REFLEX BALLON GUIDE CATHETER

{0}------------------------------------------------ # 4. 510(k) Summary according to 807.92 Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Reverse Medical -Corporation is providing the summary of Substantial Equivalence for the ReFlex™ Balloon Guide Catheter. #### 4.1 Sponsor /Applicant Name and Address Reverse Medical Corporation 13900 Alton Parkway Suite 123 Irvine, CA 92618 #### 4.2 Sponsor Contact Information Jeff Valko, President & CEO Phone: 949-215-0660 x201 Fax: 949-215-0661 Email: jvalko@reversemed.com #### 4.3 Date of Preparation of 510(k) Summary August 5, 2011 #### 4.4 Device Trade or Proprietary Name ReFlex™ Balloon Guide Catheter #### 4.5 Device Common/Usual or Classification Name Catheter, Percutaneous (Product Code: DQY) #### 4.6 Identification of the Legally Marketed Devices to which Equivalence is Being Claimed: | Name of Predicate Devices | Name of Manufacturer<br>(Town, State) | 510(k) Number | |--------------------------------------|-----------------------------------------------|--------------------| | Concentric Balloon Guide<br>Catheter | Concentric Medical, Inc.<br>Mountain View, CA | K010954<br>K021899 | {1}------------------------------------------------ K112262 page ### 510(k) Summary according to 807.92 (continued) #### 4,7 Device Description The ReFlex™ Balloon Guide Catheter is a flexible, variable stiffness composite catheter shaft has a hydrophilic coating to reduce friction during use. A compliant balloon is mounted on the distal end of the catheter. The ReFlex™ Balloon Guide Catheter dimensions are included on the individual device labels. The ReFlex™ Balloon Guide Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The proximal end of the ReFlex™ Balloon Guide Catheter has a bifurcated luer fitting to allow attachment of accessories and infusion of liquids through the system. The ReFlex™ Balloon Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. The catheter is provided sterile, non-pyrogenic, and is intended for single use only. #### 4.8 Intended Use The Reverse Medical ReFlex™ Balloon Guide Catheter is indicated for use in facilitating and guidance of intravascular catheters into selected blood vessels in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. | | Concentric Balloon Guide Catheter | ReFlex™ Balloon Guide Catheter | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Numbers | K010954, K021899 | TBD | | Classification | Class II, DQY | Class II, DQY | | Indication | Indicated for use in facilitating and<br>guidance of intravascular catheters<br>into a selected blood vessel in the<br>peripheral and neurovascular<br>systems. The balloon provides<br>temporary vascular occlusion during<br>these and other angiographic<br>procedures. | Indicated for use in facilitating and<br>guidance of intravascular catheters<br>into a selected blood vessel in the<br>peripheral and neurovascular<br>systems. The balloon provides<br>temporary vascular occlusion during<br>these and other angiographic<br>procedures. | | Shaft Materials | Coaxial lumen braided shaft variable<br>stiffness catheter with radiopaque<br>marker on distal end. | Dual lumen wire reinforced shaft<br>variable stiffness catheter with<br>radiopaque marker on distal end. | | Proximal End<br>Configuration | Luer Hub | Luer Hub | | Radiographic<br>markers/radiopacity | Radiopaque marker at distal tip | Radiopaque marker at distal tip | | Balloon | Compliant | Compliant | | Packaging | Catheter attached to packaging card<br>inside PET/PE/Tyvek pouch<br>inside SBS carton. | Catheter in polyethylene hoop attached<br>to packaging card inside PET/PE/Tyvek<br>pouch inside SBS carton. | | Sterilization | EtO | EtO | #### 4.9 Comparison to Predicate Devices {2}------------------------------------------------ K112262 page 3 of 4 ### 510(k) Summary according to 807.92 (continued) #### 4.10 Summary of Non-Clinical Data ### 4.10.1 Biocompatibility and Sterilization The ReFlex™ Balloon Guide Catheter is classified as Externally Communicating Devices, Circulating Blood, Limited Contact (≤ 24 hours). Results of the testing demonstrate that the blood contacting materials are biocompatible. Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993-1 guidelines "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." The ReFlex™ Balloon Guide Catheter successfully passed all of the following biocompatibility tests: | Test | Method | |----------------------------------------|--------------------------------------------------------| | Cytotoxicity | L929 MEM Elution Test | | Sensitization | Kligman Maximization | | Intracutaneous Reactivity (Irritation) | Intracutaneous Injection Test | | Systemic Toxicity (Acute) | ISO Acute Systemic Injection Test | | Hemocompatibility | Complement Activation | | Hemocompatibility | Hemolysis | | Hemocompatibility | Inactivated Partial Thromboplastin Time Test | | Hemocompatibility | <i>In vivo</i> thrombogenicity | | Pyrogenicity | USP Material Mediated Rabbit Pyrogen Test | | EtO Residuals | Ethylene oxide and Ethylene chlorohydrins<br>residuals | Sterilization conditions have been validated according to ANSI / AAMI / ISO 11135, Sterilization of Health Care Products-Part 1: Requirement, validation and routine control of a sterilization process for medical devices to provide a Sterility Assurance Level (SAL) of 108. ### 4.10.2 Design Verification (Bench-Top Testing) The physical, mechanical, and performance testing of the ReFlex™ Balloon Guide Catheter demonstrate that the product is substantially equivalent to the currently marketed predicate devices. Design verification testing was conducted to evaluate the physical and mechanical properties of the ReFlex™ Balloon Guide Catheter. All studies were conducted in accordance with Reverse Medical Design Control procedures. All testing was performed on units that were sterilized and met all inspection criteria. Tests on the ReFlex™ Balloon Guide Catheter included: {3}------------------------------------------------ K112262 page 4 of 4 ### Verification and Test Summary | In vitro Tests | Result | |---------------------------------------------------------------------------------------------------|--------------------------| | Dimensional and Visual Inspection | Met established criteria | | Guidewire Compatibility | Met established criteria | | Microcatheter Compatibility | Met established criteria | | Torque Strength | Met established criteria | | Kink Resistance | Met established criteria | | Tip Buckling Test | Met established criteria | | Flexibility Test (including tip flexibility) | Met established criteria | | Tensile Strength | Met established criteria | | Catheter Leak Test (Liquid Leakage) | Met established criteria | | Catheter Leak Test (Air Leakage) | Met established criteria | | Dynamic Pressure Test | Met established criteria | | Static Burst Test | Met established criteria | | Aspiration Test | Met established criteria | | Hub Gauging | Met established criteria | | Corrosion Resistance | Met established criteria | | USP Particulate Test | Met established criteria | | Navigation, Accessibility, & Simulated Vascular Occlusion Capabilities in vitro | Met established criteria | | Balloon Inflation/Deflation Times | Met established criteria | | Balloon Cycle Fatigue | Met established criteria | | Balloon Rated Volume (informational purposes) | Met established criteria | | Balloon Compliance (informational purposes) | Met established criteria | | In vivo Tests | Result | | System Deliverability, Compatibility, Visibility, and Temporary Vascular<br>Occlusion Performance | Met established criteria | | Acute Histopathology of Treated Vessels | Met established criteria | | Biocompatibility Testing | Met established criteria | The physical, mechanical, and performance testing of the subject ReFlex™ Balloon Guide Catheter demonstrate that the product is Substantially Equivalent to the currently marketed predicate devices. #### 4.11 Substantial Equivalence The performance of the ReFlex™ Balloon Guide Catheter in this submission demonstrates that the product is substantially equivalent to the performance of the predicate devices. The equivalence was shown through comparison of component materials and specifications, performance, biocompatibility testing, and sterilization validation. The ReFlex™ Balloon Guide Catheter 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. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 NOV - 2 2011 Reverse Medical Corporation c/o Mr. Jeffrey Valko 13700 Alton Parkway Suite 167 Irvine, CA 92618 Re: K112262 Trade Name: ReFlex Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: October 10, 2011 Received: October 11, 2011 Dear Mr. Valko: 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. {5}------------------------------------------------ Page 2 – Mr. Jeffrey Valko 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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. Sincerely yours, Brom D. Zucker Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ N11000:2 page ## 3. Indications for Use 510(k) Number (if known): K112262 Device Name: Reverse Medical ReFlex™ Balloon Guide Catheter Indications for Use: The Reverse Medical ReFlex™ Balloon Guide Catheter is indicated for use in facilitating and guidance of intravascular catheters into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over the Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) 510(k) i