REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Reverse Medical. The logo is in black and white and features the words "Reverse Medical" in a bold, sans-serif font. To the upper right of the word "Medical" is the trademark symbol. Underneath the words is a curved line that starts thin on the left and gradually thickens as it curves upward to the right, ending in an arrowhead. ## K123803 ## 510(k) Summary 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 Reverse Medical MVP™ Micro Vascular Plug System. ## Device Trade or Proprietary Name Reverse Medical MVP™Micro Vascular Plug System ## Sponsor /Applicant Name and Address Reverse Medical Corporation 13700 Alton Parkway Suite 167 Irvine, CA 92618 ## Sponsor Contact Information Linda D'Abate Reverse Medical Vice President, RA/CA/QA ## Date of Preparation of 510(k) Summary June 24, 2013 ## Device Common/Usual or Classification Name Device Embolization, Vascular (21 CFR 870.3300, Product Code: KRD) ## Identification of the Legally Marketed Devices to which Equivalence is Being Claimed: | Name of Predicate<br>Devices | Manufacturer | 510(k) Number | |----------------------------------------------------------------------------------|----------------------------------------|---------------| | AMPLATZER® Vascular Plug 4 | AGA Corporation<br>Plymouth, MN | K113658 | | Azur Peripheral HydroCoil<br>Endovascular Embolization<br>System - Detachable 35 | MicroVention, Inc.<br>Tustin, CA | K093002 | | Axium Detachable Coil System | ev3 Endovascular, Inc.<br>Irvine, CA | K081465 | | InZone Detachment System<br>with the IZDS Connecting Cable | Boston Scientific, Inc<br>Freemont, CA | K103008 | | Guglielmi Detachable Coil<br>Power Supply | Boston Scientific, Inc<br>Freemont, CA | K001083 | ## Device Description The Reverse Medical Micro Vascular Plug (MVP) is a micro vascular occlusion device comprised of a detachable embolic plug attached to a composite delivery wire and designed for delivery via a microcatheter (0.021" ID). The MVP is a self-expandable, ovoid-shaped device made from Nitinol with an 2 2013 JUL {1}------------------------------------------------ ePTFE partial cover. The device is secured at both ends with platinum marker bands. The Reverse Medical MVP is intended to reduce or occlude vascular blood flow of vessels having a diameter of 1.5 – 3.0mm. The proximal marker band attaches to a delivery wire that pushes through a commercially available catheter to the intended treatment site. The Reverse Medical Detachment Box regulates detachment of the implant device from the delivery wire by electrolytic means during deployment, and monitors, detects, signals and measures the time of detachment. The Reverse Medical Cable Set – 275 cm length (Model RMCS – 2.75US) is provided sterile. The cable set connects to the Detachment Box through a bayonet type dual pin connector that ensures correct polarity. The Reverse Medical Cable Set and Detachment Box will be sold separately. One 9-volt battery and a sterile needle (20 G or 22 G) will also be needed for use with the Reverse Medical Micro Vascular Plug (MVP). #### Intended Use The Reverse Medical MVP is intended for use to obstruct or reduce the rate of blood flow in the peripheral vasculature. | | New Device | Predicate Devices | | | | | |-------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Reverse Medical<br>MVP System | AMPLATZER®<br>Vascular Plug 4 | Azur Peripheral<br>HydroCoil<br>Endovascular<br>Embolization<br>System –<br>Detachable 35 | Axium Detachable<br>Coils | InZone Detachment<br>System with the IZDS<br>Connecting Cable | Guglielmi Detachable<br>Coil Power Supply | | 510(k) No. | K123803 Class II<br>KRD 870:3300 | K113658 Class II<br>KRD 870:3300 | K093002 Class II<br>KRD 870:3300 | K081465 Class II<br>KRD 870:3300 | K103008 Class II<br>KRD 870:3300 and<br>HCG | K001083 Class II<br>HCG 882.5950 | | Indication for<br>use | Indicated for use<br>to obstruct or<br>reduce the rate of<br>blood flow in the<br>peripheral<br>vasculature. | Indicated for arterial<br>and venous<br>embolizations in the<br>peripheral<br>vasculature. | Intended to reduce<br>or block the rate of<br>blood flow in<br>vessels of the<br>peripheral<br>vasculature. | The AXIUM<br>Detachable Coils are<br>also indicated for<br>arterial and venous<br>embolizations in the<br>peripheral<br>vasculature | Intended for use with<br>all versions of BSC<br>Detachable Coils in the<br>embolization of<br>intracranial aneurysms<br>and other vascular<br>malformations of the<br>neuro and peripheral<br>vasculature. | Intended for use with<br>all versions of Boston<br>Scientific/Target's<br>Guglielmi Detachable<br>Coils in the<br>embolization of<br>intracranial<br>aneurysms and other<br>vascular<br>malformations of the<br>neuro and peripheral<br>vasculature | | Method of<br>Placement | Delivery wire<br>through a 0.021" ID<br>microcatheter. | Delivery wire | Delivery wire | Delivery wire<br>(pusher) | Delivery