Hospira Sapphire Sets

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and the future. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 6, 2016 Hospira, Inc. David Blonski Director Regulatory Affairs 375 North Field Drive Lake Forest, Illinois 60045 Re: K160492 Trade/Device Name: Hospira Sapphire Sets Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: December 1, 2016 Received: December 2, 2016 Dear David Blonski: 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. {1}------------------------------------------------ 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 of medical devicerelated adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". There is also a "-s" below the name. The signature is a stylized loop with a dot above it. Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K160492 Device Name Hospira Sapphire Set Indications for Use (Describe) Hospira Sapphire sets are indicated for the delivery of fluids from a container to a patient's vascular system. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the Hospira logo. The logo features the company name "Hospira" in a sans-serif font, with the "H" slightly larger than the other letters. Above the name is an abstract graphic consisting of three curved lines that converge at the top, resembling a stylized representation of a plant or a medical symbol. The logo is presented in grayscale. #### Section 5 510(k) Summary: K160492 A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 807.92 for Hospira Sapphire Sets. | Submitter Information | | |---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Hospira, Incorporated | | Address | D-393, Bldg. H3<br>375 North Field Drive<br>Lake Forest, IL. 60046 | | Phone number | 24-212-5010 | | Mobile number | 224-515-6807 | | Fax number | (224) 212-5401 | | Establishment Registration<br>Number | 3005579246 (Owner/Operator #9063339) | | Name of contact person | David Blonski, Director Regulatory Affairs | | Date prepared | 2/19/2016 | | Name of device | | | Trade or proprietary name | Hospira Sapphire Sets | | Common or usual name | Infusion pump accessory | | Classification name | Infusion Pump, 21 CFR 880.5725, Class II | | Product Code(s) | MRZ | | Legally marketed device(s) to which<br>equivalence is claimed | Q Core Medical Sapphire Sets - K123049 (Predicate 510(k))<br>Hospira Plum Sets - K141789 (reference 510(k) for technological characteristics)<br>Life Care PCA Infusion System - K043256 (reference 510(k) for technological characteristics) | | Reason for 510(k) submission | New IV administration sets to be used with Q Core Medical Ltd.'s Sapphire Infusion System. | | Device description | Hospira Sapphire Sets are intended for use with the Sapphire Infusion System. Hospira<br>Sapphire sets are comprised of various components including the following: male luer adapter<br>with cap, female luer with cap, piercing pin connector, sapphire cassette, tubing, flow control<br>device, in-line adapter, injection site assembly, check valve, and burette chamber. Hospira<br>Sapphire sets are configured to ensure the intended use of the device is met. The sets are<br>disposable devices for single patient use. | | Intended Use of Device | Hospira Sapphire sets are intended for use with the Sapphire Infusion System to deliver fluids<br>from a container to a patient's vascular system. Hospira Sapphire Sets are indicated for the<br>delivery of fluids from a container to a patient's vascular system. | | Indication for use | Hospira Sapphire Sets are indicated for the delivery of fluids from a container to a patient's<br>vascular system. | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the Hospira logo. The logo features the company name "Hospira" in a sans-serif font, with the "H" slightly larger than the other letters. Above the name is an abstract graphic consisting of three curved lines converging at the top, resembling a stylized plant or a modern architectural element. The logo is presented in grayscale. | Summary of the technological characteristics of the device compared to the predicate device | | | |---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | Predicate | Proposed Device | | Indications for Use | The Q Core Sapphire infusion pump is<br>intended for the controlled delivery through<br>intravascular,<br>subcutaneous, intra-arterial and epidural<br>routes. The pump is designed to deliver<br>saline, Total Parenteral<br>Nutrition, lipids, IV medication, epidural<br>medication, blood and blood products.<br>The Sapphire pump includes the following<br>infusion modes for all intended uses:<br>Continuous, Intermittent,<br>TPN, PCA, Multi-step, and Epidural.