OASIS THROMBECTOMY CATHETER SYSTEM

{0}------------------------------------------------ 2/23/99 #### SUMMARY OF SAFETY AND EFFECTIVENESS Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness. ## A. GENERAL INFORMATION | | Owner Operator Submitting Boston Scientific Corporation | |------------------------|----------------------------------------------------------| | | this Premarket Notification: One Boston Scientific Place | | | Natick, MA 01757 | | | (508) 650.9174 | | Contact Person: | Wanda M. Carpinella | | | Regulatory Affairs Department | | Device Generic Name: | Thrombectomy Catheter | | Device Classification: | 74 DXE, Catheter Embolectomy | ### B. INDICATIONS FOR USE The Oasis Thrombectomy System is a percutaneous, hydrodynamic, mechanical thrombectomy device designed for use with standard angiographic injectors. The catheter uses a high velocity saline stream to microfragment and remove thrombus from hemodialysis access grafts. ## C. DESCRIPTIVE CHARACTERISTICS The catheter features an outer shaft and is comprised of three: an inflow lumen to supply saline to the catheter tip, an outflow lumen for removal of thrombotic material and a guidewire lumen to accommodate an 0.018 inch guidewire. The catheter is 6F in diameter and is available in soft and braided configurations. # D. SUBSTANTIAL EQUIVALENCE The subject thrombectomy catheter has been shown to be substantially equivalent to the Fogarty Embolectomy Balloon Catheter and Microvena's 8F Clot Buster Amplatz Thrombectomy Catheter. Results from a randomized, prospective clinical trial established that the proposed thrombectomy catheter is safe and effective for treatment of thrombosed hemodialysis grafts when compared to pulsed spray thrombolytic therapy. #### E. PACKAGING, STERILIZATION, AND PYROGENICITY The catheter is packaged in a heat-sealed Tyvek/mylar pouch. The product is sterilized using ethylene oxide gas. Boston Scientific monitors bacterial endotoxins on product on a monthly basis. ### F. CONCLUSION Based on the information presented, Boston Scientific Corporation believes that the thrombectomy catheter meets the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to other currently thrombectomy catheters. {1}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird, with three curved lines representing its wings or feathers. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 3 1999 Ms. Laura Mondano Manager Requlatory Affairs Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 Re: K982363 > Oasis™ Thrombectomy Catheter System Trade Name: Regulatory Class: II Product Code: MCW Dated: November 23, 1998 Received: November 25, 1998 Dear Ms. Mondano: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the qeneral controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listinq of devices, qood manufacturing practice, and labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such {2}------------------------------------------------ Page 2 - Ms. Laura Mondano Existing major requlations affecting your device additional controls. can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, " Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Thomas J. Callahan Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health {3}------------------------------------------------ 510(k) Number (if known): New Application Oasis™ Thrombectomy System Device Name: Indications for Use: The Oasis Thrombectomy System is a percutaneous, hydrodynamic, mechanical thrombectomy device designed for use with standard angiographic injectors. The catheter uses a high velocity saline stream to microfragment and remove thrombus from hemodialysis access grafts. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Christopher for TJC Division of Cardiovascular, Respiratory, and Neurological Devic 510(k) Number Prescription Use (Per 21 CRF 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)