MIVI 6F GUIDE CATHETER

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 right, with flowing lines beneath them, possibly representing water or movement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 18, 2014 MiVi Neuroscience, LLC Ms. Michelle Straight VP of Quality & Regulatory 10900 73td Avenue North, Suite 150 Maple Grove, MN 55369 Re: K140557 Trade/Device Name: MiVi 6F Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 14, 2014 Received: August 15, 2014 Dear Ms. Straight, 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 {1}------------------------------------------------ the quality systems (OS) 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/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 -S 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K140557 Device Name MiVi 6F Guide Catheter Indications for Use (Describe) The MiVi 6F Guide Catheter is indicated for use in facilitating the insertion and guidance of microcathers into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter. 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) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Carlos L. Pena -S 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}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for MIVI Neuroscience. The logo features the word "MIVI" in large, bold, teal letters, with the word "NEUROSCIENCE" in smaller letters underneath. To the right of the text is a teal silhouette of a human head, with the brain and blood vessels visible. The entire logo is enclosed in a rounded teal rectangle. 10900 73rd Ave. North, Suite 150 Maple Grove, MN 55369 # 510(k) SUMMARY: K140557 ## Date Prepared: 3-Mar-2014 ### Submitter's Name / Contact Person #### Manufacturer MiVi Neuroscience, LLC 10900 73rd Ave N, Suite 150 Maple Grove, MN 55369 ### Contact Person Michelle Straight Vice President of RA/QA Phone: 612-940-7240 Fax: 763-577-1044 Email: mstraight@mivi.neuro.com #### General Information | Trade Name | MiVi 6F Guide Catheter | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common / Usual Name | Guide Catheter | | Classification Name | Percutaneous Catheter (21 CFR 870.1250, Product Code DQY) | | Regulatory Classification | | | Class | II | | Panel | Neurodiagnostic and Neurotherapeutic Device (NNDB) Division of Neurological and Physical Medicine Devices (DNPMD) | | Predicate Device(s) | Stryker Concentric ^® Medical, Inc. K110483 Modified HD Guide Catheter Stryker Concentric ^® Distal Access Catheters Models 90120, 90121, 90130, 90131, 90160, 90161 and 90162 | #### Device Description The MiVi 6F Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance microcatheters into a selected blood vessel in the peripheral, coronary or neurovascular system. A radiopaque marker is included on the distal end for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. A luer hub on the proximal end allows attachments for flushing, insertion of catheters and aspiration. It is used in junction with a rotating hemostatic valve with side-arm adapter for flushing, catheter insertion and aspiration. The MiVi 6F Guide Catheter has a straight distal tip and is available in a 110 cm length and 6F diameter. {4}------------------------------------------------ #### Intended Use / Indications The MiVi 6F Guide Catheter is indicated for: use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter. #### Principle of Operation The device will be utilized to endovascularly insert and guide microcatheters under fluoroscopy so that the microcatheters can deliver contrast agents or other devices during diagnostic and/or therapeutic procedures for patients with arterial disease or damage. #### Accessories There are no accessories to the MiVi 6F Guide Catheters. | | Subject Device | Predicate Device | Predicate Device | |--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | MiVi 6F Guide<br>Catheter | Stryker Concentric®<br>Medical, Inc. K110483<br>Modified HD Guide<br>Catheter<br>Stryker Concentric<br>REF 90170 and 90171 | Stryker Concentric®<br>Distal Access Catheters<br>REF 90120, 90121,<br>90130, 90131, 90160,<br>90161 and 90162 | | Classification | II, DQY | II, DQY | II, DQY | | Indications for<br>Use | The MiVi 6F Guide<br>Catheter is indicated<br>for use in facilitating<br>the insertion and<br>guidance of<br>microcatheters into a<br>selected blood