JMS PLANECTA STOPCOCK

{0}------------------------------------------------ K070143 Page 1 of 2 # 510(k) Summary of Safety and Effectiveness #### Manufacturer and contact Information 1. APR 1 0 2007 - 1.1 Manufacturer JMS Co., Ltd. 12-17 Kako-Machi, Naka-Ku Hiroshima, Japan 1.2 Sponsor JMS North America Corperation 22320 Foothill Blvd., Suite 350 Hayward, CA 94541 USA #### 1.3 Contact Information Swee Cheau, Chong Manager of RA & QA JMS North America Corporation 22320 Foothill Blvd., Suite 350 Hayward, CA 94541 Telephone: (510) 888-9090 Fax: (510) 888-9099 #### 2. Device Name Common / Usual Name: PN Stopcock (PNSC) Proprietary / Trade Name: JMS Planecta® Stopcock Classification Name: Stopcocks, I.V. Sets Panel : General Hospital Product Code : FMG Regulation : 21 CFR 880.5440 #### 3. Device Intended use JMS Planecta® Stopcock (PNSC) is indicated for fluid flow directional control and for providing access port(s) for administration of solutions, withdrawal of fluids and pressure monitoring. JMS Planecta® Stopcock can be used by itself, or as component to administration/extension set, and aids in the prevention of needle stick injuries #### Predicate Device Name 4. JMS Planecta® device (510(k) 023668) is used as the predicate device because of the identical needleless access port design. Ohmeda Inc.'s Connecta® Plus 1 and Connecta® Plus 3 3-way Stopcock (510(k) 974083) is used to compare the characteristics and performance of three-way stopcocks. JMS Planecta® Stopcock is substantially equivalent to the following predicate devices which are legally marketed with desired intended use, design, safety and effectiveness: {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the text "K070143 Page 2 of 2" written in cursive. The text appears to be handwritten, with a slightly uneven and flowing style. The phrase "Page 2 of 2" indicates that this is the second page of a document. ### Table A: Comparison Matrix | Classification Name: | Stopcock, I.V.<br>Sets | Intravascular Administration Set | | |---------------------------|---------------------------|----------------------------------|-------------------------------| | Device Type | Intended Device | Predicate Device | | | 510(k) Number | - | K023668 | K974083 | | Proprietary Name: | JMS Planecta®<br>Stopcock | JMS Planecta® | Connecta Plus 3-way Stopcocks | | Device<br>Classification: | 21 CFR 880.5540 | 21 CFR 880.5540 | 21 CFR 880.5540 | | Classification: | Class II | Class II | Class II | | Device Panel Code: | 80 | 80 | 80 | | Device Product<br>Code: | FMG | FPA | FMG | #### ട്. Device Description The JMS Planecta® Stopcock is a disposable device for one time use. The device consists of a body with integrated female and male connector at extreme ends, a handle (either 1-bar or 3-bar types), pre-slit septum, access port cap and a rotatable lock nut for locking over the female connector of another component. The device contains three channels for fluid flow. The handle/swivel nut contains two independent passageways. A fluid pathway can be achieved by rotating the handle to one of the three channels. There are 'arrow' marks on the handle of 3-bar type and 'OFF' indication on the 1-bar handle to indicate the 'open' and 'closed' position of fluid path, respectively. JMS Planecta® Stopcock, incorporated with an injection/sampling port accessible with a needleless syringe or regular male connector. JMS Planecta® Stopcock keeps the system closed and the minimal dead space at the access port reduces the chances of bacteremia caused by bacterial proliferation. Contamination by environmental microbes is also reduced by the resealability characteristics of the pre-slit rubber septum. #### 6. Technological Characteristics and Substantial Equivalence The configurations, labeling, packaging, materials and mode of sterilizations of the JMS Planecta® Stopcock are similar to legally marketed predicate devices and are used for fluid flow directional control and for providing access port(s) for administration of solutions. The intended device and all other predicate devices are labeled sterile, nonpyrogenic and for single use only. JMS Planecta® Stopcock demonstrates substantial equivalence to the said predicate devices with regards to intended use, material, biocompatibility, and overall performance characteristics. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Swee Cheau, Chong Manager of Regulatory Affairs & Quality Assurance JMS North America Corporation 22320 Foothill Boulevard, Suite 350 Hayward, California 94541 APR 1 0 2007 Re: K070143 Trade/Device Name: JMS Planecta® Stopcock (PNSC) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: January 12, 2007 Received: January 16, 2007 Dear Mr. Chong: 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. {3}------------------------------------------------ Page 2 - Ms. Chong 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 (QS) 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) 276-0115. 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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Clair Liu, 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 {4}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT 510(K) Number: K070143 Device Name : JMS Planecta® Stopcock (PNSC) Indications For Use: ، JMS Planecta® Stopcock (PNSC) is indicated for fluid flow directional control and for providing access port(s) for administration of solutions, withdrawal of fluids and pressure monitoring. JMS Planecta® Stopcock can be used by itself, or as component to administration/extension set, and aids in the prevention of needle stick injuries. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR Section 801.109) con Contics, Devices Nuraber K47014). 005_p1