Viradius Neurowire

{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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 16, 2015 MIVI Neuroscience, Inc. Mr. Randy LaBounty Vice President Regulatory and Clinical Affairs 6545 City West Parkway Eden Prairie, Minnesota 55344 Re: K151825 Trade/Device Name: Viradius™ Neurowire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: October 13, 2015 Received: October 14, 2015 Dear Mr. LaBounty: 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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. {1}------------------------------------------------ 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/ResourcesforYou/Industry/default.htm. 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 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, Carlos L. Pena =5//△ Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K151825 Device Name ViradiusTM Neurowire Indications for Use (Describe) The Viradius™ Neurowire is intended for selective placement of catheters within the neuro and peripheral vasculature. Type of Use (Select one or both, as applicable) 2 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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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ # 510(k) Summary – K151825 | Manufacturer: | MIVI Neuroscience, Inc.<br>6545 City West Parkway<br>Eden Prairie, MN 55344 | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Matt Ogle<br>President and CEO<br>Telephone: 952-944-3834 | | Date Summary<br>Prepared | October 12, 2015 | | Trade Name of<br>Device: | Viradius™ Neurowire | | Common Name of<br>Device: | Guidewire | | Classification of<br>Device: | 21 CFR 870.1330 - Class II | | Product Code: | MOF - Primary<br>DQX - Secondary | | Predicate Device: | NeuroScout Steerable Guidewire, 510(k)#: K100351 | | Performance Data: | The following bench testing was performed in support of the Viradius<br>Neurowire and to establish substanstial equivalence to the NeuroScout<br>Steerable Guidewire:<br>Bond and Joint Tensile StrengthTorque ResponseUltimate Torque ReponseTip DeflectionPush TrackSurface IntegrityGuidewire DiameterGuidewire LengthCatheter CompatibilityKink ResistanceFlex TestDistal Fracture TestTip Bending and RetentionDevice Coating Adhesion | {4}------------------------------------------------ - Corrosion Test - . Coating Integrity – Simulated Use A Design Validation study was performed on the bench model to assess the usability of the Viradius Neurowire compared to the previously cleared NeuroScout Steerable Guidewire. Biocompatibility testing, sterilization and one year accelerated aging study was also performed. No clinical studies were performed as there are no change to the indications for use or the fundamental scientific technology of the device. - Conclusion: The Viradius Neurowire is substantially equivalent to the currently cleared NeuroScout Steerable Guidewire based on the successful completion of non-clinical bench and design validation testing as well as similar principles of design, operation and indications for use. ## Device Description The Viradius™ Neurowire consists of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. The distal section of the guidewire is coated with a hydrophilic coating and the proximal portion of the device is coated with a hydrophobic coating. The guidewire is inserted into a polyethylene hoop and then placed along with a torque device into a labeled poly/tyvek pouch and ethylene oxide sterilized. The pouch, along with an Instruction for Use paper insert is placed into a labeled shipping box. #### Indication for Use The Viradius™ Neurowire is intended for selective placement of catheters within the neuro and peripheral vasculature. #### Device Comparison The table below provides a comparision of the technological characteristics of the Viradius | | Viradius Neurowire | NeuroScout Steerable<br>Guidewire (K100351) | Rationale for<br>Difference (If<br>Present) | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for<br>Use | The ViradiusTM<br>Neurowire is intended<br>for selective placement<br>of catheters within the<br>neuro and peripheral<br>vasculature. | The NeuroScout<br>Steerable Guidewire is<br>intended for selective<br>placement of<br>microcatheters and<br>other devices within<br>the neuro and<br>peripheral vasculature. | Similar indications,<br>included devices<br>tested with the<br>Viradius Neurowire. | | Materials | | | | | Core Material | Stainless Steel | Stainless Steel | N/A | | | Viradius Neurowire | NeuroScout Steerable<br>Guidewire (K100351) | Rationale for<br>Difference (If<br>Present) | | Coil Material | Platinum/Tungsten | Platinum/Tungsten | N/A | | Coil to Core<br>Bond Material | Silver Braze | Adhesive | Bench testing<br>indicated similar<br>tensile strength. | | Coating/Distal | Hydrophilic | Hydrophilic | The materials used for<br>the Viradius | | Coating/<br>Proximal | Polytetrafluoro-<br>ethylene (PTFE) | Hydrophilic | Neurowire were<br>shown to be<br>biocompatible per ISO<br>10993 testing.