CATHETER TUNNELER

{0}------------------------------------------------ ## 1972554 Docember 22, 1997 2. Summary of Safety and Effectiveness Information: 2a. & 2d. Gerard Medical, Inc. Company Name and Address: 6 City Depot Rd. P.O. Box 940 Charlton City, MA 01508 Company Telephone No.: (508) 248-1562 Richard Cayer, Jr. Company Contact Name: September 24, 1997 Summary Date: Catheter Tunneler Proprietary Name: Tunneler (accessory to catheter or Common or Usual Name: implanted vascular access system) Surgical Tunneler Classification Name: Class: Unclassified Legally Marketed Substantially Bquivalent Device: Manufactured by Bard Access Systems Catheter Tunneler. (Division of C.R. Bard, Inc. ) Device Description and Intended Usage: Gerard Medical plans to manufacture and market a catheter This device will be used to create a subcutaneous path tunneler. The design of the device is such for an intraluminal catheter. that the distal tip can separate subcutaneous tissues when manual force is applied in the direction of the tip along the length of The device has a means to the device proximal to the tip. connect the catheter in order to draw it through the subcutaneous The tunneler may be constructed of any material tunnel. (eg. metal or plastic) which permits separation of, and passage through, subcutaneous layers and is suitable for contact with The initial device that we plan to produce and this tissue. market is made of the plastic Delrin 500. We may, at a later date, provide an additional model that would consist of a medical grade stainless steel. {1}------------------------------------------------ Summary of Safety and Effectiveness Information 2a. & 2d. (continued): When utilized during a surgical procedure, the tunneler must be able to withstand the force applied to create the subcutaneous Also, during this procedure, the catheter must remain path. connected to the distal end of the device. As part of the Manufacturing Specification that we are creating for this device, we will mandate that the following tests be performed for the appropriate percentage of our finished devices prior to their being released for usage. Test #1: With the distal end (i.e. front end) of the device squarely abutted against an immovable flat surface, a 5 pounds force test will be performed. Test #2: With a catheter connected to the proximal end (i.e. back end) of the device, a 2 pound tension test will be performed. For this test the catheter will be pulled in two directions, both linearly (i.e. straight) and at a 45 degree angle. Note that, based on our bench testing, the above levels of stress are significantly higher than would be anticipated during the actual surgical procedure. 3. {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Richard Cayer, Jr. ·President Gerald Medical, Incorporated 6 City Depot Road P.O. Box 940 01508 Charlton, Massachusetts DEC 22 1997 K972555 Re : Catheter Tunneler Trade Name: Requlatory Class: Unclassified Product Code: 1.35 Dated: September 24, 1997 September 29, 1997 Received: Dear Mr. Cayer: 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 The general controls provisions of the Act 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 requlations 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 requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 {3}------------------------------------------------ Page 2 - Mr. Cayer through 542 of the Act for devices under the Electronic and the Man Castmal provisions, or other Federal 1 through 542 of the Act for devices under the 2000-11-11 Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as the FDA This letter will allow you co begin additions. The FDA described in your 510(K) premarker not revice to a legally finding of substantial equivalence of your device to your finding of substantial equivatence or your sification for your marketed predicate device results in a crabbission and the market. If you desire specific advice for your device on our labeling and and the CER Box 201 and additionally 809.10 for in If you desire specific advice for your and additionally 809.10 for in regulation (21 CFR Part 801 and additionally 809.10 for in regulation (21 CM Pat bor bor and contact the Office of vitro diagnostic devices), please contact the Office of yitro diagnostic devices), prease concass of for questions on Compliance at (301) 594-4618. Additionally, for quease contact Compliance at (301) 594-4616. Addrise, please contact the promotion and advertising of your device, please not the promotion and advertualing of your design. Also, please note the Office of Compliated at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 800mm . Other gener the Act ma Other general premarket notification on your responsibilities under the Act may be information on your responsibilities ands- turers Assistance obtained from the Division of Smart Manuzacoan 443-6597 or at at its toll-free number (800) 638-2041 or (301) 443-6597 or at at its toll-free number (800) 638-2041 of (302) 2007-10-11 (1) its internet address "http://www.fda.gov/cdrh/damamain.html". sincerely yours, Alatros Klatowski Ulatowski Timoth Director Director and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 4 of 10 10(k) Number (if known): _ 14 9 7 2 5 5 5 5 Catheter Tunneler evice Name:___________________________________________________________________________________________________________________________________________________________________ ndications For Use: :・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ A catheter tunneler is indicated whenever a surgeon would like to create a minimally invasive subcutaneous path for an implanted The implanting surgeon would oftentimes utilize the catheter. tunneler when implanting our TrimPort Systems. Our TrimPort Tunneler when implantang one indicated whenever patient therapy implancable reseated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERDED) Concurrence of CDRH, Office of Device Evaluation (ODE) not o 510(k) N rescription Use Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)