<br>The pump is intended to be used by both<br>licensed health care professionals in a<br>clinical environment, and<br>home users in an ambulatory environment.<br>The Sapphire pump is designed to follow the<br>patient through<br>the various care areas, and in pre-hospital<br>medical ground transportation.<br>The dedicated Q Core administration sets for<br>the Sapphire pump are intended for single-<br>patient use and<br>single-use only. | Hospira Sapphire Sets are indicated for the<br>delivery of fluids from a container to a<br>patient's vascular system. | | Discussion of change in<br>indication for use | The differences between the predicate and proposed indications for use stated above are not<br>critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the proposed<br>device. The predicate indication for use stated above is primarily related to use of the<br>Sapphire Infusion pump with an inclusionary statement that the Q Core administration sets<br>for the Sapphire pump are intended for single-patient use and single-use only. The Hospira<br>Sapphire sets are intended for use with the Sapphire pump and as such are a component of<br>the predicate device system. The proposed sets are also intended for single patient use and<br>single-use only. The proposed Hospira Sapphire sets have the same intended use, and as<br>indicated below are tested to the same performance standards as the predicate sets and<br>therefore do not affect the safety and effectiveness predicate device system. | | | Design and Materials of<br>Construction | The design and materials of construction of<br>all components for the set, with the<br>exception of the Sapphire Cassette, are as<br>cleared under the 510(k)s K141789 and<br>K043256 which are reference 510(k)s for<br>technological characteristics.<br>The design and materials of construction of<br>the Sapphire Cassette are as cleared under<br>the predicate Q Core Medical Ltd. 510(k)<br>K123049. | The design and materials of construction for<br>all components of the sets remain the same<br>as the predicate product. | | Summary of non-clinical tests<br>for determination of substantial<br>equivalence | All materials of construction for Hospira<br>Sapphire Sets meet the applicable material<br>test requirements for ISO 10993 as<br>demonstrated in the predicate 510(k)s. | All materials of construction for Hospira<br>Sapphire Sets remain the same as the<br>predicate product. Additional data has been<br>generated demonstrating that Hospira<br>Sapphire sets, which are comprised of a<br>combination of Hospira IV set components<br>with the Sapphire Cassette, meet the<br>applicable material test requirements for<br>ISO 10993 as follows: | | | | <b>ISO Standard Biological Effect</b><br>10993-4                Hemocompatibility<br>10993-5                Cytotoxicity<br>10993-10               Sensitization<br>10993-11               Intracutaneous Irritation<br>Systemic Toxicity<br>Subacute Toxicity<br>Pyrogenicity | | | Performance testing for all Hospira Sapphire<br>set components, with the exception of the<br>Sapphire Cassette, was conducted as<br>indicated in the predicate 510(k)s to ensure<br>the device performs as intended in<br>accordance with applicable standards. All<br>testing is acceptable.<br><br>Performance testing for the Q Core Medical<br>Ltd. Sapphire Cassette , was conducted as<br>indicated in the predicate 510(k) to ensure<br>the cassette performs with the Sapphire<br>Pump as intended in accordance with<br>applicable standards.<br><br>All testing is acceptable. | New performance data has been generated<br>to ensure the Hospira Sapphire Sets, a<br>combination of Hospira IV set components<br>with the Sapphire Cassette, perform as<br>intended in accordance with:<br>ISO 8536-4, 6.1 Particulate Contamination<br>ISO 8536-4, 6.2 Leakage<br>ISO 8536-4, 6.3 Tensile Strength<br>ISO 1135-4, 5.3 Tensile Strength<br><br>Additionally, flow rate accuracy testing<br>using the proposed Hospira Sapphire Sets<br>and the Sapphire Infusion System has been<br>conducted.<br><br>All testing is acceptable.<br><br>The product Sterility Assurance Level | | | The product Sterility Assurance Level is 10-6 | is 10-6 | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the Hospira logo. The logo features the company name "Hospira" in a sans-serif font, with the "H" slightly larger than the other letters. Above the name is an abstract graphic consisting of three curved lines that converge at the bottom and spread out at the top, resembling stylized blades of grass or a stylized flower. The logo is presented in grayscale. # Conclusion Hospira Sapphire Sets meet the functional claims and intended use as described in the product labeling. Hospira Sapphire Sets are substantially equivalent to the predicate device.