ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS

{0}------------------------------------------------ Traditional 510(k) Submission Rotablator™ Rotational Atherectomy System with the Peripheral RotaLink™ Plus SEP 1 3 2012 74 K12|7 # 510(k) Summary ## per 21 CFR §807.92 | Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 | | | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------| | Contact Name<br>and<br>Information | Beth Torok<br>Principal Regulatory Affairs Specialist<br>Phone: 763-494-1273<br>Fax: 763-494-2222<br>e-mail: beth.torok@bsci.com | | | | Date Prepared | 15 June 2012 | | | | Proprietary<br>Name | Rotablator™ Rotational Atherectomy System with the Peripheral<br>RotaLink™ Plus | | | | Common Name | Rotational Angioplasty System | | | | Product Code | MCW - Catheter, Peripheral, Atherectomy | | | | Classification | Class II, 21 CFR Part 870.4875 - Intraluminal Artery Stripper | | | | Predicate<br>Device(s) | Peripheral Rotablator® Rotational<br>Angioplasty System with the<br>RotaLink™ Exchangeable Catheter | K993648 | 24 November 1999 | | | Peripheral Rotablator® Rotational<br>Angioplasty System with the<br>Support and Rail RotaWire™<br>Guidewires | K960379 | 25 April 1996 | | | Peripheral Rotablator® Rotational<br>Angioplasty System with Dynaglide | K933238 | 24 August 1993 | | | Rotablator wireClip | K913450 | 06 September 1991 | | Device<br>Description | The Rotablator Rotational Atherectomy System with the Peripheral<br>RotaLink Plus is a catheter based angioplasty device that utilizes a high<br>speed, rotating, diamond-coated burr to ablate occlusive material and<br>restore luminal patency. The burr spins at up to 190,000 RPM and ablates<br>material into very fine particles that are carried distally and removed via the<br>reticuloendothelial system. There are three main components that<br>comprise the Rotablator Rotational Atherectomy: 1) the Peripheral<br>RotaLink Plus, 2) Peripheral RotaWire Guidewire with the wireClip Torquer,<br>and 3) Rotablator Console with Dynaglide foot pedal. Rotaglide, a lubricant<br>is also available as an accessory. | | | | Intended Use<br>of Device | 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. | | | · {1}------------------------------------------------ ### Traditional 510(k) Submission · . Rotablator™ Rotational Atherectorny System with the Peripheral RotaLink™ Plus | 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. | | |---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------| | Performance<br>Data | Currently no FDA mandated or voluntary performance standards exist for<br>this atherectomy catheter. Bench testing and biocompatibility testing were<br>performed to support a determination of substantial equivalence. The<br>results of these tests provide reasonable assurance that the proposed<br>device has been designed and tested to assure conformance to the<br>requirements for its intended use. No new safety or performance issues<br>were raised during the testing and, therefore, these devices may be<br>considered substantially equivalent to the predicate devices.<br>The following biocompatibility and chemical characterization tests were<br>completed on the Rotablator Rotational Atherectomy System;<br>Peripheral RotaLink Plus: | | | | Natural Rubber Latex | Intracutaneous Reactivity Test<br>(Irritation) | | | Hemolysis Assay: Extract Method | Acute Systemic Injection Test | | | Hemolysis Assay: Direct Contact<br>Method | Materials Mediated Rabbit<br>Pyrogen Test | | | Complement Activation C3a 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 Assay | FTIR Analysis | | | Guinea Pig Maximization<br>Sensitization Test: Method for<br>Biomaterial Extracts | | . · ・ · : : > ・ · > > - {2}------------------------------------------------ #### Traditional 510(k) Submission Rotablator™ Rotational Atherectomy System with the Peripheral RotaLink™ Plus | Peripheral RotaWire Guidewire: | | |------------------------------------------------------------------------------------------------------------|------------------------------------------------| | Natural Rubber Latex | Intracutaneous Reactivity Test<br>(Irritation) | | Hemolysis Assay: Direct Contact<br>Method | In vitro Cytotoxicity Test: MEM<br>Elution | | Complement Activation C3a and<br>SC5b-9 Assay | Materials Mediated Rabbit<br>Pyrogen Test | | Partial Thromboplastin Time<br>(PTT) | USP Physicochemical Test for<br>Plastics | | In vitro Hemocompatibility Assay | Acute Systemic Injection Test | | Guinea Pig Maximization<br>Sensitization Test: Method for<br>Biomaterial Extracts | | | Rotaglide: | | | Hemolysis Assay: Direct Contact<br>Method | In vitro Cytotoxicity Test: MEM<br>Elution | | Partial Thromboplastin Time<br>(PTT) | Materials Mediated Rabbit<br>Pyrogen Test | | The following in-vitro performance tests were completed on the Rotablato<br>Rotational Atherectomy System: | | | Peripheral 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 | Peripheral RotaWire Guidewire and wireClip Torquer: | Corrosion | Torque Transmission | |--------------------|---------------------| | Radiodetectability | Pushability | | Fracture | Tip Deflection | | Flexure | Stiffness | | Tensile Strength | Torque to Fail | | Tip Formability | Functional Life | #### Conclusion Based on the indications for use, technological characteristics, safety and performance testing, the Rotablator Rotational Atherectomy System with the Peripheral RotaLink Plus has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Rotablator Rotational Angioplasty System as submitted in K993548, K960379, K933238, and K913450. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 SEP 13 2012 Boston Scientific Corp. % Ms. Beth Torok One Scimed Place Maple Grove, MN 55311 Re: K121774 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: June 15, 2012 Received: June 18, 2012 Dear Ms. Torok: 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. {4}------------------------------------------------ Page 2 - Beth Torok 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/CDRH0ffices/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 vours, Sincerely yours, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): K121774 Device Name: Rotablator™ Rotational Atherectomy System with the Peripheral RotaLink™ Plus Indications for Use: The Rotablator™ Rotational Atherectomy System is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for endovascular 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) (Division Sian-Off) Division of Cardiovascuk 510(k) Number Page 1 of 1