PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set

{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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 18, 2016 Darlene Hull Regulatory Affairs Specialist C.R. Bard, Inc. 605 North 5600 West Salt Lake City, Utah 84116 Re: K153440 Trade/Device Name: PowerLoc Max® Power-Injectable Infusion Set, SafeStep® Huber Needle Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: July 19, 2016 Received: July 20, 2016 Dear Darlene Hull: 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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, # Michael J. Ryan -S for 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}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K153440 Device Name PowerLoc MAX® Power-Injectable Infusion Set #### Indications for Use The PowerLoc MAX® Power-Injectable Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle is used to access surgically implanted vascular ports. The PowerLoc MAX® Power-Iniectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc MAX® Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 qauge and 20 gauge needles, and 2 ml/s for 22 gauge needles. 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) 区 # 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." | FORM FDA 3881 (8/14) | Page 1 of 1 | PSC | |------------------------------------|-------------|-----| | Publishing Services (301) 443-6740 | EF | | Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31. 2017 See PRA Statement below. 510(k) Number (if known) K153440 Device Name SafeStep® Huber Needle Set Indications for Use The SafeStep® Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids into the port. The SafeStep® Huber Needle safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlesticks. Type of Use (Select one or both, as applicable) 区 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." | FORM FDA 3881 (8/14) | |------------------------------------| | Publishing Services (301) 443-6740 | Page 1 of 1 PSC {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font. Below that, in a smaller font, are the words "ACCESS SYSTEMS". # 510(k) Summary 21 CFR § 807.92(a) | General<br>Provisions | Submitter Name:<br>Address: | Bard Access Systems, Inc.<br>605 North 5600 West<br>Salt Lake City, UT 84116 | |-----------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Contact Person:<br>Telephone Number:<br>Fax Number:<br>Date of Preparation: | Darlene Hull<br>Regulatory Affairs Specialist<br>(801) 522-5613<br>(801) 522-5425<br>23 November 2015 | | Subject<br>Devices | Trade Name:<br>Common Name:<br>Classification Name:<br>Product Code/<br>Regulation: | PowerLoc MAX® Power-Injectable Infusion Set<br>Huber Needle Intravascular Administration Set<br>Intravascular Administration Set<br>FPA<br>21 CFR § 880.5440 | | | Trade Name:<br>Common Name:<br>Classification Name:<br>Product Code/<br>Regulation: | SafeStep® Huber Needle Set<br>Huber Needle Intravascular Administration Set<br>Intravascular Administration Set<br>FPA<br>21 CFR § 880.5440 | | Predicate<br>Devices | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | SafeStep® MAX Power-Injectable Infusion Set<br>Intravascular Administration Set<br>K073050<br>Bard Access Systems, Inc. | | | Trade Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer: | Luther Safety Huber Needle Set<br>Intravascular Administration Set<br>K040527<br>Bard Access Systems, Inc. | {5}------------------------------------------------ | | PowerLoc MAX® Power-Injectable Infusion Set | | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | The PowerLoc MAX® Power-Injectable Infusion Set is a standard non-<br>coring intravascular administration set with a non-coring Huber type<br>right angle needle and a manually activated needle-stick prevention<br>safety mechanism which reduces the risk of accidental needlestick<br>injuries by shielding the needle. The device is used to access<br>surgically implanted vascular ports and is indicated for use in the<br>administration of fluids and drugs, as well as blood sampling. | | | | The PowerLoc MAX® Power-Injectable Infusion Set is also indicated<br>for power injection of contrast media into the central venous system<br>only through an implanted port that is also indicated for power<br>injection. The maximum recommended infusion rate at 11.8 cPs is 5<br>ml/s for 19 gauge and 20 gauge