AZUR Vascular Plug

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 20, 2020 MicroVention Inc. Ganesh Balachander Regulatory Affairs Specialist 35 Enterprise Aliso Viejo, California 92656 Re: K191680 Trade/Device Name: AZUR Vascular Plug Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: June 21, 2019 Received: June 24, 2019 # Dear Ganesh Balachander: 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. 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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) K191680 Device Name AZUR Vascular Plug Indications for Use (Describe) The AZUR Vascular Plug is indicated for use to reduce or block the rate of blood flow in arteries of the peripheral vasculature X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### 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 #### SUBMITTER MicroVention Inc. 35 Enterprise, Aliso Viejo, CA, 92656 Phone:714-847-8000 Contact Person: Ganesh Balachandar Date Prepared: March 19, 2020 ## DEVICE Name of the Device: AZUR Vascular Plug Common Name: Vascular Embolization Device Classification Name: Device, Embolization, arterial Regulatory Class: Class II, 21 CFR 870.3300 Product Code: KRD #### PREDICATE DEVICE Medtronic Micro Vascular Plug (K150108) #### REFERENCE DEVICE MicroVention AZUR CX D35 Peripheral Coil System (K151358) #### DEVICE DESCRIPTON The AZUR Vascular Plug consists of an AZUR vascular occlusion plug implant that is attached to a delivery wire which is intended to be delivered to the treatment site through a microcatheter. The AZUR Vascular Plug implant is an embolization device consisting of a conformable, self-expanding nitinol braided wire frame surrounding a flexible, occlusive membrane. The implant comes in three sizes, small (5 mm), medium (8 mm) and large (10 mm). The implant is deployed in an appropriately sized vessel to reduce or block the flow of blood. The implant has radiopaque markers to provide visual confirmation of deployment location during the interventional treatment. The implant is delivered through a microcatheter on a detachable delivery system. The delivery wire attached to the AZUR Vascular Plug implant is 185cm in length and an outer diameter suitable for delivery through a 0.027" ID microcatheter. A detachment controller powers the delivery pusher to detach the implant. The microcatheter and the detachment controller are provided separately. #### INDICATIONS FOR USE The AZUR Vascular Plug is indicated for use to reduce or block the rate of blood flow in arteries of the peripheral vasculature. {4}------------------------------------------------ ## COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE The subject device, AZUR Vascular Plug has the following similarities to the predicate device, Micro Vascular Plug (K150108), same device classification, same indications for use, same principle of operation, same device design, similar materials and same sterility assurance level and method of sterilization and hence the subject device is substantially equivalent to the predicate device (Table 1). | Table 1: Comparison of Technological Characteristics with Predicate Device | | | | | |----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Device<br>Attributes | MicroVention AZUR<br>Vascular Plug<br>(Subject Device) | Medtronic Micro<br>Vascular Plug<br>(Predicate Device) | Rationale for Difference<br>(If Present) | | | FDA Medical Device Classification | | | | | | Device<br>Classification | Class II, KRD, 21 CFR<br>870.3300 | Class II, KRD, 21 CFR<br>870.3300 | No difference. Identical device<br>classification | | | Indications for Use | | | | | | Intended Use<br>Statement | Indicated for use to reduce<br>or block the rate of blood<br>flow in arteries of the<br>peripheral vasculature. | Intended to reduce or<br>block the rate of blood<br>flow in vessels of the<br>peripheral vasculature. | No difference. Identical<br>Intended use statement. | | | Principle of Operation/Fundamental Scientific Technology | | | | | | Function | Allows the device to<br>obstruct or reduce the rate<br>of blood flow | Allows the device to<br>obstruct or reduce the rate<br>of blood flow | No difference. Identical<br>function. | | | Anatomical<br>Location | Peripheral Vasculature | Peripheral Vasculature | No difference. Identical<br>anatomical vessels. | | | Device Design | | | | | | Plug (implant<br>description) | Self-expandable nitinol<br>frame with a PTFE and<br>PET cover over the<br>internal wire frame | Self-expandable nitinol<br>frame with a PTFE cover<br>over the proximal section | Similar device design.