PILLING WECK SURGICAL Y STENT FORCEPS

{0}------------------------------------------------ 4/27/99 Image /page/0/Picture/1 description: The image shows the logo for "Pilling Weck". The logo consists of a stylized "W" symbol on the left, followed by the text "Pilling Weck" in a bold, serif font. The "W" symbol has a diamond shape above it. K990547 ﺗ ## 510 (k) Summary - Submitter Name, Address, and Date of Submission. 1. Mrs. Julie A Beaumont Group Regulatory Affairs Technician Pilling Weck Group Tall Pines Park Jaffrey, New Hampshire 03452 (603) 532-7706 Telephone: (603) 532-6179 Facsimile: jbeaumont@tfx.com E-Mail: Contact: Same as above - Name of the Device, Common, Proprietary (if Known), and 2. Classification. Classification Name: Pilling Weck Surgical Y Stent Forceps / (Bronchoscope (Flexible or Rigid) Common Name: Stent Forceps Proprietary Name: Stent Forceps/(Bronchoscope(Flexible or Rigid) - Identification of the legally marketed device to which 3. the submitter claims equivalence. The Stent Forceps/(Bronchoscope(Flexible or Rigid) is substantially equivalent to the Karl Storz Stent Applicator Forceps. - Description of the Device. 4 . The Stent Forceps/(Bronchoscope(Flexible or Rigid) A Telefiex Company One Weck Drive, P.O. Box 12600 Research Triangle Park, North Carolina 27709 (919) 544-8000 Image /page/0/Figure/17 description: The image shows a curved line. The line is thin and black. The curve is concave up. {1}------------------------------------------------ consists of a hand controlled forcep with a specially designed grasping tip to restrain the bronchial limbs of the Y Stent and mechanically hold the stent limbs together for insertion into the trachea. Once positioned, the forceps are released and the bronchial limbs of the stent return to their Y position. The Forceps is then withdrawn. ## Intended Use of the Device. 5 . The Pilling Weck Surgical Y Stent Forceps (Bronchoscope (Flexible or Rigid)is to inset tracheobronchial stents during ENT procedures ## Summary of Technological Characteristics. 6. The Pilling Weck Surgical Y Stent Forceps(Bronchoscope (Flexible or Rigid)are substantially equivalent to the predicate devices, since the basic features, designs and intended uses are the same. The differences between the Pilling Weck Surgical devices and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices. {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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol resembling three abstract human profiles or flowing lines, possibly representing people or services provided by the department. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 7 1999 Mrs. Julie A. Beaumont Group Regulatory Affairs Technician Pilling Weck Group Tall Pines Park Jaffrey, New Hampshire 03452 Re: K990547 Trade Name: Pilling Weck Surgical Stent Forceps Regulatory Class: II Product Code: 77 EOQ Dated: February 19, 1999 Received: February 22, 1999 Dear Mrs. Beaumont: 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 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. 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 vour device can be found in the Code of Federal Regulations. 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 (OS) 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 . {3}------------------------------------------------ Page 2 - Mrs. Julie A. Beaumont 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) 594-4613. 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/dsmamain.html". Sincerely yours, A. Ralph Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Kaqus47 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications for Use: The Pilling Weck Surgical Y Stent Forceps (Bronchoscope (Flexible or Rigid) is to inset tracheobronchial stents during ENT procedures PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use_ | Over-The-Counter Use_ | |-------------------|-----------------------| |-------------------|-----------------------| (Per 21 CFR 801.109) For Harry, Juablut (Division Sign-Off) Division of Ophthalmic Devices | 510(k) Number | K990547 | |---------------|---------| |---------------|---------|