needles and 2 ml/s for 22 gauge<br>needles. The PowerLoc MAX® Power-Injectable Infusion Set is<br>offered with and without a Y-site. | | | Device<br>Descriptions | SafeStep® Huber Needle Set | | | | The SafeStep® Huber Needle Set is a standard right angle Huber<br>needle and administration set with a needlestick prevention feature,<br>designed for use with a vascular access infusion system. It is<br>manufactured with conventional medical grade, biocompatible<br>materials. The SafeStep® Huber Needle Set operates as a standard<br>Huber needle with the addition of a safety feature to aid in the<br>prevention of needlestick injuries to the health practitioner. The<br>SafeStep® Huber Needle Set is offered with and without a Y-site. | | | | Stabilization Device | | | | The stabilization device is intended for use as an accessory to the<br>subject PowerLoc MAX® and SafeStep® infusion sets, and is supplied<br>pre-loaded with the subject devices. It is placed centrally over the<br>implanted port so that the base surrounds the implanted port under the<br>skin. The infusion set needle handle is pressed down until the needle<br>has entered the port septum, then the stabilization device is lifted off of<br>the needle. The stabilization device is then discarded per hospital<br>protocol. | | | Intended Use | Both the subject PowerLoc MAX® Power-Injectable Infusion Set and<br>SafeStep® Huber Needle Sets, with and without the stabilization<br>device, are intended for use in the administration of fluids and drugs,<br>as well as blood sampling through surgically implanted vascular ports. | | | Indications For<br>Use | PowerLoc MAX® Power-Injectable Infusion Set | | | | The PowerLoc MAX® Power-Injectable Infusion Set is an intravascular<br>administration set with a non-coring right angle needle and manually<br>activated needle stick prevention safety mechanism which reduces the<br>risk of accidental needlestick injuries by shielding the needle. The | | | | needle is used to access surgically implanted vascular ports. | | | | The PowerLoc MAX® Power-Injectable Infusion Set is indicated for<br>use in the administration of fluids and drugs, as well as blood sampling<br>through surgically implanted vascular ports. | | | | When used with ports that are indicated for power injection of contrast<br>media into the central venous system, the PowerLoc MAX® Power-<br>Injectable Infusion Set is also indicated for power injection of contrast<br>media. For power injection of contrast media, the maximum<br>recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20<br>gauge needles, and 2 ml/s for 22 gauge needles. | | | | SafeStep® Huber Needle Set | | | | The SafeStep® Huber Needle Set is a device intended for insertion<br>into the septum of a subcutaneously implanted port and for the infusion<br>of fluids into the port. The SafeStep® Huber Needle safety feature is<br>manually activated during needle removal, and is designed to aid in the<br>prevention of accidental needlesticks. | | | Technological<br>Characteristics | Technological characteristics including design and function of the<br>subject devices, the PowerLoc MAX® Power-Injectable Infusion Set<br>and SafeStep® Huber Needle Set without stabilization device, are<br>similar with respect to those of the predicate devices, SafeStep® MAX<br>Power-Injectable Infusion Set and Luther Safety Huber Needle Set. | | | | The subject devices may be used with a pre-loaded stabilization device<br>accessory that is intended to stabilize the port during access and aid<br>insertion of the needle into the port. The stabilization device utilizes<br>materials that are a different formulation than materials used in the<br>predicate devices, and have not been used in another legally marketed<br>device within the same classification regulation with the same intended<br>use. The stabilization device constitutes a change to the ergonomics of<br>the patient/user interface of the subject devices, but does not change<br>the design or function of the subject devices when used as an<br>accessory to these devices. | | | Performance<br>Tests | Verification and validation tests were performed in accordance with<br>Design Controls per 21 CFR §820.30. The following performance data<br>were referenced in support of the substantial equivalence<br>determination. Testing was performed based on Bard Access Systems<br>(BAS) internal test protocols as well as on existing standards that are<br>relevant to the subject devices. | | | | Testing performed based on BAS internal test protocols are as follows: | | | | Slide Force testing was performed to ensure that the force<br>required to slide the needle down the length of the stabilization<br>device did not exceed the force required to insert the needle in | | {6}------------------------------------------------ {7}------------------------------------------------ | the port septum.