SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)

{0}------------------------------------------------ Page 1 of 2 K072894 ### 510(k) SUMMARY as required by 807.92 Summary of Safety & Effectiveness Information #### 1. Device Name ## Proprietary Name SURFLO® Winged Infusion Set with Needle Protection (Surshield") Classification Name Intravascular Administration Set (80FPA) NOV 9 6 2007 21CFR, Section 880.5440 Classification: Class II #### 2. Reason for Submission This 510k is being submitted to extend the cleared Surflo Winged Infusion Set with Needle Protection (Surshield) (K052887) product line to include a 25 Gauge needle size taking into consideration the potential issues of safety and effectiveness specific for a smaller/thinner needle. This 510k will provide supporting information that the 25 Gauge Surflo Winged Infusion Set with Needle Protection (Surshield) design is safe and effective and an acceptable extension of the current cleared Surflo Winged Infusion Set with Needle Protection (Surshield) product line (K052887). #### 3. Intended Use The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick. Note: This is the same intended use as the predicate device, Surflo Winged Infusion Set with Needle Protection (Surshield), cleared under K052887. #### 4. Description The 25 Gauge Terumo Surflo Winged Infusion Set with Needle Protection (Surshield) is a sterile, single use device consisting of a needle attached to a winged hub, tubing, adapter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-to-wing junction. The shield cover can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto needle using a one- or twohanded technique. An audible click is noted upon activation. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needle stick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it. The device possesses 350 mm length tubing. {1}------------------------------------------------ Page 2 of 2 K072894 #### 5. Substantial Equivalence The 25G Surflo Winged Infusion Set with Needle Protection (Surshield), manufactured by Terumo Europe N.V., submitted in this 510(k) file is substantially equivalent in intended use, description/specifications, technology/principles of operation, materials and performance to the following cleared devices: - Surflo Winged Infusion Set with Needle Protection (Surshield) (K052887), manufactured by 1. Terumo Europe N.V. - 25G Surshield Safety Winged Infusion Set (K031266), manufactured by Terumo Medical 2. Products (Hangzhou), China Any differences between the devices do not raise any significant issues of safety and effectiveness. #### Additional Safety Information 6. The sterility of the Surflo Winged Infusion Set with Needle Protection (Surshield) is assured by using a validated sterilization method qualified in accordance with EN 550: "Sterilization of Medical Devices: Validation and routine control of ethylene oxide" and ISO 11135: "Medical Devices: Validation and routine control of ethylene oxide sterilization" to a sterility assurance level (SAL) of 10th as required by EN 556-1: "Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - 1: Requirements for terminally sterilized medical devices". Ethylene oxide residual levels resulting from EtO sterilization are in compliance with EN ISO 10993-7: " Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals" The 25 Gauge Surflo Winged Infusion Set with Needle Protection (Surshield) is an Externally Communicating device, Circulating Blood, Limited Exposure (24 hrs). The device's blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and testing". The expiration dating for the 25 Gauge Surflo Winged Infusion Set with Needle Protection (Surshield) has been established at 5 years which is the same as the cleared Surflo Winged Infusion Sets with Needle Protection (Surshield). {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces to the right. 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 NOV 0 6 2007 Mrs. M.J. Aerts Manager Regulatory Affairs Terumo Europe N.V. Researchpark Zone 2 Haasrode Interleuvenlaan 40 B-3001 Leuven BELGIUM Re: K072894 Trade/Device Name: Surflo® Winged Infusion Set with Needle Protection (Surshield") Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 03, 2007 Received: October 11, 2007 Dear Mrs. Aerts: 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 - Mrs. Aerts 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) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nil Rb. Qd. 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 (if known): K072894 Device Name: Surflo® Winged Infusion Set with Needle Protection (Surshield™) Indications for Use: The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the . peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: JC972894 Page ___ of __________________________________________________________________________________________________________________________________________________________________