<br>The results of comparative<br>bench testing, physician<br>usability study and animal study<br>establish the substantial<br>equivalency of the subject<br>device, AZUR Vascular Plug | | | Plug Diameter,<br>Unconstrained | Small: 5 mm<br>Medium: 8 mm<br>Large: 10 mm | MVP-5Q: 6.5 mm<br>MVP-7Q: 9.2 mm<br>MVP-9Q: 13.0 mm | | | | Target Vessel<br>Diameter | Small: 2.5-4.5mm<br>Medium:4.5mm-6.5mm<br>Large: 6.5mm-8.0mm | MVP-5Q: 3-5mm<br>MVP-7Q: 5-7mm<br>MVP-9Q: 7-9mm | and the predicate device, Micro<br>Vascular Plug. | | | Radiopaque<br>Markers | Platinum marker bands at<br>each end of the plug | Platinum marker bands at<br>each end of the plug | Identical marker bands | | | Method of<br>placement | Delivery wire through a<br>0.027" ID Microcatheter | Delivery wire through a<br>0.027" to 0.043" ID<br>Percutaneous catheter | The AZUR Vascular Plug is<br>designed to be delivered<br>through a smaller ID (0.027"<br>inner diameter) microcatheter. | | | Detachment<br>System | Thermoelectric<br>Detachment | Mechanical Detachment | The results of bench testing.<br>and physician usability study<br>establish the substantial<br>equivalency of the subject<br>device, AZUR Vascular Plug<br>and the predicate device, Micro<br>Vascular Plug. | | | Device Material | | | | | | Materials of<br>Construction | Nitinol, ePTFE, PET,<br>Platinum, Dymax 1128<br>and Polyolefin | Nitinol, PTFE, Platinum,<br>SS301, Solder,<br>Polypropylene sheath,<br>Urethane and<br>Cyanoacrylate | Similar device material. The<br>materials used for the AZUR<br>Vascular Plug was shown to be<br>biocompatible per ISO<br>10993 testing. | | | Other Attributes | | | | | | Sterilization<br>Process | EtO (Ethylene Oxide) | EtO (Ethylene Oxide) | No difference. Identical<br>sterilization process. | | | Method of<br>Supply | Sterile, single use | Sterile, single use | No difference. Identical method<br>of supply. | | | Accessories | No accessories | Torquer | AZUR Vascular Plug does not<br>use a torque device. | | {5}------------------------------------------------ # K191680 # COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH REFERENCE DEVICE The subject device, AZUR Vascular Plug has the following similarities to the reference device AZUR CX D35 Peripheral Coil System (K151358) :same principle of operation, same delivery wire length, {6}------------------------------------------------ same delivery wire materials, same detachment mechanism and similar delivery wire catheter compatibility and hence the subject device is substantially equivalent to the reference device. PERFORMANCE DATA ## Biocompatibility testing The biocompatibility evaluation for the AZUR Vascular Plug device was conducted in accordance with ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Guidance on Selection of Tests. The implant is considered a permanent implant blood contacting device, and the pusher is considered an external communicating device, limited (<24hour) circulating blood contacting device. The battery of testing for the device included the following tests: ## Implant - . Cytotoxicity - Sensitization - Irritation or Intracutaneous Reactivity - Acute Systemic Toxicity ● - Subacute/Subchronic Toxicity ● - Genotoxicity - . Material Mediated Pyrogenicity - Implantation ● - Hemocompatibility - Carcinogenicity ## Pusher - . Cytotoxicity - Hemocompatibility ● - Subacute/Subchronic toxicity ● # HDPE Introducer sheath - . Cytotoxicity # Mechanical, Visual, and Material Characterization testing Bench testing conducted for the AZUR Vascular Plug device included the following: - . Visual/Dimensional Inspection - . Electrical Resistance - Exhaustive Extraction Study ● - Simulated Use - Preparation/Flush ● - Introduction ● - Tracking - . Advancement - . Kink Resistance - Flexibility ● - Catheter Compatibility - Deployment ● - Retraction ● - Detachment ● - Wall Apposition ● {7}------------------------------------------------ - Migration Resistance ● - Overall performance - Radial force ● - Attachment strength - . Implant joint Tensile Strength - . Pusher Sleeve Retention - . Particulate - Nickel Ion Release - Corrosion - Magnetic Resonance (MR) Testing - Radiopacity - Occlusion Time ● - Shelf Life # Animal Study The AZUR Vascular Plug was evaluated in a number of animal studies including multiple animal species and implantation sites. This analysis included the following studies: - Porcine large animal study - Intramuscular implant rabbit study ## CONCLUSION The AZUR Vascular Plug is substantially equivalent to the identified predicate device based on the same intended use, design, materials, principle of operation and overall technological characteristics. The nonclinical data support the substantial equivalence of the subject device and the verification and validation testing demonstrate that the subject device should perform as intended when used as instructed in the instructions for use.