameter used for target vessel<br>diameter 3.0-5.0 mm | Length<br>(mm)<br>12<br>12 | | Treatment Method | Permanent Implant | Permanent Implant | | Permanent Implant | | Permanent Implant | | | | How Applied | Via catheter through guide sheath to<br>to target vessel | Via guiding catheter to the<br>target vessel | | Via guiding catheter to the<br>target vessel | | Via catheter through guide sheath to<br>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 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.