EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF

{0}------------------------------------------------ # VII. 510(K) SUMMARY | Manufacturer: | SCHNEIDER/NAMIC<br>Glens Falls, New York 12801 | |----------------------|-------------------------------------------------------------------------| | Contact Person: | Karin L. Smith<br>Regulatory Affairs Specialist | | | Telephone Number: (518) 798-0067<br>Facsimile Number: (518) 742-4463 | | Date Prepared: | August 28, 1998 | | Trade Name: | Emcee™ Infusion Introducer Sheath Set | | Common Name: | Catheter Introducer | | Classification Name: | Introducer, Catheter | | Predicate Devices: | Emcee™ Introducer Set (K980504)<br>LocalMed™ InfusaSleeve™ II (K952317) | #### Intended Use: The Emcee Infusion Introducer Sheath Set is intended for use in facilitating the The Emcee Infusion introduction of cathers, interventional devices and temporary pacing leads percutaneous introduction of catheters, interventional devices administered perculaneous introduction of canied. Fills and will deliver therapeutics shooth through the stopcock sidearm to the vasculature wall surrounding the sheath. #### Product Description: The Emcee Infusion Introducer Sheath Set is comprised of a percutaneous introducer The Encee Infusion maroducor Biso contain a guidewire. The Emcee Infusion Introducer Sheath Set may also be a part of a kit. Design Fcatures have been added to the Emcee Introducer Set (K980504) to enhance the Design Natures nave been sacilitating the percutaneous introduction of catheres, interventional devices, and temporary pacing leads into the vasculature. These design interventional devices, and temporary parting of the sheath shaft in conjunction with a Icatures include the uddition of the dilator (from a point slightly distal to the dilator hub to a point proximal to the sheath tip). These design features permit a fluid ulfator nub to a point proximal to the space between the outer dilator wall and the inner sheath wall, and exiting into the vasculature lumen via the sheath sideholes. 983039 {1}------------------------------------------------ #### VII. 510(K) Summary (Cont.) The Emcee Infusion Introducer Sheath Set functions equivalently to the Emcee Into Lucer Set for vasculature access. The dilator/sheath assembly is advanced into the vasculature over a guidewire. The dilator is then removed with the guidewire, leaving the sheath in the vasculature. Devices can now be inserted through the sheath. When desired by the physician, the sheath-dilator system can be used to deliver therapeutic solutions. Prior to infusing therapeutic solutions, the modified dilator is reintroduced. The therapeutic solution can then be administered via the stopcock on the sheath sidearm, and will be delivered into the vasculature lumen via the sheath sideholes. Components of the Emcee Infusion Introducer Sheath Set have a lubricious coating for a smooth entrance and removal from the vasculature. ## Comparison to Predicate Device: The Emcee Infusion Introducer Sheath Set indications and design are substantially equivalent to the predicate devices. ## Performance Testing: The Emcee Infusion Introducer Sheath Set has been subjected to non-clinical performance testing to provide data supporting its safety and effectiveness for its intended uses. #### Biocompatibility: The materials used in the Emcee Infusion Introducer Sheath Set have been subjected to biocompatibility testing having its basis in International Standards Organization (ISO) 10993-1 (1992)E "Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests". The Emcee Infusion Introducer Sheath Set is considered to be biocompatible. {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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three arms or lines extending from it. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 7 1999 MAY Ms. Karin L. Smith Regulatory Affairs Specialist Boston Scientific Corporation NAMIC Technology Center 18 Pruyn's Island Glens Falls, NY 12801-4400 Re : кавзозя Trade Name: Emcee™ Infusion Introducer Sheath Sct Regulatory Class: II Product Code: DYB February 4, 1999 Dated: Received: February 9, 1999 Dear Ms. Smith: 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 general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. {3}------------------------------------------------ Page 2 - Ms. Karin L. Smith with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation 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 obrigation you might matectronic 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. Callahon Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ II. Premarket Notification Required Information (Cont.) ## INDICATIONS FOR USE Page 1 of 1 510(k) Number__ Device Name: Emcee™ Infusion Introducer Sheath Set Indications For Use: Intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature. The device also will deliver therapeutic solutions administered through the stopcock sidearm to the vasculature wall surrounding the sheath, (PLEASE DO NOT WRITE BEI.OW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluations (ODE) ormatizing | Labels | Values | |-------------------|---------------------| | Division Sign-Off | L. Gabriel Ja Naser | | Date | 5/7/99 | | 510(k) Number | K983039 | Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use Emcee™ Infusion Introducer Sheath Set