HOSPIRA INFUSION BLOOD SETS

{0}------------------------------------------------ Hospira Infusion Blood Sets K101677 ## 510(k) SUMMARY - B A summary of 510(k) safety and effectiveness information in accordation with the requirements of 21 CFR 807.92. | Submitter Information [21 CFR 807.929(a)(1)] | | |-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Hospira Incorporated | | Address | D-389, Bldg H2, 375 N. Field Drive, Lake Forest, Illinois 60045 | | Phone number | 224-212-5316 | | Fax number | 224-212-5401 | | Establishment Registration<br>Number | 9063339 | | Name of contact person | Karen Keener | | Date prepared | July 20, 2010 | | Name of the device [21 CFR 807.92(a)(2)] | | | Trade or proprietary name | Hospira PVC Infusion Blood Set | | Common or usual name | Fluid delivery tubing | | Classification name | Sets, Administration, Intravascular | | Classification panel | General Hospital | | Regulation | 880.5440 | | Product Code(s) | FPA | | Legally marketed device(s)<br>to which equivalence is<br>claimed [21 CFR<br>807.92(a)(3)] | Hospira Infusion Blood sets utilize components from various Hospira<br>Infusion set families; including but not limited to:<br>Lifeshield Latex-Free Veniloop Connector with Prepierced Injection<br>Site, Non-DEHP (K063239)<br>Lifeshield Latex-Free Plum Non-Vented Blood set (K030002)<br>HEMA Y-Type Transfusion Blood Filter Pump Set 100 Inch-SL with<br>Prepierced Reseals (Latex-Free) (K780880) | | Reason for 510(k)<br>submission | To offer a non-DEHP PVC alternative Infusion set with a manual<br>blood pump. | | Device description<br>[21 CFR 807.92(a)(4)] | The Hospira PVC Infusion Blood Sets with/without the Manual blood<br>pump consists of Non-DEHP PVC tubing and components previously<br>cleared in Hospira 510k's. The change addressed in this submission,<br>is the material used to construct the cylindrical blood pump. The<br>modified design incorporates a ball check valve previously used in<br>the bulb style manual blood pump. Other changes include minor<br>dimensional and geometric changes. | | Intended use of the device<br>[21 CFR 807.92(a)(5)] | Hospira infusion sets are intended for the delivery of fluids, including<br>but not limited to, blood and blood products, from a container to a<br>patient's vascular system. | {1}------------------------------------------------ #### Hospira Infusion Blood Sets K101677 Attachment 2 | Performance Data [21 CFR 807.92(b)] | | | | |---------------------------------------------------------------------------------------------------------------|----------------------|-----------------------------------------------------------------------------------------------------------|--------------------| | Summary of non-clinical tests conducted for determination of substantial equivalence<br>[21 CFR 807.92(b)(1)] | | | | | Performance Test Summary-New Device | | | | | Characteristic | Standard/Test Method | Standard / Test Title | Device Performance | | Biocompatibility | ISO 10993-5: 2009 | Cytotoxicity | Pass | | Biocompatibility | ISO 10993-10: 2002 | Sensitization | Pass | | Biocompatibility | ISO 10993-10: 2002 | Irritation /<br>Intracutaneous<br>Reactivity | Pass | | Biocompatibility | ISO 10993-11:2006 | Systemic Toxicity<br>(Acute) | Pass | | Biocompatibility | ISO 10993-4:2002 | Hemocompatibility | Pass | | SAL 10-6 | ISO 11137-2:2006 | Sterility | Pass | | Packaging | ISO 1135-4:2004 | Transfusion<br>Equipment for<br>Medical Use | Pass | | Particulate | | | | | Bond Strength | | | | | Piercing function | | | | | Flow characteristics | | | | | Specific Required<br>Physical Characteristics | | | | | Gravity Set<br>Characteristics | 8536-4:2004 | Infusion<br>Equipment for<br>Medical Use; Part<br>4. | Pass | | Dimensional<br>Conformance<br>and<br>Connection compatibility | ISO 594-2 | Conical Fittings<br>with a 6% (Luer)<br>Taper for syringes,<br>needles, and<br>certain other<br>equipment | Pass | Summary Discussion of Bench Performance Data The Hospira Blood administration sets with 200-micron filter and Non-DEHP PVC manual blood pump passed all specified test requirements. The validation and verification testing confirmed product meets user needs and design inputs for an administration set containing a manual blood pump. Testing also confirmed physical attributes and device performance meet requirements of the standards listed in the 'Performance test summary" above. These standards address sterility, biocompatibility, particulate, leakage, tensile strength, filter characteristics, drip tube performance, flow control, and simulated actual conditions of use. {2}------------------------------------------------ # K101677 #### Hospira Infusion Blood Sets K101677 #### Attachment 2 Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)] Not required. Bench testing can adequately address the safety and efficacy of this product. Statement of Safety and Efficacy [21 CFR 807.92] The Hospira Infusion Blood Sets with/without Manual Blood Pump meet the functional claims, and intended use as described in the product labeling. The safety and effectiveness are equivalent to the predicate Hospira Administration Blood Sets with Manual Blood Pump. The claim for substantial equivalence is supported by the information provided in the 510(k) submission. {3}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993=0002 Ms. Karen Keener Global Regulatory Associate Hospira, Incorporated 375 North Field Drive Lake Forest, Illinois 60045 Re: K101677 Trade/Device Name: Hospira Infusion Blood Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 29, 2010 Received: July 30, 2010 AUG11 2010 Dear Ms. Keener: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Keener 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance, 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours Susan Dunne Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology; General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Section 5: # 510(k) Number (if known) K IO| 6 7 7 Device Name: Hospira Infusion Blood Sets Indications for Use: Hospira Administration sets are intended for the delivery of fluids including but not limited to blood and blood products from a container into a patients vascular system. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over –The- Counter Use {Part 21 CFR *)& Subpart C) (Please do not write below this line – continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K101677 Section 5: Indications for use Page 1 of 1