FLEXNEEDLE PLUS

{0}------------------------------------------------ MAY 1 4 1999 K990693 ## 13. 510(K) SUMMARY - (1) ACT Medical 150 California Street Newton, MA 02458 Contact Person: Wendy Shotts Date Summary Prepared: February 26, 1999 - (2) Trade or Proprietary Name: FlexNeedle® Plus Intravascular Administration Set Common Name: Intravascular Administration Set Classified Name: - (3) Predicates: Luther L-Cath (K# unknown) Bard Access Systems Winged Infusion Set (K# unknown) - Description of Device: The FlexNeedle Plus is comprised of a flexible catheter, a (4) body with elastomeric septum and side port; sidearm tubing with a luer infusion fitting, cap and pinch clamp; and an insertion stylet with a safety housing for capturing the sharp upon removal. - Intended Use: The FlexNeedle Plus is intended for use in the short term or (ર) intermittent transcutaneous cannulation of implanted venous access ports and is designed with the purpose of reducing accidental needlesticks. - The FlexNeedle Plus has the same technological characteristics as the predicate (6) devices in that it is a hollow tube with a luer fitting intended to remain in a subcutaneous access port in order to provide access to the bloodstream. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 4 1999 Ms. Wendy V. Shotts Quality Engineer Act Medical, Incorporated 150 California Street Newton, Massachusetts 02458 Re : K990693 FlexNeedle® Plus Trade Name: Requlatory Class: II Product Code: FPA March 2, 1999 Dated: Received: March 3, 1999 Dear Ms. Shotts: 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Please note: this response to your the Federal Register. 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. {2}------------------------------------------------ Page 2 - Ms. Shotts 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 the regulation entitled, "Misbranding (21 CFR 807.97). Other general 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, Timothy A. Ulatowski Dired tor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Center for Devices and Radiological Health K990693 Page 1 of 15 510(k) Number (if known): Flex Needle ® Plus Device Name: Indications for Use: The Flex Needle ® Plus is intended for use in the short term or intermittent transcutaneous cannulation of implanted venous access ports and is designed with the purpose of reducing accidental needlesticks. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurence of CDRH, Office of Device Evaulation (ODE) *for PXC 5/14/99* (Division Sign-Off) (Division of Dental, Infection Control, General Hospital Devices k) Number PRESCRIPTION DEVICE (Posted July 1, 1998) ﻨﺠﻮ (Optional Format 3-10-98) Back to the Indications for Use Page