AXERA 2 ACCESS SYSTEM MODEL AXE200

{0}------------------------------------------------ K123135 p. 1 of 2 Image /page/0/Picture/1 description: The image is an abstract black and white drawing. It features a series of intersecting lines of varying thicknesses. The lines are arranged in a seemingly random pattern, creating a sense of chaos and movement within the composition. ## JAN 2 8 2013 Arstasis ## SECTION 2. 510(k) SUMMARY | Sponsor/Submitter: | Arstasis, Inc. | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 740 Bay Road | | Contact Person: | Debra Cogan | | | Director, Quality Assurance, Regulatory & Clinical Affairs | | | Phone: (650) 261-8073 | | Date of Submission: | October 4, 2012 | | Device Trade Name: | AXERA 2 Access System | | Common Name: | Catheter Introducer | | Device Classification: | Class II | | Regulation Number: | 21 CFR 870.1340 | | Classification Name: | Catheter Introducer | | Product Code: | DYB | | Predicate Device: | AXERA Access System (K121521) | | Device Description: | The AXERA 2 is a device that is comprised of a latchwire, anchor<br>mechanism, shaft and handle with control features. | | Indications for Use: | The AXERA Access System is intended to provide access for the<br>percutaneous introduction of devices into the peripheral vasculature<br>and to promote hemostasis at the arteriotomy site as an adjunct to<br>manual compression. AXERA is indicated for use in patients<br>undergoing diagnostic femoral artery catheterization procedures<br>using 5F or 6F introducer sheaths. | | Technological<br>Characteristics | The AXERA 2 Access Device is designed to create a shallow<br>access path through the arterial wall for the guidewire to enter the<br>vessel lumen. | | Performance Data | Device is unchanged for the predicate device. The predicate device<br>met all performance testing acceptance criteria. | {1}------------------------------------------------ K123135 p. 2 of 2 Summary of Substantial Equivalence: There are no changes to the Indications for Use. The clinical section of the Instructions for Use was amended to include a summary of the RECITAL study results. The clinical summary includes data related to patient safety, device performance and efficacy, including time to hemostasis, time to ambulation, time to sit up 45 degrees, time to discharge eligibility and actual discharge. Device is unchanged for the AXERA 2 Access System. Bench Testing performed for the predicate device is applicable and was not repeated for the subject AXERA 2 Access Device. All acceptance criteria for bench testing performed for the predicate device were met and test results demonstrated that the predicate device met performance requirements for its intended use. No new issues of safety or effectiveness have been raised when compared to the predicate device. Prior bench testing of the AXERA 2 device included device functionality, deployment forces (heel, needle, plunger), release forces (heel), flex conditioning (latchwire), resistance of latchwire to damage by flexing, tensile strength of multiple joints (latchwire, anchor, heel, plunger, plunger tube, needle), compressive strength (handle/anchor, plunger lockout), and torque loading (handle/anchor), corrosion resistance testing, biocompatibility testing, preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical investigations. Multiple clinical evaluations were conducted. The short term safety and clinical performance of the device were established. The long term safety, as well as the ability to access and re-access, was retrospectively studied in a smaller cohort of patients. In summary, the cumulative data provided herein demonstrates that the AXERA 2 Access System is substantially equivalent to its predicate in providing access to the arterial lumen and facilitating the introduction and placement of devices into the peripheral vasculature and achievement of hemostasis. 1 The preliminary Animal Studies and Cadaver Assessments were conducted using prototypes of a similar design and configuration. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of a human figure in profile, with three overlapping faces suggesting community and support. The graphic is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the top half of the logo. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Arstasis. Inc. c/o Ms. Debra Cogan Director, Quality Assurance, Regulatory & Clinical Affairs 740 Bay Road Redwood City, CA 94063 Re: K123135 Trade Name: AXERA 2 Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: December 19, 2012 Received: December 20, 2012 Dear Ms. Cogan: 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 JAN 2 8 2013 {3}------------------------------------------------ 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, Matthew G. Hillebrenner for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 19 21 27 Traditional 510(k) ## SECTION 1. INDICATIONS FOR USE STATEMENT 510(k) Number (if known): Trade Name: AXERA 2 Access System Common Name: Catheter Introducer K123135 Indications For Use: The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths. 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) .g.killelea (Division Sign-Off) Division of Cardiovascular Devices 123135 510(k) Number of Page __