vessel<br>in the peripheral,<br>coronary and neuro<br>vascular systems. | The Modified HD Guide<br>Catheter is indicated for<br>facilitating the insertion<br>and guidance of an<br>occlusion catheter,<br>infusion catheter or<br>other appropriate<br>microcatheter into a<br>selected blood vessel in<br>the peripheral, coronary<br>and neuro vascular<br>systems. It may also be<br>used as a diagnostic<br>angiographic catheter. | The Distal Access<br>Catheter is indicated for<br>use in facilitating the<br>insertion and guidance of<br>an occlusion catheter,<br>infusion catheter or other<br>appropriate<br>microcatheter into a<br>selected blood vessel in<br>the peripheral, coronary<br>and neuro vascular<br>systems. It may also be<br>used as a diagnostic<br>angiographic catheter. | | Shaft<br>Materials<br>Materials, Packaging and Sterilization | PTFE lined PEBAX<br>with stainless steel<br>braid | PTFE lined polymer<br>with stainless steel braid | PTFE lined polymer<br>with stainless steel braid | | Proximal End | Hub with female luer | Hub with female luer | Hub with female luer | | Configuration | conical fitting | conical fitting | conical fitting | | Packaging | Catheter attached to an<br>SBS packaging card<br>inside PET/PE/Tyvek<br>pouch, inside SBS box | Catheter attached to SBS<br>packaging card inside<br>carton | Catheter attached to SBS<br>packaging card inside<br>carton | | Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | #### Comparison to Predicate Devices: {5}------------------------------------------------ | | Subject Device | Predicate Device | Predicate Device | |---------------------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------| | Feature | MiVi 6F Guide<br>Catheter | Stryker Concentric®<br>Medical, Inc. K110483<br>Modified HD Guide<br>Catheter<br>Stryker Concentric<br>REF 90170 and 90171 | Stryker Concentric®<br>Distal Access Catheters<br>REF 90120, 90121,<br>90130, 90131, 90160,<br>90161 and 90162 | | Dimensions | | | | | Effective<br>Length | 107.3 cm | 105 cm<br>120 cm | 115 cm to 136 cm | | Outer Diameter | 6F | 6.3F | 3.9F to 5.2F | | Inner Diameter | Distal: .054"<br>Proximal: .064" | .070" | .038" to .057" | | Tip Shape | Straight | Straight | Straight | #### Design verification testing of the MiVi 6F Guide Catheter consisted of: | Performance Test | Result | |----------------------|--------------------------| | Push/Track | Met established criteria | | Stent Crossing | Met established criteria | | Tip Stiffness | Met established criteria | | Torque Response | Met established criteria | | Kink Resistance | Met established criteria | | Tensile | Met established criteria | | Luer Leakage | Met established criteria | | Coating Adhesion | Met established criteria | | Coating Uniformity | Met established criteria | | Coating Thickness | Met established criteria | | Surface Integrity | Met established criteria | | Radiopacity | Met established criteria | | System Introduction | Met established criteria | | Device Compatibility | Met established criteria | Testing was conducted in accordance with ISO 10555-1:2013, ISO 10555-3:2013, AAMI TIR42:2010, ISO 594-1 and ISO 594-2 standards and FDA guidance: FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters September 8, 2010. Shelf Life Testing (Product and Packaging) and Distribution Shipping Challenge Conditioning and Testing were performed and the devices met established criteria. Packaging Verification Testing complies with EN ISO 11607-1 and assessed the ability of finished packages to withstand the effects of anticipated hazards of the distribution environment on essential packaging characteristics and the ability of packaging to protect the device and to maintain sterility (sterile barrier testing). Biocompatibility testing was conducted in accordance with EN ISO 10993-1. MiVi 6F Guide Catheters have been classified according to EN ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing as follows: {6}------------------------------------------------ Category: Externally Communicating Contact type: Circulating blood Contact Duration: Limited exposure (≤24 hours) Based on this classification, tests relevant to the device described within this premarket notification were selected and conducted in accordance with EN ISO 10993-1 and its applicable sub-parts. The MiVi 6F Guide Catheter devices meet ethylene