<br>Materials of this type<br>are widely used in<br>similar medical<br>devices. | | Dimensions | | | | | Distal Diameter | 0.012" | 0.011" | Distal diameter needs<br>to be equal or less<br>than proximal<br>diameter for catheter<br>compatibility. | | Proximal<br>Diameter | 0.014" | 0.014" | N/A | | Overall Length | 205 cm / 300 cm | 205 cm / 300 cm | N/A | | Coil Length | 18 cm | 10 cm | Extension of the<br>flexible coil length. | | Other Device Comparisons | | | | | Radiopaque<br>Marker | No discrete marker<br>Platinum Coil at<br>distal tip | No discrete marker<br>Platinum Coil at<br>distal tip | N/A | | Tip Shape/<br>Configuration | Straight | Straight | N/A | | Sterility Method | Ethylene Oxide | Ethylene Oxide | N/A | | Package | Hoop placed in<br>Breathable Pouch | Hoop placed in<br>Breathable Pouch | N/A | {5}------------------------------------------------ # Sterilization and Shelf Life The packaged Viradius Neurowire is sterilized using a validated ethylene oxide (EO) sterilization cycle. The sterilization cycle has been validated to ensure a sterility assurance level (SAL) of 10-6 in accordance with ISO 11135-1:2007. Aging studies for the Viradius Neurowire have established the product and packaging remain functional and maintain sterility for up to one year. Aging studies for packaging integrity, seal strength and device functionality were performed and met all acceptance {6}------------------------------------------------ criteria. ## Biocompatibility Biocompatibility testing was performed in compliance with AAMI/ANSI/ISO 10993-1:2009. All studies were conducted in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFT part 58. | Test | Result | |----------------------------|--------| | Cytotoxicity | Pass | | Sensitization | Pass | | Intracutaneous Reactivity | Pass | | Systemic | Pass | | Toxicity (Acute) | Pass | | Material Medicated Pyrogen | Pass | | Hemocompatibiity | Pass | #### Performance Testing - Bench A summary of the pre-clinical bench testing performed on the Viradius Neurowire is presented in the table below. | Test | Method | Conclusion | |-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------| | Bond and Joint<br>Tensile Strength | The guidewire, including all joints, must not<br>suffer damage when subjected to tensile force. | All devices met<br>acceptance criteria. | | Ultimate Torque<br>Response | The guidewire must withstand a minimum<br>complete rotations without physical damage. | All devices met<br>acceptance criteria. | | Torque Response | Distal tip rotation shall be equivalent to predicate<br>guidewire. | All devices met<br>acceptance criteria. | | Tip Deflection | Tip deflection force shall be comparable to<br>selected competitor guidewires. | All devices met<br>acceptance criteria. | | Push Track –<br>Anatomical<br>Model | Force required to advance guidewire through<br>simulated tortuous neurovascular arteries shall be<br>comparable to predicate device. | All devices met<br>acceptance criteria. | | Surface Integrity | Guidewire surface shall not have any particulate<br>visible to the naked eye under close inspection<br>without magnification. | All devices met<br>acceptance criteria. | | Guidewire<br>Diameter | The diameter was measured. | All devices met<br>acceptance criteria. | | Guidewire<br>Length | The length was measured. | All devices met<br>acceptance criteria. | | Catheter<br>Compatibility | Guidewire shall be compatible with<br>microcatheters, distal access catheters, guide<br>catheters, and fluids. | All devices met<br>acceptance criteria. | | Kink Resistance | Proximal shaft shall not kink when subjected to a<br>bend radius. | All devices met<br>acceptance criteria. | | Flex Test | In accordance with ISO 11070:2014 8.5 the<br>guidewire shall not fracture, loosen, or fail in such<br>a manner that any section of the coil is left free to<br>stretch, a sharp, or potentially traumatic fracture | All devices met<br>acceptance criteria. | {7}------------------------------------------------ | Distal Fracture<br>Test | surface is exposed, any part of the device becomes<br>separated such that it would not be removable by<br>withdrawing the device from use, or coated<br>guidewires show flaking of the coating.<br>In accordance with ISO 11070:2014 8.4 the<br>guidewire shall not fracture, loosen, or fail in such<br>a manner that any section of the coil is left free to<br>stretch, a sharp, or potentially traumatic fracture<br>surface is exposed, or any part of the device<br>becomes separated such that it would not be<br>removable by withdrawing the device from use. | All devices met<br>acceptance criteria | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------| | Tip Bending and<br>Retention | After insertion through a competitive<br>microcatheter, the bend radius shall not degrade. | All devices met<br>acceptance criteria | | Device Coating<br>Adhesion | After simulated use, the guidewire coating shall<br>not exhibit any scratches, flaking, or generate any<br>loose coating material. | All devices met<br>acceptance criteria | | Particulate<br>Testing | The guidewire was evaluation for particulate<br>generation under simulated use in a representative<br>tortuous model | Number and size of<br>particulates generated<br>was adequate | | Corrosion Test | The guidewire shall not exhibit visual corrosion<br>when immersed in sodium chloride solution | All devices met<br>acceptance criteria | ## Performance Testing - Animal No animal study was performed as there is no change to the indications for use or the fundamental scientific technology for the Viradius Neurowire. Substantial equivalence of the Viradius Neurowire has been established to the predicate device through the results of bench testing. # Performance Testing - Clinical No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the Viradius Neurowire. Substantial equivalence of the Viradius Neurowire has been established to the predicate device through the results of bench and design validation testing.