CHURCHILL MEDICAL SYSTEMS STOPCOCK

{0}------------------------------------------------ Ko12/57 ## SEP 1 1 2001 ## 510(K) Summary This summary of 510(K) safety and effectiveness information is submitted in accordance with the requirements of SMDA and 21 CFR 807.92 | 1. | Submitter: | Churchill Medical Systems, Inc. | |----|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Address: | 87 Venture Drive<br>Dover, NH 03820 | | | Phone: | 603-743-5988 | | | Fax: | 603-743-6328 | | | Contact: | Keith Paluch (Consultant) | | 2. | Device Name: | 4 way Stopcock | | | Trade Name:<br>Classification | 4 Way "Hi-Flow" Stopcock Latex Free, Lipid Resistant | | | Name: | IV Set Stopcock, IV Administration Set | | 3. | Classification: | Class II, General Hospital 80 FPA | | 4. | Predicate Device: | Ohmeda Connecta Plus 1 and Plus 3, 2 and 3 way stopcocks (K974083) | | 5. | Device Description: | The Churchill Medical Systems 4 way stopcock consist of a housing<br>with two one male luer with rotating lock ring. The diversion handle<br>opens or closes each port. | | 6. | Intended Use: | This device is used to direct and control the flow of fluids. They are<br>added to IV cannula or extension sets for simultaneous or alternate<br>administration of fluids. | | 7. | Performance Summary: | This device is manufactured and tested in accordance with physical,<br>chemical and biological specification conforming to the applicable<br>requirements set forth in ISO 10993, USPXX111, ISO 11607-1, ISO<br>11135, USP Pyrogenicity test requirements as well as documented<br>internal requirements for physical testing. | | 8. | Conclusion: | This device shares similar technical characteristics to 4 way stopcocks<br>currently available in the marketplace. Specifically, this device<br>performs similarly to the predicate device, referred to as Connecta Plus<br>1 and 3 Stopcocks (K974083). Testing summary results confirm this<br>device to be safe and effective and substantially equivalent to the<br>predicate device. | : {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes. ## Public Health Service ## SEP 1 1 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Keith Paluch Manager Churchill Medical Systems, Incorporated 87 Venture Drive Dover, New Hampshire 03820 K012157 Re : Churchill Medical Systems Stopcock Trade/Device Name: Requlation Number: 880.5440 Regulatory Class: II Product Code: FMG Dated: July 2, 2001 Received: July 11, 2001 Dear Mr. Paluch: We have reviewed your Section 510(k) notification of intent to we have reviewed your boosed above and we have determined the market the device fally equivalent (for the indications for use stated in the enclosure) to legally marketed predicate use stated in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to che chat 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 The general controls controls provisions of the Act. 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 be burfeer to bacting 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug edrough perion (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: {2}------------------------------------------------ Page 2 - Mr. Paluch this response to your premarket notification submission does Unis response to your promason wight have under sections 531 not arrect any obirgation for devices under the Electronic Chrough 542 Of the not 10- 10- 10regulations. This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your sist. I quivalence of your device to a legally Finding of Bubbeandaries results in a classification for your marketed predicate device robated in the 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 regulation (2) (2) devices) , please contact the Office of Compliance at (301) 594-4518. Additionally, for questions on ebmprianoc as (advertising of your device, please contact che Dromocron and adversee at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, Obtained From the Drisumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Indications For Use 510(k) Number (if known): K012157 Device Name: Churchill Medical Systems Stopcock Indications For Use: Churchill Medical Systems Stopcock is a valve for use in I.V. therapy and pressure monitoring to direct and control the flow of medical fluids. Patrua Cissente (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_K Concurrence of the CDRH, Office of Device Evaluation (ODE) Prescription Use_ Or Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________