wire | Delivery wire | | Radiopaque<br>markers | Platinum marker<br>bands at each end | Radiopaque marker<br>bands at each end | N/A | Radiopaque position<br>marker | Radiopaque position<br>marker | Radiopaque position<br>marker | | Proximal End<br>Configuration | Proximal marker<br>band and<br>attachment for<br>pusher wire | Radiopaque marker<br>band and micro<br>screw attachment | N/A | N/A | N/A | N/A | | Detachment<br>System | Yes - Electrolytic | Yes - Mechanical | Yes - Thermal | Yes - Mechanical | Yes - Electrolytic | Yes - Electrolytic | | Battery<br>Operated | Yes | No | Yes | No | Yes | Yes | ## Comparison to Predicate Devices {2}------------------------------------------------ ## Summary of Non-Clinical Data #### Biocompatibility and Sterilization The device was characterized as an implant, internal communicating device, which contacts circulating blood for exposure ≥ 30 days. The Reverse Medical MVP 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 Reverse Medical MVP successfully passed all of the following biocompatibility tests, demonstrating that the materials are biocompatible: | Test | Results/Acceptance | |--------------------------------------------|-----------------------------------------------------------------------| | Cytotoxicity | Non-Cytotoxic | | Kligman Maximization<br>Sensitization Test | Non-Sensitizing | | Intracutaneous Injection | Non-Irritant | | Systemic Injection | Non-Toxic | | Material-Mediated Pyrogenicity | Non-Pyrogenic | | Genotoxicity/Mutagenicity | Non-Mutagenic | | In Vitro Mouse Lymphoma Assay | Non-Mutagenic | | In Vivo Mouse Lymphoma | Non-Mutagenic | | Hemolysis | Non-Hemolytic | | Complement Activation C3a and<br>SC5ba-9 | No greater biological response than corresponding control | | Inactivated Partial | Minimal, passed acceptance criteria | | Thromboplastin Time | Non-activator, passed acceptance criteria | | Platelet and Leukocycte Counts | Test articles: No range or acceptable level established. | | Muscle Implantation | Intramuscular Implantation- 4 and 13 week, passed acceptance criteria | #### Test Result Summary 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 10 °. ## Design Verification (Bench-Top Testing) The physical, mechanical, and performance testing of the Reverse Medical MVP System 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 Reverse Medical MVP. 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 Reverse Medical MVP System included: {3}------------------------------------------------ #### Verification and Test Summary - Visual Inspection . - . Dimensional Inspection - Tensile Strength . - USP Particulate - . Radial Force - . Microcatheter Compatibility - . Detachment Time - . Torque Strength - Plug Foreshortening ● - . Nickel Release - Corrosion Resistance (potentiodynamic and galvanic). - Flow Occlusion/Reduction � - Magnetic Resonance Compatibility . - Labeling ● - Packaging . - Shelf Life - Sterility - Biocompatibility . - Detachment Box and Cable Set All tests performed passed successfully. The physical, mechanical, and performance testing of the Reverse Medical MVP System demonstrate that the product is safe and effective for its labeled indications and is Substantially Equivalent to the currently marketed predicate devices ## Substantial Equivalence The performance of the Reverse Medical MVP System 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, animal testing, and sterilization validation. The Reverse Medical MVP System 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}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a simple, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 2, 2013 Reverse Medical Corporation c/o Mr. Jeffrey Valko 13700 Alton Parkway, Suite 167 Irvine, CA 92618 Re: K123803 Trade/Device Name: Reverse Medical Micro Vascular Plug System Regulation Number: 21 CFR 870.3300 Regulation Name: Device. Vascular, For Promoting Embolization Regulatory Class: Class II Product Code: KRD Dated: June 10, 2013 Received: June 11, 2013 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. 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. {5}------------------------------------------------ Page 2 - Mr. Jeffrey Valko If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please . contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/MedicalDeyices/Safety/ReportalProblem/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/ResourcesforYou/Industry/default.htm. Sincerely yours, # Bram D. Zuckerman -S Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ 3. Indications for Use 510(k) Number (if known):_ Device Name: Reverse Medical™ Micro Vascular Plug (MVP™) Indication for Use: : ・ The Reverse Medical™ Micro Vascular Plug (MVP™) System is intended for use to obstruct or reduce the rate of blood flow in the peripheral vasculature. 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) Bram D. Zuckerman -S 2013.07.02 17:24:16 -04'00'