MANIFOLD WITH EXTENSION SET

{0}------------------------------------------------ JUL 3 | 1998 K982368 Interpore Cross Manifold With Extension Set Interpore Cross International - Confidential - ### 510(K) SUMMARY ### SUBMITTED BY Lynn Rodarti Manager, Regulatory Affairs INTERPORE International 181 Technology Drive Irvine, California 92618 (714) 453-3200 Date Submitted: July 2, 1998 ## CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME Classification Name: Stopcock, I.V. Set Common/Usual Name: Stopcock Manifold Product Classification: Class II Proprietary Name: Manifold with Extension Set #### PREDICATE DEVICE Medex Guide-Flo Stopcock Manifold Gangs, Preamendment Device and Baxter Stopcock Manifold Gangs, 510(k) K962531. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92. #### INDICATIONS-FOR-USE The Interpore Cross International Manifold with Extension Set is intended to provide multiple access sites into a common fluid path for blood, plasma or The luer connectors on either end of the stopcock gang allow solutions. connection to an Extension Set for fluid transfer (i.e., blood, plasma, or solution). ### DEVICE DESCRIPTION The Interpore Cross Manifold with Extension Set consists of individual stopcocks assembled in series through common luer fittings to form a manifold or stopcock gang. These pre-assembled stopcock gangs provide multiple access sites into a common fluid path for blood, plasma or solutions. {1}------------------------------------------------ # Interpore Cross Manifold With Extension Set The luer connectors on either end of the stopcock gang (Manifold) allow connection to the Extension Set for fluid transfer. The backing plate can be used to attach the stopcock manifold gang to an IV pole. # COMPARISON TO THE PREDICATE DEVICE Cross Manifold with Extension Set is technologically The Interpore substantially equivalent to the predicate devices in every respect. ## DISCUSSION OF NONCLINICAL TESTS Data regarding the functional performance of the proposed Manifold have been generated. Testing included ease of assembly, unscrewing torque, air leakage, liquid leakage, separation force, resistance to overriding, pressure seal testing, Manifold flow rate, mechanical security of stopcock gangs to backing plate. The data indicate that the proposed Manifold meets or exceeds all functional requirements and support its suitability for use. {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 . || " JUL 31 1998 Ms. Lynn Rodarti Manager, Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618 K982368 Re : Manifold with Extension Set Trade Name: Regulatory Class: II Product Code: FMG Dated: July 6, 1998 Received: July 7, 1998 Dear Ms. Rodarti: 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 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 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 {3}------------------------------------------------ Page 2 - Ms. Rodarti 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) 594-4692. 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 requlation 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, S. Sutro fer Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K982368 Page 1 of 1 510(k) Number (if known): Manifold with Extension Set Device Name: ### Indications-For-Use: The Interpore Cross International Manifold with Extension Set is intended to provide multiple access sites into a common fluid path for blood, plasma or solutions. The luer connectors on either end of the stopcock gang allow connection to the Extension Set for fluid transfer (i.e., blood, plasma, or solution). ### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Patricia Cincenti (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ **Prescription Use** (PER 21 CFR 801.109) OR #### Over-The-Counter Use (Optional Format 1-2-96)