SMARTSITE STOPCOCK

{0}------------------------------------------------ ORIGINAL PR # SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris® Products® SMARTSITE® STOPCOCK DEC 1 4 2007 #### SUBMITTER INFORMATION | A. | Company Name: | Cardinal Health, Alaris® Products | |----|--------------------------------|------------------------------------------------------------------------------------------------| | B. | Company Address: | 10221 Wateridge Circle<br>San Diego, CA 92121-2733 | | C. | Company Phone:<br>Company Fax: | (858) 617-5889<br>(858) 617-5960 | | D. | Contact Person: | Stacy L. Lewis<br>Principal Regulatory Affairs Specialist<br>Cardinal Health, Alaris® Products | | E. | Date Summary Prepared: | December 12, 2007 | #### DEVICE IDENTIFICATION | A. | Generic Device Name: | Stopcock | |----|-------------------------|-------------------------------------| | B. | Trade/Proprietary Name: | SmartSite® Stopcock | | C. | Classification: | Class II | | D. | Product Code: | FMG, Stopcock, IV Administration Se | ## DEVICE DESCRIPTION The SmartSite® Stopcock is a single use 4-way stopcock with an integrated SmartSite® needle free valve on the side port. Arrows on the handle point to the direction of flow. The side port consists of a SmartSite® needle free valve that provides closed, needle-free access that seals upon removal and does not require re-capping between uses. {1}------------------------------------------------ ## SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris® Products SMARTSITE® STOPCOCK Page 2 of 3 #### DEVICE DESCRIPTION (Continued) The SmartSite® Stopcock share similar characteristics and will operate the same as currently marketed stopcocks, as an accessory to an IV administration set that regulates the directional flow to a patient's vascular system and provides an access port(s) for the administration of solutions. #### SUBSTANTIAL EQUIVALENCE The Cardinal Health, Alaris® Products SmartSite® Stopcock is of comparable type and is substantially equivalent to the following predicate devices: | Predicate Device | Manufacturer | 510(k) No. | Date Cleared | |------------------------------------|-------------------------------------|------------|--------------| | Elcam Closed Swabbable<br>Stopcock | Elcam Medical | K060231 | 04/13/06 | | SmartSite® Needle Free Valve | Cardinal Health, Alaris<br>Products | K960280 | 04/04/96 | #### INTENDED USE The SmartSite® Stopcock is indicated for fluid flow, directional control and for providing access port(s) for administration of solutions and blood products. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. The SmartSite® valve port allows the user to access the primary line without the use of a needle. #### TECHNOLOGICAL CHARACTERISTICS A comparison of the technological characteristics of the SmartSite® Stopcock and the predicate devices has been performed. The results of this comparison demonstrate that the SmartSite® Stopcock is equivalent to the marketed predicate devices in technological characteristics. {2}------------------------------------------------ ## SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris® Products SMARTSITE® STOPCOCK Page 3 of 3 ### PERFORMANCE DATA The performance data indicate that the SmartSite® Stopcock meets specified requirements and is substantially equivalent to the predicate devices. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The text is black and the background is white. Image /page/3/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted with three intertwined strands and a stylized wing-like element above it. The text reads, "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA". DEC 1 4 2007 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Stacy L. Lewis Principal Regulatory Affairs Specialist Cardinal Health, Alaris Products 10020 Pacific Mesa Boulevard San Diego, California 92121-2772 Re: K071400 Trade/Device Name: SmartSite® StopCock Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: November 27, 2007 Received: November 28, 2007 Dear Ms. Lewis: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {4}------------------------------------------------ Page 2 - Ms. Lewis Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-00115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Anthon D.mister for Shirin, Ph.D. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## ATTACHMENT A ## INDICATIONS FOR USE 510(k) Number: K071400 SmartSite® Stopcock Device Trade Name: #### Indications For Use: The SmartSite® Stopcock is indicated for fluid flow, directional control and for providing access port(s) for administration of solutions and blood products. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. The SmartSite® valve port allows the user to access the primary line without the use of a needle. Prescription Use X (Per 21 CFR 801.109) Over-The-Counter Use PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) OR Concurrence of CDRH, Office of Device Evaluation (ODE) Cenir Homan To 1471444