INTRAVASCULAR RETRIEVAL DEVICE

{0}------------------------------------------------ 510(k) Premarket Notification: COOK Vascular™, Incorporated Intravascular Retrieval Devices March 20, 1998 MAY 2 6 1998 ## 510(K) SUMMARY March 20, 1998 98106/ Submitted By: Neal Fearnot, Ph.D. President MED Institute, Incorporated 1400 Cumberland Ave. West Lafayette, IN 47906 | Device Name | DC# | |-----------------------------------------------------|---------| | Byrd Dilator Sheath Set - Polypropylene | K893480 | | Byrd Dilator Sheath Set - Teflon | K902469 | | Byrd Stainless Steel Dilator Sheath | K902502 | | Byrd Workstation | K902477 | | | K914555 | | Byrd Telescoping Stainless Steel Dilator Sheath Set | K922354 | | Needle's Eye Snare | K961992 | Device Description and Intended Use: The devices consist of sheaths and snares Device Description and Intended OSC. The percutaneous dilation of tissue surrounding the intended for use in patiens requiring the percents on and/or in patients requiring the first cardiac leads, indwelling catheters, and releign organisms of catheter tubing or wire guides, and other foreign objects. | Predicate Devices | DC# | |------------------------------------------|---------| | Metal Reinforced Flexible Dilator Sheath | K945586 | | Wilkoff Locking Stylet | K970690 | Substantial Equivalence: The 510(k) submission serves to notify FDA of labeling Substantial Equivalence. " The STQ(x) backings have been made to the devices; revisions made to previously cleared devices. No changes the seme intended use they are substantially equivalent to the predicate devices, having the same intended use and technological characteristics. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract image of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 6 1998 Neal Fearnot, Ph.D. President MED Institute, Inc. A Cook Group Company P.O. Box 2402 West Lafayette, IN 47906 Re: K981061 Trade Name: Byrd Dilator Sheath Set-Polypropylene Regulatory Class: II Product Code: GCC Byrd Dilator Sheath Set-Teflon Trade Name: Regulatory Class: II Product Code: GCC Byrd Stainless Steel Dilator Sheath Trade Name: Requlatory Class: II Product Code: DRE . Workstation Intravascular Retrieval Set Trade Name: Regulatory Class: II Product Code: DRE Byrd Telescoping Stainless Steel Dilator Trade Name: Sheath Set Requlatory Class: II Product Code: GCC Needle's Eye Snare Trade Name: Regulatory Class: II Product Code: DXE Dated: March 20, 1998 Received: March 23, 1998 Dear Dr. Fearnot: 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 {2}------------------------------------------------ ## Page 2 - Dr. Neal Fearnot 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. 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. 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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"(21CFR 807.97). {3}------------------------------------------------ ## Page 3 - Dr. Neal Fearnot 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. Ca lahan, Ph.D. Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): Byrd Dilator Sheath Set - Polypropylene or Teflon Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: The Byrd Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. Byrd Stainless Steel Dilator Sheath Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: The Byrd Stainless Steel Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. Byrd WORK STATION™ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: The Byrd WORK STATION™ is intended for use in patients requiring the percutaneous retrieval of cardiac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects. Byrd Telescoping Stainless Steel Dilator Sheath Set Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: The Byrd Telescoping Stainless Steel Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: The NEEDLE'S EYE™ Snare is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides, and other foreign objects. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) _ (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96)