<br>Stabilization Device Removal Force testing was performed to<br>ensure that it was not difficult to remove the stabilization device<br>once the subject needle was inserted into the port.<br>Acceptability of the Stabilization Device to verify that the | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | stabilization device was clinically acceptable in the placement<br>of a port access needle. | | | Acceptability of GuardIVa® with Stabilization Device to<br>validate the use as directed in the IFU of the antimicrobial<br>dressing with the stabilization device. | | | In addition to BAS internal protocols, the following guidance<br>documents and standards were used to determine appropriate<br>methods for evaluating the performance of the device: | | | • ISO 23908 First edition 2011-06-11 Sharps injury protection -<br>Requirements and test methods - Sharps protection features for<br>single-use hypodermic needles, introducers for catheters and<br>needles used for blood sampling | | | • ISO 8536-4 Fifth edition 2010-10-01 Infusion equipment for<br>medical use - Part 4: Infusion sets for single use, gravity feed<br>[Including: Amendment 1 (2013)]10. | | | • BS EN ISO 8536-10:2015 Infusion equipment for medical use -<br>Part 10: Accessories for fluid lines for single use with pressure<br>infusion equipment. | | | • ISO 10993-1 Fourth edition, 2009-10-15 - Biological Evaluation<br>of Medical Devices Part 1: Evaluation and Testing within a risk<br>management process. | | | • ISO 10993-7: 2008 - Biological evaluation of medical devices -<br>Part 7: Ethylene oxide sterilization residuals. | | | • ISO 11135: 1994 - Medical Devices - Validation and Routine<br>Control of Ethylene Oxide Sterilization. | | | • BS EN ISO 11607-1 Packaging for terminally sterilized medical<br>devices Part 1: Requirements for materials, sterile barrier<br>systems and packaging systems. | | | • ISO 594-1: 1986, Conical Fittings with a 6% (Luer) Taper for<br>Syringes, Needles, and Certain Other Equipment. | | | • ISO 594-2: 1998, Conical Fittings with a 6% (Luer) Taper for<br>Syringes, Needles and Certain Other Medical Equipment - Part<br>2: Lock Fittings. | | | • ISO 9626 AMD 1: 2001 - Stainless Steel Needle Tubing for<br>Manufacture of Medical Devices. | | | • ISO 10555-1: 2013 – Intravascular catheters – Sterile and | | | | single-use catheters – Part 1: General requirements.<br>• ISO 11137-1: 2006 – Sterilization of health care products –<br>Radiation - Part 1: Requirements for development, validation<br>and routine control of a sterilization process for medical<br>devices. | | | • ISO 7864: 1993 – Sterile hypodermic needles for single use. | | | • FDA Guidance Medical Devices with Sharps Injury Prevention<br>Features issued August 9, 2005. | | | • FDA Guidance Establishing Safety and Compatibility of Passive<br>Implants in the Magnetic Resonance (MR) Environment issued<br>December 11, 2014. | | | The subject devices met all predetermined acceptance criteria derived<br>from the above listed references and demonstrated substantially<br>equivalent performance as compared to the cited predicate devices. | | | Risk management, including a failure modes and effects analysis<br>(FMEA), of the subject device was conducted in accordance with BS<br>EN ISO 14971:2012, Medical Devices – Risk Management for Medical<br>Devices. | | Summary of<br>Substantial<br>Equivalence | Based on the intended use, technological characteristics, and safety<br>and performance testing, the subject PowerLoc MAX® Power-<br>Injectable Infusion Set and SafeStep® Huber Needle Set used with<br>and without the stabilization device meet the requirements that are<br>considered sufficient for its intended use as compared to the predicate<br>devices cited. Therefore, the subject devices are substantially<br>equivalent to the predicates. | {8}------------------------------------------------