ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS

{0}------------------------------------------------ ## K133566 510(k) Summary ﻪ - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - ن ته DEC 2 0 2013 | Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311<br>Phone: 763-255-0877<br>Fax: 763-494-2222 | | | | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|------------------------------------------------|------------------| | Contact Name<br>and<br>Information | Maylin Truesdell<br>Senior Regulatory Affairs Specialist<br>Phone: 763-255-0877<br>Fax: 763-494-2222<br>e-mail: maylin.truesdell@bsci.com | | | | | Date Prepared | November 19, 2013 | | | | | Proprietary<br>Name | Rotablator™ Rotational Atherectomy System with the Peripheral<br>RotaLink™ Plus | | | | | Common Name | Rotational Angioplasty System or Rotational Atherectomy System | | | | | Product Code | MCW - Catheter, Peripheral, Atherectomy | | | | | Classification | Class II, 21 CFR Part 870.4875 - Intraluminal Artery Stripper | | | | | Predicate<br>Devices | Rotablator® Rotational Angioplasty System<br>K901206, September 14, 1990 | | | | | | Rotablator™ Rotational Atherectomy System with the Peripheral<br>RotaLink™ Plus | | | | | | K121774, September 13, 2012 | | | | | Device<br>Description | The Rotablator Rotational Atherectomy System with the Peripheral<br>RotaLink Plus consists of an Advancer pre-connected to a Catheter. The<br>advancer functions as a guide for the sliding elements that control burr<br>advancement and the catheter portion of the device guides the burr<br>through the vasculature to the treatment site. The Peripheral RotaLink<br>Plus devices are provided sterile and non-pyrogenic. It is intended for one<br>procedure use only. The Rotablator Rotational Atherectomy System with<br>the Peripheral RotaLink Plus currently offers burr sizes 1.5, 1.75, 2.00,<br>2.15, 2.25, 2.38 and 2.5mm, with 1.25mm being introduced in this<br>submission. | | | | | Intended Use | The Rotablator Rotational Atherectomy System with the Peripheral<br>RotaLink Plus is intended to ablate occlusive material and restore luminal<br>patency in the peripheral vasculature. | | | | | Indications for<br>Use | The Rotablator Rotational Atherectomy System is intended for<br>percutaneous use in peripheral vessels in patients with occlusive<br>atherosclerotic disease who are acceptable candidates for endovascular<br>procedures. | | | | | | K133566 | | | Page 2 of 2 | | Comparison of<br>Technological<br>Characteristics | The Rotablator Rotational Atherectomy System with the Peripheral<br>RotaLink Plus incorporates substantially equivalent device materials and<br>design, packaging materials and design, fundamental technology,<br>manufacturing processes, sterilization process and intended use as those<br>featured in the Boston Scientific predicate devices, Peripheral Rotablator<br>Rotational Angioplasty System with the RotaLink Exchangeable Catheter. | | | | | Performance<br>Data | The following in-vitro performance tests were completed on the Peripheral<br>RotaLink Plus: | | | | | | Strain Relief | | Burr Cutting Ability | | | | Operational Speeds | | Tensile Strength | | | | Stall Torque | | | Brake Engagement | | | Infusate Temperature Generation | | Infusate Flow Rate | | | | Catheter Advancement | | Lumen Patency | | | | Component Interface Compatibility | | Functional Life | | | | The following biocompatibility and chemical characterization tests were<br>completed on the Peripheral RotaLink Plus: | | | | | | Natural Rubber Latex | | Intracutaneous Reactivity Test<br>(Irritation) | | | | Hemolysis Assay: Extract<br>Method | | Acute Systemic Injection Test | | | | Hemolysis Assay: Direct<br>Contact Method | | Materials Mediated Rabbit<br>Pyrogen Test | | | | Complement Activation C3a<br>and SC5b-9 Assay | | USP Physicochemical Test for<br>Plastics | | | | Partial Thromboplastin Time<br>(PTT) | | In vitro Cytotoxicity Test: MEM<br>Elution | | | | In vitro Hemocompatibility<br>Assay | | FTIR Analysis | | | | Guinea Pig Maximization<br>Sensitization Test: Method for<br>Biomaterial Extracts | | | | | Conclusion | Based on the indications for use, technological characteristics, and safety<br>and performance testing, the Peripheral Rotablator Atherectomy System<br>with the Peripheral RotaLink Plus has been shown to be appropriate for its<br>intended use and is considered to be substantially equivalent to the<br>Peripheral Rotablator Rotational Angioplasty System as submitted in<br>K901206 and K121774. | | | | . {1}------------------------------------------------ . r . . . . . . . ・ {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 20, 2013 Boston Scientific Corporation Ms. Maylin Truesdell Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566 Re: K133566 Trade/Device Name: Rotablator Rotational Atherectomy System with the Peripheral RotaLink Plus Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: November 19, 2013 Received: November 20, 2013 Dear Ms. Truesdell: 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. However, we remind you 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 {3}------------------------------------------------ Page 2 - Ms. Maylin Truesdell 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 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/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, Kenneth J. Cavanaugh -S for Bram D. Zuckerman, M. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use K133566 510(k) Number (if known): Device Name: Rotablator™ Rotational Atherectorny System with the Peripheral RotaLink™ Plus Indications for Use: The Rotablator Rotational Atherectory System is intended for perculaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular procedures. Prescription Use _ × (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) K