Oxide (EO) and ethylene chlorohydrin (ECH) residuals specified in EN ISO 10993-7:2008, Biological Evaluation of Medical Devices -Part 7: Ethylene Oxide Sterilization Residuals. A sterility assurance level (SAL) of 10-6 will be demonstrated. Testing showed the device, including its packaging, to be biocompatible for its intended use as an externally communicating, circulating blood contacting device as classified under EN ISO 10993-1:2009. The MiVi 6F Guide Catheter successfully passed all of the following biocompatibility tests and was found to be safe and effective and substantially equivalent to the predicate device from a biocompatibility perspective. | Test | Results | Conclusions | |------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | Cytotoxicity - ISO MEM Elution<br>Assay | The test article scored '0' at 24, 48, and 72 hours and is<br>considered non-cytotoxic | Not cytotoxic | | Irritation or Intracutaneous<br>Reactivity - ISO Intracutaneous<br>Reactivity Test | Animals in the study showed no<br>abnormal clinical signs, no<br>significant dermal reactions at the<br>injection and control sites at the<br>24, 48, and 72 hour observation<br>period. | Non-irritating | | Hemocompatibility<br>Hemolysis - ASTM Hemolysis<br>Direct Contact and Extract<br>Methods | The test article had a blank<br>corrected hemolytic index of<br>0.1% above the control in the<br>direct contact test. The test<br>article had a blank corrected<br>hemolytic index of 0.0 % above<br>the control in the extract test. | Non-hemolytic | | Hemocompatibility<br>Thrombosis - Four Hour<br>Thromboresistance Evaluation in<br>Dogs | The combined analysis of APTT,<br>platelet counts, device weights,<br>and clinical observations<br>indicated that the animal's<br>clotting abilities were not<br>compromised after implantation<br>of the devices. The test article<br>had similar thromboresistance<br>results to the predicate device so<br>was found to be substantially<br>equivalent to it. | Similar<br>thromboresistance<br>characteristics as control<br>Stryker Concentric<br>Guide Catheter<br>Predicate Device. | {7}------------------------------------------------ | Test | Results | Conclusions | |------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Hemocompatibility<br>Complement Activation -<br>Complement Activation C3a and<br>SC5b-9) | The test article concentrations of<br>C3a was 1.0 and the predicate<br>device was 3.2 and SC5b-9 was<br>0.0 and the predicate device was<br>1.1 so the test article was not<br>found to be an activator of<br>complements. The test article<br>results were also comparable to<br>the predicate device so was found<br>to be substantially equivalent to<br>it. | Comparable to Stryker<br>Concentric Guide<br>Catheter predicate<br>device for complement<br>activation. Not an<br>activator | | Pyrogenicity - Limulus<br>Amebocyte Lysate (LAL) Limit<br>Test | Both test articles contained<br><0.005 EU/mL and <0.200<br>EU/device | Non-pyrogenic | | Sensitization - ISO Guinea Pig<br>Maximization Test | None of the animals challenged<br>with the test article extracts were<br>observed with a sensitization<br>response greater than '0'. | Non-sensitizing | | Systemic Toxicity (Acute) - ISO<br>Acute Systemic Injection Test | No clinical signs consistent with<br>toxicity were observed and body<br>weight changes were within<br>acceptable parameters over the<br>course of the study. | Non-toxic | | Ethylene Oxide Residuals -<br>Ethylene Oxide and Ethylene<br>Chlorohydrin | The 6F MiVi Guide Catheter had<br>.094 mg EO/device and .015 mg<br>ECH/device so met both the EO<br>and ECH requirements | Met the ISO 10993-<br>7:2008/ requirements<br>for EO residuals. | ## Summary of Clinical Performance Data Not applicable as no clinical data was needed to demonstrate substantial equivalence to the predicate devices. ## Conclusion MiVi Neurosciences has determined its 6F Guide Catheter to be substantially equivalent to the current legally marketed predicate devices because of the following: - 1. Intended use and indications for use are the same as for the predicate devices. - 2. There is no difference in the fundamental scientific technology or the devices. - 3. The risk assessments and successful verification testing including testing to EN ISO 10555-1 and EN ISO 10555-3, raise no new questions of safety and effectiveness.