Universal Spike

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 2, 2015 B. Braun Medical, Inc. Ms. Tracy Maddock Senior Regulatory Affairs Specialist 901 Marcon Boulevard Allentown, Pennsylvania 18109 Re: K150787 Trade/Device Name: Universal Spike Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: October 28, 2015 Received: October 29, 2015 Dear Ms. Maddock: 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}------------------------------------------------ Page 2 - Ms. Tracy Maddock. 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K150787 Device Name Universal Spike Indications for Use (Describe) For the transfer of solutions from one container to another. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED, #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. {3}------------------------------------------------ D Bruun Medical Inc. STOtk) Premarket Notification l'inversal Spike | 5. | 510(k) Summary | K150787 | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>610-266-0500<br><br>Contact: Tracy Maddock, RAC<br>Sr. Regulatory Affairs Specialist<br>Phone: (610) 596-2545<br>Fax: (610) 266-4962<br>E-mail: Tracy.Maddock@bbraun.com | | | DATE: | December 2, 2015 | | | DEVICE NAME: | Universal Spike | | | COMMON OR<br>USUAL NAME: | IV Fluid Transfer Set | | | DEVICE<br>CLASSIFICATION: | Class II per 21 CFR 880.5440<br>Intravascular Administration Set, product code LHI<br>Classification Panel: General Hospital | | | PREDICATE DEVICES: | B. Braun Dispensing Pin with One-Way Valve, K943181 | | ## DESCRIPTION: The B. Braun Universal Spike is a sterile, single use, disposable fluid transfer device consisting of a closure-piercing component capable of piercing and penetrating the closure of a fluid container, an air-inlet component which allows the dispensing from both rigid and pressure collapsible dispensing containers, and a distal female luer lock adapter which provides access for the attachment of a syringe or fluid transfer set. The closure-piercing component and luer lock adapter are covered by protective caps which prevent contamination of the device until its point of use. ## INTENDED USE INDICATIONS FOR USE: For the transfer of solutions from one container to another. {4}------------------------------------------------ A Brunin Medical Inc. 519(k) Premarket Notification l'niversal Spike # SUBSTANTIAL EQUIVALENCE: The Universal Spike is substantially equivalent to the B. Braun Dispensing Pin with One-Way Valve (K943181). ## Comparison of Technological Characteristics with the Predicate Device The proposed device has the same intended use and the same or similar technological characteristics as the predicate device. The proposed spike is similar in design, having the same type of components such as a piercing component with protective cap, an air inlet and a distal luer lock adapter with cap as the predicate device. These components are also constructed of similar materials. Both devices are provided as sterile packaged devices sterilized by ethylene oxide for single use. A table summarizing the comparison between the Universal Spike and the predicate device is provided below. | Characteristic | Predicate Device - K943181<br>Dispensing Pin with One-Way<br>Valve | Proposed<br>Universal Spike | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Intended for the transfer of solutions<br>from one container to another | For the transfer of solutions from one<br>container to another | | Components | Vented or non-vented spike with or<br>without air filter and distal female<br>luer lock hub (can be attached to<br>syringe or IV fluid transfer set) | Vented spike with air inlet filter and<br>distal female luer lock connector (can<br>be attached to syringe or fluid transfer<br>set) | | Materials of<br>construction | Spike Guard – LDPE | Spike Cap - LDPE | | | Piercing Device - ABS | Spike Body - ABS | | | Air Inlet<br>Housing - Polypropylene<br>Filter - Pallflex | Air Inlet<br>Housing - Polypropylene<br>Filter -3 micron membrane | | | Female Luer Lock - Polycarbonate | Female Luer Lock - ABS | | | Female Luer Lock Cap - HDPE | Female Luer Lock cap –<br>Polypropylene | | | Back Check Valve<br>Housing Top and Bottom -<br>Polycarbonate | N/A | | | Punched Disk - Silicone | | | | | | | Configurations | • Normal sized spike or lower<br>volume, mini spike<br>• Air-inlet vents or non-vented | • Normal sized spike<br>• Air inlet filter | | Sterilization<br>Method | Ethylene oxide | Ethylene oxide | - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - {5}------------------------------------------------ B. Brunn Medical Inc. 510fk) Premarket Nortfication I 'niversal Spike ## Performance Testing The proposed Universal Spike was subjected to functional and performance testing to demonstrate that the device performs as intended. The following testing was performed on the subject device to the performance criteria listed or included in the referenced standard: - . Chemical Analysis (ISO 8536-4, ISO 10993-18) - Visual Control (ISO 22413, ISO 8536) . - . Fragmentation Test (ISO 22413) - . Penetration Force (ISO 8536-2) - Spike retention / seal ability (ISO 8536-2) � - . Patency Test (ISO 8536-4) - Pressure Test / Leakage (no leakage shall be detected when device is subjected to air . pressure of 450 mmHg) - Pull Test (cap and spike must withstand a minimum tensile force of separation between 4,41- 44.13 Newtons - Free Flow (ISO 22413) . - Particulate Contamination (USP <788>) � - Luer testing (ISO 594-1) - Biocompatibility (ISO 10993-1) - Cytotoxicity (MEM Elution, ISO 10993-5) 0 - 0 Delayed-type hypersensitivity (Guinea Pig Maximization, ISO 10993-10) - Intracutaneous Reactivity (ISO 10993-10) 0 - Acute Systemic Toxicity (ISO 10993-11) 0 - Hemocompatibility (Hemolysis, ASTM F756, ISO 10993-4) 0 - Material-Mediated Pyrogenicity (Rabbit Pyrogen, USP <151>, ISO 10993-11) 0 No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device. # CONCLUSION: Results of functional and performance testing conducted on the proposed device demonstrate that the Universal Spike is substantially equivalent to the predicate device.